On April 1, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy.

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This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic cooperative networks of CCTG, GI Cancer Trials in Australia and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium (including Unicancer, GERCOR and FFCD). The BATTMAN (CO.33) trial serves as the registrational-enabling study for BOT+BAL enrolling approximately 830 patients and is expected to complete global enrollment quickly, reflecting the unprecedented investigator and patient enthusiasm worldwide, including strong interest from sites and physicians engaged through Agenus’ paid named patient and French AAC access programs.

"Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program," said Dr. Steven O’Day, Chief Medical Officer, Agenus. "This study advances our goal of developing effective immunotherapies for patients who currently have few options. We’re grateful to our partners at CCTG, GI Cancer Trials in Australia, and PRODIGE and to the dedicated investigators, site staff, and patients driving this global effort."

"Our collaboration with Agenus builds on years of cooperative-group research aimed at bringing immunotherapy benefits to patients with microsatellite-stable colorectal cancer—those historically left without effective options," said Dr. Chris O’Callaghan, DVM, PhD, Senior Investigator, Canadian Cancer Trials Group. "Earlier CCTG studies suggested that doublet immunotherapy could extend survival even in cold tumors, and the magnitude and durability of responses seen with botensilimab and balstilimab in earlier studies warrant their investigation in a phase 3 trial."

"The enthusiasm among investigators has been remarkable—within days of Health Canada submission, leading centers across Canada moved to open the study. We’re eager to advance this global effort and potentially transform outcomes for patients who have exhausted all other treatments," said Dr. Jonathan Loree, MD, MSc, FRCPC, CO.33 Study Chair.

About the BATTMAN (CO.33) Trial

The BATTMAN (CCTG CO.33) (NCT07152821) trial is a global Phase 3, randomized, controlled study evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. Conducted as an international cooperative group study led by the Canadian Cancer Trials Group (CCTG), the trial will enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand. Participating academic networks include CCTG, the GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE), sponsored by UNICANCER. This registrational-enabling study is designed to support potential regulatory submissions for BOT+BAL in this difficult-to-treat patient population. Patients interested in learning more about the study, including eligibility and enrollment information, can visit: View Source

(Press release, Agenus, APR 1, 2026, View Source [SID1234664131])

On April 1, 2026 Voro Therapeutics, a biotechnology company pioneering tumor-activated biologics to improve the safety and efficacy of cancer therapies, reported upcoming oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 and the Antibody Engineering & Therapeutics (AET) Europe conference.

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Voro Therapeutics will present new preclinical data showcasing the power of its proprietary PrimeBody biologics platform and the broad therapeutic index of its lead program, VOR-101. The presentations will demonstrate how PrimeBody’s novel protease-cleavable linkers and affinity-tuned masking domains drive tumor-selective activation, enabling the safe and effective deployment of highly potent warheads that are not achievable with conventional approaches. Voro will also highlight the platform’s broader potential through applications in T-cell engagers, antibody-drug conjugates and cytokines.

Presentation Details

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026

San Diego Convention Center • San Diego, CA • April 17–22, 2026

Date: April 20th, 2026

Session: MS.IM01.02 – Advances in Therapeutic Antibodies

Title: Tumor-Activated PrimeBody Biologics Platform Enables More Potent CD47 Targeting and Superior Therapeutic Index in Preclinical Models

Presenter: Aaron Springer, PhD, Associate Director of Preclinical Biology, Voro Therapeutics

Conference Link: View Source

Antibody Engineering & Therapeutics (AET) Europe

Congress Center Basel • Basel, Switzerland • May 27–29, 2026

Date: May 29th, 2026

Session: Masked, Gated, Conditionally Activated Antibodies

Title: Tumor-Activated PrimeBody Platform Unlocks the Safe and Effective Delivery of Potent Biologics Beyond the Reach of Conventional Approaches

Presenter: Ugur Eskiocak, PhD, Co-Founder and CEO, Voro Therapeutics

Conference Link: https://informaconnect.com/antibody-engineering-europe/

(Press release, Voro Therapeutics, APR 1, 2026, View Source [SID1234664129])

On April 1, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s fourth quarter and full year ended December 31, 2025, and provided a corporate update.

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"2025 was a strong year of executing upon our goals, and we continue to move all our programs forward this year. As we progress our clinical development pipeline, we have strategically strengthened our clinical and drug development expertise with Craig Tendler, M.D., providing the strategic and operational services consistent with those of a Chief Medical Officer to oversee clinical development strategy and operations of the company’s pipeline, including our VISTA inhibiting antibody, TBS-2025," said Dr. James Bianco, President and CEO of TuHURA Biosciences. "Craig brings a depth of experience that is invaluable to us as we look forward to several targeted key milestones in our VISTA program this year. Our IFx-2.0 Phase 3 study in front-line Merkel Cell Carcinoma (MCC) continues to enroll, and we now anticipate completing enrollment in mid-2027. Additionally, we continue to make important advancements toward preclinical proof-of-concept in our first-in-class immune modulating antibody drug conjugates (ADC) program and anticipate presenting new data at a scientific conference later this year."

Dr. Bianco continued, "We are grateful to have the unwavering support of our shareholders, who are committed to supporting our programs and realizing the potentially meaningful opportunity each one addresses."

Corporate Highlights

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Initiated a randomized Phase 3 Accelerated Approval Trial for IFx-2.0 in first line treatment of patients with advanced or metastatic Merkel Cell Carcinoma (MCC) as adjunctive therapy to Keytruda (pembrolizumab). Phase 3 study trial being conducted under a Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA). Primary endpoint of Overall Response Rate (ORR) qualifies for accelerated approval process. Key secondary endpoint of Progression Free Survival (PFS) may satisfy the requirement for a post confirmatory trial, converting accelerated approval to regular approval.

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Initiated Phase 1b/2a Study of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP). Trial designed to evaluate the safety and feasibility of IFx-Hu2.0 in combination with Keytruda when administered via Interventional Radiology (IR) in patients with deep- seated tumors without associated cutaneous tumors.

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Closed acquisition of Kineta gaining rights to TBS-2025, a novel VISTA inhibiting antibody, for $10.5 million.

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Raised gross proceeds of $21.2 million in registered direct offerings and private placements

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Presented data demonstrating the Delta Opioid Receptor (DOR) as a new target in overcoming acquired resistance to immune checkpoint inhibitors at ASH (Free ASH Whitepaper). Selected for Oral Presentation by the Scientific Committee of American Society of Hematology (ASH) (Free ASH Whitepaper) new scientific evidence that DOR is expressed on tumor-associated Myeloid-Derived Suppressor Cells (MDSCs), and its inhibition decreases immune suppressing capabilities of MDSCs by downregulating expression of multiple genes associated with MDSC induced immunosuppression. Data also presented in the poster session demonstrated that the DOR is also expressed on tumor associated macrophages (TAMs) and DOR inhibition appears to reverse TAM mediated T cell suppression with the potential to overcome resistance to checkpoint inhibitors and other cancer immunotherapies.

Upcoming Targeted Milestones by Program

IFx-2.0 (Innate immune agonist)

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1H 2026: Anticipate Orphan Drug Designation for IFx-2.0 in MCC
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2H 2026: Anticipate preliminary data from the Phase1b/2a study of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP)
•
2H 2027: Anticipate topline results from the Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to Keytruda (pembrolizumab) in first line treatment for advanced or metastatic MCC

TBS-2025 (VISTA inhibiting antibody)

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June 2026: Meeting with the FDA to discuss the development plan for TBS-2025 in NPM1 mut r/r AML

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2H 2026: Anticipate initiation of Phase 1b/2 trial of VISTA in NPM1 mut r/r AML

Lead ADC Selection

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1H 2026: Select lead ADC in AML
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2H 2026: Expect to initiate ADC in vivo proof of concept (POC) studies
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2H 2026: Anticipate POC data in humanized model of AML
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2H 2026: Presentations at key scientific meetings

Summary of Financial Results for the Full Year 2025

Cash and cash equivalents of $3.6 million at December 31, 2025, with an additional $7.5 million received in Q1 2026 from the 2025 registered direct offering. As of December 31, 2025, TuHURA’s total shares outstanding were approximately 52.9 million.

Research and development expenses were $20.5 million and $13.3 million for the 12 months ended December 31, 2025, and 2024, respectively. On a pro forma basis, which includes a full year of Kineta research and development, these expenses were $22.1 million and $18.7 million for the 12 months ended December 31, 2025, and 2024, respectively.

General and administrative (G&A) expenses were $7.6 million and $3.9 million for the 12 months ended December 31, 2025, and 2024, respectively.

Net cash outflows from operating activities were ($27.7) million and ($14.7) million for the 12 months ended December 31, 2025, and 2024, respectively.

Net cash flows from financing activities were $19.9 million and $29.7 million for the 12 months ended December 31, 2025, and 2024, respectively.

(Press release, TuHURA Biosciences, APR 1, 2026, View Source [SID1234664128])

On April 1, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PAS-004 for the treatment of NF1-associated PN causing significant morbidity.

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"We appreciate the FDA’s decision that PAS-004 meets the criteria for Fast Track designation for this indication," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "The ability to have early and frequent interactions with the FDA supports our goal to expeditiously develop PAS-004 for patients with NF1-associated PN causing significant morbidity."

Fast Track designation includes the following opportunities to facilitate Fast Track product development:

Frequent communications with the FDA review team throughout the product development process

Rolling Review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application

In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met. For more information, see the FDA’s website at
View Source

The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565).

About NF1- PN

Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, APR 1, 2026, View Source [SID1234664127])

On April 1, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.

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The extension follows Orca Bio’s recent submission of updated chemistry, manufacturing and controls (CMC) information in response to requests from the FDA as part of the standard review process. The FDA classified the submission as a Major Amendment (MA) to the BLA, which extends the review by three months. Importantly, the FDA has not requested any additional clinical data. Orca Bio believes that the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA.

"We appreciate the frequent engagement with the FDA throughout the review process," said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. "Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible."

The BLA for Orca-T was granted Priority Review by the FDA and Orca-T previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation.

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA).

(Press release, Orca Bio, APR 1, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-fda-review-extension-of-bla-for-orca-t-for-the-treatment-of-hematologic-malignancies [SID1234664126])