ACTG Announces Launch of Clinical Trial Evaluating Combination of Three Novel Immune-based Therapies for HIV Cure




ACTG Announces Launch of Clinical Trial Evaluating Combination of Three Novel Immune-based Therapies for HIV Cure

Study will enroll participants who initiated treatment shortly after acquiring HIV

LOS ANGELES, April 19, 2024 (GLOBE NEWSWIRE) — ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of A5374, a phase 1/2a study evaluating the safety, tolerability, and antiviral effect of a novel combination regimen that includes therapeutic T-cell vaccines, two broadly neutralizing antibodies (bNAbs), and an immune-system boosting treatment among people living with HIV who started antiretroviral treatment (ART) during acute (early) HIV infection. A5374 (Triple Immune Strategy for HIV Remission) is a multi-site, randomized, placebo-controlled trial. The study hypothesizes that this combination regimen will be safe and result in a longer period of viral control during a closely monitored pause in ART (known as an analytic treatment interruption) compared to placebo.

While current ART can manage HIV very well, it does not cure it and people living with HIV have to take it for the rest of their lives in order to suppress viral replication and protect their immune systems. The approach being studied in A5374 is part of a potential path toward enabling the immune system to manage HIV in the absence of ART for weeks or months.

“We expect that controlling HIV in the absence of ART will require a combination of novel treatments to decrease the number of cells harboring HIV and simultaneously stimulate the immune system to keep the virus from replicating,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “A5374 is a pivotal trial and we are hopeful that it will provide us with important insights into how to boost the immune system so that it can control HIV.”

A5374 will enroll 45 participants aged 18 years and older who started combination ART within 28 days of acute HIV diagnosis (30 who will receive active study treatment and 15 who will receive placebo). The study will last up to approximately two years for each participant.

After enrollment, participants will continue taking their HIV medications and will either receive a series of novel treatments or placebo. The novel regimen includes a T-cell vaccine regimen (vaccines vectored by replication-deficient chimpanzee adenovirus ChAdOx1 and poxvirus MVA, each containing six small fragments of HIV); broadly neutralizing antibodies (teropavimab, also known as GS-5423 or 3BNC117-LS, and zinlirvimab, also known as GS-2872 or 10-1074-LS); and vesatolimod (a toll-like receptor 7 or TLR7 agonist, which acts as an immune booster). After about 16 months in the study, participants will stop taking ART. They will be closely monitored for increases in HIV viral load, decreases in CD4 T-cell counts, and symptoms, and will resume taking ART if there is a signal that HIV is rebounding or if they become pregnant. The study will compare the length of time that participants in the active treatment and placebo groups experience viral control while they are off ART.

“Our goal with this study is to demonstrate that enhancing immune responses to HIV will lead to sustained suppression of HIV during treatment interruption,” said A5374 Protocol Chair Sharon A. Riddler, M.D., M.P.H., University of Pittsburgh.

Carefully monitored analytic treatment interruptions are an important part of HIV cure clinical trials. They can help determine whether a research intervention can reduce latent HIV (HIV that is “hidden” in different cells and tissues but not replicating) or increase immune function and delay or prevent latent HIV from actively replicating.

A5374 will take place at up to 10 sites in the United States and Brazil. It is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (which also funds ACTG), under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. The University of Oxford is supplying the T-cell vaccines and conducting endpoint assays. Gilead Sciences is supplying the bNAbs and TLR7 agonist.

A5374 is led by Dr. Riddler and Cynthia L. Gay, M.D., M.P.H., University of North Carolina (UNC) (Co-vice Chair) and John Mellors, M.D., University of Pittsburgh (Co-vice Chair). ACTG is led by Dr. Currier and Joseph J. Eron, M.D., UNC (ACTG Vice-Chair).

For more information about A5374, please visit clinicaltrials.gov.

About ACTG
ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.

Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH.

Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net 

PharmAla Closes Private Placement and Concurrent Debt Settlement




PharmAla Closes Private Placement and Concurrent Debt Settlement

VANCOUVER, British Columbia, April 19, 2024 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that, further to its press release dated April 10, 2024 (the “April 10 Release”), the Company has closed its previously announced non-brokered private placement offering (the “Offering”) effective today (the “Closing Date”) through the issuance of 4,166,665 Units for gross proceed of $750,000. Capitalized terms not otherwise defined herein have the meanings attributed to them in the April 10 Release.

Each Unit was sold at a price of $0.18 per Unit and consisted of one Common Share and one-half of one Warrant. Each whole Warrant entitles the holder thereof to acquire one Additional Share at a price of C$0.27 per Additional Share at any time prior to 4:30 pm (Toronto Time) on the date that is thirty six months following the Closing Date, provided that, if the closing price of the Common Shares on the CSE is $0.38 or greater per Common Share for a period of ten consecutive trading days at any time after the completion of the Offering, the Company may accelerate the Warrant Term, in compliance with the policies of the CSE, such that the Warrants shall expire on the date which is thirty days following the date a press release is issued by the Company announcing the reduced Warrant Term in accordance with the terms and conditions of the certificate representing such Warrants, as further outlined in the April 10 Release.

The Company intends to use the net proceeds of the Offering for the securing of global patent rights for its portfolio of novel intellectual property assets, manufacture of products for sale, clinical trials into the Company’s novel patented drug candidates, sales, general corporate and working capital purposes.

All securities issued under the Offering are subject to: (i) a four month and one day hold period from the date of issuance and (ii) applicable legends as required pursuant to the United States Securities Act of 1933, as amended.

Debt Settlement

The Company also announces that the Company has completed a debt settlement in the amount of $108,000 with a third-party consultant of the Company to preserve the Company’s cash for working capital through the issuance of 600,000 Common Shares at a price of $0.18 per Common Share (the “Debt Settlement”).

The Common Shares issued in connection with the Debt Settlement are subject to a statutory hold period of four months and one day from the date of issuance.

Related Party Transaction

NKO Consulting Corp., a company controlled by Nicholas Kadysh, a director and officer of the Company (the “Participating Insider”) participated in the Offering and acquired an aggregate of 277,778 Units. The participation of the Participating Insider in the Offering constitutes a “related party transaction”, as such term is defined in MI 61-101. In completing the Offering, the Company has relied on exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101, on the basis that the fair market value of the Participating Insider’s participation in the Offering does not exceed 25% of the market capitalization of the Company, as determined in accordance with MI 61-101.

Further details will be included in a material change report to be filed by the Company. The Company did not file a material change report more than 21 days before the closing date of the Offering. In the Company’s view, the shorter period was necessary to permit the Company to close the Offering in a timeframe consistent with usual market practice for a transaction of this nature and was reasonable and necessary to improve the Company’s financial position in a timely manner.

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca

Neither the CSE nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “strategy”, “expects” or “does not expect”, “intends”, “continues”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “will be taken”, “will launch” or “will be launching”, “will include”, “will allow”, “will be made” “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding the use of proceeds from the Offering.

Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements. Although the Company believes that the expectations reflected in these statements are reasonable, such statements are based on expectations, factors, and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Company’s control, including but not limited to the risk factors discussed under the heading “Risk Factors” in the Company’s management’s discussion and analysis, and elsewhere in this press release, as such factors may be further updated from time to time in our periodic filings, available at www.sedarplus.ca, which factors are incorporated herein by reference. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results, or otherwise, or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

Lifeward Announces the Appointment of Mike Swinford to its Board of Directors




Lifeward Announces the Appointment of Mike Swinford to its Board of Directors

Experienced healthcare and rehabilitation technology professional brings more than 30 years of experience in commercialization and new business development

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 19, 2024 (GLOBE NEWSWIRE) — ReWalk Robotics Ltd. (DBA Lifeward™) (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global market lead delivering life-changing solutions to revolutionize what is possible in rehabilitation, recovery, and the pursuit of life’s passions in the face of physical limitation or disability, announced that the Board has approved the appointment of Mike Swinford to the Board of Directors, effective April 18, 2024.

Mr. Swinford has been Chief Executive Officer of Numotion since July 2014, where he has grown the company to become the largest provider of mobility and independence solutions in the United States – serving over 400,000 individuals annually with Spinal Cord Injuries, Traumatic Brain Injuries, ALS, Muscular Dystrophy, Cerebral Palsy, Multiple Sclerosis, Spinal Muscular Atrophy, Amputees and many other mobility related disabilities. As CEO at Numotion, he has expanded commercial coverage with over 5000 health plans, rehab hospitals, specialty and multi-disciplinary clinics, skilled nursing facilities, primary care, and home health providers. He has led efforts for benefit coverage determination for Power Wheelchair Seat Elevation systems in 2023 and is actively leading efforts for Power Standing Wheelchairs and reform of Service and Repair regulations and reimbursement levels.

Prior to Numotion, he had a highly successful 22-year career at GE Healthcare, including serving as the President and CEO of GE Healthcare Services and as an officer of General Electric Company. Mr. Swinford held various operational and commercial roles throughout his career leading through various business cycles from start-ups to turnarounds. Mr. Swinford also serves as a director of CareATC, a technology enabled population health primary care provider, as well as a director of Aspen Surgical, a global surgical supply manufacturer. 

“As someone who is passionate about improving healthcare access and inclusion for people with disabilities, I am excited to join the Board of Directors of Lifeward,” said Mr. Swinford. “I look forward to bringing my knowledge of the industry and my experience with CMS coverage implementation to help Lifeward further its commercialization strategies for the benefit of the disabled community.”

“Mike Swinford brings unique experience and familiarity with the industry and reimbursement to our Board,” said Jeff Dykan, Chairman of the Board of Directors of Lifeward. “He has a remarkable track record that is an excellent fit with our focus on commercialization and expanded access to devices for physical rehabilitation and recovery, and his commitment to furthering opportunities for people with disabilities is an inspiration to us all. This is another step to increase the direct commercialization skills and experience within our Board. We are delighted to welcome Mike to the Board.”

For more information, please visit GoLifeward.com

About Lifeward
Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity systems, the ReStore Exo-Suit, and the MyoCycle FES Systems.

Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. For more information on the Lifeward product portfolio, please visit GoLifeward.com.

ReWalk^®, ReStore^® and Alter G^® are registered trademarks of ReWalk Robotics Ltd. (DBA Lifeward) and/or its affiliates.

Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Such forward-looking statements may include projections regarding the Company’s future performance and other statements that are not statements of historical fact and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek,” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Lifeward’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements are more fully discussed in the Company’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, Lifeward undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Lifeward Media Relations:
LifeSci Communications
E: media@golifeward.com

Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward
E: ir@golifeward.com

CorMedix Inc. Announces CMS Grants TDAPA to DefenCath




CorMedix Inc. Announces CMS Grants TDAPA to DefenCath

BERKELEY HEIGHTS, N.J., April 19, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath^® meets the criteria for a Transitional Drug Add-On Payment (TDAPA) in the anti-infective functional category, beginning on July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers, and aligns with CorMedix’s upcoming outpatient launch in July.

Joseph Todisco, Chief Executive Officer of CorMedix commented, “CMS determination of TDAPA eligibility for DefenCath is a critical step toward ensuring this innovative preventative drug product is available for patients in the outpatient dialysis setting. We are pleased that CMS was able to take timely action on our application for a July 1st effective date, and we intend to work closely with outpatient dialysis providers to ensure proper TDAPA implementation.”

DefenCath (taurolidine and heparin) catheter lock solution (CLS) is approved by the U.S. Food and Drug Administration (FDA) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (HD-CVC). To learn more about DefenCath, visit DefenCath.com.

DefenCath^® (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION

These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.

LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

DefenCath is contraindicated and has warnings and precautions in patients with:

• Known heparin-induced thrombocytopenia (HIT).
• Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.

If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.

To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see the full Prescribing Information.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath^®, which was approved by the FDA on November 15, 2023 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

VPR Brands LP Reports Record Annual Financial Performance for Fiscal Year 2023




VPR Brands LP Reports Record Annual Financial Performance for Fiscal Year 2023

The Company Concluded the Year With Revenue Doubling, Alongside Substantial Improvements in Gross Profit Margins and Net Income

FORT LAUDERDALE, FL, April 19, 2024 (GLOBE NEWSWIRE) — via NewMediaWire – VPR Brands LP (OTCQB: VPRB), a leader in the innovation and monetization of intellectual properties within the electronic cigarette and vaporizer sector, today announced its financial results for the fiscal year ended December 31, 2023. Demonstrating significant growth and enhanced operational efficiency, the company concluded the year with revenue doubling, alongside substantial improvements in gross profit margins and net income.

Annual Financial Highlights:

• Revenues: Increased significantly to $9,853,825, up from $4,927,616 in 2022. The growth is attributed to increased customer sales and the introduction of new royalty revenue streams.
• Net Income: Reported a net income of $3,812,605, reversing a net loss of $203,697 in 2022, showcasing the company’s effective strategies and operational execution.
• Cost of Sales: Rose to $4,972,497, reflecting the increased sales volume, with gross margins impressively expanding to 50.3% in 2023 from 33% in 2022, driven by higher-margin direct-to-consumer online sales and higher wholesale margins.
• Operating Expenses: Increased to $2,210,072 as compared to $1,828,195 in 2022 due to enhanced advertising activities and additional advertising to support the expanded sales and revenue base.
• Cash Flow from Operations: Improved to a positive $3,481,356 in 2023 from a negative $312,423 in 2022, indicating robust operational health and enhanced cash management.

Liquidity and Capital Resources:

• Total Assets: Grew to $3,191,246 from $1,632,528 in 2022, bolstered by increased Cash, Inventory, and Accounts Receivable from the growth in sales.
• Total Liabilities: Decreased to $2,576,936 from $3,951,020 in 2022, significantly reducing the company’s debt profile and enhancing financial stability.

Other Financial Updates:

• Other Income: Other income netted $1,141,350 in 2023, mainly from a litigation settlement which contributed $2,400,172.
• Financing Activities: Net cash used in financing activities was $1,706,517 in 2023, a pivot from net cash provided of $332,254 in 2022, reflecting a strategic reduction in debt levels.

Executive Comments:

Kevin Frija, CEO of VPR Brands LP, stated, “2023 was a pivotal year for VPR Brands. We’ve successfully optimized our patent and trademark portfolio and expanded our market presence, resulting in historic revenue levels and profitability. Our strategic focus on Intellectual Property Monetization, including licensing has positioned us strongly within the competitive landscape.”

Dan Hoff, COO, added, “Our operational achievements this year reflect our commitment to excellence and innovation. With new products in the pipeline and an expanding rapidly into new segments through licensing, we are poised for continued growth, diversification and are focused on delivering sustainable value to our shareholders.”

About VPR Brands LP:

VPR Brands is a technology company and an IP holding company engaged in various monetization strategies of its U.S. patents covering electronic cigarette, vaporizer technologies, and related accessories. The company designs, develops, markets, and distributes products oriented towards the cannabis markets, including the ELF and HONEYSTICK brand of vaporizers and DISSIM Lighters. VPR Brands is actively enforcing its patents and exploring and monetizing licensing opportunities.

For more information about VPR Brands, please visit www.vprbrands.com

Forward-Looking Statements:

This news release contains statements that involve expectations, plans, or intentions, and other factors discussed from time to time in the company’s Securities and Exchange Commission filings. These statements are forward-looking and are subject to risks and uncertainties, so actual results may vary materially. The company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. The company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

Corporate Communications:

For further information, please contact Kevin Frija at kevin.frija@vprbrands.com.

Amarna Therapeutics announces appointment of Aurelia Caparrós as new Chief Business Officer




Amarna Therapeutics announces appointment of Aurelia Caparrós as new Chief Business Officer

Leiden, The Netherlands, 19 April 2024 – Amarna Therapeutics, a privately-held biotechnology company developing transformative gene therapies in a range of rare and prevalent diseases,  including Type 1 Diabetes Mellitus, today announces the appointment of Aurelia Caparrós as the Company’s new Chief Business Officer (CBO), effective 1^st of April 2024.

Aurelia brings more than 25 years of healthcare industry experience with expertise in business development, strategy and global marketing including P&L responsibilities spanning diverse geographies. She held global leadership roles for amongst others Novartis, led multiple enterprise transformation programs and implemented strategic growth initiatives to achieve business goals while fostering the culture of inclusion and enterprise mindset. As the new CBO, she will be responsible for driving Amarna’s future growth and expansion, both in the Netherlands and Spain.

Her key responsibilities will include identifying assets, companies, and areas of interest, designing tailored partnering structures, and securing attractive deals through the entire deal-making process. Aurelia will also play a crucial role in promoting Amarna as the partner of choice at business partnering meetings and scientific conferences, as well as supporting the company’s investor relations and fundraising activities.

“We are thrilled to welcome Aurelia Caparrós as our new Chief Business Officer,” said Henk Streefkerk, CEO and Medical Director of Amarna Therapeutics BV. “Her exceptional leadership and deep industry expertise will be invaluable as we continue to expand our business and bring our transformative gene therapies to patients in need.”

=== E N D S ===

About Amarna
Amarna Therapeutics has developed a groundbreaking non-immunogenic viral platform to deliver any transgene of choice into humans. It is advancing a pipeline of transformative gene therapies for a range of rare and prevalent diseases, including monogenetic indications, autoimmune diseases and chronic inflammation. The lead program Nimvec™ AM510 is being developed for the treatment of patients with Type 1 Diabetes Mellitus. Follow up programs include Multiple Sclerosis, Age-related Macular Degeneration, and Hemophilia.

About Type 1 Diabetes Mellitus
Type 1 Diabetes is a debilitating disease occurring in millions of patients globally, with rising incidences each year, where despite advancements in therapy the life expectancy remains lower than the general population. Diabetes is an autoimmune disease where self-reactive T lymphocytes selectively attack and destroy insulin-producing β cells lodged within the pancreas, leaving the patient unable to maintain glucose homeostasis. Proinsulin (PI) is the primary self-antigen involved in the autoimmune β cell destruction. To date, Type 1 Diabetes cannot be cured, and the glucose homeostasis can be more or less maintained in patients by daily insulin injections. Although Diabetes is seen as a manageable disease nowadays, secondary complications of the current therapy are considerable and lead to significant morbidity and mortality. Using Nimvec™ AM510 we intend to restore the immune tolerance to proinsulin and potentially cure the patients.

More information on www.amarnatherapeutics.com

Follow us on LinkedIn
https://www.linkedin.com/company/amarna-therapeutics-b.v.

For further inquiries please contact:

Amarna Therapeutics
Henk Streefkerk, CEO
E-mail: info@amarnatherapeutics.com

LifeSpring Life Sciences Communication, Amsterdam
Léon Melens
Tel: +31 6 538 16 427
E-mail: lmelens@lifespring.nl

Aurelia Caparrós, New Chief Business Officer Amarna Therapeutics, Leiden, The Netherlands

Attachment

• Aurelia Caparros

FDA approves Roche’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer




FDA approves Roche’s Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer

• Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)¹
• This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy²
• The National Comprehensive Cancer Network® (NCCN®) Guidelines recommend routine testing for ALK, EGFR and PD-L1 biomarkers in people with early-stage NSCLC to inform adjuvant therapy selection

Basel, 19 April 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥ 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour.

“With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At Roche, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”

“The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer, who until now, were not able to receive ALK-specific therapy,” said Ken Culver, Director of Research and Clinical Affairs at ALK Positive, Inc. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC. Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”

The approval is based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.001) compared with platinum-based chemotherapy in people with completely resected IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.¹ In an exploratory analysis, an improvement of central nervous system (CNS) disease-free survival was observed (HR=0.22; 95% CI: 0.08-0.58).¹ The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.¹ These data were presented as a late-breaking oral at the European Society of Medical Oncology Congress 2023 Presidential Symposium in October 2023 and were also recently published in the New England Journal of Medicine in April 2024.

Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC. It has demonstrated significant efficacy in patients, including those with CNS metastases, and now with this approval, these benefits could extend to people with early-stage disease. Routine testing of resected surgical tissue or biopsy for ALK, EGFR and PD-L1 biomarkers in patients with stage IB to IIIA and select IIIB (UICC/AJCC 8th edition) NSCLC, in addition to in the advanced setting, is recommended by international guidelines, including the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®), to support clinicians’ decision-making. About 5% of people with NSCLC are ALK-positive, equating to approximately 90,000 people worldwide diagnosed each year.^3-5

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. For this review, FDA collaborated with the Australian Therapeutics Goods Administration (TGA), Health Canada (HC), Israel’s Ministry of Health (IMoH) Pharmaceutical Administration, Switzerland’s Swissmedic, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (UK MHRA). Brazil’s National Health Surveillance Agency (ANVISA) and Singapore’s Health Sciences Authority (HSA) will also be participating as Type C Project Orbis Partners. Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Data from the Phase III ALINA study will also be used for filing submissions to additional global health authorities, including the European Medicines Agency

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomised, active-controlled, multicentre, open-label study evaluating the efficacy and safety of adjuvant Alecensa® (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer. The study included 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival (DFS). Secondary outcome measures include overall survival, central nervous system-DFS, and percentage of patients with adverse events.

About lung cancer
Lung cancer is one of the leading causes of cancer death globally.⁶ Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.⁶ Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small-cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.⁷ Today, about half of all people with early lung cancer (45-76%, depending on disease stage) still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.² Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.⁸

About Alecensa® (alectinib)
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, Kamakura Research Laboratories for people with non-small cell lung cancer (NSCLC) whose tumours are identified as anaplastic lymphoma kinase (ALK) positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan and China.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have six approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease. Roche is committed to improving treatment of early-stage lung cancers to help increase the chance of cure for more people.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Wu Y-L et al. Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer. NEJM. 2024;390:1265-1276.
[2] Pignon JP et al. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE collaborative group. J Clin Oncol 2008. 20;26(21):3552-9.
[3] Barlesi, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet 2016. 387(10026):1415-1426.
[4] Tian, et al. Clinical characteristics and sequence complexity of anaplastic lymphoma kinase gene fusions in Chinese lung cancer patients. Lung Cancer 2017. 114:90-95.
[5] Cancer.Net®. Lung Cancer – Non-Small Cell: Statistics. [Internet; cited April 2024]. Available from: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
[6] Thandra KC, et al. Epidemiology of lung cancer. Contemp Oncol. 2021;21(1):45-52.
[7] American Cancer Society: What Is Lung Cancer? [Internet; cited 2024 April] Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
[8] Hendricks LE, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4): 339-357.

Roche Global Media Relations
Phone: +4 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

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• 19042024_ Alecensa ALINA PHASE III FDA_EN

Addex to Present at the Swiss Biotech Day 2024




Addex to Present at the Swiss Biotech Day 2024

Geneva, Switzerland, April 19, 2024 – Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug development, announced today that CEO, Tim Dyer, will present at the Swiss Biotech Day 2024 conference taking place April 22 – 23, 2024 at the Congress Center in Basel, Switzerland.

In his live presentation, scheduled for 13:45 – 14:00 CEST, on April 23, 2024, in the Samarkand room on the third floor, Mr. Dyer will provide a corporate update and discuss recent developments at Addex.

Mr. Dyer will be available for one-on-one meetings throughout the conference. For more information or to schedule a one-on-one meeting with management, please contact IR@addexpharma.com.

About Addex Therapeutics:
Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical study for the treatment of epilepsy. The Company’s second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in dyskinesia associated with Parkinson’s disease and post-stroke/TBI recovery. Addex partnership with Indivior on GABAB PAM is advancing multiple drug candidates through clinical candidate selection for substance use disorder. Under the agreement with Indivior, Addex is advancing an independent GABAB PAM program for chronic cough through clinical candidate selection. Addex also holds a 20% share in a private company, Neurosterix LLC which is advancing a portfolio of allosteric modulator programs including M4 PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild neurocognitive disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. For more information, visit www.addextherapeutics.com

  
 Contacts: 

Addex Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2023, as filed with the SEC on April 18, 2024, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements. 

2024 Helen Keller Achievement Awards Ceremony Celebrates Media Inclusion




2024 Helen Keller Achievement Awards Ceremony Celebrates Media Inclusion

• Filmmaker Shawn Levy and Actor Marilee Talkington Honored as Trailblazers for Inclusion
• Lucasfilm Lauded as Leader in Accessible Entertainment

LOS ANGELES, April 18, 2024 (GLOBE NEWSWIRE) — The American Foundation for the Blind (AFB) celebrated this evening the achievements of those champions for inclusion in media and the arts during its annual Helen Keller Achievement Awards held at the Japanese American National Museum in downtown Los Angeles. The evening’s honorees — filmmaker Shawn Levy, actor and advocate Marilee Talkington, and Lucasfilm Ltd. — were recognized for their steadfast commitment to keeping Helen Keller’s spirit alive as they drive inclusion in media for people with disabilities. 

“Our honorees this year have truly demonstrated the power that inclusive media can play toward making dreams a reality,” said AFB president and CEO Eric Bridges. “Helen knew well how the power of perception could be leveraged to expand opportunities for people with disabilities, which is why we are excited to bring the awards this year to Los Angeles and shine the light on those who bring inclusion to the global stage.”

Shawn Levy is recognized for his outstanding work with the recent Netflix series All the Light We Cannot See, which captured the heartfelt story of a young blind woman who kept hope alive during her nightly radio broadcast in Nazi-occupied France during World War II. After a nationwide search to find the perfect protagonist for the series, Levy cast the young first-time actor Aria Mia Loberti, who brought unique authenticity to the role. Under Levy’s direction, Loberti transcended the common tropes often ascribed to someone who is blind and brought forward a genuine humanity that speaks to anyone who has ever wrestled with love amidst loss.

With over 25 years of experience on stage and screen, Marilee Talkington has proven that a visually impaired actor’s diverse range of experiences can deepen a person’s craft in the dramatic arts. Talkington is honored not just for breaking through the glass ceiling for performers with disabilities but also for clearing a path for others to follow. Founding the AC3: Access Acting Academy, the first-of-its-kind actor training studio for performers who are blind or have low vision, has allowed Talkington to shift the perception of performers with disabilities. But Talkington’s advocacy also extends its reach to fans of the visual arts, having worked with institutions like the Guggenheim Museum to make art more accessible for patrons who are blind, low-vision, or have other disabilities.

Lucasfilm was recognized during the evening ceremony for its long-standing commitment to providing the highest quality of audio-described content for audiences who are blind, deafblind, or have low vision. Accepting the award was Michael Kohn, Director of Distribution Operations for Lucasfilm, who is responsible for expanding accessible media across Disney’s vast network of distribution channels. Under Kohn’s leadership, Lucasfilm has been recognized as a leader in creating and distributing audio-described content, having also received the 2022 People’s Choice Award from the American Council of the Blind.

Since 1994, the Helen Keller Achievement Award has recognized the finest thought leaders, change-makers, and performing artists committed to carrying on Keller’s mission to create a world of full and equal inclusion for people with disabilities. For over 40 years, Helen Keller was AFB’s leading ambassador, inspiring millions worldwide as she demonstrated all that can be accomplished through determination and perseverance.

AFB continues to honor Keller’s legacy by recognizing exceptional individuals and organizations from industry, education, and the arts who have distinguished themselves in pursuit of expanding possibilities for those who are blind, deafblind, or have low vision. Past honorees include author and advocate Haben Girma, tech leader and entrepreneur Bernard Newcomb, Chef Christine Ha, actor Charlie Cox, and performing artists Ray Charles and Stevie Wonder.

Founded in 1921, the American Foundation for the Blind creates equal opportunities and expands possibilities for people who are blind, deafblind, or have low vision through advocacy, thought leadership, and strategic partnerships. In addition to publishing the Journal of Visual Impairment & Blindness (JVIB), AFB is also the proud steward of the Helen Keller Archive, which is available on the AFB website at www.afb.org.

CONTACT: Contact:Tony Stephens, Director of Communications
 917.676.5266 | tstephens@afb.org

Histogen Files for Voluntary Chapter 11 Protection to Facilitate Wind-Down, Maximize Share Offering




Histogen Files for Voluntary Chapter 11 Protection to Facilitate Wind-Down, Maximize Share Offering

SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) — Histogen Inc. (HSTO, the “Company” or “Histogen”), a drug development company for treatment of bacterial skin infections, today announced that it has filed voluntary petitions for relief under subchapter V of Chapter 11 of the U.S. Bankruptcy Code (“Chapter 11”) in the United States Bankruptcy Court for the Southern District of California to confirm a plan of liquidation that will distribute all value to stakeholders, including shareholders.

Histogen intends to promptly propose and confirm a plan of liquidation and make distributions to the benefit of its estate. The Company announced on Sept. 18, 2023, that it had discontinued further development and would seek approve for a Plan of Dissolution.

Histogen is represented by DLA Piper, LLP as its legal counsel and Armanino LLP as its financial advisor.

ABOUT HISTOGEN
Histogen Inc. was a clinical-stage therapeutics company focused on developing potential clinical and preclinical drugs for a variety of antiapoptotic and anti-inflammatory effects.

CONTACT: MEDIA CONTACT
Martin Stein
AMF Media Group
martin@amfmediagroup.com