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Kairos Pharma to Present Positive Safety and Efficacy Data from Phase 2 Prostate Cancer Trial at ESMO 2025

On October 7, 2025 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company dedicated to addressing resistance to current cancer therapeutics, reported that it has been selected to present at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Kairos Pharma, OCT 7, 2025, View Source [SID1234656481]). Kairos’s presentation, titled, "Preliminary safety and clinical activity from a Phase 2 study of apalutamide and carotuximab in advanced, castration-resistant prostate cancer" will take place in Berlin, Germany on October 17–21, 2025.

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Prostate cancer remains one of the most diagnosed cancers in men, with over a million new cases annually in the U.S. alone. Resistance to androgen-targeted therapies represents a major clinical challenge in patients with metastatic castration-resistant prostate cancer (mCRPC).

The presentation will highlight results from an interim analysis of the randomized Phase 2 trial evaluating ENV105 (carotuximab), a first-in-class CD105 antagonist. The trial is enrolling 100 men at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute at the University of Utah with mCRPC who had progressed on prior hormone therapies. Patients are randomized to receive apalutamide in the presence or absence of ENV105.

"The data we will be presenting at the 2025 ESMO (Free ESMO Whitepaper) Congress demonstrates encouraging safety and early efficacy findings from our Phase 2 trial," said Neil Bhowmick, PhD, Kairos Pharma CSO. "This is an important venue for us to share the therapeutic potential of ENV105 for patients with few remaining treatment options after hormone therapy resistance develops."

Cellectis to Present Data on Non-Viral Gene Therapy and TALE Base Editors at the ESGCT Annual Congress

On October 7, 2025 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that findings highlighting the strong potential of circular single-stranded DNA (CssDNA) as a universal, efficient non-viral template for gene therapy, along with a comprehensive study of TALE base editors (TALEB) off-targets in the nuclear genome, will be presented at the European Society of Cell and Gene Therapy (ESGCT) annual congress, that will take place on October 7-10, 2025, in Sevilla, Spain (Press release, Cellectis, OCT 7, 2025, View Source [SID1234656480]).

Poster presentation:

Title: Circularization of Single-Stranded DNA Donor Template Unleashes the Power of Non-Viral Gene Delivery for Long-Term HSCs editing

Presenter: Julien Valton, Ph.D., Vice President Gene Therapy at Cellectis

Date/Time: Wednesday, October 8, 2025 from 2:00 p.m. to 3:30 p.m. CET

Poster number: P0439

Over the past decade, non-viral DNA template delivery has been used with engineered nucleases to target single-stranded DNA sequences in hematopoietic stem and progenitor cells (HSPCs).

While developed for gene therapy purposes, so far this method has been restricting to gene corrections. To expand this scope, Cellectis developed an editing process using its gene editing technology and kilobase-long circular single-stranded DNA donor templates.

Research data show that:

· CssDNA editing process achieved high gene insertion frequency in viable HSPCs.

· CssDNA-edited HSPCs show a higher propensity to engraft and maintain gene edits in a murine model than adeno-associated viruses (AAV)-edited HSPCs.

These data highlight the strong potential of CssDNA as a universal and efficient non-viral DNA template for gene therapy applications.

The research was also presented as an oral presentation at the Homology-Directed Repair: The Path Forward Workshop in Sevilla on October 6, 2025.

Poster presentation:

Title: Comprehensive analysis of TALEB off-target editing

Presenter: Maria Feola, Ph.D., Senior Scientist, Team Leader Gene Editing at Cellectis

Date/Time: Thursday, October 9, 2025 from 2:00 p.m. to 3:30 p.m. CET

Poster number: P0506

TALE base editors (TALEB) are fusions of a transcription activator-like effector domain (TALE), split-DddA deaminase halves, and an uracil glycosylase inhibitor (UGI).

These recent additions to the genome editing toolbox can directly edit double strand DNA, converting a cytosine (C) to a thymine (T) through the formation of an uracil (U) intermediate without the need of DNA break. Base editing has great potential in therapeutic applications. However, being able to avoid potential off-target effects is key toward this goal.

To evaluate TALEB safety, Cellectis combined advanced bioinformatic predictions with multiple experimental approaches to investigate potential off-target effects in the nuclear genome of primary T cells.

The study found no evidence of biases towards off-site C-to-T editing at sites flanked by CTCF binding sites, a key DNA-binding protein that regulates genome organization and gene expression at genome wide level.

These results provide a strong framework for the safe development of TALEB in therapeutic cell engineering, supporting their potential for future nuclear and mitochondrial applications.

Biomea Fusion Announces Pricing of Public Offering of Securities

On October 7, 2025 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported the pricing of its previously announced underwritten public offering consisting of (i) 11,195,121 shares of its common stock and accompanying warrants to purchase an aggregate of 11,195,121 shares of common stock (or pre-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors, pre-funded warrants to purchase an aggregate of up to 1,000,000 shares of its common stock and accompanying warrants to purchase an aggregate of up to 1,000,000 shares of common stock (or pre-funded warrants in lieu thereof), at an exercise price of $0.0001 per pre-funded warrant (Press release, Biomea Fusion, OCT 7, 2025, View Source [SID1234656479]). In addition, Biomea has granted the underwriters a 30-day option to purchase up to an additional 1,829,268 shares of common stock and/or warrants to purchase 1,829,268 shares of common stock at the public offering price, less underwriting discounts and commissions. The common stock and pre-funded warrants are being sold in combination with an accompanying warrant to purchase one share of common stock (or a pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $2.50 per share, is immediately exercisable from the date of issuance and will expire three years from the date of issuance. The combined offering price of each share of common stock and accompanying common stock warrant is $2.05. The combined offering price of each pre-funded warrant and accompanying common stock warrant is $2.0499.

All of the shares, pre-funded warrants and accompanying common stock warrants in the offering are being sold by Biomea. The gross proceeds to Biomea from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $25.0 million, excluding any exercise of the underwriters’ option to purchase additional shares and/or warrants. The offering is expected to close on October 8, 2025, subject to the satisfaction of customary closing conditions.

Jefferies is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

The shares of common stock, pre-funded warrants and common stock warrants and shares of common stock issuable upon the exercise of the pre-funded warrants and common stock warrants are being offered by Biomea pursuant to an effective shelf registration statement on Form S-3 (File No. 333-289262), that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on August 5, 2025 and declared effective on August 15, 2025. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on October 6, 2025, and is available for free on the SEC’s website located at View Source The final prospectus supplement and accompanying prospectus relating to and describing the terms of the 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 also be obtained from: Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

Trogenix announces £70 million / $95 million Series A financing to drive clinical development of potentially curative therapies for aggressive cancers

On October 6, 2025 Trogenix Ltd ("Trogenix"), a pioneering biotech company dedicated to developing innovative cancer therapies, reported the completion of its Series A financing, raising £70 million / $95 million. The funding will enable the rapid advancement of its robust pipeline of potentially curative cancer therapies across multiple aggressive solid tumours into the clinic.

Ken Macnamara, Chief Executive Officer at Trogenix, said:

"This significant investment accelerates our lead programme in glioblastoma and follow-on programme in colorectal cancer liver metastases through the clinic, advances our pipeline in liver and lung cancers, and further enhances our Odysseus platform. We are honoured to have the support of existing and new investors who share our mission to deliver breakthrough treatments and pursue cures for the thousands of patients and families facing devastating diagnoses each year."

The Series A financing was led by IQ Capital with participation from founding investor 4BIO Capital, returning investors Cancer Research Horizons, the Brain Tumor Investment Fund, and new investors Eli Lilly and Company, Meltwind, LongeVC, and Calculus Capital, as well as undisclosed private investors. The investment underscores the transformative, curative potential of Trogenix’s precision genetic medicines driven by the Company’s Odysseus platform that identifies and targets the universal vulnerabilities of solid tumours. Trogenix’s revolutionary technology delivers highly potent combination payloads that kill cancerous cells and stimulate the immune system whilst leaving surrounding healthy tissue untouched, thereby changing the treatment paradigm for cancer patients.

Max Bautin, Co-founder and Managing Partner at lead investor, IQ Capital, said:

"Our outsized investment in Trogenix in today’s selective funding landscape reflects our confidence in the company’s world-leading science, exceptional management team and a clear roadmap for delivery both in the clinic and commercially. We are particularly excited by the potential opportunities ahead across Trogenix’s pipeline and look forward to our future collaboration."

This investment in Trogenix also represents Cancer Research Horizons’ largest investment to-date, highlighting the transformational potential of Trogenix’s breakthrough technology in cancer treatment.

Iain Foulkes, Chief Executive Officer at Cancer Research Horizons, commented:

"Trogenix’s platform technology is a powerful example of the innovation we seek to accelerate. Representing our largest investment to date, this partnership reflects our commitment to advancing science with the potential to transform cancer treatment. As they advance into clinical trials for glioblastoma, one of the hardest to treat cancers, we’re pleased to support a team whose work could reshape therapeutic approaches and improve outcomes for patients facing the greatest need."

Dima Kuzmin, Co-founder and Managing Partner at founding investor, 4BIO Capital, and Chairman of Trogenix, added:

"We are proud to have supported Trogenix through the initial incubation stage and spin-out from the University of Edinburgh, and are very happy to continue our support alongside this strong syndicate. It is exciting to see the company forge ahead with its clinical development to deliver a pioneering portfolio of cancer therapies to patients in need."

(Press release, Trogenix, OCT 6, 2025, View Source [SID1234656873])

MaxCyte announces strategic platform license agreement with Moonlight Bio to advance T cell therapies for solid tumors

On October 6, 2025 MaxCyte, Inc. (Nasdaq: MXCT), a leading cell-engineering company providing enabling platform technologies to advance the discovery, development, and commercialization of next-generation cell-based therapeutics, reported the signing of a Strategic Platform License (SPL) agreement with Moonlight Bio, a preclinical-stage biotechnology company based in Seattle, Washington (Press release, Moonlight Bio, OCT 6, 2025, View Source [SID1234656512]).

Moonlight Bio will deploy MaxCyte’s Flow Electroporation technology and ExPERT platform to support the scalable development and manufacturing of its T cell therapy pipeline.

"We’re proud to partner with Moonlight Bio as they advance their gene-edited cell therapies through clinical development," said Maher Masoud, President and CEO of MaxCyte. "Our globally supported, GMP-ready and regulatory-proven ExPERT platform is built to accelerate clinical and commercial manufacturing and enable robust, scalable cell engineering. We’re excited to support Moonlight Bio’s innovative approach to optimizing gene-editing outcomes and advancing next-generation T cell therapies."

"We look forward to collaborating with MaxCyte and leveraging their proven, GMP-compliant electroporation technology along with their deep scientific and regulatory expertise to build our clinical manufacturing process," said Jordan Jarjour, Chief Scientific Officer of Moonlight Bio. "At Moonlight Bio, we are committed to delivering T cell therapies that overcome the barriers to success in solid tumors, which account for the majority of the global cancer burden."

Under the SPL, Moonlight Bio obtains non-exclusive research, clinical, and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. In return, MaxCyte is entitled to receive annual licensing fees and program-related revenue.