On April 1, 2026 Frontier Medicines Corporation, a clinical-stage precision medicines company unlocking the proteome to develop small molecule oncology and immunology drugs against previously undruggable disease-causing targets, reported that the Company has granted LG Chem, Ltd. ("LG Chem"), a leading global company headquartered in South Korea that specializes in life sciences as one of its core businesses, an exclusive worldwide license to develop and commercialize FMC-220 outside of Greater China, with Frontier retaining ownership and full control in Greater China. FMC-220 is Frontier’s first-in-class covalent p53 Y220C activator being evaluated for the treatment of solid tumor cancers with TP53 loss-of-function mutations.

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"This partnership with LG Chem marks an exciting and pivotal step for Frontier and for the FMC-220 program, underscoring the promise of our proprietary Frontier Platform to address historically challenging targets and deliver differentiated, covalent precision therapies," said Chris Varma, Ph.D., co-founder, chairman, and chief executive officer of Frontier Medicines. "Through this collaboration with LG Chem, the FMC-220 program will continue to advance, progressing toward translating the encouraging preclinical data we have demonstrated to date for FMC-220 into meaningful impact for patients. We are thrilled to partner with LG Chem, whose global development and commercialization expertise will be instrumental in bringing this therapy to patients worldwide."

FMC-220 covalently binds the mutant cysteine residue introduced by the Y220C substitution in TP53. TP53 Y220C is a common missense mutation found in approximately 1-3% of cancers, particularly prevalent in solid tumors such as lung, breast, ovarian and colorectal cancers. Preclinical data presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 showed that FMC-220 delivers unprecedented potency, selective engagement, and durable anti-tumor activity at low doses across a broad range of tumor models, including those harboring co-mutations such as those in KRAS.

Dr. Jeewoong Son, President of LG Chem Life Sciences Company, said, "FMC‑220 is an innovative approach that targets genetic mutations with limited existing treatment options," adding that the company will "work to validate its potential as a treatment option that could deliver benefits to patients."

Under the terms of the agreement, LG Chem will be responsible for regulatory filings, global clinical development, and commercialization in the licensed territories, and Frontier retains an option for enhanced financial participation through partial funding of the confirmatory clinical trial. Frontier will receive an upfront payment and is eligible to receive additional clinical, regulatory, and commercial milestone payments, and mid-single-digit to double-digit royalties on net sales.

FMC-220 was discovered using the Frontier Platform, integrating chemoproteomics and AI for covalent-based drug discovery. FMC-220 is the second potential first-in-class program to advance from the platform, following FMC-376, a dual ON/OFF KRASG12C inhibitor currently in clinical development.

(Press release, Frontier Medicines, APR 1, 2026, View Source [SID1234664138])

On April 1, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that it has extended the expiration of the tender offer to purchase all outstanding shares of common stock of Arcellx. The offer remains at a purchase price of (1) $115.00 per share, net to the seller in cash, without interest, subject to any withholding tax, plus (2) one contractual contingent value right (CVR), which represents the right to receive one contingent payment of $5.00 per CVR in cash, without interest, and subject to any withholding tax, payable on March 31, 2030, subject to cumulative worldwide sales of Arcellx’s anitocabtagene autoleucel (anito-cel) product exceeding $6.0 billion on or prior to December 31, 2029.

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The tender offer, which was previously scheduled to expire at one minute after 11:59 p.m., Eastern Time, on April 2, 2026, has been extended to expire at 5:00 p.m., Eastern Time, on April 24, 2026. The transaction is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions.

Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Gilead that, as of 5:00 p.m., Eastern Time, on March 31, 2026, approximately 4,389,763 shares have been validly tendered and not validly withdrawn in the tender offer, representing approximately 7.5% of the outstanding shares as of such date and time. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer. Questions or requests for assistance may be directed to Innisfree M&A Incorporated, the information agent for the tender offer, by calling toll free (877) 800-5182.

(Press release, Gilead Sciences, APR 1, 2026, View Source [SID1234664137])

On April 1, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for A2B543, an autologous CAR T-cell therapy designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression.

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Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.1

"Receiving Fast Track designation for A2B543 from the U.S. FDA is a key milestone for A2 Bio in accelerating this promising precision CAR T-cell therapy for cancer patients," said Jim Robinson, chief executive officer of A2 Bio. "We are deeply committed to patients facing cancer and other devastating diseases, and we believe in the potential for A2B543 to address unmet needs in cancer therapy."

A2B543 is being investigated in the ongoing EVEREST-2 clinical study (NCT06051695) which is evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2) autologous logic-gated investigational cell therapies in patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

A2B543 is comprised of autologous Tmod cells expressing a MSLN-targeted CAR activator, an HLA-A*02-targeted blocker, and an inducible, membrane-tethered IL-12 (mem-IL-12) booster. The inducible mem-IL-12 booster, which activates only upon engagement with tumor antigens, is designed to enhance the long-term potency and persistence of Tmod while reducing toxicity associated with systemic IL-12.2

The A2 Bio proprietary Tmod technology platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

(Press release, A2 Biotherapeutics, APR 1, 2026, View Source [SID1234664136])

On April 1, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has entered into a development and manufacturing agreement with Cytovance Biologics (www.cytovance.com), a leading full-service contract development and manufacturing organization ("CDMO") specializing in mammalian and microbially expressed biologics, to produce cGMP clinical materials for its planned Phase 2 clinical trial of its breast cancer vaccine.

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The agreement follows positive final Phase 1 results in which the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. Based on these results, Anixa is advancing preparations for a Phase 2 clinical trial.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By generating an immune response against α-lactalbumin-expressing cells, the vaccine is designed to potentially provide both therapeutic and preventive benefits for patients with tumors expressing this protein. The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "With final Phase 1 data demonstrating safety, tolerability, and strong immune responses in 74% of participants, we are focused on advancing this program toward Phase 2. Our agreement with Cytovance represents an important operational milestone as we work to secure cGMP clinical supply for the next stage of development." Dr. Kumar continued, "As we advance toward the Phase 2 trial, we expect to provide near-term updates on our progress."

"We are pleased to partner with Anixa to manufacture clinical materials for its Phase 2 breast cancer vaccine trial," said Ping Zhang, CEO of Cytovance Biologics. "Our team is committed to delivering high-quality cGMP manufacturing solutions that support innovative biotech programs. We look forward to leveraging our development and production capabilities to help advance this promising immunotherapy candidate."

(Press release, Anixa Biosciences, APR 1, 2026, View Source [SID1234664135])

On April 1, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo (TSE :4568) to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma.

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Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care.

In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all IDH1-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control. In the Phase 1 study in Japan of 47 participants with recurrent or progressive IDH1-mutant glioma with enhancing (predominantly high-grade) and non-enhancing (predominantly low-grade) tumors, safusidenib showed clinical activity in both populations. Data from a Phase 2 study in Japan of safusidenib in 27 patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma was published online in the November 2025 issue of Neuro-Oncology. The data published reflected a March 10, 2023 data cut-off. As of February 2026, 12 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years. Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting.

"We believe safusidenib has immense potential to address significant patient needs in IDH1-mutant glioma, and our current development plan focuses on patient groups with limited or no FDA-approved targeted treatment options. We are thrilled to now have the exclusive global development and commercialization rights to explore this investigational medicine’s potential across these devastating brain tumors," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With this agreement now final, we plan to expand the pivotal Phase 3 SIGMA study into Japan, continue to advance the robust global development of safusidenib, and pursue presentation and publication of longer-term data from the Phase 2 study to ensure the scientific community is up to date on these findings."

"The invention of new medicines is at the core of what we do at Daiichi Sankyo and safusidenib is a strong example of our expertise in science and technology," said Yuki Abe, Ph.D., Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "We continuously evaluate the best approach to accelerate the delivery of promising medicines to patients and we are confident that Nuvation Bio will carry this program forward, utilizing their strong expertise in clinical development and commercialization to explore the full potential of safusidenib for patients with IDH1-mutant glioma."

About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.

About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. In Phase 1 and Phase 2 clinical studies, safusidenib delayed disease progression and provided durable responses across grades and risk groups with a favorable risk-benefit profile.

About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.

(Press release, Nuvation Bio, APR 1, 2026, https://www.prnewswire.com/news-releases/nuvation-bio-announces-acquisition-of-japan-rights-to-safusidenib-from-daiichi-sankyo-302730492.html [SID1234664134])