Swarm Oncology Ltd. and Cellex Cell Professionals GmbH Announce Strategic Partnership to Advance Swarm’s Innovative T Cell Therapies for Solid Cancers

On February 24, 2025 Swarm Oncology Ltd. (‘Swarm Oncology’ or ‘Swarm’), a biotechnology company pioneering novel T cell therapies to achieve long-term remission in patients with advanced solid cancers, reported a strategic partnership with Cellex Cell Professionals GmbH (‘Cellex’), a leading contract development and manufacturing organization (‘CDMO’) specializing in cell and gene therapy (‘CGT’) manufacturing with a particular focus on clinical and commercial supply of T cell therapies (Press release, Swarm Oncology, FEB 24, 2025, View Source [SID1234650489]).

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Despite advancements in oncology, more than 82% of patients with advanced metastatic cancer ultimately succumb to their disease. Current immunotherapies provide only limited survival benefits due to challenges such as T cell exhaustion, inadequate cell numbers, and limited antigen diversity. Swarm’s breakthrough T cell therapy platform, Swarm-T, integrates in vivo immune priming with proprietary ex vivo manufacturing to generate highly potent, non-exhausted, polyclonal T cells. Unlike conventional approaches, Swarm-T overcomes key limitations by delivering a powerful and sustained immune attack against solid tumors.

Through this partnership, Cellex will supply cellular starting material and oversee process transfer, GMP manufacturing, and quality control. Additionally, Cellex will provide regulatory compliance support and specialized infrastructure to accelerate Swarm’s therapies toward clinical trials in 2026. The partnership aims to accelerate clinical timelines, reduce manufacturing bottlenecks, and enhance scalability, to bring Swarm’s innovative T cell therapies to solid tumor patients in need.

Martin Olin, CEO of Swarm, said: "Swarm’s mission is to transform immunotherapy by overcoming its limitations and driving solid cancers into long-term remission. With Cellex’s deep expertise in cell collection, therapy manufacturing, and regulatory compliance, we can ensure a seamless, high-quality manufacturing process and advance clinical development, bringing life-changing treatments to patients with the reliability and scale they need."

"We are excited to contribute to Swarm’s mission to drive innovation in solid cancer treatment," said Prof. Dr. Gerhard Ehninger, Cellex’s CEO. "With our modern facilities and over 10 years of experience in T cell therapy manufacturing, we are well-positioned to help bring these transformative therapies to the clinic faster and more efficiently."

GSK completes acquisition of IDRx, Inc.

On February 24, 2025 GSK plc (LSE/NYSE: GSK) reported that it has completed the acquisition of IDRx, Inc. (IDRx), a Boston-based, clinical-stage biopharmaceutical company dedicated to developing precision therapeutics for the treatment of gastrointestinal stromal tumours (GIST) (Press release, GlaxoSmithKline, FEB 24, 2025, View Source [SID1234650474]).

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As announced previously1, the acquisition includes lead molecule IDRX-42, an investigational, highly selective tyrosine kinase inhibitor (TKI) that is designed to improve outcomes for patients with GIST. IDRX-42 has demonstrated activity against all clinically relevant primary and secondary KIT mutations, a key medical need in current GIST treatment. GIST typically presents in the gastrointestinal (GI) tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation, and survival of tumour cells (primary or activating mutations).2 90% of patients treated in the first line develop new KIT mutations (secondary or resistance mutations) that typically lead to relapse with limited therapeutic options.3

Hesham Abdullah, Senior Vice President, Global Head Oncology R&D, GSK, said: "This acquisition adds to GSK’s growing pipeline of targeted therapeutics for cancers originating in the gastrointestinal tract. We plan to advance IDRX-42 for second line treatment of gastrointestinal stromal tumours, where there are no approved treatments to effectively address all resistance mutations, and accelerate development in an earlier setting."

Financial Considerations
The total cash consideration for this acquisition amounts to up to $1.15 billion. This includes an upfront payment of $1 billion, with the possibility of an additional $150 million milestone payment contingent upon success-based regulatory approval. GSK will also be responsible for success-based milestone payments as well as tiered royalties for IDRX-42 owed to Merck KGaA, Darmstadt, Germany.

About GIST
GIST represent the most prevalent form of soft tissue sarcoma, with an estimated annual global diagnosis of 80,000 to 120,000 patients.4 GIST commonly manifests in the GI tract, with approximately 80% of cases being attributed to mutations in the KIT gene.5 These mutations, known as primary or activating mutations in exons 9 and 11, drive the growth, proliferation, and survival of tumour cells. In the first line of treatment, around 90% of patients develop secondary or resistance mutations in exons 13 and 17 of the KIT gene, leading to relapse with limited therapeutic alternatives.6 Notably, there are currently no approved TKIs capable of effectively targeting the full range of clinically significant primary and secondary mutations in KIT.

About IDRX-42
IDRX-42 is a highly selective, investigational small molecule TKI designed to target all key KIT mutations in GIST. The U.S. Food and Drug Administration (FDA) has granted IDRX-42 Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST.

Aadi Bioscience to Present at the TD Cowen 45th Annual Healthcare Conference

On February 24, 2025 Aadi Bioscience, Inc. (NASDAQ: AADI) reported its presentation at the TD Cowen 45th Annual Healthcare Conference, taking place March 3-5, 2025, in Boston, MA. Dave Lennon, PhD, CEO, will present a company overview on Monday, March 3, 2025, from 9:50 – 10:20 AM ET (Press release, Aadi Bioscience, FEB 24, 2025, View Source [SID1234650490]).

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The presentation will be webcast live on the IR pages of the Aadi Bioscience website and will be available for replay for approximately 30 days following the investor event.

IN8bio to Present at the H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference

On February 24, 2025 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and co-founder, will be presenting at the (Press release, In8bio, FEB 24, 2025, View Source [SID1234650475]):

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H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference
Date/Time Tuesday, February 25, 2025, at 11:00 a.m. ET.
Webcast Link View Source

A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

MAIA Biotechnology Announces Non-Brokered Private Placement of Approximately $1.43 Million

On February 24, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 952,300 shares of common stock at a purchase price of $1.50 per share, in a non-brokered private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, FEB 24, 2025, View Source [SID1234650491]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.85 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 26, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be approximately $1.43 million, prior to offering expenses payable by the Company. The Company closed a private placement of approximately $2.7 million on February 24, 2025 and the aggregate gross proceeds from both private placements are expected to be $4.1 million, prior to deducting offering expenses payable by the Company. The Company intends to use the combined net proceeds received from the two private placements to fund the starting cost for Part C of the Phase 2 THIO -101 clinical trial and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act or applicable state securities laws and do not have registration rights. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities issued in the Private Placement will be "restricted securities" under the U.S. Securities Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.