Tryp Therapeutics Inc. Announces Signing of Definitive Agreement with Exopharm Limited

, 12/11/2023 / 04:00, EST/EDT – EQS Newswire – Tryp Therapeutics Inc. (Regulated Unofficial Market in Berlin, Frankfurt, Munich, Stuttgart, Tradegate Exchange; Canadian Stock Exchange, Nasdaq OTC)

KELOWNA, BC / ACCESSWIRE / December 11, 2023 / Tryp Therapeutics Inc. (“Tryp” or the “Company“) (CSE:TRYP), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs, is pleased to announce that the Company has entered into an arrangement agreement (the “Arrangement Agreement“) with Exopharm Limited ACN 163 765 991 (“Exopharm” or the “Purchaser“) dated as of December 8, 2023, pursuant to which Exopharm has agreed to acquire all of the issued and outstanding common shares in the capital of Tryp (the “Tryp Shares“) in consideration of the issuance of 4.52 ordinary shares in the capital of Exopharm (the “Exopharm Shares“) for each one (1) Tryp Share. The arm’s length transaction will be completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) (the “Arrangement“).

Key Transaction Highlights

  • The purchase price of CAD$0.08 represents a 78% premium to the closing price of $0.045 and a 112% premium to the 20-day volume weighted price of $0.0378 per Tryp Share on December 8, 2023
  • Tryp shareholders expected to receive 4.52 Exopharm Shares for each one (1) Tryp Share held, representing an aggregate transaction value of approximately $12.8 million.
  • Both the Board and the Special Committee unanimously recommend that Tryp securityholders vote in favor of the Arrangement.
  • The majority of the directors of the combined entity to be appointed by Tryp.
  • Tryp’s clinical programs and development strategy will remain as the foundation of the combined entity.
  • The combined entity is expected to relist on the Australian Securities Exchange (the “ASX“) in Q1 2024 subject to, among other conditions, receipt of the requisite approval of Exopharm shareholders and raising a minimum of AUD$6,000,000 under a public offering.
  • The Arrangement is subject to customary closing conditions, including approvals from Tryp securityholders and Exopharm shareholders, from the ASX and the Supreme Court of British Columbia (the “Court“).

Jason Carroll, Chief Executive officer of Tryp, said “joining forces with Exopharm heralds a new era for Tryp, where we expect our combined strength and shared vision to elevate us to the prominent platform of the ASX. With enhanced access to capital and the evolving landscape of the Therapeutic Goods Administration (TGA) regulations in Australia for select psychedelics, we see even more paths forward to innovate and grow. I am thrilled to emphasize that our ongoing clinical commitments and our TRP-8803 R&D program remain unchanged and will be pursued with the same vigor and dedication. It is not expected that Exopharm’s current R&D program will be pursued following completion of the transaction. With this merger, we’re even better positioned to serve our stakeholders.”

The Arrangement Agreement is the culmination of an extensive and robust review of strategic alternatives available to maximize shareholder value that was conducted by the Company’s board of directors (the “Board“) and a special committee of the Board (the “Special Committee“).

Pursuant to the terms and conditions of the Arrangement Agreement, Exopharm has agreed to acquire 100% of the issued and outstanding Tryp Shares in consideration of 4.52 Exopharm Shares per one (1) Tryp Share. The consideration reflects a 78% premium to the closing price of the Shares on the Canadian Securities Exchange (the “CSE“) of $0.045 on December 8, 2023, the last trading day of the Tryp Shares prior to the announcement of the Arrangement. Pursuant to the Arrangement Agreement, holders of convertible securities of Tryp, including stock options, common share purchase warrants, secured convertible debentures and unsecured convertible notes (collectively, the “Tryp Convertible Securities“) will receive replacement securities of Exopharm having substantially similar economic terms in accordance with the rules of the ASX.

The Board, after receiving the recommendation of the Special Committee, has determined that the Arrangement, including the transactions contemplated thereunder, is fair to holders of Tryp securities and is in the best interests of the Company. Accordingly, the Board approved the Arrangement Agreement and recommends that securityholders vote their securities in favour of the Arrangement.

Each of the directors and executive officers of Tryp have entered into voting and support agreements with the Purchaser and have agreed to, among other things, vote their securities in favour of the Arrangement.

The Arrangement Agreement

Pursuant to the Arrangement, each Tryp Share outstanding immediately prior to the effective time of the Arrangement will be transferred to and purchased by the Purchaser in consideration of 4.52 Exopharm Shares and each Tryp Convertible Security outstanding immediately prior to the effective time of the Arrangement will be exchanged for securities of Exopharm having substantially similar economic terms, in accordance with the rules of the ASX.

The Arrangement is subject to a number of closing conditions, including: the approval of the Court; the approval of the ASX and all other applicable third party and regulatory consents for the Arrangement; the Company obtaining the requisite approval of its securityholders; Exopharm obtaining the requisite approval of its shareholders; no more than 10% of the Company’s shareholders exercising their rights of dissent in connection with the Arrangement, and the satisfaction of certain other closing conditions customary for a transaction of this nature.

The Arrangement Agreement includes customary provisions, including non-solicitation, right to match, and fiduciary out provisions, as well as certain representations, covenants and conditions which are customary for a transaction of this nature. The Arrangement Agreement provides for a termination fee payable by either party in certain circumstances in the event the Arrangement does not close.

Further information regarding the Arrangement will be contained in a management information circular that Tryp will prepare, file and mail to the Tryp securityholders (the “Circular“) in connection with an annual and special meeting of the Tryp securityholders to be held to consider the Arrangement (the “Meeting“). All securityholders are urged to read the Circular once available as it will contain important additional important information concerning the Arrangement. The Arrangement Agreement will also be filed on SEDAR+.

Only the holders of Tryp Shares, Tryp option holders and Tryp warrant holders at the close of business on the record date will be entitled to vote at the Meeting. The Arrangement will require the approval of (i) at least 66⅔% of the votes cast by Tryp shareholders; and (ii) at least 66⅔% of the votes cast by holders of Tryp Convertible Securities, voting as a class.

Advisors and Counsel

Pushor Mitchell LLP is acting as legal counsel to Tryp in Canada and K&L Gates LLP is acting as legal counsel to Tryp in Australia in connection with the Arrangement.

Osler, Hoskin & Harcourt LLP is acting as legal counsel to Exopharm in Canada and Hamilton Locke Pty Ltd is acting as legal counsel to Exopharm in Australia.

ACNS Capital Markets Pty Ltd trading as Alto Capital acted as Tryp’s advisor to Tryp’s recently closed private placement of unsecured convertible notes which raised approximately AUD$3,390,000, and is acting Exopharm’s corporate advisor in connection with the Arrangements.

About Tryp

Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%. The Company has also started a Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and is preparing to initiate a Phase 2a clinical trial (IND has been cleared to proceed) with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from IBS. Each of the studies are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety and patient experience. For more information, please visit www.tryptherapeutics.com.

About Exopharm

Exopharm (EX1) is a leader in advancing and manufacturing technologies for exosome-based medicines using exosomes or extracellular vesicles (EVs) as a chassis for improved and non- viral drug-delivery.
Exosomes can be loaded with a variety of active pharmaceutical ingredients (APIs) and can be targeted to selected cell-types and tissue types, improving the safety-profile of the APIs and providing better treatments. Exosomes can be used to deliver small molecule drugs, mRNA, DNA and other types of APIs. Currently Exopharm is executing a strategy to maximize the significant value of the company’s IP position in the exosome field.

The Exopharm Shares to be issued under the Arrangement have not been and will not be registered under the U.S. Securities Act of 1933 and may not be offered or sold in the United States absent registration or applicable exemption from registration requirements. It is anticipated that any securities to be issued under the Arrangement will be offered and issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933 provided by Section 3(a)(10) thereof.

Completion of the Arrangement is subject to a number of conditions, including but not limited to, all requisite regulatory, court and exchange approvals, the approval of the Court as well as the approvals of the securityholders of Tryp and shareholders of Exopharm. The Arrangement cannot close until the required approvals are obtained. There can be no assurance that the Arrangement will be completed as proposed or at all.

Investors are cautioned that, except as disclosed in the Circular to be prepared in connection with the Arrangement, any information released or received with respect to the Arrangement may not be accurate or complete and should not be relied upon. Trading in the securities of the Company should be considered highly speculative.

Neither the CSE nor the Market Regulator (as that term is defined in the policies of the CSE) has in any way passed upon the merits of the Arrangement and associated transactions and neither of the foregoing entities accepts responsibility for the adequacy or accuracy of this release or has in any way approved or disapproved of the contents of this press release.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

Investor & Media Contact

Peter Molloy
Chief Business Officer
Tryp Therapeutics Inc.
pmolloy@tryptherapeutics.com

Forward-looking Statements:

Certain information in this news release is considered forward-looking within the meaning of certain securities laws and is subject to important risks, uncertainties and assumptions. This forward-looking information includes, among other things, information with respect to the Company’s beliefs, plans, expectations, anticipations, estimates and intentions. The words “may”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “anticipate”, “estimate”, “expect”, “intend”, “plan”, “target” and similar words and expressions are used to identify forward-looking information. Forward-looking information in this news release relates to, among other things: anticipated benefits of the Arrangement to securityholders; the timing and receipt of required securityholder, Court, and regulatory approvals for the Arrangement; the ability of Exopharm to complete a prospectus offering and the amount to be raised thereunder, the composition of the board of directors of the combined entity, the ability of the Company and Exopharm to satisfy the other conditions to, and to complete, the Arrangement.

These statements reflect the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant uncertainties and contingencies. Many factors, both known and unknown could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements or information and the Company has made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the satisfaction or waiver of all applicable conditions to closing of the Arrangement including, without limitation, receipt of all necessary securityholder, court and regulatory approvals or consents and lack of material changes with respect to the Company and its business, all as more particularly set forth in the Arrangement Agreement. In respect of the forward-looking statements and information concerning the anticipated completion of the proposed Arrangement and the anticipated timing for completion of the Arrangement, the Company has made certain assumptions that management believes are reasonable at this time, including assumptions as to the time required to prepare and mail Meeting materials and the satisfaction of all closing conditions. These dates may change for a number of reasons, including unforeseen delays in preparing Meeting materials; inability to secure necessary securityholder, court and regulatory approvals in the time anticipated or the need for additional time to satisfy the other conditions to the completion of the Arrangement. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release concerning these times. In addition, in the event the Arrangement Agreement is terminated in certain circumstances, the Company may be required to pay a termination fee to the Purchaser, the result of which could have a material adverse effect on the Company’s financial position and results of operations and its ability to fund growth prospects and current operations.

The forward-looking information in this news release describes the Company’s expectations as of the date of this news release. Readers are cautioned against attributing undue certainty to forward-looking statements or information. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affecting such statements or information, other than as required by applicable law.

SOURCE: Tryp Therapeutics

12/11/2023 EQS Newswire / EQS Group AG

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Ocedurenone: A Novel Therapy for Uncontrolled Hypertension in Advanced Chronic Kidney Disease

EMJ Nephrology interviewed two World-renowned experts in nephrology and cardiology, George Bakris and Faiez Zannad, regarding the challenges of treating uncontrolled hypertension (uHTN) in patients with advanced chronic kidney disease (CKD), a large unmet need for safe, effective therapies, and the potential of one therapy, Ocedurenone, to address this need.

Original article: EMJ-8.1-2023-1.pdf (emg-health.com)

Large Unmet Need

Patients with advanced CKD have a high burden of disease, compounded by serious comorbidities, most commonly hypertension. Controlling hypertension is vital in these patients to reduce the associated risks of morbidity and mortality, as well as reducing cardiorenal risk, but treatment options are limited due to safety concerns with the use of existing agents.

Current Options

Bakris:”The PATHWAY-2 trial showed that in people with resistant hypertension without advanced CKD, spironolactone produced a greater reduction in blood pressure than a β-blocker and an α-blocker. However, it presents safety risks to patients when administered.”

“Then there is eplerenone, given twice a day, while safe, has a much weaker effect on blood pressure reduction than spironolactone. That’s all we’ve got, so that’s what people use.”

Dr Bakris also mentioned two existing nonsteroidal MRAs, esaxerenone which is “approved exclusively in Japan, for which there are no placebo-controlled comparisons”, and Finerenone which “reduces blood pressure (placebo subtracted) variously from 3 mmHg (ARTS-DN, FIGARO-DKD, and FIDELIO-DKD studies) to approximately 8 mmHg (subset analysis from ARTS-DN study, eGFR of approximately 68, though office blood pressure from the same study showed around 3 mmHg reduction)”.

Future Option – Ocedurenone

Bakris:”Now, Ocedurenone, a non-steroidal MRA, shows clear promise in patients whose standard of care includes two, three, or more drugs. Ocedurenone is the only drug that has consistently steadied resistant hypertension in people with advanced CKD.”

In the first dedicated study of patients with uncontrolled hypertension and advanced CKD (BLOCK-CKD), Ocedurenone demonstrated efficacy in lowering blood pressure, together with a favorable safety profile. The experts were optimistic that it could provide a much-needed treatment option for these patients, with the added potential for reduction in the risk of cardiorenal outcomes.

“This study showed that Ocedurenone reduces SBP by 11 mmHg (placebo-subtracted), a reduction that could lead to potential approval. No other agent to date has steadied blood pressure as well in this group of patients. And the point is that these are the patients who need the most help.”

Zannad reinforced the importance of the hyperkalemia data for the clinical safety of Ocedurenone:”With Ocedurenone, we may for the first time have an MRA that is both safe and efficacious.”

Bakris added:”A Phase 3 study (CLARION-CKD) of Ocedurenone in a similar patient population is ongoing. I remain optimistic that the signal seen in the BLOCK-CKD study will be seen in this larger study.”

“I remain excited about Ocedurenone. Its tolerability and efficacy in lowering blood pressure in a very high-risk group will have a significant impact on morbidity.”

“Mineralocorticoid receptors are so ubiquitous which may allow for indications beyond CKD and cardiovascular conditions. This is likely just the beginning for Ocedurenone.”

About Ocedurenone (KBP-5074)

KBP Biosciences is a global, clinical-stage biotechnology company, headquartered in Princeton, NJ, focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet medical needs.

Ocedurenone (KBP-5074) is a non-steroidal MRA discovered and developed by KBP Biosciences. At present, the Phase 3 clinical trial of the first indication for Ocedurenone, advanced CKD and uncontrolled hypertension, is underway.

About KBP Biosciences, please visit https://www.kbpbiosciences.com/.

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting




MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

Findings validate clinical proof of mechanism of MTL-CEBPA as a combination therapy in solid tumor cancers

Company to initiate out-licensing activities of its immuno-oncology portfolio, including MTL-CEBPA

LONDON–(BUSINESS WIRE)–MiNA Therapeutics Limited, the pioneer in small activating RNA (RNAa) therapeutics, will present positive updated biomarker data from its Phase 1a/b TIMEPOINT study of MTL-CEBPA in combination with the anti-PD1 checkpoint inhibitor, pembrolizumab, in adults with advanced solid tumors at the annual meeting of the American Association of Cancer Research (AACR) in Orlando, Florida. Findings from the Phase 1b portion of the study validate the clinical proof of mechanism of MTL-CEBPA as a combination treatment and identify a novel predictive biomarker of clinical response. The data will be presented on Tuesday, April 18, during a late-breaking research session beginning at 9:00 am EDT.

MTLCEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cells. Dysregulated myeloid cells are implicated in several diseases including solid tumor cancers. MTL-CEBPA is designed to improve the effectiveness of checkpoint inhibitors and other immunotherapies by enhancing the body’s immune response and ability to attack the cancerous cells. Interim data from an open-label, multi-center study demonstrated the safety, tolerability, immunological and clinical activity of MTL-CEBPA in combination with pembrolizumab.

Anti-PD1 checkpoint inhibition has significantly advanced the treatment of cancer, but many patients are resistant to treatment and present with tumors that resemble an ‘immune-desert’,” said Robert Habib, CEO of MiNA Therapeutics. “The updated analysis of TIMEPOINT shows that MTL-CEBPA used in combination with anti-PD1 checkpoint inhibitors profoundly reprograms the tumor microenvironment, reducing resistance and enabling infiltration of disease-fighting T-cells.”

The TIMEPOINT study also identified a novel predictive biomarker of clinical response to the combination treatment, presenting an opportunity for further evaluation as a potential companion diagnostic. The novel biomarker predicted clinical response across multiple tumor types.

MiNA plans to explore out-licensing opportunities for its immuno-oncology portfolio, which uniquely combines the capability to specifically restore or boost any dysregulated gene target with clinically validated in vivo delivery to myeloid immune cells.

MiNA’s immuno-oncology portfolio includes the following programs:

  • MTLCEBPA, which has been cleared for evaluation in a global Phase 2 clinical trial in combination with the tyrosine kinase inhibitor, sorafenib, in advanced hepatocellular carcinoma (HCC or liver cancer) and in a Phase 1 clinical trial in pediatric patients with MPS1 Hurler Syndrome
  • MTL-STING currently in pre-clinical development
  • Additional programs currently in discovery

About TIMEPOINT

TIMEPOINT is a global Phase 1a/b clinical study in patients with solid tumor malignancies to assess the safety and tolerability of MTLCEBPA in combination with pembrolizumab in patients who are ineligible or resistant to standard therapies. The study has received clearance from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). To learn more about the TIMEPOINT clinical study, visit ClinicalTrials.gov (NCT04105335).

The poster presentation at AACR entitled, “MTL-CEBPA in combination with pembrolizumab converts an immune desert to an inflamed TME in solid tumors resistant to checkpoint blockade,” will be available on MiNA’s website in the Publications section under “RNA Activation”.

About MTL-CEBPA

MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases, and in solid tumor cancers these cells have been identified as a critical barrier to induction of clinical response for many therapies. In pre-clinical studies, MTL-CEBPA has been shown to improve the anti-tumor activity of cancer therapies by targeting dysregulated myeloid cells and reducing or eliminating their suppressive effect on immune response and therapies in the tumor microenvironment.

About MiNA Therapeutics

MiNA Therapeutics is the global leader in small activating RNA therapeutics or RNAa. Harnessing innate mechanisms of gene activation, RNAa therapeutics are a revolutionary new class of medicines that can restore or boost normal function of genes and thereby protein-modulated pathways in patients’ cells. We are advancing a proprietary pipeline of new medicines with an initial focus on genetic medicine, while collaborating with leading pharmaceutical companies to apply our technology platform across a broad range of other therapeutic areas. Based on our unique know-how in RNA activation, we are expanding the possibilities of RNA-based medicine for patients. www.minatx.com

Contacts

MiNA Therapeutics

Peter Bains, CBO

+44 208 811 6700

bd@minatx.com

Media:
Mike Beyer

Sam Brown, Inc.

mikebeyer@sambrown.com
+1 312-961-2502

Epic Sciences Raises $24M in Series G Financing to Continue Funding Commercialization of DefineMBC

Epic Sciences Raises $24M in Series G Financing to Continue Funding Commercialization of DefineMBC




Epic Sciences Raises $24M in Series G Financing to Continue Funding Commercialization of DefineMBC

Funding will accelerate commercial launch of DefineMBC™

SAN DIEGO–(BUSINESS WIRE)–Epic Sciences, Inc. (“Epic” or “Epic Sciences”), a privately held diagnostics company, has completed a $24 million Series G which together with its $43 million Series F financing, totals $67 million raised in the last twelve months. The company will use the capital from this additional round of private investment to fund the commercial infrastructure required to commercialize the three component tests of DefineMBC, which together provide a comprehensive blood-based biopsy result for patients with metastatic breast cancer.

The investment was co-led by Deerfield Management and Arsenal Capital Partners, and included broad participation from the company’s shareholders including Blue Ox Healthcare Partners, Domain Ventures, and Labcorp.

“I’m excited to announce that Epic’s pre-launch activities related to DefineMBC have exceeded our expectations. We have delivered comprehensive test results to 700 patients and their oncologists in our Clinical Experience Program,” said Lloyd Sanders, President and CEO, Epic Sciences. “We have surveyed the physicians participating in the Clinical Experience Program and their responses indicate that oncologists see the value in DefineMBC’s ability to provide actionable information that allows them to better care for their patients.”

DefineMBC™ provides the most comprehensive blood-based biopsy results available to patients with metastatic breast cancer by delivering a report which includes:

  • detection of circulating tumor cells (CTCs)
  • assessment of HER-2 cellular protein expression coupled with

    • single-cell sequencing of identified cells to assess amplification of the ERBB2 gene locus
  • assessment of ER cellular protein expression
  • a plasma-based, 56-gene panel of cell-free DNA including

    • ERBB2 and PIK3CA
    • tumor mutational burden (TMB)

The new investment will enable the company’s efforts related to the commercialization of the DefineMBC tests, including the continued expansion of the company’s new market-facing departments: sales, product marketing, customer service, medical affairs, payer markets, and billing. The investment also continues to fund the development of additional concordance and outcomes data for the DefineMBC tests.

Andrew El Bardissi, a member of the company’s board of directors and Partner at Deerfield Management, said, “Deerfield is pleased to support Epic Sciences at this critical stage of commercialization. We believe DefineMBC is poised to change the management of metastatic breast cancer.”

About Epic Sciences

Epic Sciences, Inc. is developing and marketing novel diagnostics to guide therapy selection and monitor disease progression, personalizing and advancing the treatment and management of prostate and breast cancers. The company’s liquid biopsy platform leverages proven, proprietary cell analysis capabilities as well as cell-free analysis to provide more complete, efficient analysis and clearer insights – Comprehensive Cancer Profiling. Using its full-service CAP/CLIA-accredited laboratory and research support services, Epic Sciences partners with leading pharmaceutical companies and major cancer centers around the world to improve patient outcomes.

For more information, visit www.epicsciences.com or follow us on LinkedIn, Facebook or Twitter.

About Arsenal Capital Partners

Arsenal is a leading private equity firm that specializes in investments in healthcare and industrial growth companies. Since its inception in 2000, Arsenal has raised institutional equity investment funds of more than $10 billion, has completed more than 250 platform and add-on investments, and achieved more than 30 realizations. Arsenal invests in industry sectors in which the firm has significant prior knowledge and experience. The firm works with management teams to build strategically important companies with leading market positions, high growth, and high value-add. Visit www.arsenalcapital.com for more information.

Contacts

Brian.Strike@EpicSciences.com

Alpha Cancer Technologies (ACT) Publishes Pre-Clinical Study Results in Cancer Cell International Demonstrating Excellent Safety and Significant Anti-Tumor Activity from the Company’s Next Generation ADC, ACT-903

Alpha Cancer Technologies (ACT) Publishes Pre-Clinical Study Results in Cancer Cell International Demonstrating Excellent Safety and Significant Anti-Tumor Activity from the Company’s Next Generation ADC, ACT-903




Alpha Cancer Technologies (ACT) Publishes Pre-Clinical Study Results in Cancer Cell International Demonstrating Excellent Safety and Significant Anti-Tumor Activity from the Company’s Next Generation ADC, ACT-903

ACT-903 conjugate demonstrated significant anti-tumor activity, with tumors becoming undetectable in 9 of 10 mice, and all 10 mice surviving through Day 60 with no obvious signs of toxicity

ACT’s technology highlights the potential to use the natural function of AFP as a carrier protein to deliver a payload uniquely targeted to cancer cells, while reducing risk of immune reactions or anti-drug antibody accumulation

Alpha fetoprotein conjugates had a very low percentage of free toxin detectable in blood after administration, and did not show any bone marrow accumulation of cytotoxic payload, suggesting limited off-target toxicity

TORONTO–(BUSINESS WIRE)–#ACT903–Alpha Cancer Technologies Inc. (ACT), a biopharmaceutical company focused on developing and commercializing targeted immuno-oncology and immunomodulation therapies based on its proprietary recombinant human Alpha Fetoprotein (AFP) platform, today announced the publication of pre-clinical study results in Cancer Cell International highlighting the company’s recombinant human AFP (ACT-101) conjugate with maytansine in mouse xenograft models of colorectal cancer. Results from the study demonstrate the exceptional safety profile and potent anti-tumor activity of multiple ACT-101 conjugates through the successful targeting of the alpha fetoprotein receptor uniquely located on cancerous cells and myeloid-derived suppressor cells (MDSCs).

The AFP receptor has been found on the surface of cancer cells and MDSCs exclusively, making it an attractive target for the delivery of toxins selectively to tumor cells and MDSCs. Human AFP acts as a shuttle protein, transporting a variety of molecules including targeted anti-cancer agents inside the cell via the AFP receptor. ACT-101 is a recombinantly produced non-glycosylated form of human AFP, which will carry and deliver maytansine and other chemotherapy payloads to tumor cells via the AFP receptor. The selection of maytansine was based on its prior efficacy in clinical studies when incorporated into ADCs.

The AFP receptor has emerged as a novel target for cancer therapeutics given the expression of AFP on most cancers and MDSCs, and lack of presence on normal tissues. Studies were performed to investigate the use of ACT-101 conjugated with maytansine for targeted toxin delivery to cancer. Four structurally different ACT-101-maytansinoid conjugates containing cleavable glutathione sensitive linkers were initially investigated in a mouse xenograft model of colorectal cancer (COLO-205). Reduction in tumor volume was seen for all four conjugates compared to control (p < 0.05). The anti-tumor effects of the conjugate selected for further development, ACT-903, persisted after treatment discontinuation, with tumors becoming undetectable in 9 of 10 mice, and all 10 mice surviving through Day 60 with no obvious signs of toxicity. A follow-up study performed in the same model compared the effects of single intravenous doses of ACT-903 (10–50 mg/kg) to control groups receiving vehicle or ACT-101. A significant reduction of tumor burden compared to control was achieved in the 40 and 50 mg/kg dose groups. Survival was also significantly prolonged in the 40 mg/kg and 50 mg/kg cohorts. Free maytansine blood levels at 4 hours were 0.008% of the dose, indicating stability in circulation as was expected based on in vitro plasma stability studies. No obvious signs of toxicity were seen in any of the treated groups. The observed efficacy and excellent tolerability of ACT-903 in these xenograft models support advancing the development of ACT-903 into clinical studies.

“Based on the evidence we continue to observe in our pre-clinical studies, we believe ACT-903 has the potential to address the limitations of current-generation antibody drug conjugates through a targeted delivery exclusively to cancer and immune suppressor cells, allowing for greater efficacy with minimal toxicity,” said Dr. Igor Sherman, CEO of ACT. “Given the broad range of cancer cells expressing the AFP receptor, we believe our technology offers a potential pan-cancer opportunity and we look forward to continuing the development of this program to bring it to cancer patients in the shortest possible time.”

The manuscript, titled “High anti-tumor activity of a novel alpha-fetoprotein-maytansinoid conjugate targeting alpha-fetoprotein receptors in colorectal cancer xenograft model,” was published in Cancer Cell International on April 5, 2023 and the full manuscript can be accessed here.

About Alpha Cancer Technologies, Inc.

Alpha Cancer Technologies Inc., (ACT) is a private clinical stage biotechnology company with immuno-oncology, theranostics and immunomodulation platforms under development. The company’s drug products use ACT’s patented recombinant human alpha fetoprotein (AFP or ACT-101). ACT’s immuno-oncology products target AFP receptors uniquely expressed on almost all solid and liquid tumors and immune suppressor cells but are absent on normal cells. This approach utilizes next-generation ADC technology and offers the benefits of much lower toxicity and greater efficacy compared to conventional chemotherapy and other targeted therapies. ACT is based in Toronto, Ontario, Canada. For more information, please visit www.alpha-cancer.com

Contacts

Richard Potts, Chair

Alpha Cancer Technologies Inc.
Tel: +1 (416) 464-2678

Email: rpotts@alpha-cancer.com

Igor Sherman, Ph. D., President & CEO

Alpha Cancer Technologies Inc.
Tel: +1 (416) 826-6626

Email: isherman@alpha-cancer.com

For investors, please contact:
Stephen Jasper

Gilmartin Group
Tel: +1 (858) 525-2047

Email: stephen@gilmartinir.com

Rallybio Announces Clinical Proof-of-Concept Results for RLYB211, an Anti-HPA-1a Polyclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), Published in the Journal of Thrombosis and Haemostasis

Rallybio Announces Clinical Proof-of-Concept Results for RLYB211, an Anti-HPA-1a Polyclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), Published in the Journal of Thrombosis and Haemostasis




Rallybio Announces Clinical Proof-of-Concept Results for RLYB211, an Anti-HPA-1a Polyclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), Published in the Journal of Thrombosis and Haemostasis

Data Support Potential Use of an Anti-HPA-1a Antibody as Prophylaxis for FNAIT —

— In March 2023, Rallybio Announced Clinical Proof-of-Concept Achieved for its Lead Product Candidate, RLYB212, a Monoclonal Anti-HPA-1a Antibody, in the First Quarter of 2023 —

NEW HAVEN, Conn.–(BUSINESS WIRE)–Rallybio Corporation (Nasdaq: RLYB) today announced publication of Phase 1 / 2 proof-of-concept results for RLYB211, a polyclonal anti-HPA-1a antibody derived from human plasma for the prevention of FNAIT. FNAIT is a rare and life-threatening bleeding disorder in which maternal alloantibodies directed against fetal platelets can lead to devastating outcomes for the fetus/neonate. There are currently no approved therapies for the prevention or treatment of FNAIT. The findings were published in the Journal of Thrombosis and Haemostasis, the official journal of the International Society on Thrombosis and Haemostasis.

Rallybio’s randomized, single-blind, placebo-controlled, study investigated the ability of a single dose of intravenous RLYB211 to eliminate HPA-1a-positive platelets transfused into HPA-1a-negative healthy subjects. The platelet transfusion in this study was selected based on the precedent of historical clinical trial designs to assess the efficacy of anti-D prophylaxis, in which the transfusion of antigen positive cells is designed to mimic a catastrophic fetal maternal hemorrhage. As has been shown with anti-D prophylactic agents, the ability of RLYB211 to drive the rapid and complete elimination of antigen positive cells is a surrogate indicator of its potential to prevent maternal alloimmunization, and therefore FNAIT. In Cohort 1, subjects received RLYB211 or placebo one hour after transfusion of HPA-1a positive platelets and in Cohort 1B subjects received RLYB211 or placebo followed by platelet transfusion one week later. Proof-of-concept was defined as ≥90% reduction in platelet elimination half-life compared to placebo.

The publication stated:

  • RLYB211 accelerated the elimination of HPA-1a positive platelets versus placebo, with all subjects meeting proof-of-concept criteria for greater than 90% reduction in platelet elimination half-life compared to placebo.
  • Rapid elimination of transfused platelets was evident 7 days after RLYB211 administration, simulating prophylactic administration of an anti-HPA-1a antibody prior to a fetal-maternal bleed.
  • RLYB211 was well tolerated and no serious adverse events were reported.

“We are pleased that these clinical results were published in the Journal of Thrombosis and Haemostasis, indicating that RLYB211 markedly accelerated the elimination of HPA-1a-positive platelets. We believe that these data demonstrate the prophylactic potential of anti-HPA-1a antibodies to prevent HPA-1a alloimmunization and occurrence of FNAIT,” said Róisín Armstrong, Ph.D., Rallybio’s FNAIT Program Lead. “Our FNAIT program continues to advance and as previously announced, we are pleased that an abstract reporting results from the Phase 1b proof-of-concept study for RLYB212, our monoclonal candidate, has been accepted for presentation at the upcoming 31st Congress of International Society on Thrombosis and Haemostasis in June.”

Dr. Christof Geisen, Institute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service, and a key collaborator in the RLYB211 study, stated, “In addition to the rapid elimination of transfused platelets in all subjects, the effect of RLYB211 was also demonstrated when it was administered one week prior to platelet transfusion, suggesting a durable potential treatment effect for HPA-1a-specific antibodies and that FNAIT might safely be prevented by rapidly eliminating platelet antigen from maternal circulation before alloimmunization can occur.”

The RLYB211 Phase 1 / 2 results were published in the April issue (Volume 21, Issue 4, Pages 838-849) of the Journal of Thrombosis and Haemostasis, https://doi.org/10.1016/j.jtha.2022.11.041.

Given the advantages of small volume subcutaneous dosing of RLYB212 as compared to RLYB211 and the expected manufacturing and supply efficiencies for RLYB212, Rallybio announced in March 2023 that the Company will not continue development of RLYB211.

About FNAIT

Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is a potentially life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns. FNAIT can arise during pregnancy due to an immune incompatibility between an expectant mother and her fetus in a specific platelet antigen called human platelet antigen 1, or HPA-1. There are two predominant forms of HPA-1, known as HPA-1a and HPA-1b, which are expressed on the surface of platelets. Individuals who are homozygous for HPA-1b, meaning that they have two copies of the HPA-1b allele and no copies of the HPA-1a allele, are also known as HPA-1a negative. Upon exposure to the HPA-1a antigen, these individuals can develop antibodies to that antigen in a process known as alloimmunization. In expectant mothers, alloimmunization can occur upon mixing of fetal blood with maternal blood. When alloimmunization occurs in an expectant mother, the anti-HPA-1a antibodies that develop in the mother can cross the placenta and destroy platelets in the fetus. The destruction of platelets in the fetus can result in severely low platelet counts, or thrombocytopenia, and potentially lead to devastating consequences including miscarriage, stillbirth, death of the newborn, or severe lifelong neurological disability in those babies who survive. There is currently no approved therapy for the prevention or treatment of FNAIT.

About Rallybio

Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of maternal fetal health, complement dysregulation, hematology, and metabolic disorders. The company has two clinical stage programs: RLYB212, an anti-HPA-1a antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) and RLYB116, a C5 complement inhibitor with the potential to treat several diseases of complement dysregulation, as well as additional programs in preclinical development.

Rallybio is headquartered in New Haven, Connecticut with an additional facility at the University of Connecticut’s Technology Incubation Program in Farmington, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to management. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning the ability of RLYB212 and RLYB211, and the prophylactic administration of HPA-1a-specific antibodies, to clear platelets and prevent alloimmunization in pregnant women, and the anticipated threshold effect for rapid and complete elimination of HPA-1a positive platelets, the expected progress, results, and plans for RLYB212 and RLYB211, the initiation, substance, design and timing of our planned or ongoing studies for RLYB212, the timing of the availability of data from such studies, our expectations regarding reporting of data from such studies, and our expectations regarding the usefulness of data from such studies. The forward-looking statements in this press release are only predictions and are based largely on management’s current expectations and projections about future events and financial trends that management believes may affect Rallybio’s business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our ability to successfully initiate and conduct our planned clinical trials, including the ongoing and future clinical trials for RLYB212 for the prevention of FNAIT, and complete such clinical trials and obtain results on our expected timelines, or at all, whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements and whether we will be successful raising additional capital, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio’s filings with the U.S. Securities and Exchange Commission (SEC), including Rallybio’s Annual Report on Form 10-K for the period ended December 31, 2022, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risks and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.

Contacts

Investors
Ami Bavishi

Head of Investor Relations and Corporate Communications

475-47-RALLY (Ext. 282)

abavishi@rallybio.com

Hannah Deresiewicz

Stern Investor Relations, Inc.

212-362-1200

hannah.deresiewicz@sternir.com

Media
Tara DiMilia

908-369-7168

Tara.dimilia@tmstrat.com

Morphogenesis Inc. Acquires TυHURA Biopharma’s First-in-Class Antibody Drug Conjugates (ADCs) Technology Designed to Overcome Acquired Resistance to Cancer Immunotherapy

Morphogenesis Inc. Acquires TυHURA Biopharma’s First-in-Class Antibody Drug Conjugates (ADCs) Technology Designed to Overcome Acquired Resistance to Cancer Immunotherapy




Morphogenesis Inc. Acquires TυHURA Biopharma’s First-in-Class Antibody Drug Conjugates (ADCs) Technology Designed to Overcome Acquired Resistance to Cancer Immunotherapy

Proprietary bi-functional ADCs target and inhibit unique Delta receptor on tumorassociated Myeloid Derived Suppressor Cells (MDSCs); increasing tumor’s susceptibility to checkpoint inhibitors and cellular therapies

TAMPA, Fla., March 28, 2023 (GLOBE NEWSWIRE) — Morphogenesis Inc., a Phase 3 clinical stage biopharmaceutical company developing novel personalized cancer vaccines, announced today that it has entered into a definitive asset purchase agreement, in a stock for stock transaction, to acquire TυHURA’s novel ADCs targeting MDSCs to modulate tumor microenvironment immunosuppression. The technologies were developed by researchers at Moffitt Cancer Center, West Virginia Research Corporation and TυHURA. Through this acquisition, Morphogenesis now has exclusive worldwide license rights to TυHURA’s patents and patented technologies related to the ADC platform.

“Tumor-associated MDSCs are a major obstacle to immunotherapy, being responsible for acquired resistance to checkpoint inhibitors, and contribute to T cell and NK cell exhaustion, preventing cellular therapies from being more effective in attacking cancer. TυHURA’s technology represents a new paradigm. Unlike conventional ADCs where an antibody is used as a targeting agent and a cellular toxin is the payload, TuHURA’s ADCs are bi-functional, where a small molecule inhibitor of MDSC function is the targeting agent, and an immune effector like a checkpoint inhibitor is the payload. These bi-functional ADCs block MDSC’s immune suppressing effects, while localizing an immune effector in the tumor microenvironment. Through this technology represents a promising new approach to overcoming resistance to cancer immunotherapy,” commented James A. Bianco, M.D., Chief Executive Officer of Morphogenesis. “We believe through this strategic acquisition, TυHURA’s novel technology will be complementary to our IFx personalized cancer vaccine technology in addressing obstacles to overcoming resistance to immunotherapies.”

“TυHURA and Moffitt researchers are the first to identify a novel Delta receptor on MDSCs that controls many of MDSC immune suppressing functions, representing a major advance in the ability to increase a tumor’s susceptibility to immune attack, with the promise of increasing the effectiveness and safety profile of immunotherapy,” added Alan F. List, M.D., former President and CEO of Moffitt Cancer Center, a noted expert on the central role of MDSCs contribution to tumorigenesis and resistance to immunotherapy, and member of the independent committee of the Morphogenesis Board of Director’s who evaluated and negotiated the TυHURA asset purchase.

“Modulating the tumor microenvironment is an area of intense research and development among large pharmaceutical companies given its importance in preventing the effective use of immunotherapies like checkpoint inhibitors. This acquisition not only provides Morphogenesis a truly novel approach to block MDSC induced immunosuppression, but also significantly de-risks and bolsters our development pipeline. We look forward to further elucidating the unique characteristics of the Delta receptor and advancing a new generation of bi-functional ADCs toward first-in-human clinical trials,” concluded Dr. Bianco.

About TυHURA Biopharma

TυHURA is a Delaware Company founded by James Bianco, M.D. in 2019 in partnership with Moffitt Cancer Center, where researchers, in collaboration with Dr. Bianco, identified a unique Delta receptor highly expressed on tumor-associated MDSCs linked to MDSC’s migration and their potent immune suppressing functions. The Company has several worldwide exclusive licenses from Moffitt Cancer Center to these and related technologies. Moffitt is a shareholder of TυHURA.

The Company also licensed a complementary novel technology from West Virginia University, conjugating small molecule Delta receptor inhibitors to immune effectors, like checkpoint inhibitors. The current generation of ADC’s utilize an antibody as the targeting agent and a cellular toxin as the payload. In contrast, TυHURA’s first in class bi-functional ADCs utilize a highly selective small molecule inhibitor to target the Delta receptor on MDSCs with an immune effector as the payload. These novel ADCs are bi-functional shutting off MDSC immune suppression of the tumor microenvironment, while localizing an immune effector like a checkpoint inhibitor on MDSCs in the microenvironment, increasing their effectiveness, while limiting indiscriminate toxicity to normal tissues from checkpoint released cytotoxic T cells.

About Morphogenesis

Morphogenesis is a Phase 2/3 clinical stage biotechnology company developing IFx-Hu2.0, a novel intratumoral pDNA, and Ifx-Hu3.0, an intravenous or autologous whole cell mRNA, as personalized cancer vaccines. Clinical studies have demonstrated IFx-Hu2.0’s ability to overcome primary resistance to checkpoint inhibitors like pembrolizumab. Following IFx-Hu2.0 therapy among patients progressing on checkpoint inhibitor therapy, rechallenge with checkpoint inhibitors resulted in durable systemic partial or complete anti-tumor responses in patients with advanced Merkel cell carcinoma. Similar rates of anti-tumor responses were observed in advanced refractory melanoma and squamous cell carcinoma. Based on these data and discussions with the FDA, the Company expects to initiate a single Phase 3 registration trial in first line therapy of patients with advanced Merkel cell carcinoma in sequence with pembrolizumab in late 2023.

The Company’s IFx technology uses a proprietary gene technology to allow tumor cells to express an immune activating bacterial protein on the surface of the tumor cell. In doing so it “tricks” the body’s immune system to attack the tumor by making tumor cells look like bacteria. Recognizing the bacterial protein molecular patterns as being foreign, the patient’s immune system is activated “ingesting” the tumor cell, educating the patient’s immune system to all of the patient’s tumor’s neoantigens regardless of their number or uniqueness. In doing so the Company’s technology provides a more potent and multivalent response against the entire complement of neoantigens in a patient’s tumor.

Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
morphogenesis@jtcir.com

Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer




Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

SINGAPORE–(BUSINESS WIRE)–Prestige Biopharma has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PBP1510 (International Non-proprietary name: Ulenistamab), in the treatment of unresectable or metastatic pancreatic adenocarcinoma (PDAC) that has relapsed following and/or is refractory to at least one line of prior therapy.

PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases. PAUF overexpression promotes key cellular functions, including proliferation, migration, invasion, and growth of pancreatic cancer cells, and contributes to the development of acquired resistance to chemotherapeutic agents. PBP1510 is designed to target these key biological mechanisms that results in limited effectiveness of current treatment options and rapid progression of pancreatic cancer.

By effectively inhibiting the tumorigenic effects of PAUF overexpression in preclinical models, PBP1510 represents a promising therapeutic strategy for addressing the unmet medical needs of pancreatic cancer patients. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic.

The first-in-human Phase 1/2a study is an open-label, multicentre, two-part study in patients with advanced/metastatic pancreatic cancer. Phase 1 is a dose-escalation phase, wherein PBP1510 will be administered, either as monotherapy or in combination with gemcitabine, in two separate dose-escalation cohorts. From Phase 1 part of the study a recommended Phase 2a dose (RP2D) will be determined based on the analysis of pharmacokinetics, safety, and efficacy data. Phase 2 is a dose-expansion phase, wherein PBP1510 at the RP2D in combination with gemcitabine will be administered to evaluate efficacy and safety of PBP1510.

Overall, the Phase 1/2a study aims to collect important safety data on the use of PBP1510 as a monotherapy or in combination with gemcitabine and explore the efficacy of a combined PBP1510 and gemcitabine regimen. The study will substantiate the preclinical findings of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity, as anticipated from their distinct mechanisms of action.

With Fast Track designation from the FDA, PBP1510 represents a promising advancement in the treatment of pancreatic cancer. Prestige Biopharma intends to take full advantage of the benefits offered by the designation to provide faster access for patients in need.

Contacts

info@prestigebio.com

Top 6 Arizona bioscience startups in 2023

Top 6 Arizona bioscience startups in 2023




On the rise in 2023: Six Arizona bioscience startups

Phoenix area, Tucson companies selected for Flinn Foundation program

PHOENIX–(BUSINESS WIRE)–#Arizona–The Arizona bioscience startups representing the 10th cohort of the Flinn Foundation Bioscience Entrepreneurship Program are developing innovative products and devices to better treat cancer, improve mental health, provide long-lasting refrigeration of blood and medicine, and more efficiently and safely move patients.

The six early-stage firms competitively selected for the 2023 program include two companies each from Phoenix, Scottsdale, and Tucson.

Over the next year, the program participants will receive $30,000 in funding, a personalized learning plan with other support services facilitated by the Arizona Bioindustry Association (AZBio), and invitations to exclusive gatherings of Arizona bioscience and policy leaders as well as convenings with fellow entrepreneurs.

“These companies are developing cutting-edge diagnostics and treatments—for someone suffering from cancer to social isolation—which are critical to our physical and mental health,” said Tammy McLeod, Flinn Foundation president and CEO. “A record 48 firms applied for our program this year—a testament to Arizona’s vibrant bioscience startup culture.”

The 2023 Flinn Foundation Bioscience Entrepreneurship Program participants are:

Delta Development Team (Tucson)

Delta Development Team is a developer of ruggedized refrigeration systems, specializing in military applications. The Tucson-based company leveraged the knowledge and wisdom of military medical personnel to design its Autonomous Portable Refrigeration Unit, which provides days of use from one battery charge and is designed to withstand harsh weather conditions, so medical-care teams can take it with them no matter where their skills are needed.

EMR Data Cloud (Scottsdale)

Located in Scottsdale, EMR Data Cloud offers a platform for clinical genetic testing with electronic medical record (EMR) integration. Users can order genomic panels and other laboratory tests with just a few clicks on its platform. The company’s lab-integration technology bridges the gap between health care providers and diagnostic laboratories and quickly transfers information, including clinical notes, family history, medication lists, and insurance information in seconds.

Reference Medicine (Phoenix)

This Phoenix-based company’s mission is to become a one-stop shop for oncology biospecimens, enabling researchers to easily get specimens they need, at half the cost, to build cancer diagnostics. The company will address the gap in the oncology biospecimen market by combining partnerships with accredited teams worldwide with an innovative approach to specimen formatting. Its approach ensures that each set of specimens is fully utilized and creates a variety of formats, enabling the company to connect an individual donation to a diverse group of diagnostic research teams—increasing supply of critical specimens while driving down the cost for researchers.

Televeda (Phoenix)

Televeda is a mental-health platform used by public-health and community-based organizations to combat social isolation for vulnerable populations. The platform incorporates robust accessibility designs including a proprietary live-streaming user interface, an administration dashboard for CBOs to source content, hybrid-event management for broadcasting, data-reporting, and white-labeling. The Phoenix-based company helps streamline operations, saving clients 15-25 hours and $2,000-4,000 a month while improving their community-outreach metrics.

The Patient Company (Scottsdale)

The Patient Company is reimagining how patients are moved, starting with lateral patient transfer—moving a patient from one flat surface to another. The process currently takes a median of 22 minutes and is the second-leading cause of injury for health care employees. The Scottsdale-based company has developed SimPull™, a device that can be operated by a single clinical staff member, allowing for safe, efficient, and effective lateral transfer of patients, while decreasing the transfer time to 2 minutes.

TheraCea Pharma (Tucson)

Tucson-based TheraCea Pharma addresses the greatest challenge in the emerging $145 billion cancer immunotherapy market by providing clinical diagnostic products for patient selection and therapy guidance. TheraCea detects immunotherapy biomarkers using PET imaging. The company has developed a set of diagnostic agents that allow oncologists and pharmaceutical companies to select the right segment of patients who will be responsive to specific immunotherapy drugs.

The Flinn Foundation program attracted applicants from across the state. The six firms were selected following a two-stage review process, including virtual interviews with more than a dozen finalists.

The $30,000 in funding support each company receives is administered by AZBio, a trade association that promotes Arizona’s bioscience sector. Each participant receives a one-year membership to both AZBio and Arizona’s Bioscience Roadmap Steering Committee, which includes about 135 leaders from the public and private sectors in science, health care, business, academia, and policy who guide Arizona’s Bioscience Roadmap.

The Flinn Foundation has competitively selected 60 Arizona companies and provided $1.78 million in funding support since the inception of the program in 2014.

To learn more about the Flinn Foundation Bioscience Entrepreneurship Program and the selected firms, visit flinn.org/entrepreneur.

Contacts

Brian Powell, Flinn Foundation Communications Manager, (602) 744-6806, bpowell@flinn.org
Brad Halvorsen, Flinn Foundation Executive Vice President, (602) 744-6803, bhalvorsen@flinn.org

Top 6 Arizona bioscience startups in 2023

Tvardi Therapeutics Announces First Patients Dosed in Phase 2 Trial of TTI-101 in Metastatic Breast Cancer

Tvardi Therapeutics Announces First Patients Dosed in Phase 2 Trial of TTI-101 in Metastatic Breast Cancer




Tvardi Therapeutics Announces First Patients Dosed in Phase 2 Trial of TTI-101 in Metastatic Breast Cancer

The REVERT Trial is Evaluating STAT3 Inhibitor, TTI-101, Added to Palbociclib and an Aromatase Inhibitor to Overcome Resistance and Improve Clinical Outcomes for Metastatic Breast Cancer Patients

HOUSTON–(BUSINESS WIRE)–#IPF–Tvardi Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, announced that the first breast cancer patients have been dosed in the Phase 1b/2 REVERT trial of TTI-101 added to palbociclib and aromatase inhibitor (AI) therapy in adult patients with HR+/HER2 palbociclib-resistant metastatic breast cancer. The first patients were dosed at the Washington University School of Medicine Siteman Cancer Center by Cynthia Ma, MD, PhD, Professor of Medicine, Clinical Director of the Breast Cancer Program, Section of Medical Oncology.

In the US, approximately 74,000 patients per year are diagnosed with HR+/HER2 metastatic breast cancer. These patients are generally treated with CDK4/6 inhibitors (such as palbociclib) and an AI. Unfortunately, the vast majority of these patients acquire resistance to palbociclib and AI therapy and their tumors continue to metastasize. Recent research has demonstrated that this resistance is driven by the activation of a protein in tumors known as STAT3. Tvardi has developed a STAT3 inhibitor, TTI-101, that has been well tolerated and has clinical activity across a broad range of tumors. The REVERT trial has been designed to add TTI-101 to palbociclib and AI therapy when breast cancer patients acquire resistance to standard therapy.

“I am excited the Washington University School of Medicine Siteman Cancer Center was the first to enroll patients to this important trial. The addition of TTI-101 to palbociclib and AI directly addresses the mechanism which leads to patients becoming resistant to the standard of care. TTI-101 has the potential to improve clinical outcomes for HR+/HER2 metastatic breast cancer patients,” said Cynthia Ma, MD, PhD.

“STAT3 is a well-known driver of tumor resistance. Based on Phase 1 trial data, TTI-101 specifically targets STAT3, and is well-positioned to reverse the resistance pathway for metastatic breast cancer,” said Imran Alibhai, PhD, CEO of Tvardi. “This is the first of three Phase 2 trials in metastatic breast cancer, advanced liver cancer, and idiopathic pulmonary fibrosis that Tvardi has initiated to address diseases driven by STAT3.”

For more information about the REVERT breast cancer trial that is enrolling at sites throughout the US, please visit ClinicalTrials.gov (NCT05384119).

About Tvardi Therapeutics

Tvardi is a privately held, clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3, a key regulatory protein positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. STAT3 also plays a central role in the pathogenesis of many inflammatory and fibrotic diseases. The company’s lead product, TTI-101, completed enrollment in its first-in-man Phase 1 trial of relapsed/refractory patients with advanced solid tumors. To date, TTI-101 monotherapy has been well-tolerated and has clinical activity across a broad range of tumors including multiple durable radiographic objective responses. The company has now initiated three Phase 2 clinical programs in hepatocellular carcinoma (NCT05440708), metastatic breast cancer (NCT05384119), and idiopathic pulmonary fibrosis (NCT05671835). To learn more, please visit https://tvarditherapeutics.com/.

Contacts

Tvardi Investor Relations

Sara Manning

ir@tvardi.com