On April 2, 2026 CanWell Pharma Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAN016, a HER2-targeting dual-payload ADC. The company will initiate a Phase I clinical study to evaluate CAN016 in solid tumor patients who have experienced disease progression following prior ADC therapies.

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About CAN016

CAN016 is an ADC in development by CanWell Pharma Inc. for ADC pre-treated solid tumors. Developed using CanWell’s StarLinker platform, CAN016 is distinguished by its integration of two distinct MoA cytotoxic agents within a single antibody construct, leading to enhanced anti-tumor activity through complementary mechanisms. This design is expected to counter the resistance mechanisms that limit the efficacy of conventional single payload ADCs.

In preclinical studies, CAN016 effectively delivered dual cytotoxic payloads into tumor cells leading to synergistic tumor cell killing, inhibition of proliferation, and apoptosis. CAN016 has demonstrated potent anti-tumor activity in multiple CDX and PDX models, including those resistant to currently approved HER2-targeted ADC therapies.

The Phase I study will assess the safety, tolerability, and pharmacokinetics of CAN016, determine the recommended dose for subsequent clinical development, and explore preliminary anti-tumor efficacy across a range of HER2-expressing ADC pre-treated solid tumors.

(Press release, Canwell Pharma, APR 2, 2026, View Source [SID1234664161])

On April 2, 2026 AstraZeneca reported that positive high-level results from the EMERALD-3 Phase III trial showed Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE) demonstrating a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation.

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At this interim analysis for overall survival (OS), a key secondary endpoint, this combination also demonstrated a trend toward OS improvement versus TACE alone.

Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, before TACE, and then alongside TACE.

Although not formally tested at this time, data for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed strong trends toward improved PFS and OS. The trial will continue to follow OS and other key secondary endpoints in both investigational arms.

HCC is the most common type of liver cancer.1 In 2026, more than 200,000 patients with HCC will be eligible for embolisation, a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.2-4 However, most patients who receive embolisation experience disease progression or recurrence within six to ten months.5

Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial said, "Dual immunotherapy with durvalumab and tremelimumab in the STRIDE regimen represents a meaningful advance for patients with embolisation-eligible liver cancer, who currently lack systemic treatment options to keep their cancer from progressing or recurring, with a trend of improving survival. EMERALD‑3 shows we can now significantly reduce the risk of disease progression with STRIDE as the immunotherapy backbone alongside lenvatinib and TACE."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "EMERALD‑3 now shows that bringing the dual immunotherapy STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve outcomes in earlier‑stage liver cancer. This builds on the HIMALAYA Phase III trial data in patients with advanced, unresectable disease, where the STRIDE regimen has already demonstrated durable overall survival benefit. We are discussing these positive data with global regulatory authorities while awaiting the final results from the key secondary endpoints."

The safety profile for each combination was consistent with the known profiles of each medicine, and there were no new safety findings.

These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

(Press release, AstraZeneca, APR 2, 2026, View Source [SID1234664130])

On April 2, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California from April 17-22, 2026. The Company will showcase new data on CLD-401, a systemically delivered oncolytic virus that is designed to express high levels of IL-15 superagonist ("IL-15 SA") only in the tumor microenvironment ("TME"), currently in IND-enabling studies.

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CLD-401 is the lead candidate from the Company’s RedTail platform, a systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401 is engineered to express high levels of IL-15 SA, a known T- and NK-cell activator, in the TME. Data at AACR (Free AACR Whitepaper) will detail the pattern of CLD-401 mediated-IL-15 SA expression and the subsequent immune changes in the TME, leading to a robust therapeutic response. The Company expects to file an IND for CLD-401 by the end of 2026.

"We continue to advance the RedTail platform and its breakthrough capabilities through our lead asset, CLD-401," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We expect to file an IND for CLD-401 by end of 2026 and enter the clinic shortly thereafter."

"The data we will present at AACR (Free AACR Whitepaper) will characterize the pharmacokinetic pattern of IL-15 SA expression and resulting changes in the TME" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The ability of CLD-401 to induce high levels of IL15-SA expression in the TME but not systemically may dramatically alter the therapeutic window of cytokine treatment."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, APR 2, 2026, View Source [SID1234664146])

On April 2, 2026 Palleon Pharmaceuticals, a company developing engineered enzyme therapies that remove excessive sialic acid to treat autoimmune diseases and cancer, reported upcoming presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place in San Diego from April 17 – 22. Palleon will make an oral presentation during the "New Drugs on the Horizon" series on Sunday, April 19 and will present a poster on Wednesday, April 22.

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Details of Palleon’s Presentations:

American Association for Cancer Research Annual Meeting
Title: A First-in-Class Human Sialidase-Armed Anti-B7-H3 Antibody that Enhances Innate and Adaptive Antitumor Immune Responses
Abstract ID: 7158
Oral Presentation Session Date and Time: Sunday, April 19 from 3:00 PM to 4:30 PM PT
Poster Presentation Session Date and Time: Wednesday, April 22 from 9:00 AM to 12:00 PM PT
Session Category: Experimental and Molecular Therapeutics
Session Title: Overcoming Microenvironmental and Delivery Barriers in Cancer Therapy

HLX316/E-688 is a first-in-class investigational treatment developed from Palleon’s EAGLE (Enzyme-Antibody Glycan-Editing) Platform. Palleon’s HLX316/E-688 is being developed in China by Shanghai Henlius Biotech and is designed to address key mechanisms of immune evasion by enhancing the desialylation of tumor cells that express B7-H3 to help restore both innate and adaptive anti-tumor responses in the tumor microenvironment. The China National Medical Products Administration (NMPA) has cleared Henlius’ Investigational New Drug (IND) application for a Phase 1 clinical trial of HLX316/E-688 in China for the treatment of advanced or metastatic solid tumors.

The presentations will be made available on the Glycobiology Education section of Palleon Pharmaceuticals’ website.

(Press release, Palleon Pharmaceuticals, APR 2, 2026, View Source [SID1234664162])

On April 2, 2026, Lisata Therapeutics, Inc. (the "Company" or "Lisata") and Kuva Labs Inc., a Delaware corporation ("Parent"), together with Kuva Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Parent ("Purchaser"), reported to have agreed to extend the date by which Purchaser is obligated to commence the tender offer for all of the outstanding shares of common stock of the Company pursuant to the previously announced Agreement and Plan of Merger, dated as of March 6, 2026, by and among Parent, Purchaser and the Company (the "Merger Agreement"), from April 3, 2026, to April 13, 2026, or such other date as may be agreed to between the Company and Parent. Purchaser has not yet commenced the tender offer. The Company has been informed by Parent that Parent is currently seeking alternative sources of financing on terms more favorable to Parent to fund the tender offer, and intends to launch the tender offer when its financing is finalized. The Company is in discussions with Parent regarding the financing and timing of the commencement of the tender offer. There can be no assurance as to when the tender offer will commence, if at all.

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(Press release, Lisata Therapeutics, APR 2, 2026, View Source [SID1234664400])