On February 18, 2026 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a clinical-stage biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported that the first patient has been dosed in its global ASCEND Phase 1/2 clinical trial evaluating CR-001, an investigational PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors.

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"The initiation of ASCEND is a significant milestone for Crescent and the development of CR-001, which we believe has the potential to be a best-in-class therapy and immuno-oncology backbone," said Ellie Im, M.D., chief medical officer of Crescent. "We are excited to be working with clinicians across the globe as we strive to improve the standard of care for people living with cancer. ASCEND is designed to comprehensively assess the clinical profile of CR-001, including its potential in both first-line and previously treated patients, and to generate a robust data set to drive our development strategy across multiple indications."

ASCEND (NCT07335497) is a global, open-label Phase 1/2 clinical trial evaluating CR-001 in multiple solid tumor types, including non-small cell lung cancer (NSCLC) and various gastrointestinal and gynecological cancers, in both treatment-naïve and previously treated patients. The trial is expected to enroll up to 290 patients in dose-escalation, backfill and dose-optimization cohorts at centers across multiple regions, including the United States, Europe and Asia Pacific. The primary objectives of the study are to evaluate the safety and tolerability of CR-001. Secondary objectives include assessment of pharmacokinetic and pharmacodynamic profiles, identification of the recommended Phase 2 dose, and evaluation of preliminary antitumor activity, including overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS).

Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose escalation and backfill cohorts.

About CR-001 (also known as SKB118)

CR-001 (SKB118) is an investigational tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells, and blocking VEGF is intended to reduce blood supply to tumor cells and to inhibit tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust antitumor activity. CR-001 is currently being evaluated as a monotherapy in ASCEND, a global Phase 1/2 trial in patients with advanced solid tumors. CR-001’s anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with Crescent’s antibody-drug conjugates (ADCs) in development. The first Phase 1/2 ADC combination trial with CR-001 is expected to initiate in the second half of 2026.

Under its strategic collaboration, Crescent has granted Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., exclusive rights to research, develop, and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan).

CR-001 was discovered by Paragon Therapeutics, an antibody discovery engine founded by Fairmount.

(Press release, Crescent Biopharma, FEB 18, 2026, View Source [SID1234663670])

On February 18, 2026 Iaso Therapeutics, Inc., a biotechnology company redefining infectious disease prevention with its novel synthetic vaccine platform, reported that it will present at the 2026 World Vaccine Congress in Washington, D.C., on Tuesday, March 31. President and CEO Robert Forgey, MS, MBA, will provide an overview of Iaso’s technology and commercial strategy during his live presentation at the Innovator Showcase.

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2026 World Vaccine Congress
Date: Tuesday, March 31
Time: 1:30 p.m. ET
Session: Innovator Showcase
Location: Walter E. Washington Convention Center, Washington, D.C.

The presentation will showcase how Iaso’s synthetic vaccine platform delivers the broad protection and scalable production needed to combat infectious diseases, including the escalating threat of antimicrobial resistance, to transform global health.

In addition to the presentation, Iaso will host meetings with industry stakeholders, including investors and strategic partners, at Booth 589 in the Emerging Business Zone.

(Press release, Iaso Therapeutics, FEB 18, 2026, View Source [SID1234662750])

On February 18, 2026 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, reported preclinical data on ANK-203, a first-in-class anchored immunotherapy using monoclonal antibody CD137 (4-1BB). The data were presented today in an oral session, "Agonistic CD137 (4-1BB) anchored immunotherapy (ANK-203) elicits potent 4-1BBL signaling in vitro and therapeutic responses against established tumors without systemic toxicity in vivo" (abstract # 64034) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology Conference in Los Angeles, CA.

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"Our anchored immunotherapy platform has already demonstrated promising clinical activity with tolododekin alfa, validating our approach to improving the therapeutic index of potent immune modulators, like IL-12," said Howard Kaufman, MD, and Chief Executive Officer at Ankyra Therapeutics. "ANK-203 extends our platform’s application beyond cytokines to monoclonal antibodies and expands our pipeline, reinforcing its versatility and underscoring the potential to realize the promise of therapeutics that have been shelved due to toxicity."

ANK-203 is designed to activate the CD137 (4-1BB) immune pathway through localized delivery and retention at the tumor site. In preclinical studies, ANK-203 demonstrated robust activation of the CD137 (4-1BB) immune pathway and regression of established tumors following localized administration. Treatment was well tolerated, with no significant safety signals observed. In addition to local tumor control, ANK-203 induced anti-tumor responses in distant, untreated tumors, suggesting the induction of a systemic immune response.

"CD137 has long been recognized as a powerful immune costimulatory molecule with a high potential for cancer immunotherapy, but safety challenges have constrained its clinical potential," said Sailaja Battula, PhD, Chief Scientific Officer at Ankyra Therapeutics. "By anchoring CD137 locally, ANK-203 enables focused immune activation where it matters most – at the tumor site – while minimizing systemic exposure, offering a differentiated approach to maximize clinical benefit."

Based on these findings, Ankyra plans to advance ANK-203 through additional preclinical studies to further characterize immune mechanisms and support potential clinical development.

(Press release, Ankyra Therapeutics, FEB 18, 2026, View Source [SID1234662766])

On February 18, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that management will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, taking place virtually from February 25-26, 2026. Management, including Ben Zeskind, Chief Executive Officer, and Brett Hall, Chief Scientific Officer, will discuss the company’s pipeline, platform, and business strategy.

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Format: Company Presentation and 1×1 Investor Meetings

Date/Time: Thursday, February 26, 2026, at 10:00 am ET

The presentation will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, FEB 18, 2026, View Source [SID1234662751])

On February 18, 2026 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended December 31, 2025, as well as key recent clinical and corporate developments.

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"CEL-SCI is focused on two major value-driving milestones in the near term—starting enrollment in our U.S. FDA confirmatory Registration trial of Multikine in head and neck cancer and advancing Multikine globally in markets including Saudi Arabia. We plan to commence enrollment this summer in our confirmatory study of Multikine in head and neck cancer. Data from this study will be submitted as part of registration applications to allow commercialization and sale of Multikine in the U.S. and other key global markets. Prior studies have shown that pre-surgical tumor responses, such as tumor size reduction and downgrading of the disease by a physician, following Multikine treatment predict substantial survival benefit for the patients. We believe that these pre-surgical tumor responses after the three-week treatment with Multikine, before any other treatment has been administered, could be the basis of an accelerated marketing application for Multikine," stated CEL-SCI CEO, Geert Kersten. "Concurrently, we have been active in Saudi Arabia, pursuing the potential for Multikine to be available to patients with head and neck cancer following the filing for Breakthrough Medicine Designation there in the second half of 2025."

Clinical and Corporate Developments:

CEL-SCI, in conjunction with its CRO Ergomed, expects to start patient enrollment in the summer of 2026 for the 212-patient U.S. Confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection)* in newly diagnosed locally advanced head and neck cancer patients. Pre-surgical tumor responses, following a very short treatment with Multikine, can be assessed within weeks after full enrollment for rapid confirmation of Multikine’s anti-tumor activity, creating the potential for early accelerated approval in the U.S. CEL-SCI plans to seek accelerated approval based on early tumor response data. Ergomed is providing comprehensive global clinical operations support to ensure the timely and efficient execution of the trial. CEL-SCI and Ergomed are building on their previous successful collaboration for the global Phase 3 trial of Multikine, the largest study ever conducted in head and neck cancer. In the Phase 3 study, Multikine treatment, given right after diagnosis and before any other treatment, significantly increased the 5-year overall survival rate of the treated patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
CEL-SCI is actively engaged with potential partners and investors in Saudi Arabia to advance Multikine to market. A Breakthrough Medicine Designation application for Multikine for the treatment of head and neck cancer was submitted to the Saudi Food and Drug Authority (SFDA). The designation, if granted, will allow patient access to Multikine for the indication, as well as reimbursement/sale in Saudi Arabia.
Financial Results

During the three months ended December 31, 2025, research and development expenses were $3.7 million compared to $4.4 million for the three months ended December 31, 2024. General and administrative expenses for the three months ended December 31, 2025 were $1.7 million compared to $2.5 million for the three months ended December 31, 2024. Net loss was $5.5 million for three months ended December 31, 2025 compared to $7.1 million in the prior year period. Cash used for operating activities during the quarter was $4.0 million. Basic and diluted net loss per common share was $0.68 for the three months ended December 31, 2025, compared to $3.25 for the three months ended December 31, 2024.

(Press release, Cel-Sci, FEB 18, 2026, View Source [SID1234662767])