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.

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.

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."

On February 24, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its partner on ivonescimab, Summit Therapeutics Inc. (NASDAQ: SMMT) has entered into a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of Pfizer’s antibody drug conjugates (ADCs) across multiple solid tumor settings (Press release, Akeso Biopharma, FEB 24, 2025, View Source [SID1234650488]).

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"Rapidly developing novel mechanisms that go beyond what is currently available to patients and physicians is what we believe will make the most significant impact for those facing the greatest challenges from cancer today," noted Bob Duggan and Dr. Maky Zanganeh, Summit’s Co-CEOs. "As we seek to accelerate the development of our potentially transformative ivonescimab across non-small cell lung cancer and other solid tumor settings, this collaboration will allow us to quickly advance beyond our promising late-stage development plan to evaluate ivonescimab in combination with some of the most innovative ADCs from Pfizer."

The goal of the collaboration is to evaluate ivonescimab, in combination with several unique Pfizer ADCs across multiple solid tumor settings to accelerate the advancement of potentially landscape-changing combinations, which seek to improve the standards of care for patients facing serious unmet needs. Each study intends to evaluate ivonescimab plus one of Pfizer’s vedotin ADCs in individual, distinct solid tumor settings to determine the safety profile and potential anti-tumor activity of the combinations.

"We are excited to partner with Summit Therapeutics to explore the clinical synergy of our therapies," said Megan O’Meara, M.D., Head, Oncology Early Stage Development, Pfizer. "Together, we are advancing the exploration of our ADCs in rational, differentiated combinations with a bispecific antibody designed to address the unique complexities of tumor biology. This collaboration represents the next wave of investigational targeted combinations with the potential to transform treatment options for people living with cancer."

Under the terms of the agreement, Summit will provide ivonescimab for use in the proposed studies, and Pfizer will be responsible for conducting the operations of the studies. The studies will be overseen by both Summit and Pfizer. Both parties retain their respective rights to their products. The studies combining ivonescimab with Pfizer’s vedotin ADCs are planned to begin in the middle of this year. Further details on the clinical trials will be announced at a later date by Summit.

About Ivonescimab (AK112/SMT112)

Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’s license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

On February 24, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, reported the publication of the GEMSTONE-303 study results for sugemalimab (brand name: Cejemly) in the prestigious Journal of the American Medical Association (JAMA) (Press release, CStone Pharmaceauticals, FEB 24, 2025, View Source [SID1234650487]).

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GEMSTONE-303 is a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared to placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma with PD-L1 CPS ≥5. The dual primary endpoints were OS and investigator-assessed PFS. Key secondary endpoints included PFS assessed by the Blinded Independent Central Review Committee (BICR), objective response rate (ORR), and duration of response (DoR).

The GEMSTONE-303 article published in JAMA highlights the following key efficacy and safety findings:

In patients with PD-L1 CPS ≥5, the sugemalimab group showed statistically significant and clinically meaningful improvements in both OS and PFS compared with the control group.
Median OS was 15.6 months in the sugemalimab group compared with 12.6 months in the control group, with a hazard ratio (HR) of 0.75 (95% CI, 0.61-0.92), P=0.006, indicating that sugemalimab plus CAPOX could reduce the risk of death by 25%.
Median PFS was 7.6 months in the sugemalimab group versus 6.1 months in the control group, with a HR of 0.66 (95% CI, 0.54-0.81), P<0.001.
Grade ≥3 treatment-related adverse events (TRAE) occurred in 53.9% of patients in the sugemalimab group and 50.6% in the control group, indicating that the safety of this combination regimen was manageable.
Subgroup analyses demonstrated consistent clinical benefits across all pre-defined subgroups, including patients with varying PD-L1 expression levels:

Sugemalimab plus CAPOX significantly prolonged OS in patients with PD-L1 CPS ≥10; median OS was 17.8 months in the sugemalimab group compared with 12.5 months in the control group, with a HR of 0.64 (95% CI, 0.48-0.85), P=0.002.
In patients with PD-L1 CPS ≥10, median PFS was 7.8 months in the sugemalimab group compared with 5.5 months in the control group, with a HR of 0.58 (95% CI, 0.43-0.77), P<0.001.
In patients with PD-L1 CPS ≥10, ORR was 71.4% in the sugemalimab group compared with 48.6% in the control group.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are honored to see the GEMSTONE-303 study results published in JAMA. This study establishes sugemalimab in combination with chemotherapy as the new standard first-line treatment for patients with PD-L1 CPS ≥5 G/GEJ adenocarcinoma. To date, sugemalimab has been approved for five indications in China. Internationally, we have expanded its regulatory pathways and forged commercialization partnerships in various global markets. The compelling clinical data from GEMSTONE-303 reinforce our confidence in advancing the global registration and commercialization of sugemalimab. We are committed to unlocking its full clinical potential and providing greater survival benefits to patients worldwide."

Professor Lin Shen, Peking University Cancer Hospital, the leading principal investigator of the GEMSTONE-303 study, said: "Before the availability of PD-1 monoclonal antibodies, chemotherapy was the standard first-line treatment for unresectable, locally advanced or metastatic G/GEJ adenocarcinoma, with median OS rarely exceeding one year. The combination of anti-PD-1 antibodies and chemotherapy has significantly extended survival for these patients. The GEMSTONE-303 study builds on this progress. As the first anti-PD-L1 antibody approved for this patient population, sugemalimab specifically targeted the PD-L1-expressing population in its pivotal study, achieving significant efficacy with a manageable safety profile. The acceptance and publication of these results in JAMA affirm the innovation of GEMSTONE-303 and the valuable contributions of all researchers and participants involved."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.
The European Commission (EC) has approved sugemalimab (brand name: Cejemly) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.

The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.