Category Archives: Biotech Companies Oncology Cancer

Theolytics successfully closes latest financing raising total of £19M ($24.5M) and welcomes Sound Bioventures as new investor

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Oxford, UK April 17th, 2024. Theolytics, a biotechnology company developing next-generation oncolytic viral therapies, today announced it has successfully closed its latest financing round, raising a total of £19M ($24.5M) with the addition of Sound Bioventures as a new investor. Sound Bioventures joins a strong international syndicate of existing investors participating in the round that includes M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises and the University of Oxford.

The proceeds from this financing round further strengthen the company’s position as it advances its lead oncolytic adenovirus – THEO-260 – into clinical trials in ovarian cancer. The first trials are planned for this year and will aim to demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients.

Following this investment, Thomas Tan, Principal at Sound Bioventures, will join Theolytics’ Board of Directors.

Charlotte Casebourne Stock, Chief Executive Officer of Theolytics, said; “We’re on the brink of a potential step-change for the oncolytic adenovirus field. Our lead asset THEO-260 will be entering the clinic this year, and at this key juncture we are pleased to complete this significant financing and welcome Sound Bioventures as a new investor alongside our existing investors. Sound Bioventures’ extensive oncology experience, network, operational expertise and collaborative approach will bring important benefits to Theolytics and I am delighted to welcome Thomas Tan to our Board.”

Thomas Tan, Principal at Sound Bioventures, added; “The oncolytic virus modality is rapidly evolving, and we believe that Theolytics is well positioned at the forefront of this exciting therapy area. With THEO-260 about to enter the clinic, we see a significant opportunity to help bring an important and potentially practice-changing therapy to the many women suffering from this fatal disease. I look forward to working with the Board and management team bringing our hands-on approach to support the company’s unwavering fight against cancer.”

“THEO-260 has the potential to bring a much-needed new therapy to ovarian cancer patients and their families that are impacted by this devastating disease,” said Mike Grey, Executive Chair of the Board. “Theolytics is at a pivotal point as it approaches its first clinical trial and we are delighted to welcome Sound Bioventures, a highly knowledgeable and experienced investor with extensive oncology and company building expertise, to our group of leading international investors.”

About Ovarian Cancer (OC)

It is estimated that around 7,500 women in the UK and 20,000 women in the US will be diagnosed with ovarian cancer in 2024. More than 75% of cases will be diagnosed at an advanced stage (grade-III/IV) with less than 25% of patients expected to survive for more than five years.

Standard-of-care, first-line treatments combine cytoreductive-surgery, platinum-based chemotherapies, and paclitaxel. Although initially effective, more than 70% of patients relapse within three years and become resistant to platinum-based therapies. There are no effective treatments for platinum-resistant OC and at this point patients have a life-expectancy of less than 12 months.

About THEO-260

THEO-260 is a next-generation oncolytic adenovirus for the treatment of (platinum-resistant) ovarian cancer. It is highly efficacious in killing cancer cells and cancer-associated fibroblasts in ovarian cancer patient tumour samples. The destruction of cancer-associated fibroblasts, in addition to cancer cells, is a potentially differentiating feature of THEO-260 as cancer-associated fibroblasts in stromal-rich tumours are a barrier to the effectiveness of many cancer treatments. THEO-260 is being explored as a therapeutic for intravenous and intraperitoneal delivery.

About Theolytics

Theolytics is working to develop next-generation oncolytic viral therapies. The company has pioneered a new approach to develop efficacious, targeted candidates suitable for systemic intravenous delivery.

The company is focused on the advancement of its lead program THEO-260 into the clinic with the ambition of providing better outcomes for patients with ovarian cancer, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and hematological malignancies where there remains significant unmet need.

Theolytics, which was founded in 2017 and is headquartered in Oxford, UK, is backed by international life sciences investors M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises, Sound Bioventures and the University of Oxford.

www.theolytics.com

About our Investors

For more information on our investors please see the following websites:
M Ventures 
Taiho Ventures 
Epidarex Capital 
Oxford Science Enterprises
Sound Bioventures
The University of Oxford

Contacts

Theolytics
enquiries@theolytics.com

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

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Ivonescimab alone or combined with chemotherapy led to intracranial responses among 34% of patients with brain metastases at baseline – 23% achieved a complete response

All patients who did not achieve an intracranial response demonstrated stable disease or non-progression by RANO criteria irrespective of cohort

Median intracranial PFS of 19.3 months observed across combined cohorts of ivonescimab administered as monotherapy or in combination with chemotherapy

No cases of intracranial bleeding were observed in these patients with brain metastases

Detailed safety and anti-tumor activity updates from Phase II trial for ivonescimab plus chemotherapy in multiple NSCLC settings, including 1L squamous NSCLC

MIAMI–(BUSINESS WIRE)–$SMMT–Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic. Two posters featuring updated ivonescimab data will be displayed from 12:00 to 12:45pm Central European Time. The posters will also be made available on our website after the presentation period.


The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC. This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.

Notably, median intracranial progression-free survival was 19.3 months across all patients analyzed. Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria. All patients who did not achieve a response demonstrated stable disease or non-progression; no patients experienced intracranial disease progression at the time of the initial follow-up scan. No cases of intracranial bleeding complications were observed in these patients.

“We are pleased to see ivonescimab’s favorable intracranial response rates and median intracranial progression-free survival as well as promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC,” said Dr. H. Jack West, Vice President of Clinical Development at Summit. “We are grateful for the patients and clinical investigators supporting these trials, and our ongoing collaboration with our partners at Akeso.”

The second poster titled, “Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Non-Small Cell Lung Cancer” includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first-line treatment of squamous and non-squamous advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). Summarized updates in NSCLC patients with EGFR mutations after a tyrosine kinase inhibitor (TKI) and NSCLC patients who have received prior PD-(L)1 plus doublet chemotherapy treatment are included as well.

Of significance, first-line advanced or metastatic squamous NSCLC patients experienced a median PFS of 11.1 months (95% CI: 9.5 – 16.3 months). In addition, first-line patients with advanced or metastatic non-squamous tumors experienced a median PFS of 13.3 months (95% CI: 8.3 – 16.4 months). Median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months. The frequency of treatment-emergent adverse events (TEAEs) leading to the discontinuation of ivonescimab was 11.1% and 2.8%, respectively, in patients with squamous and non-squamous tumors. The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. West, with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK) with contribution by Summit staff.

Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:

  • HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (NCT05184712)
  • HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (NCT05899608)

About the ELCC 2024 Posters

Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer

ELCC Presentation No.: 68P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases

ELCC Presentation No.: 174P

Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

About Summit Therapeutics

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow us on X @summitplc.

Summit Forward-looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Appendix: Glossary of Critical Terms Contained Herein

Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.

Avidity – Avidity is the accumulated strength of multiple binding interactions.

Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.i

Baseline – The condition of a patient at the start of the clinical trial; a patient’s health status upon starting a clinical trial prior to receiving therapy.

Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.ii

Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.iii

Intracranial – Within the cranium or skull.

PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.iv

PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells. v

PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.

PFS – Progression-Free Survival.

RANO – Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.

SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.

T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.vi

Tetravalent – A tetravalent molecule has four binding sites or regions.

Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.vii

VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.viii

i Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

ii Stefan MI, Le Novère N. Cooperative binding. PLoS Comput Biol. 2013;9(6)

iii US National Cancer Institute, a part of the National Institute of Health (NIH). https://www.cancer.gov/about-cancer/treatment/types/immunotherapy. Accessed March 2024.

iv Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

v Han Y, et al. PD-1/PD-L1 Pathway: Current Researches in Cancer. Am J Cancer Res. 2020 Mar 1;10(3):727-742.

vi Cleveland Clinic. https://my.clevelandclinic.org/health/body/24630-t-cells. Accessed March 2024.

vii MD Anderson Cancer Center. https://www.mdanderson.org/cancerwise/what-is-the-tumor-microenvironment-3-things-to-know.h00-159460056.html. Accessed March 2024.

viii Shibuya M. Vascular Endothelial Growth Factor (VEGF) and Its Receptor (VEGFR) Signaling in Angiogenesis: A Crucial Target for Anti- and Pro-Angiogenic Therapies. Genes Cancer. 2011 Dec;2(12):1097-105.

Contacts

Contact Summit Investor Relations:
Dave Gancarz

Chief Business & Strategy Officer

Nathan LiaBraaten

Senior Director, Investor Relations

investors@smmttx.com

InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

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BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib as first-line therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China.

This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death. The preliminary result has demonstrated a good efficacy and safety profile.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications related to lymphoma have been included in the National Reimbursement Drug List (NRDL) in China. In the treatment of relapsed/refractor CLL/SLL patients with orelabrutinib, the overall response rate and complete response rate reached 93.8% and 30% respectively, demonstrating an outstanding efficacy and safety profile.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “InnoCare has developed strong pipeline in hemato-oncology that covers a variety of important hemato-oncology targets, including BTK, BLC2, CD19, CD20xCD3, E-3 ligase, etc. ICP-248 and orelabrutinib are important global assets of our company in the field of hematology, with multiple clinical studies conducted in China and the United States. We will accelerate clinical development and look forward to providing CLL/SLL patients with more efficient and safe treatment options.”

CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. There are 191,000 newly diagnosed CLL cases and 61,000 deaths every year globally1. The incidence rate of CLL/SLL is on the rise in China2.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

_________________________

1 American Journal of Hematology
2 Ybanlv

Contacts

Media
Chunhua Lu

86-10-66609879

chunhua.lu@innocarepharma.com

Investors
86-10-66609999

ir@innocarepharma.com

FogPharma Announces $145 Million Financing to Support Ongoing Clinical Development of FOG-001 and Accelerate Helicon Peptide Portfolio

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Financing led by Nextech Invest and joined by new investors RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and Alex Gorsky

CAMBRIDGE, Mass.–(BUSINESS WIRE)–FogPharma®, a clinical-stage biopharmaceutical company dedicated to delivering a new class of therapies that go beyond the limits of currently available medicines using its Helicon™ peptide platform, today announced the successful closing of a $145 million Series E financing round. The financing was led by Nextech Invest with participation from other new investors including RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and former chairman and CEO of Johnson & Johnson, Alex Gorsky.

There was strong support by existing investors, including ARCH Venture Partners, Fidelity Management & Research Company, GV, Cormorant Asset Management, funds and accounts advised by T. Rowe Price Associates, Inc., Farallon Capital Management, venBio Partners, Invus and Milky Way Investments. Alexis Borisy, an accomplished investor and entrepreneur, also joined the company’s board of directors in the position designated to Nextech.

The financing will fund the ongoing clinical development of FOG-001, the company’s first-in-class intracellular TCF-blocking β-catenin inhibitor currently being evaluated in a Phase 1/2 study in solid tumors. The round will also accelerate the development of its robust portfolio of unique discovery programs, deepen its data science capabilities and strengthen its core Helicon therapeutics platform.

FOG-001 is a Helicon designed to block the key oncogenic step in the Wnt/β-catenin signaling pathway, one of the most frequently activated pathways in a variety of cancers. Mutations in the pathway are particularly prevalent in colorectal cancer, the second leading cause of all global cancer deaths, with an estimated two million new cases per year, according to the World Health Organization. Despite significant biological validation of the β-catenin:TCF interaction as a cancer driver, no existing treatment has been able to disrupt it due to its inaccessibility to antibody and traditional small molecule medicines.

“Millions of colorectal cancer patients have been told by their oncologists that no more can be done for them. We believe FOG-001 may represent the long-awaited major technological breakthrough needed to address one of the most common yet unaddressed oncogenic signaling pathways,” said Mathai Mammen, M.D., Ph.D., FogPharma’s chairman, president and chief executive officer. “This financing will allow us to execute on our expanded clinical development and commercialization strategy to deliver FOG-001 to patients, while simultaneously strengthening our discovery efforts against other compelling intracellular targets that drive a range of diseases.”

FOG-001 is the first of several wholly-owned programs generated by FogPharma’s Helicon platform being advanced to address biologically validated disease-driving intracellular targets by modulating protein-protein and protein-DNA interactions inside the cell. FogPharma’s Helicon platform combines ultra-diverse and tunable stabilized helical peptides with custom-built computational physics and artificial intelligence (AI) techniques to enable the discovery and development of novel programs across a vast array of intracellular targets that have never before been drugged.

“We are excited by the tremendous potential of FOG-001 to meaningfully change the therapeutic landscape through a novel approach, and are equally impressed by FogPharma’s robust pipeline of programs for significant drivers of cancer,” said Nextech Managing Partner Thilo Schroeder, Ph.D. “The company’s rapid progress across its growing pipeline demonstrates FogPharma’s team is enabled to deliver on the vast potential of its Helicon therapeutics platform.”

The financing follows a period of rapid growth for the company as its leadership team has expanded with industry veterans with track records in clinical, commercial and data science execution. This includes the company’s Chairman, President and Chief Executive Officer Mathai Mammen, M.D., Ph.D.; healthcare data science pioneer and Chief Data Officer Brandon Allgood, Ph.D.; Chief Technical Operations Officer Rohin Mhatre, Ph.D.; and Chief Business Officer Gregory Miller, MPH, MBA.

About FogPharma®

FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell. FOG-001, the company’s first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass. For more information, please visit: www.fogpharma.com.

Contacts

Media
Ten Bridge Communications

Rebecca Spalding

rebecca@tenbridgecommunications.com

GENESIS Pharma – Exclusive Distribution Agreement with Regeneron Pharmaceuticals to Commercialize cemiplimab in Greece, Cyprus and Malta

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Cemiplimab is an effective PD-1 inhibitor approved by the European Medicines Agency for certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, advanced non-small cell lung cancer and advanced cervical cancer.

ATHENS, Greece–(BUSINESS WIRE)–GENESIS Pharma, a regional biopharma company specialized in the commercialization of innovative medicines targeting severe and rare diseases in Central and Eastern Europe, announces an exclusive distribution agreement for the cancer medicine cemiplimab in Greece, Cyprus and Malta with Regeneron Ireland DAC. Regeneron Ireland DAC is a wholly owned subsidiary of Regeneron, a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.

Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune® technology. In the European Union, cemiplimab is indicated for adults as monotherapy treatment for certain patients with locally advanced or metastatic basal cell carcinoma (BCC), as monotherapy treatment for certain patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC), as both monotherapy or in combination with chemotherapy for certain patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and as monotherapy treatment for certain patients with recurrent or metastatic cervical cancer.

The two companies will work to seamlessly complete the transition of all relevant commercialization activities by the second quarter of 2024.

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “For more than 20 years our company has been committed to ensure patient access to innovative therapies for serious diseases in several European markets building upon a constantly growing network of partners that includes leading global biopharma companies. It is thus our honor to initiate a new agreement with Regeneron, a pioneering company committed to cutting-edge science, that further enhances our long-term expertise and focus on medicines targeting difficult-to-treat cancers.”

About GENESIS Pharma: GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies.

For more information, please visit www.genesispharmagroup.com or follow GENESIS Pharma on LinkedIn.

Contacts

Media:
Natalia Karahaliou

nkarahaliou@genesispharma.com
+30 210 87 71 605

VERAXA Biotech AG acquires Synimmune GmbH to expand cancer pipeline

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Zurich, 29th of December 2023: VERAXA Biotech AG, a pioneering company in the development of superior antibody-based cancer therapies and a portfolio company of Xlife Sciences AG (SIX: XLS), is proud to announce the acquisition of Synimmune GmbH and its innovative Phase I antibody (FLYSYN) for the treatment of Acute Myeloid Leukemia (AML). This marks a major milestone in the company’s history and with the expansion of VERAXA’s cancer pipeline it is hope for patients battling AML – one of the most common types of acute leukemia in adults.

The FLYSYN antibody was acquired by VERAXA Biotech AG from Xlife Sciences AG portfolio company Synimmune GmbH via a share deal. The deal included an upfront payment as well as several milestones and will reach a total deal value of up to 32 million EUR. With this clinical asset, VERAXA strengthens its internal cancer pipeline of innovative antibodies and antibody-drug conjugates (ADCs).

AML, characterized by its prevalence in individuals over the age of 68 and accounting for approximately 1% of all cancer occurrences, has long presented a challenge in the medical community, particularly for those under 45 where it is less common. The successful First-in-Man multicenter clinical study of FLYSYN focused on patients with AML who had measurable residual disease (MRD). The introduction of FLYSYN, is a testament to VERAXA Biotech AG’s commitment to advancing healthcare and providing innovative solutions for serious health conditions.

Oliver R. Baumann, CEO of Xlife Sciences AG comments: «Securing the innovative Phase I antibody, FLYSYN, for Acute Myeloid Leukemia (AML) treatment marks a significant step forward. This milestone reflects our commitment to advancing healthcare and sets the stage for a promising future in reshaping AML treatment. »

Dr. Christoph Antz, CEO of VERAXA Biotech AG, stated: «With FLYSYN, we are one step closer to offering better, more effective treatments for those affected by Acute Myeloid Leukemia. »

As we continue to navigate the complexities of AML treatment, VERAXA Biotech AG remains steadfast in its mission to transform the landscape of medical care. For more information about VERAXA Biotech AG and our work in AML treatment, please visit www.veraxa.com.

 

Financial calendar

Annual Report 2023 23 April 2024
Annual Shareholders Meeting 2024 20 June 2024
Half-Year Report 2024 19 September 2024

Contact 
Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch
Information related to VERAXA Biotech AG: Dr. Christoph Antz, antz@veraxa.com

Xlife Sciences AG 
Talacker 35, 
8001 Zurich, Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange

End of Inside Information

Language: English
Company: Xlife Sciences AG
Talacker 35
8001 Zürich
Switzerland
Phone: +41 44 385 84 60
E-mail: info@xlifesciences.ch
Internet: www.xlifesciences.ch
ISIN: CH0461929603
Valor: A2PK6Z
Listed: SIX Swiss Exchange
EQS News ID: 1806049

 
End of Announcement EQS News Service

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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

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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.

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 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:

  • MTL‑CEBPA, 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 MTL‑CEBPA 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

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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

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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

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

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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 tumor–associated 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