Frontier Medicines Announces Exclusive Licensing Agreement for FMC-220, a First-in-Class Covalent p53 Y220C Activator, with LG Chem, Ltd.

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])

FORE Biotherapeutics Receives Breakthrough Therapy Designation for Plixorafenib

On April 1, 2026 FORE Biotherapeutics, a registration stage company dedicated to developing targeted therapies to treat patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG). Fore Bio believes this is the first BTD granted to a targeted therapy for HGG. Plixorafenib is a novel BRAF inhibitor that is a dimer breaker with high selectivity for BRAF alterations.

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The FDA granted this BTD based on data from approximately 25 patients treated in the completed Phase 1/2a clinical trial and ongoing Phase 2 FORTE basket evaluating plixorafenib in BRAF V600E-mutated central nervous system (CNS) tumors. The CNS tumors treated in FORTE include HGG, low-grade gliomas (LGG), and other primary brain and spinal cord tumors in adults and children. BTD is designed to speed the development and regulatory review of new medicines that are intended to treat a serious or life-threatening condition and that have shown encouraging early results, which demonstrate substantial improvement on one or more clinically significant endpoints (e.g., improved efficacy or improved safety with similar efficacy, etc.), over available therapies.

"High-grade gliomas are aggressive primary brain tumors associated with poor outcomes despite multimodality treatment approaches," said Macarena da la Fuente M.D., Chief, Neuro-Oncology Division, Department of Neurology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. "In addition to their limited prognosis, patients experience substantial morbidity related to both the disease itself and the toxicities of current therapies. Therefore, there remains a critical need for novel treatments that are not only effective but also better tolerated."

"The granting of Breakthrough Therapy Designation is a significant development milestone for plixorafenib and reinforces our conviction in its unique mechanism of action which, further supported by the tolerability and efficacy profile seen in BRAF-altered tumors, underscores the potential of plixorafenib as a treatment option for patients living with difficult to treat cancers," said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. "BRAF alterations are an important actionable driver in the molecularly integrated clinical decision paradigm for the treatment of high-grade gliomas, and plixorafenib has demonstrated a differentiated profile in patients with primary CNS tumors, including glioblastoma and other high-grade gliomas. The maturation of the data from FORTE may help validate these findings, with BTD status further accelerating the delivery of this promising therapy to patients. We look forward to continued collaboration with the FDA to further advance plixorafenib and to advancing our FORTE basket trial in several types of BRAF altered malignancies."

Data from the Phase 1/2a trial, which were previously presented at ASCO (Free ASCO Whitepaper) 2023 and SNO 2023, show that plixorafenib achieved a 67% overall response rate (ORR) in a pre-specified subgroup of patients with refractory MAPK inhibitor naive BRAF V600-mutated primary CNS tumors with robust anti-tumor activity further supported by duration of response (DOR), and clinical benefit rate (CBR) across BRAF-altered tumor types and CNS histologies. As of the last reporting, the BRAF V600E primary CNS basket of the FORTE study met the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) supporting that the study may continue as planned on the basis of responses assessed by blinded independent central review (BICR), in addition to the IDMC’s ongoing oversight for safety.

BTD provides Fore with more frequent and intensive guidance from and dialogue with the FDA, including the involvement of senior reviewers, as well as eligibility for rolling and priority review of the marketing application. These benefits have the potential to accelerate the development and review of plixorafenib.

Plixorafenib previously received Fast Track Designation for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies and Orphan Drug Designation (ODD) for the treatment of primary brain and CNS malignancies. These, in addition to the BTD, continue to support the development of plixorafenib for the treatment of BRAF-altered primary CNS tumors in adults and children as the broader data set from FORTE continues to mature to provide a sufficient number of patients to support a robust benefit-risk profile across refractory high grade and low grade CNS biomarker-selected histologies.

About the Global Phase 2 FORTE Basket Study
The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600 primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the Bayesian adaptive design of the trial, interim efficacy analyses are conducted in each basket, for which the company reported a positive outcome from the BRAF V600 CNS basket in the third quarter of 2025.

About BRAF Altered Recurrent Primary CNS Tumors
BRAF altered recurrent primary CNS tumors represent a high unmet medical need and a large market opportunity for plixorafenib. In the advanced treatment setting, patients are offered currently approved therapies, but those therapies have significant limitations in efficacy, tolerability, and safety.

About Plixorafenib
Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

(Press release, Fore Biotherapeutics, APR 1, 2026, View Source [SID1234664123])

Zai Lab Announces Global Clinical Trial Collaboration and Supply Agreement to Evaluate Novel DLL3 ADC, Zocilurtatug Pelitecan, in Combination with a Bispecific T-cell Engager Therapy

On April 1, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported a global clinical trial collaboration with Amgen Inc. (NASDAQ: AMGN) to evaluate Zai Lab’s investigational delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), zocilurtatug pelitecan (zoci, formerly ZL-1310), in combination with Amgen’s IMDELLTRA (tarlatamab-dlle), a DLL3-targeting Bispecific T-cell Engager (BiTE) therapy in patients with extensive-stage small cell lung cancer (ES-SCLC).

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As part of this collaboration agreement, Amgen will sponsor a global Phase 1b study to evaluate the safety and efficacy of zoci in combination with IMDELLTRA in patients with ES-SCLC. Zai Lab will retain full ownership of zoci and will supply Amgen with the study drug.

"In combination, this dual-targeting strategy has the potential to increase the rate and deepen responses both systemically and, in the brain, address resistance pathways, and unlock new treatment paradigms for patients with small cell lung cancer," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "These two approaches leverage complementary mechanisms — our ADC delivers a potent cytotoxic payload directly to DLL3-expressing tumor cells, while the T-cell engager is designed to activate T-cells by binding the same antigen and eliciting an immune response against the tumor."

Zoci is a DLL3-targeting ADC for small cell lung cancer. Zai Lab has presented data from a Phase 1/2 clinical trial of zoci at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium 2025 and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, demonstrating a high response rate in heavily pretreated SCLC patients, including strong intracranial activity, and a tolerable safety profile. Amgen’s IMDELLTRA received FDA approval and is currently marketed in the U.S. for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Please see full Prescribing Information, including Boxed Warnings, for IMDELLTRA.

About Zocilurtatug Pelitecan (zoci, formerly ZL-1310)

Zoci is a novel ADC in Zai Lab’s global oncology pipeline targeting DLL3, an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. Zoci comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.

Zoci is being evaluated in a global development program, which includes DLLEVATE, a pivotal trial to further evaluate the safety and efficacy of zoci compared to investigator’s choice single agent therapy in patients with relapsed ES-SCLC; a phase 1b/2 trial evaluating zoci in selected solid tumors including extrapulmonary neuroendocrine carcinoma; and a phase 1a/1b trial evaluating zoci as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of ES-SCLC.

Zoci’s safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential as a backbone ADC in first-line combination regimens, including those that reduce the burdens of chemotherapy. Zoci received FDA Orphan Drug Designation and FDA Fast Track Designation for the treatment of SCLC.

About Small Cell Lung Cancer (SCLC)

SCLC is one of the most aggressive and lethal solid tumors, accounting for ~15% of approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Two-thirds of all SCLC patients are diagnosed at extensive stage3, which is associated with high rates of relapse and poor prognosis. The outcomes of the patients with ES-SCLC are dismal, with median survival of approximately 12 months following initial therapy4 and a ~5-10% overall five-year survival rate5. Treatment options have historically been limited once a patient progresses. IMDELLTRA is the first DLL3-targeting bispecific T-cell engager therapy to demonstrate an overall survival benefit in this patient population. The combination of zocilurtatug pelitecan and IMDELLTRA has the potential to build on these gains by further improving efficacy while maintaining manageable safety.

(Press release, Zai Laboratory, APR 1, 2026, View Source [SID1234664139])

Janux Therapeutics Announces Development Candidate Nomination Under Bristol Myers Squibb Collaboration, Triggering $35 Million Milestone Payment

On April 1, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported the nomination of a development candidate under its collaboration and exclusive worldwide license agreement with Bristol Myers Squibb. The milestone was achieved following the identification of a tumor-activated therapeutic, utilizing Janux’s TRACTr platform, targeting an undisclosed solid tumor antigen expressed across several human cancer types, triggering a $35 million milestone payment to Janux.

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"This milestone underscores the strength of our approach to generating value through both internal innovation and strategic partnerships, and reflects the continued promise of our tumor-activated platforms," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "The nomination of a development candidate highlights our ability to translate platform insights into differentiated therapeutics in collaboration with leading oncology companies."

"We are pleased to reach this important milestone with Bristol Myers Squibb, which reflects strong collaboration between our teams and the disciplined execution of our research and development efforts," said Janeen Doyle, Chief Corporate and Business Development Officer of Janux. "Advancing a program to development candidate nomination represents a key step toward IND-enabling studies and clinical development."

Under the terms of the collaboration agreement, Janux is responsible for conducting preclinical development through IND submission. Bristol Myers Squibb will hold the IND and will be responsible for subsequent clinical development and global commercialization of products arising from the collaboration. Janux will remain actively involved in the program, supporting Bristol Myers Squibb through completion of the first Phase 1 clinical study.

In addition to the $35 million milestone payment associated with development candidate nomination, Janux is eligible to receive additional development, regulatory and commercial milestone payments, as well as tiered royalties on global product sales.

(Press release, Janux Therapeutics, APR 1, 2026, View Source [SID1234664140])

Oncolytics Biotech® Completes Domicile Change to the United States

On April 1, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported the completion of the previously announced change in the jurisdiction of incorporation of Oncolytics from the Province of Alberta in Canada to the State of Nevada in the United States (the "Domestication") through a series of transactions in which the Company first continued its existence from the Province of Alberta in Canada to the Province of British Columbia in Canada on March 17, 2026. The Company will retain its office in Calgary, while the San Diego office will become the Company’s new headquarters.

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The Domestication was approved by the Company’s shareholders at the Special Meeting of Shareholders held on January 15, 2026. The Company completed the Domestication on March 31, 2026, when necessary filings were submitted to, and made effective by, the Nevada Secretary of State. The Company’s common stock will continue to trade on The Nasdaq Stock Market LLC under the ticker symbol "ONCY." Effective today, the CUSIP number applicable to the Company’s common stock will be 68237V 103, and the ISIN will be US68237V1035.

Today, most of the Company’s investors, management team, and capital markets activity are U.S.-based. We expect this transition to bring several benefits to the Company and its stockholders, including greater operational efficiency, a streamlined regulatory structure, and improved access to U.S. capital markets.

"We are encouraged by the potential benefits that Nevada’s corporate legal environment presents to biotech companies, especially given our focus on operational efficiency across the company," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we no longer qualified as a "foreign private issuer" under applicable U.S. securities laws, it made sense to overhaul our corporate structure and change Oncolytics’ jurisdiction of incorporation to reflect its status as a U.S. domestic issuer. While our clinical data and regulatory strategy will ultimately give us the best opportunity to create long-term value, we believe our new corporate structure will streamline our ability to execute on our goals."

(Press release, Oncolytics Biotech, APR 1, 2026, View Source [SID1234664125])