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.

On January 29, 2025 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, reported that the Singapore Health Sciences Authority (HSA) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel (Press release, IASO Biotherapeutics, JAN 29, 2025, View Source [SID1234649935]). This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies.

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Equecabtagene Autoleucel (trade name: FUCASO) was approved by China’s National Medical Products Administration (NMPA) on June 30, 2023, for the treatment of adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies, including at least one proteasome inhibitor and an immunomodulatory agent. As the world’s first commercialized fully human CAR-T product, FUCASO has gained recognition from healthcare professionals and patients in China or its remarkable efficacy and safety since its launch. Furthermore, it has also attracted patients from over ten countries to China to receive this innovative therapy.

Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, stated, "Expanding our global footprint is a core strategy for IASO Bio. Singapore is the first country where we have submitted an overseas NDA. The official acceptance of the NDA for Equecabtagene Autoleucel by the HSA marks a significant milestone in our journey to ‘go global.’ Equecabtagene Autoleucel has demonstrated outstanding efficacy and safety in both clinical trials and real-world settings. We will actively cooperate with the HSA throughout the regulatory process and strive to expedite the launch of this CAR-T therapy in Singapore. Upon NDA approval, we plan to implement an innovative model of ‘Manufactured in China, supplied overseas’, enabling the export of domestically produced autologous CAR-T therapies to other countries.

There is significant unmet medical need for CAR-T therapy in emerging markets. We have an experienced regulatory team for international registration and possess the capability to efficiently advance our overseas commercialization efforts. As the next step, we plan to initiate registration in multiple countries simultaneously to accelerate our global expansion.. We hope that this innovative therapy will benefit patients in more countries worldwide."

About Multiple Myeloma（MM)

Multiple myeloma (MM) is the second most common hematological malignancy in Singapore as well as globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. In Singapore, the incidence of MM in 2022 was 2.2 per 100,000 people, with a 5-year prevalence of 15.0 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses.

About FUCASO(Equecabtagene Autoleucel)

FUCASO(Equecabtagene Autoleucel) is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane, and 4-1BB co-stimulatory and CD3ζ activation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, FUCASO demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper responses, providing continuous protection and care for patients with multiple myeloma.

On January 29, 2025 Amgen (NASDAQ:AMGN) reported that the European Commission (EC) has approved BLINCYTO (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) (Press release, Amgen, JAN 29, 2025, View Source [SID1234649934]).

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"This approval represents a significant advancement, offering patients the opportunity to receive BLINCYTO earlier in their treatment pathway, with the potential to improve outcomes," said Jean-Charles Soria, senior vice president of Global Oncology Development at Amgen. "The E1910 data that served as the basis of this approval adds to the growing body of evidence of the meaningful survival impact of BLINCYTO."

The Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm (n=112) and 62.5% in the chemotherapy arm (n=112).

"While there has been some treatment progress, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at high risk of relapse," said Robin Foà, M.D., emeritus professor of hematology, Sapienza University of Rome. "The E1910 study results highlight that BLINCYTO has the potential to advance frontline consolidation treatment, including patients who are minimal residual disease (MRD)-negative, offering a crucial new option to achieve deeper remissions and improve long-term survival."

The E1910 study was designed and conducted independently from industry. ECOG-ACRIN led the trial with public funding and sponsorship provided by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement.

About Acute Lymphoblastic Leukemia (ALL)
ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. In Europe, ALL has an estimated prevalence of 1.28 persons per 100,000 people.1 Among both children and adults, the most common subtype of ALL is B-ALL.1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow.2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults.4

About BLINCYTO (blinatumomab)
BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body’s immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:

Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Patients with Philadelphia chromosome-positive B-ALL should have failed treatment with at least two tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.
Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1%.
Pediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
Pediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as part of the consolidation therapy.
Adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-ALL as part of consolidation therapy.
BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of:

Adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase of multiphase therapy.
CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older.
Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older.
EU SAFETY INFORMATION FOR BLINCYTO
The safety profile of BLINCYTO in the Phase 3 E1910 study was consistent with the known safety profile for BLINCYTO.

See BLINCYTO full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

About BiTE Technology
Bispecific T-cell Engager (BiTE) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing multiple BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit View Source