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Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

On April 17, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201 (Press release, Calidi Biotherapeutics, APR 17, 2025, View Source [SID1234653210]). This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma.

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The IND application included preclinical data demonstrating the potential of CLD-201 to evade viral inactivation by the patient’s immune system and effectively target and kill cancer cells. The upcoming clinical trials will assess the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs.

"This FDA-cleared IND is a monumental milestone for Calidi Biotherapeutics and for patients worldwide. This allogeneic virotherapy product can transform how we treat cancer. It’s a one-of-a-kind product that has never been manufactured before using adipose tissue-derived stem cells in combination with oncolytic vaccinia virus. Its versatility in being able to treat solid tumors is remarkable," said Allan Camaisa, CEO and Chairman at Calidi. "I am proud of our executives and staff that have worked tirelessly to make this application possible."

"This remarkable achievement underscores the innovative approach and dedication of our exceptional team. The potential of CLD-201 to revolutionize the treatment of multiple solid tumors is truly exciting. We are eager to see its clinical application in providing new hope and improved outcomes for patients battling these challenging cancers," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi.

"This milestone is a testament to the comprehensive and robust pre-clinical, CMC, and development package supporting the clinical advancement of CLD-201. It highlights the expertise and dedication of Calidi’s teams in pushing forward innovative immunotherapies," said Antonio F. Santidrian, PhD, Chief Scientific Officer & Head of Technical Operations at Calidi.

MOMA Therapeutics to Present Multiple Posters at the American Association for Cancer Research Annual Meeting 2025

On April 17, 2025 MOMA Therapeutics, a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, reported three poster presentations at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 25 – 30, 2025 in Chicago, IL (Press release, MOMA Therapeutics, APR 17, 2025, View Source [SID1234651984]).

AACR poster presentation details are below:

MOMA-313 is a potent and selective inhibitor of the Polθ DNA helicase domain for the treatment of HR-deficient tumors
Session Title: PO.ET09.05 – Novel Antitumor Agents 1
Location: Section 22
Abstract Number: 1749
Date/Time: April 28, 2025, 9:00 a.m. – 12:00 p.m. CT
Presenting Author: Jordan Krall, Ph.D.

TA repeat expansion outperforms MSI-H status as a predictor of sensitivity to the novel WRN inhibitor MOMA-341
Session Title: PO.ET06.07 – DNA Damage Response and Modulation of DNA Repair 2
Location: Section 15
Abstract Number: 4205
Date/Time: April 29, 2025, 9:00 a.m. – 12:00 p.m. CT
Presenting Author: Allison Drew

Orally Administered MOMA-313 as Monotherapy or Combination Therapy in Participants with Advanced or Metastatic Solid Homologous Recombination (HR)-Deficient Tumors: Phase 1 Study Design
Session Title: CTP01.02 – Phase I Clinical Trials in Progress 2
Location: Section 50
Abstract Number: CT192
Date/Time: April 29, 2025, 9:00 a.m. – 12:00 p.m. CT
Presenting Author: Amita Patnaik, M.D.

Abstracts are currently available on the AACR (Free AACR Whitepaper) website. The posters can be accessed through the "News & Publications" tab on the MOMA Therapeutics website at the time of each presentation’s starting session.

Agilent Receives European IVDR Certification for Companion Diagnostic Assay in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

On April 17, 2025 Agilent Technologies Inc. (NYSE: A) reported its PD-L1 IHC 22C3 pharmDx (Code SK006) assay reported to have received European IVDR certification for the use as a Companion Diagnostic (CDx) to aid in the identification of gastric or gastroesophageal Junction (GEJ) adenocarcinoma patients who may be eligible for treatment with KEYTRUDA (pembrolizumab) (Press release, Agilent, APR 17, 2025, View Source [SID1234651983]). PD-L1 IHC 22C3 pharmDx (Code SK006) is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada).

In addition to gastric or GEJ adenocarcinoma, PD-L1 IHC 22C3 pharmDx is IVDR certified as an aid in identifying non-small cell lung cancer (NSCLC), urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and cervical cancer patients for treatment with KEYTRUDA. Consequently, PD-L1 IHC 22C3 pharmDx is labeled for seven cancer indications and is the only IVDR-certified CDx to identify gastric and GEJ adenocarcinoma patients for treatment with KEYTRUDA.

"Immunotherapies, such as KEYTRUDA, are critical for cancer patients," said Nina Green, vice president and general manager of the Clinical Diagnostics Division at Agilent. "With the current European indication expansion of PD-L1 IHC 22C3 pharmDx into gastric or GEJ adenocarcinoma, pathology laboratories can now support an even broader patient population in determining their eligibility for relevant treatment options."

Gastric cancer is a leading cause of cancer-related mortality worldwide. In Europe, gastric adenocarcinoma, typically diagnosed at an advanced stage, has a 5-year survival rate of 26%.2 In 2022, more than 130,000 Europeans were diagnosed with gastric cancer.3

In Europe, KEYTRUDA, in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1). Furthermore, KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥1).4

PD-L1 IHC 22C3 pharmDx was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Kairos Pharma Ltd. Announces Department of Defense Grant to Support Its Study of Lead Compound ENV105 to Prevent Drug Resistance in Lung Cancer

On April 17, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA) a clinical stage company involved in treating EGFR-driven lung cancer patients with ENV105 in combination with osimertinib after they fail to respond to single-agent osimertinib in a Phase 1 trial, reported that based on recent breakthroughs in understanding non-small cell lung cancer mechanism of resistance to first line osimertinib treatment, the U.S. Department of Defense ("DoD") is providing $876,000 to advance a strategy to identify patients that are starting to develop resistance at an early stage (Press release, Kairos Pharma, APR 17, 2025, View Source [SID1234651982]). The grant was awarded to identify biomarkers for the Company’s clinical study to address the major challenge in achieving a lasting cure for lung cancer patients. The grant was awarded to Cedars-Sinai Medical Center to support research in Dr. Neil Bhowmick’s laboratory to identify biomarkers of patients with non-small cell carcinoma who have developed resistance to Osimertinib. This will provide a means to identify those patients who will benefit from ENV105.

Kairos Pharma CEO John Yu, M.D., stated, "Peer-reviewed support like this DoD grant is a testament to the sound scientific basis for our current Phase 1 trial in lung cancer patients receiving ENV105. It is particularly gratifying in the current environment, in which these grants are harder to achieve, underscoring the potential for ENV105 to help ensure effective therapy in this lung cancer form common to non-smokers. Grants like this enable us to progress with our trials while minimizing expense and managing our cash burn."

The DoD grant is designed to contribute to a strategy to limit resistance to osimertinib at its most early stages, by identifying patients that would be best helped by ENV105 treatment. In the near term, the Company expects that the funded study may lead to more effective monitoring and early detection of resistance development, allowing for more timely interventions to improve overall survival and quality of life for patients.

BigHat Biosciences and Lilly Collaborate to Advance AI-Driven Antibody Therapeutics

On April 17, 2025 BigHat Biosciences ("BigHat"), a biotechnology company with a machine learning (ML)-guided antibody discovery and development platform, reported a strategic collaboration with Eli Lilly and Company ("Lilly") (Press release, BigHat Biosciences, APR 17, 2025, View Source [SID1234651981]). In this collaboration, BigHat will deploy its Milliner platform, a suite of state-of-the-art ML technologies integrated with a synthetic biology-based high-speed wet lab, to design and engineer therapeutic antibodies with superior functionality.

BigHat and Lilly will collaborate to design and discover next-generation antibodies for up to two antibody therapeutic programs. This partnership aims to design, engineer, and develop antibodies with enhanced functionality and improved biophysical properties to create therapeutics that will benefit patients with chronic disease.

"Partnering with Lilly represents an exciting opportunity to harness the full potential of AI-driven biologic design. By combining Lilly’s deep expertise in drug discovery and development with BigHat’s machine learning-powered Milliner platform, we can accelerate the advancement of truly differentiated, next-generation protein therapeutics," said Peyton Greenside, CEO and Co-founder of BigHat.

This collaboration builds on BigHat’s strategy to engage in value-generating strategic partnerships balanced with an exciting internal pipeline of proprietary therapeutics in the areas of oncology and immunology. BigHat’s ML-powered platform is designed to tackle molecular engineering challenges and unlock the development of novel therapeutics for the improvement of patient outcomes. In addition to supporting the development of its partners’ therapeutic programs, BigHat has built and advanced a pipeline of next-gen antibody-drug conjugates (ADCs) and functionally differentiated T-cell engagers (TCEs) across indications in both oncology and immunology. BigHat is advancing a next-generation ADC for GI cancers into the clinic in 2026. Lilly Catalyze360 will provide support, while BigHat retains full global rights and control to the program.

In addition to the antibody discovery collaboration and support for BigHat’s ADC for GI cancers, Lilly will also make an equity investment in BigHat. This collaboration is part of the Lilly Catalyze360 model, which is a comprehensive approach to empower early-stage biotech startups across all therapeutic areas by providing access to funding as well as world-class lab space and/or drug development talent and resources through its three pillars: Lilly Ventures, Lilly Gateway Labs, and Lilly ExploR&D.