On April 22, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612 ) has consented over 100 and has enrolled over 75 patients (Press release, BriaCell Therapeutics, APR 22, 2025, View Source [SID1234652429]). BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026.

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BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice in a dvanced metastatic b reast c ancer (Bria-ABC).

"We are pleased at the expanding patient enrollment in our Phase 3 study, and expect this to continue to grow," stated Dr. William V. Williams, BriaCell’s President & CEO. "We believe our novel therapeutic approach has the potential to transform cancer care for metastatic breast cancer patients, and are determined to bring our novel immunotherapy to market to help these patients."

"Enrollment pace and clinical investigator interest in our Bria-ABC study is above any I have seen," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We would like to thank our dedicated clinical investigators and patients for participating in this important study. Through their efforts, we will advance our novel cancer immunotherapy to other MBC patients whose medical needs remain unmet."

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

Fifty-four clinical sites in the US are actively enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell recently announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

On April 22, 2025 Onward Therapeutics SA, a biotechnology company dedicated to advancing innovative cancer immunotherapies, reported that its subsidiary, Emercell SAS, has received Investigational Medicinal Product Dossier (IMPD) approval from the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of OT-C001, an allogeneic natural killer (NK) cell therapy, in combination with an anti-CD20 monoclonal antibody, Rituximab (Press release, Onward Therapeutics, APR 22, 2025, View Source [SID1234652024]).

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The upcoming phase 1 study (C00101 study) will enroll patients with diffuse large B-cell lymphoma (DLBCL), who have relapsed after, or are refractory to CAR-T cell therapy, or ineligible for CAR-T cell infusion. OT-C001 will be evaluated with Rituximab across various dose levels. The trial will also examine cellular kinetics and biomarkers to characterize the specific mechanism associated with therapeutic responses.

"We are delighted to have reached an important milestone of entering clinical development of OT-C001 following our strategic investments in Emercell since 2021," said Dr. C. Grace Yeh, Chairman and CEO of Onward Therapeutics,"This Phase 1 trial may validate Emercell’s patented platform technology for meaningful clinical outcomes. Along with the continued optimization of industrial manufacturing, these efforts will strengthen our ability to form strategic partnerships and advance this promising therapy."

"OT-C001 sets itself apart by utilizing a pool of multiple umbilical cord blood (UCB) samples, offering both diversity in the product and consistency across GMP batches," said Dr. Patrick Henno, Founder and ex-President of Emercell, "unlike the complex manufacturing processes of many engineered cell therapy products, OT-C001 provides a safe and scalable solution to unmet medical needs in targeted indications."

"We are excited to initiate this multicenter phase 1 trial in one of the most common and aggressive forms of non-Hodgkin lymphoma," said Dr. Alain Herrera, President of Emercell and CMO of Onward Therapeutics, "despite challenges in the cell therapy market, this achievement advances our mission to provide novel treatments for DLBCL patients in need of new therapeutic options. OT-C001 has the versatility to act as a universal platform through combinations with various monoclonal antibodies or targeted therapies; it may benefit patients across multiple indications beyond DLBCL."

About OT-C001

OT-C001 is an allogeneic cell therapy of highly activated and expanded NK cells from UCB, manufactured using a patented expansion and activation process. It targets tumor cells through direct and indirect cytotoxicity, when combined with a monoclonal antibody targeting tumor specific antigens. OT-C001 is being evaluated as a potential new treatment for advanced hematologic malignancies with monoclonal antibodies. In non-clinical in vitro, in vivo models, and toxicology studies, it was well tolerated and displayed promising anti-tumor activities.

On April 21, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz" or the "Company") reported the successful completion of its acquisition of Chimerix, Inc. ("Chimerix") for approximately $935 million in cash (Press release, Jazz Pharmaceuticals, APR 21, 2025, View Source [SID1234651992]). Chimerix is now a wholly owned subsidiary of Jazz.

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"Bringing Chimerix into Jazz adds a novel medicine to our oncology portfolio and advances our efforts to address unmet patient needs," said Bruce Cozadd, chairman and chief executive officer of Jazz. "Dordaviprone has the potential to become the first and only FDA-approved therapy for patients with H3 K27M-mutant diffuse glioma and offers a promising near-term commercial opportunity, if approved. We are excited to welcome Chimerix’s talented team as we collectively continue to advance dordaviprone, leveraging our development and commercial capabilities to deliver this therapy to patients as soon as the second half of this year."

The addition of dordaviprone, a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, further diversifies and adds near-term commercial opportunity to Jazz’s oncology pipeline. Dordaviprone is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for August 18, 2025. If approved in the U.S., the therapy may be eligible for a Rare Pediatric Disease Priority Review Voucher (PRV). Dordaviprone is also being studied in the ongoing Phase 3 ACTION trial to evaluate its use in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting.

Transaction Details

Jazz’s tender offer for all outstanding shares of common stock, par value $0.001 per share, of Chimerix expired at one minute after 11:59 p.m., Eastern Time, on April 17, 2025. Jazz has accepted for payment of $8.55 per share, in cash, without interest and subject to reduction for any applicable withholding taxes, all shares that were validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Jazz completed the acquisition of Chimerix through the merger of Pinetree Acquisition Sub, Inc., a Delaware corporation, an indirect wholly owned subsidiary of Jazz ("Purchaser") with and into Chimerix (the "Merger"). As a result of the Merger, the separate existence of Purchaser ceased, and Chimerix continued as the surviving corporation and an indirect wholly owned subsidiary of Jazz. Additional details regarding the tender can be found in a form 8-K filed by Jazz today with the SEC.

About Dordaviprone

Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 (DRD2). Dordaviprone’s unique mechanism of action includes alterations of key epigenetic modifications such as reversal of H3 K27me3-loss, which is the hallmark of H3 K27M-mutant gliomas.

On April 21, 2025 HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer and other diseases, reported that it has filed two investigational new drug (IND) applications (HF158K1 and HFK2) with China’s National Medical Products Administration for immunoliposomes carrying different cancer killing payloads (Press release, HighField Biopharmaceuticals, APR 21, 2025, View Source [SID1234652008]). The planned clinical study will evaluate the two drugs’ safety and pharmacokinetics as well as their combined therapeutic effects in solid tumor patients refractory to prior treatments.

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The two drugs are derived from HighField’s proprietary ADCplexTM platform, containing chemotherapy payloads inhibiting Topoisomerase I and Topoisomerase II activities respectively. HF158K1 (K1) and HFK2 (K2) are both fitted with HER2 antibodies for binding to cancer cell surface HER2 receptors in both HER2 high and low tumors.

K1 is being evaluated as a monotherapy in an ongoing Phase 1 trial in the US (NCT05861895). The planned Phase 1 open label, dose escalation trial of K1 and K2 in China will evaluate the safety and pharmacokinetics of K1 as a monotherapy and preliminary efficacy in combination with K2.

HighField CEO and Scientific Founder Yuhong Xu, Ph.D., explained, "The antibody-drug-conjugate (ADC) drugs are designed based on a great concept. Their specificity and efficacy in cell culture models are always perfect. However, in patients, the process of ADC tumor penetration, especially intracellular payload release inside cancer cells, is profoundly nonlinear. Therefore, increasing the dose may not lead to improved efficacy, but only increased toxicity."

Dr. Xu observed, "Upon modeling the tumor penetration and intracellular delivery process, we came up with the ‘golf cart’ approach. The liposomes ‘escort’ the payloads in a more efficient way than ADCs so there is a close to linear dose vs. intracellular delivery correlation. In this case, we can even combine two kinds of immunoliposomes carrying two different payloads and expect higher efficacy and low toxicity."

Preclinical efficacy studies in mouse tumor models showed greater efficacy from K1, K2 and the two combined than marketed ADCs with the same HER2 target. In addition, the efficacy to maximum tolerant dose (MTD) therapeutic windows are wider.

On April 21, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, APR 21, 2025, View Source [SID1234651993]):

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BofA Securities 2025 Health Care Conference at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 13, 2025
2025 RBC Capital Markets Global Healthcare Conference at 11:00 a.m. ET on Tuesday, May 20, 2025
Bernstein 41st Annual Strategic Decisions Conference at 11:00 a.m. ET on Wednesday, May 28, 2025
Goldman Sachs 46th Annual Global Healthcare Conference at 10:40 a.m. ET on Monday, June 9, 2025

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.