On January 29, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported that Chen Schor, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference being held from February 5-6, 2025 in New York (Press release, Adicet Bio, JAN 29, 2025, View Source [SID1234649940]).

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Details of the event are as follows:
Date: Wednesday, February 5, 2025
Time: 2:00 p.m. ET

The live audio webcast can be accessed on the Investors section of Adicet Bio’s website at View Source An archived replay will be available for 30 days following the presentation.

On January 29, 2025 Leveragen Inc., a Boston-based biotech company specializing in next-generation genetic models for antibody discovery, reported a strategic collaboration with Moonlight Bio, a Seattle-based biotech company pioneering advanced T cell therapies (Press release, Moonlight Bio, JAN 29, 2025, View Source [SID1234649939]). This partnership aims to develop cutting-edge T cell therapies to address some of the most challenging and difficult-to-treat cancers.

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The collaboration integrates Leveragen’s proprietary Singularity Sapiens Mouse platform, a groundbreaking tool for generating fully human single-domain antibodies, with Moonlight Bio’s expertise in T cell engineering. Together, the two companies seek to create T cell therapies with enhanced functionality, persistence, and efficacy, overcoming significant barriers in the treatment of solid tumors.

"Leveragen’s mission is to drive innovation in the fight against life-threatening diseases, and expanding our fully human single-domain antibody technology into transformative T cell therapies aligns seamlessly with this vision," said Weisheng Chen, Founder and CEO of Leveragen. "Through this partnership with Moonlight Bio, we are combining our state-of-the-art antibody discovery platform with their advanced cell engineering capabilities to develop T cell therapies that have the potential to make a meaningful difference for patients."

"At Moonlight Bio, we are dedicated to delivering T cell therapies that break through barriers obstructing successful outcomes in solid tumors – the vast majority of the global cancer disease burden," said Jordan Jarjour, Moonlight Bio’s CSO. "Leveragen’s Singularity Sapiens Mouse platform is a powerful tool for generating fully human single-domain antibodies with properties that could optimally translate into advanced T cell therapies, particularly when combined with the tools and technologies that the Moonlight Bio team is advancing. We are very excited to collaborate with Leveragen as we explore and create new solutions in this space."

Under the terms of the agreement, Leveragen will spearhead the discovery of fully human single-domain antibodies against therapeutic targets and Moonlight Bio will oversee the preclinical development of T cell therapies.

This collaboration highlights Leveragen’s leadership in single-domain antibody discovery and its commitment to advancing immunotherapy through innovative science and transformative applications.

On January 29, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported it has entered into an asset purchase agreement to acquire the listeria monocytogenes-based immuno-oncology programs and related intellectual property (IP) assets from Ayala Pharmaceuticals (OTC: ADXS) (Press release, OS Therapies, JAN 29, 2025, View Source [SID1234649938]). The assets being acquired include a Phase 2 lung cancer and Phase1 prostate cancer program, in addition to the gaining direct ownership of the underlying IP related to OS Therapies’ lead asset OST-HER2 for osteosarcoma and other HER2-related indications.

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"The assets being acquired from Ayala complete OS Therapeutics’ ownership of the key intellectual property underlying our listeria monocytogenes immunotherapy platform, as well as bolster our development pipeline with the addition of clinical-stage lung cancer and prostate cancer immunotherapy assets," said Paul Romness, MHP, Chairman & CEO of OS Therapies. "Importantly, this agreement eliminates certain near-term milestone payment obligations related to OST-HER2 in osteosarcoma, projected sales milestone payments, and significantly reduces our effective royalty rate. As a result, we have enhanced both the clinical and financial prospects for the Company with minimal impact to our cash position. The elimination of these milestones payment obligations and reduction in royalties obligations significantly improves the net present value of the OST-HER2 program while also improving our negotiating position with potential partners. Taken together, this agreement bolsters our financial and partnership prospects."

OS Therapies anticipates requesting Biologics Licensing Authorization (BLA) for OST-HER2 in osteosarcoma in the second quarter of 2025, and hopes to be granted a BLA and related Priority Review Voucher (PRV) from FDA by the end of 2025. Additionally, the Company intends to sell the PRV immediately upon issuance and does not intend to initiate any new clinical development programs until it has completed interactions with FDA around OST-HER2 in osteosarcoma.

Under the terms of the agreement, OS Therapies has agreed to pay $0.5 million in cash and issue $7.5 million worth of OS Therapies’ common shares to Ayala. The transaction is expected to close 60 days from execution of the agreement, subject to customary closing conditions.

OS Therapies previously disclosed that it completed a $7.1 million financing, priced at $4.00 per share primarily with existing shareholders, that provides the Company with sufficient cash runway into 2026 inclusive of payments to Ayala. Under the terms of the financing agreement, OS Therapies is prohibited from issuing shares to raise capital for at least 6 months and suspended the issuance of shares to raise capital under its equity line of credit so long as the price of the common stock is below $12.00. The Company’s burn rate is now approximately $0.4M per month.

As part of the financing agreement, OS Therapies agreed to appoint Karim Galzahr to the Company’s Board of Directors. Galzahr is managing partner at OKG Capital, a medtech and life science investor. Galzahr brings over 30 years of experience in all aspects of finance including M&A, asset management, corporate development and strategic advisory work across the technology sector and medical technology sectors.

"I am honored to join the OS Therapies Board of Directors at such a pivotal moment in the Company’s journey," said Galzahr, newly appointed Board Member of OS Therapies. "With compelling Phase 2b osteosarcoma data, the anticipated FDA approval of OST-HER2, and the potential to earn a saleable Priority Review Voucher, the Company is positioned to unlock the full potential of its market leading listeria-based immunotherapy platform. This acquisition not only strengthens its intellectual property portfolio but also clears financial hurdles, paving the way for groundbreaking work in osteosarcoma and expanding opportunities in lung and prostate cancer. I look forward to contributing to OS Therapies’ mission of transforming cancer care and improving patient outcomes worldwide."

Lung Cancer Asset Clinical Data

Lung Cancer

ASCO 2022 Poster: A phase 2 study of an off-the-shelf, multi-neoantigen vector (ADXS-503 / OST-503) in patients with metastatic non-small cell lung cancer either progressing on prior pembrolizumab or in the first line setting.

Conclusions: The addition of ADXS-503 (OST-503) to pembro (Keytruda) after disease progression on pembro appears to be well tolerated and induced antigen-specific T-cell responses and durable disease control in 46% of patients in Part B and 67% of patients in Part C. Additional patients are currently being enrolled into both parts of the study to further explore the potential of A503 to restore or enhance sensitivity to checkpoint inhibitors. Clinical trial information: NCT03847519.

ASCO 2022 Poster: Immunogenicity and disease control induced by a multi-neoantigen vaccine (ADXS-503 / OST-503)) in patients with metastatic non-small cell lung cancer who have progressed on pembrolizumab.

Conclusions: Adding ADXS-503 (OST-503) to pembro (Keytruda) after Progression of Disease appears to induce innate and adaptive immune responses that may restore or enhance sensitivity to checkpoint inhibitors in pts with clinical benefit. Clinical trial information: NCT03847519.
The global lung cancer treatment market size was estimated at $19 billion in 2023 according to Grandview Research and is expected to grow to over $44 billion by 2030. The global prostate cancer treatment market was estimated at $6.4 billion in 2023 according to Grandview Research and is expected to grow to over $16 billion by 2030.

On January 29, 2025 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the pricing of an underwritten public offering of 19,354,839 shares of its common stock at a price to the public of $7.75 per share (Press release, Immunome, JAN 29, 2025, View Source [SID1234649937]). All of the shares are to be sold by Immunome.

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The gross proceeds to Immunome from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $150.0 million. In addition, Immunome has granted the underwriters a 30-day option to purchase up to an additional 2,903,225 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on January 31, 2025, subject to the satisfaction of customary closing conditions.

J.P. Morgan, TD Cowen, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 13, 2024 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 29, 2025 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported a significant milestone: the treatment of the first patient with the Hemopurifier in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier (Press release, Aethlon Medical, JAN 29, 2025, View Source [SID1234649936]). This trial is designed for patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda (pembrolizumab) or Opdivo (nivolumab) (AEMD-2022-06 Hemopurifier Study). The patient was enrolled on October 29, 2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia, and treated with the Hemopurifer on January 29, 2025, by Prof. Toby Coates and the dialysis staff.

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The patient treated was determined to have progressive disease following a two-month "run -in" period of the anti-PD-1 drug Nivolumab. During this period, serial measurements of extracellular vesicles (EVs) and anti-tumor T cell activity were obtained. The patient was then treated with the Aethlon Hemopurifier for 4 hours on a single day and tolerated the procedure without complications. The patient will have follow-up safety visits, EV and T cell measurements as well as imaging for clinical response.

"Treatment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We are excited to receive the data from this first treatment cohort, anticipating insights into how the Hemopurifier may reduce tumor-derived extracellular vesicles and enhance T cell activity against tumors".

Currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

The primary endpoint of the approximately 18-patient, safety, feasibility, and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run-in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation. The Hemopurifier is an extracorporeal device that is used in concert with a blood pump. The device incorporates plasma separation, size exclusion, and affinity binding to an affinity resin containing a plant lectin. Mannose on the surface of enveloped viruses and extracellular vesicles binds to the plant lectin within the device. Extracellular vesicles released from solid tumors have been implicated in the spread of cancers known as metastasis as well as in the resistance to immunotherapy and chemotherapeutic agents. Removal of enveloped viruses and extracellular vesicles has been observed in in vitro studies and in human subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard-of-care therapy. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.