On March 17, 2025 Anocca AB, a leading T-cell immunotherapy company, reported the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state (Press release, Anocca, MAR 17, 2025, View Source [SID1234655345]). VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility.

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The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy.

Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025.

Reagan Jarvis, co-founder and Chief Executive Officer, commented, "This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years."

Zahid Bashir, Chief Medical Officer at Anocca, elaborated, "We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer."

About the VIDAR-1 clinical programme

VIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product.

More information about the clinical trial can be found at the EU’s clinical trials website.

About KRAS and PDAC

Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2).

References

1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon1166

2. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-w

On March 17, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of a best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) (Press release, Cel-Sci, MAR 17, 2025, View Source [SID1234651204]). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $2,560,000. The offering is expected to close on March 18, 2025, subject to satisfaction of customary closing conditions.

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

ThinkEquity is acting as sole placement agent 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 final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 17, 2025 CEL-SCI Corporation (NYSE American: CVM) reported it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study’s Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer (Press release, Cel-Sci, MAR 17, 2025, https://www.businesswire.com/news/home/20250316883464/en/CEL-SCIs-Head-and-Neck-Cancer-Registration-Study-Protocol-Clears-FDA-Reviewin-Talks-with-Potential-Partners-Interested-in-Commercialization-of-Multikine [SID1234651203]). The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024.

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CEL-SCI’s 73,000 square foot Multikine manufacturing facility presently has the capacity to produce over 12,000 Multikine treatments per year. Over $200 million has been invested in the facility and the development and validation of its proprietary biologic manufacturing processes.

"Given Multikine’s excellent survival data, strong statistics and the recent focus on PD-L1 as a diagnostic biomarker for predicting the most effective treatment strategy for head and neck cancer, we are pursuing discussions with key parties to help CEL-SCI complete the last study needed in order to pursue marketing approval for Multikine," stated CEL-SCI CEO Geert Kersten.

"These discussions may lead to potential partnerships involving non-dilutive funding for the 212-patient confirmatory Registration Study designed to bring Multikine to market. We are seeing new interest from highly placed individuals and commercial entities that recognize that Multikine, based on its different mechanism of action, is uniquely positioned to treat about 70% of head and neck cancer patients who have low PD-L1 tumor expression, an area where commercially available PD-L1 inhibitors such as nivolumab and pembrolizumab cannot help. These data, combined with our dedicated Multikine manufacturing facility, position Multikine as a very attractive oncology asset," Kersten concluded.

CEL-SCI completed a randomized controlled Phase 3 study conducted in 928 locally advanced, resectable head and neck cancer stage 3 and 4a patients in 23 countries on 3 continents. The Phase 3 study demonstrated strong statistical results and improved survival with Multikine neoadjuvant treatment over control. The 5-year survival rate of the target patient population that will be treated in the confirmatory Registration Study increased to 73% when patients were treated with Multikine before standard of care vs 45% for control patients who received only the standard of care treatments. The survival advantage over control was accentuated in patients who had low to zero expression of PD-L1 on their tumors and had lower disease burden by having N0 (no nodal involvement).

On March 17, 2025 Egle Therapeutics, a clinical-stage biotechnology company developing therapies targeting regulatory T cells (Tregs) for immuno-oncology and autoimmune diseases, reported that it has secured €9.3 million in state funding under the "Innovations in Biotherapies and Bioproduction" call for projects from the France 2030 plan, managed on behalf of the French government by Bpifrance (Press release, Egle Therapeutics, MAR 17, 2025, View Source [SID1234651202]).

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Founded in 2020 as a spin-off from Institut Curie, Egle Therapeutics is a clinical-stage biotechnology company specializing in immunomodulation, with the ambition to develop novel approaches to the modulation of Treg activity for the treatment of cancer and autoimmune diseases.

Egle Therapeutics has developed a proprietary translational platform to identify novel tumor-infiltrating Treg targets, with the aim of developing antibody-based candidate drugs to disable Treg function and restore an effective antitumor immune response.

In June 2020, Egle Therapeutics entered a strategic partnership with Takeda Pharmaceuticals, establishing a three-year research collaboration with an option agreement. Since its inception, the company has successfully raised nearly €56 million through equity financing and non-dilutive public funding, including the i-Lab Innovation Competition and DeepTech Development Grant.

During its Series A financing round in October 2021, the company raised €47 million, attracting renowned investors, including EQT Life Sciences, Bpifrance (INNOBIO 2 and Innovation 1), Fund Plus, Bioqube Factory Fund, T1D Fund, and Takeda Ventures.

In 2024, Egle Therapeutics achieved key milestones, including the launch of its Phase I/II clinical trial for EGL-001, the appointment of Michel Detheux as Chairman, and the appointment of Christophe Quéva as Chief Executive Officer.

"We are honored to receive this funding from the French government through France 2030. This recognition and immense support will help Egle Therapeutics advance its research and development programs in regulatory T cell modulation. The funding granted under the ‘Innovations in Biotherapies and Bioproduction’ call for projects will enable us to accelerate the development of EGL-001, our lead immuno-oncology therapeutic candidate. EGL-001 is currently being evaluated in a Phase I/II clinical trial in France and Spain."

On March 17, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its Chairman and Chief Executive Officer, Dr. Amit Kumar, will be presenting at the 2025 Cancer Advocacy Group of Louisiana ("CAGLA") NeauxCancer Conference taking place on March 27-29, 2025 at the The Roosevelt Hotel in New Orleans (Press release, Anixa Biosciences, MAR 17, 2025, View Source [SID1234651201]).

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Dr. Kumar’s presentation will provide an overview of Anixa’s pioneering programs in cancer treatment, including updates on its cutting-edge CAR-T therapy for solid tumors and its novel cancer vaccine initiatives. He will discuss the Company’s latest progress in clinical development and how Anixa is advancing next-generation immunotherapies to transform cancer care.

Details of the presentation are as follows:

Event: 2025 CAGLA NeauxCancer Conference
Date: March 28, 2025
Time: 10:00 AM CDT
Location: The Roosevelt New Orleans
Webcast: CAGLA 2025 Livestreams

The CAGLA NeauxCancer Conference is a premier gathering of leading oncology researchers, industry executives, investors and medical professionals focused on groundbreaking developments in cancer treatment and care.

For more information about the conference, visit View Source