On February 24, 2025 Vicero, Inc., a preclinical-stage biopharmaceutical company developing next-generation VINCOBODIES for immune-mediated diseases, reported compelling safety and efficacy data for VCR-036, its novel dual-targeting immunotherapy candidate (Press release, Vicero Bio, FEB 24, 2025, View Source [SID1234650494]). The findings, which demonstrate the potential of this pentavalent PD-1/CTLA-4 antibody to treat solid tumors, have been selected for late-breaker presentation at the inaugural American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-oncology (AACR IO) Conference.

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"These results highlight the potential of our bispecific PD-1/CTLA-4 program to redefine combination immunotherapy," said Vikram Kansra, PhD, Founder and Chief Executive Officer of Vicero. "Our VINCOBODY platform enables the development of multi-specific therapies designed to deliver the efficacy of dual checkpoint blockade while mitigating the toxicity challenges associated with traditional monoclonal antibodies. The promising data for VCR-036 reinforce our commitment to expanding the therapeutic window for patients with solid tumors and advancing the next generation of immuno-oncology treatments."

Key findings from the preclinical studies include:

Superior safety profile with 100% survival rate compared to 50% survival with standard combination therapy
Complete tumor regression achieved with 5 mg/kg dosing, with sustained remission after tumor rechallenge
Favorable pharmacokinetics supporting potential dosing of ~1 mg flat subcutaneous dose every 6 weeks in humans
Significantly reduced immune-related adverse events compared to combination pembrolizumab/ipilimumab therapy
"The demonstrated efficacy and safety profile of VCR-036, combined with its convenient six-week subcutaneous dosing schedule, uniquely positions this therapy to potentially address a significant unmet need in the large checkpoint inhibitor market," said Alison Finger, Chief Operating Officer of Vicero. "These attributes could offer meaningful advantages for patients and reduce the treatment burden while creating substantial value in the immunotherapy landscape. We look forward to advancing this program to the clinic."

Poster Presentation Details

Title: VCR-036 VINCOBODY: A novel, highly potent, pentavalent, toxicity-sparing PD 1/CTLA-4 VHH neutralizer with robust pre-clinical safety and efficacy
Date & Time: Tuesday, February 25, 1:45–4:45 pm
Session: Poster Session B (Poster number #LB-B009)
Presenter: Vikram Kansra, PhD, Founder and Chief Executive Officer of Vicero, Inc.

The poster will be available on www.vicerobio.com following the conference.

About VINCOBODIES
VINCOBODIES are an advancement in antibody engineering, leveraging single monomeric variable domains to offer key advantages over traditional antibody therapies. These next-generation molecules are designed to selectively target cytokines, enhancing the body’s natural immune response while achieving superior tissue penetration. With exceptional stability—remaining functional at temperatures up to 90ºC across diverse pH conditions—VINCOBODIES also streamline manufacturing and enable high-yield, high-concentration production. Most notably, their unique structural properties allow them to engage multiple targets with high affinity and avidity using a single scaffold, potentially unlocking new therapeutic possibilities.

On February 24, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 3:10 p.m. ET in Boston, MA (Press release, Nuvation Bio, FEB 24, 2025, View Source [SID1234650493]).

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A live webcast of the presentation will be available on the Nuvation Bio website at View Source An archived recording will be available for 90 days following the event.

On February 24, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) IO Annual Meeting in Los Angeles, California (Press release, Agenus, FEB 24, 2025, View Source [SID1234650492]). The oral presentation highlights translational data from the ongoing Phase 2 study evaluating botensilimab (BOT, multifunctional Fc-enhanced anti-CTLA-4) and balstilimab (BAL, anti-PD-1) in combination with MiNK Therapeutics’ agenT-797, an allogeneic invariant natural killer T (iNKT) cell therapy, in patients with refractory (2L+) gastric cancer (NCT06251973).

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"These latest data demonstrate the remarkable potential of combining BOT/BAL with a novel iNKT cell therapy to broaden and intensify immune responses against resistant gastric tumors," said Dr. Dhan Chand, Vice President of Research at Agenus. "By driving strong IFNγ production, deep T-cell infiltration, and memory T-cell activation—even in PD-1–refractory patients—the addition of agenT-797 to BOT/BAL could redefine what’s possible in late-line gastric cancer. We’re particularly encouraged by how these therapies work in concert with standard-of-care chemotherapy to transform immunologically ‘cold’ tumors into ‘hot’ immune inflamed tumors, potentially offering a new therapeutic paradigm for patients facing this challenging disease."

Highlights

Broad Immune Activation: The addition of MiNK’s allogeneic iNKT therapy, agenT-797, to BOT/BAL drove robust immune activation, including elevated interferon-gamma (IFNγ) levels, indicating potent systemic engagement and overcoming immunosuppressive pathways in PD-1–refractory gastric tumors.
Enhanced T cell Infiltration and Memory T-Cell Expansion: A marked increase in tumor-infiltrating lymphocytes (TILs), together with heightened peripheral memory T-cell activation, underscores the potential for long-lasting anti-tumor immunity when combining BOT/BAL with agenT-797 (allo-iNKTs).
Optimized Sequencing with Chemotherapy: Early administration of agenT-797 alongside BOT/BAL, before standard chemotherapy significantly amplifies immune responses, potentially reducing tumor recurrence through optimal T-cell priming, activation and mobilization.
Presentation Details:

Abstract Title: Biomarker analysis from Phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC)

Presenting Author: Dr. Samuel Cytryn, Memorial Sloan Kettering Cancer Center, New York, New York

Oral Session: Proffered Papers, Session 2; 1:39-1:45 p.m. PST

Poster Session: Poster Session, A; 1:45-4:45 p.m. PST

Date: Monday, February 24th

The presentation will be available on the publications page of the Agenus website at View Source following the start of the conference session.

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.