On May 21, 2025 Kaida BioPharma ("Kaida" or the "Company"), an early-stage pharma company dedicated to advancing targeted anti-cancer therapies to address hormone-driven cancers affecting women, reported it has entered into a manufacturing agreement with Northway Biotech, Inc. ("Northway Biotech"), an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), for the manufacturing of lead product candidate, KAD101.

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Under the terms of the agreement, Northway Biotech will leverage its expertise to develop a robust manufacturing process for KAD101. This involves developing and qualifying analytical methods, optimizing the formulation, development and scaling up of the production process, and manufacturing a cGMP drug substance batch for clinical studies.

"We are incredibly pleased to establish this important partnership with Northway Biotech, a pre-eminent CDMO, to manufacture the clinical drug product necessary for our planned Phase 1 clinical study for our lead program, KAD101. We believe that the expertise and skill sets provided to Kaida by entering into this strategic partnership represents a significant step forward for the Company and our clinical development program," commented Craig Pierson, Founder and Chairman of Kaida BioPharma. "We look forward to working closely with the Northway Biotech team to advance our lead product candidate, KAD101, and progress towards providing targeted anti-cancer therapies to address hormone-driven cancers affecting women."

"We are proud to partner with Kaida BioPharma on the development of KAD101," said Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech. "Kaida’s scientific leadership and commitment to addressing unmet medical needs make them an ideal partner, and we are committed to supporting the program as it moves toward clinical trials."

Kaida is advancing targeted anti-cancer hormonal therapies to address the root cause of cancers affecting women. The Company’s lead program, KAD101 is a novel biologic that blocks the prolactin receptor to prevent cancer cell growth signals and incite autophagy initially targeting ovarian cancer. The original biologic G129R, demonstrated encouraging results in a human clinical study with all patients showing tumor reduction on the low dose cohort with a clean safety profile as a daily injectable. The Company has transformed G129R into a bi-weekly injectable now known as KAD101 and continues to progress the development towards the launch of a Phase 1 study, expected to commence in Q4 2026/Q1 2027. Additionally, the Company is advancing KAD102, an enhanced pure antagonist of KAD101, for the treatment of uterine cancer.

(Press release, Kaida BioPharma, MAY 21, 2025, View Source [SID1234663812])

On May 21, 2025 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, reported that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5 inhibitor.

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"Dosing the first patient in the TNG456 Phase 1/2 trial marks a significant step for us and for patients with MTAP-deleted GBM," said Adam Crystal, M.D., Ph.D., President, Research and Development of Tango Therapeutics. "People with GBM currently have few treatment options and a five-year survival rate below 10%. 45% of GBM is MTAP-deleted, thus a substantial number of patients have the potential to benefit from TNG456, where preclinical studies demonstrate potency, MTAP-selectivity and brain exposure that has the potential to be sufficient for meaningful efficacy in GBM."

The Phase 1/2 clinical trial (NCT06810544) is evaluating the safety, pharmacokinetics, pharmacodynamics and antitumor activity of TNG456 as a monotherapy and in combination with abemaciclib. We are currently enrolling patients with TNG456 monotherapy in dose escalation focused on GBM.

(Press release, Tango Therapeutics, MAY 21, 2025, View Source [SID1234662281])

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.