Forlong Biotechnology to Present Clinical Data from the First-in-human Study for FL115 (IL-15 Superagonist) in US Patients with Advanced Solid Tumors at 2026 ASCO Annual Meeting

On April 21, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported a poster presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held from May 29 to June 2, 2026, at the McCormick Place in Chicago, IL.

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The presentation will detail safety, pharmacokinetics, pharmacodynamics and antitumor activities of FL115 from the first-in-human FL115-101 study conducted at 3 investigational sites in US. First patient was dosed in December 2023, and the study was completed in September 2025 with total of 11 patients treated. One patient received the 1st dose in Jul 2024, remained progression-free at the study completion, and afterwards has continued to receive FL115 treatment under a Single Patient IND Protocol/Treatment Plan.

Details of the poster presentation are as follows:

Poster Board: 291
Poster Title: Safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activities of FL115, a novel IL-15 superagonist, from the first-in-human study in patients with locally advanced/metastatic solid tumors.
Session Type/Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
About FL115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, APR 21, 2026, View Source [SID1234664648])

NextCure and Simcere’s SIM0505 (CDH6 ADC) Phase 1 Data to be Presented at ASCO 2026

On April 21, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported a poster will be presented at ASCO (Free ASCO Whitepaper) 2026 highlighting Phase 1 data for SIM0505 in the treatment of solid tumors. ASCO (Free ASCO Whitepaper) 2026 is being held May 29 – June 2 in Chicago, Illinois. SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

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"We are very pleased to announce that the Phase 1 results for SIM0505 have been accepted as a poster presentation at ASCO (Free ASCO Whitepaper) 2026. This important milestone validates our collaborative clinical approach and highlights our mission of advancing innovative medicines to treat cancer patients," said Michael Richman, President and CEO of NextCure.

Presentation Details:

Title: Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors
Poster Abstract #: 5580
Poster Board: 246
Presenter: Xiaohua Wu, MD, PhD, Chief Physician and Chairman of the Multidisciplinary Team in Gynecologic Oncology at Fudan University Shanghai Cancer Center, Shanghai, China
Session: Gynecologic Cancer
Session Date: Monday June 1, 2026
Session Time: 9:00 AM CST to 12:00 PM CDT
A full copy of the poster will be available on the NextCure website under the Investor Relations "Events & Presentations" tab following the presentation.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

(Press release, NextCure, APR 21, 2026, View Source [SID1234664664])

Entry into a Material Definitive Agreement

On April 21, 2026, Hepion Pharmaceuticals, Inc. (the "Company") reported to have entered into securities purchase agreements (the "Agreements") with certain accredited investors (the "Investors") pursuant to which the Company agreed to sell and issue to the Investors in a private placement offering (the "Offering"), an aggregate offering of 17,500,000 shares of common stock, par value $0.0001 per share (the "Common Stock") at an offering price of $0.04 per share for gross proceeds of $700,000. The Offering closed on April 21, 2026.

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The Common Stock is being offered in reliance upon the exemption from the registration requirement of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) thereof and/or Rule 506(b) of Regulation D promulgated thereunder, and applicable state securities laws. The issuance of the Common Stock has not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.

The Agreements contain customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties and termination provisions.

(Filing, Hepion Pharmaceuticals, APR 21, 2026, View Source [SID1234664681])

BriaCell Presents Robust Anti-Cancer Activity of Bria-OTS+(TM) in Preclinical Cancer Models

On April 21, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported positive data from its preclinical Bria-OTS+ platform at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 17–22 at the San Diego Convention Center in San Diego, California.

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The poster is summarized below and linked here: View Source

Title: Re-Engineering Cancer Vaccines: Bria-OTS+ Integrates Innate and Adaptive Immunity for Broad and Persistent Anti-Tumor Responses
Session Category: Clinical Research
Session Title: Vaccines and Other Immunomodulatory Agents
Session: 4/21/2026 2:00-5:00 PM
Location: Poster Section 49
Poster Board Number: 12
Poster Number: 6701

Summary: Bria-OTS+ is a personalized, off-the-shelf, next-generation genetically engineered whole-cell cancer immunotherapy platform designed to enhance efficacy and safety. Our results demonstrate that Bria-OTS+ activates key components of both the innate and adaptive immune systems to broadly target and destroy cancer cells across solid tumors. These effects include coordinated activation of CD4⁺ and CD8⁺ T cells, NK cells, NKT cells, dendritic cells, and B cells, together with increased cytokine release and sustained immune competence without exhaustion—helping address an important mechanism of cancer progression.

Data presented includes the following:

Rapid activation of innate and adaptive immune responses: Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) drove early activation and proliferation of key immune cells including CD4+ and CD8+ T cells, NK cells, and NKT cells, enhanced cytotoxic activity against parental tumor targets, and increased CD80/CD86 expression on dendritic and B cells, consistent with improved antigen-presentation.
Sustained, long-lasting and targeted anti-tumor activity: Bria-BRES+ and Bria-PROS+ generated durable cytokine responses and maintained cytotoxic, serial killing activity through repeated cancer cell challenges without evidence of functional exhaustion. Bria-OTS+ also showed limited induction of immunosuppressive cell populations including regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs).
Broad tumor recognition may reduce escape risk: Bria-BRES+ and Bria-PROS+ cells demonstrated anti-tumor activity against multiple tumor targets, supporting the potential of Bria-OTS+ to drive broad, cross-tumor immune responses, reduce immune escape, and limit cancer progression.
Bria-OTS+ proposed mechanism of action: Following intradermal administration, Bria-OTS+ is designed to activate T cells and NK cells directly, while professional antigen-presenting cells (APCs) take up tumor specific antigens, migrate to regional lymph nodes and prime tumor-specific T cells to drive a systemic anti-tumor immune response.
Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, "We are thrilled with our data showing early, strong, and long-lasting anti-cancer activity of Bria-OTS+ in multiple cancer models, boosting the immune system response, and potentially overcoming common cancer cell resistance mechanisms. Our findings strongly support targeted anti-cancer effects of Bria-OTS+ and warrant additional testing of the Bria-OTS+ platform in clinical settings."

"Based on these promising preclinical findings, we are advancing Bria-OTS+ with the goal of entering the clinic for our first indications of metastatic breast cancer and prostate cancer later this year, with additional indications (lung cancer and melanoma) planned for 2027," added Dr. William V. Williams, BriaCell’s President and CEO.

(Press release, BriaCell Therapeutics, APR 21, 2026, View Source [SID1234664853])

Black Diamond Therapeutics Announces Oral Presentation of Silevertinib Phase 2 Data in Frontline EGFRm NSCLC Patients at the 2026 ASCO Annual Meeting

On April 21, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.

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Details for the Oral Presentation:

Session Type/Title: Rapid Oral Abstract Session – Lung Cancer—Non-Small Cell Metastatic
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations
Abstract: 8519
Presenter: Julia Rotow, MD, Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at 8:00 AM EDT on the Black Diamond website here)

Details for the Poster Presentations:

Session Type/Title: Poster Session – Lung Cancer—Non-Small Cell Metastatic
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in previously treated patients with non-small cell lung cancer with non-classical and C797S EGFR mutations
Abstract: 8620
Poster Board: 410
Presenter: Helena Yu, MD, Memorial Sloan Kettering Cancer Center
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Session Type/Title: Poster Session – Central Nervous System Tumors
Title: Randomized phase 2 study to evaluate the efficacy and safety of silevertinib in combination with temozolomide in newly diagnosed patients with EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma
Abstract: TPS2098
Poster Board: 460a
Presenter: Patrick Wen, MD, Dana-Farber Cancer Institute
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT

Posters will become available on June 1, 2026 at 8:00 AM EDT on the Black Diamond Therapeutics website here.

About Silevertinib

Silevertinib is an oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It also potently inhibits key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR‑mutant NSCLC or EGFR‑altered GBM have been treated with silevertinib.

In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline NSCLC patients harboring a broad spectrum of non-classical EGFR mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate as of a November 3, 2025 data cutoff. No new safety signals were observed.

The Company is also initiating a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM in the second quarter of 2026.

(Press release, Black Diamond Therapeutics, APR 21, 2026, View Source [SID1234664601])