On May 22, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported the publication of two abstracts on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website in advance of the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 30-June 3 in Chicago, Illinois (Press release, Allogene, MAY 22, 2025, View Source [SID1234653293]).

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An oral presentation will feature ALLO-316, an investigational AlloCAR T product targeting CD70. ALLO-316 is currently being studied in patients with advanced or metastatic renal cell carcinoma (RCC). Leveraging the proprietary Dagger technology to enable robust CAR T cell expansion, it stands as the first and only allogeneic CAR T product to show promise in treating solid tumors. The upcoming presentation will share updated data from the Phase 1 TRAVERSE study with a focus on the Phase 1b expansion cohort in which patients were treated with a standard regimen of cyclophosphamide and fludarabine followed by a single dose of 80 million CAR T cells.

In addition, a Trial-in-Progress (TIP) poster will highlight the innovative design of the ongoing pivotal Phase 2 ALPHA3 trial evaluating cemacabtagene ansegedleucel (cema-cel) as part of a first line (1L) consolidation strategy in patients with large B-cell lymphoma (LBCL) who remain minimal residual disease (MRD) positive at the completion of 1L chemoimmunotherapy.

Allogene Presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.
Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Session Date and Time: Sunday, June 1, 9:45AM-12:45PM CT
Presentation Time: 12:21 PM-12:33 PM CT

ALPHA3: A pivotal phase 2 study of first line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy.
Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster Session Display Date and Time: Sunday, June 1, 9:00AM-12:00PM CT

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

On May 22, 2025 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases at ASCO (Free ASCO Whitepaper) (Press release, Adagene, MAY 22, 2025, View Source [SID1234653292]).

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Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope added, "The 20 mg/kg Q6W dose has demonstrated a significant reduction in treatment-related toxicities – with fewer than 20% Grade 3 adverse events and no discontinuations – while maintaining a near 30% ORR, including in patients with peritoneal involvement. Notably, responders in the 20 mg/kg cohorts remain on treatment, supported by tumor assessments, CEA levels, and ctDNA biomarkers." Dr. Fakih continued, "It is exciting to see the higher ORR and durable responses. There is also early separation shown on the Kaplan-Meier overall survival curves when compared to historical controls. These data are consistent with the more mature overall survival seen in the 10 mg/kg cohorts."

"CTLA-4 has been studied for over a decade, with toxicity remaining the primary limiting factor in maximizing efficacy," said Peter Luo, Ph.D., CEO and President of R&D at Adagene. "We are pleased with our predictive PK/PD framework, which integrates molecular design features and mechanism of action with clinical and preclinical tumor/plasma PK data for cross-reactive ADG126 in combination with anti-PD-1 therapy. This framework guides dosing regimens for MSS CRC patients without liver metastases, optimizing ADG126’s therapeutic index to maximize efficacy while minimizing cumulative treatment-related toxicities for long-term clinical benefit. Our masking technology further reduces toxicity, allowing patients to remain on treatment longer for sustained benefit."

As of April 22, 2025, a total of 67 MSS CRC patients with no liver metastases including those with peritoneal involvement were treated with ADG126 at a dose of either 10 mg/kg or 20 mg/kg, in combination with KEYTRUDA (pembrolizumab: 200 mg, Q3W), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy. The 10 mg/kg dose was administered once every three weeks or once every six weeks. The 20 mg/kg dose was administered once as a loading dose, followed by 10 mg/kg every three weeks, or 20 mg/kg every six weeks.

In the dose expansion phase of the study, patients in the 10 mg/kg Q3W cohort demonstrated an ORR of 17% and patients in the 20 mg/kg cohorts demonstrated a confirmed ORR of 29%. Median duration of response (DoR) in the 10 mg/kg cohorts was 6.2 months, while the median DoR was not yet reached in the 20 mg/kg cohorts and all the responses are ongoing. Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, comparing favorably with current standard of care treatments and historical benchmarks. Median OS for the 20 mg/kg cohorts has not yet been reached.

Both 20 mg/kg cohorts achieved equivalent ORRs at 29%, while adverse events were less severe and seen less frequently with Q6W dosing compared to a 20mg/kg loading dose followed by 10mg/kg Q3W.

As data continue to mature in the 20 mg/kg cohorts, the Company plans to discuss dosing regimen with regulatory bodies and obtain their endorsement for the next phase of clinical development.

ASCO Poster Details

· Abstract Title: Safety and Efficacy of ADG126 (an Anti-CTLA-4 Masking Antibody) in Combination with Pembrolizumab: Updated Results of Phase 1b/2 Study in Advanced MSS CRC
· Date: Saturday, May 31, 2025
· Poster Viewing: 9:00 AM-12:00 PM CDT
· Onsite Location: McCormick Place, Chicago, IL, Board #248
· Abstract Number: 3579

Poster will be made available on the Publications page of the company’s website here.

On May 21, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) in an underwritten public offering (Press release, Cel-Sci, MAY 21, 2025, View Source [SID1234653286]). All of the shares of common stock (and/or Pre-Funded Warrants) are being offered by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital.

ThinkEquity is acting as sole book-running manager for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying base prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying base prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

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 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 May 21, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) (Press release, InnoCare Pharma, MAY 21, 2025, View Source [SID1234653285]). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China.

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"The data from the Chinese clinical study of Minjuvi – similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR)," said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. "The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients."

"The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL," said Professor Weili Zhao from Shanghai Ruijin Hospital. "We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo’ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy."

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "Today’s approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China."

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients.

Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases1.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

In the United States, Monjuvi (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

On May 21, 2025 ME Therapeutics Holdings Inc. ("ME Therapeutics" or the "Company") (CSE: METX) (FSE: Q9T), a publicly listed preclinical biotechnology company working on novel cancer fighting drugs in the field of immuno-oncology, reported that its subsidiary, ME Therapeutics Inc., is receiving advisory services and up to $140,000 in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) (Press release, ME Therapeutics, MAY 21, 2025, View Source [SID1234653284]). The project will support the research and development of ME Therapeutic’s mRNA therapeutic program targeting myeloid cell biology for the treatment of cancer and inflammatory disease.

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"We are pleased to receive this support from NRC IRAP, which builds on advisory services and funding received in past years, to allow us to further advance preclinical studies for our mRNA therapeutic candidates that target key myeloid cell pathways," said Salim Dhanji, CEO of ME Therapeutics. "Our team at ME Therapeutics passionately believes myeloid cell-derived mRNA therapies represent the next wave of treatments for patients with cancer and inflammatory disease who today have limited treatment options, and we are committed to bringing these potential new approaches to the clinic as soon as possible."

ME Therapeutics’s proprietary mRNA sequences have been engineered to encode for proteins that can modify the immune response in vivo in a targeted manner. Their lead mRNA therapeutic candidate is specifically designed to modulate immune cells in the tumour microenvironment and stimulate an anti-cancer immune response. Preclinical testing has already demonstrated encouraging anti-cancer activity in a mouse model of colorectal cancer. In addition, ME Therapeutics is exploring design modifications of its mRNA candidates to modulate mRNA expression in a tissue-specific manner for increased efficacy and safety.