On October 22, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, reported the initiation of the DAYBreak clinical trial, a pivotal single-arm Phase 2 study of bexobrutideg (NX-5948) in patients with relapsed or refractory chronic lymphocytic leukemia.

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DAYBreak and the planned Phase 3 confirmatory study of bexobrutideg will evaluate the 600 mg dose taken once daily (QD). The selection of the 600 mg dose follows the completion of the analysis of data from a randomized cohort within the Phase 1b study comparing 200 mg and 600 mg in accordance with Project Optimus and reflects alignment with global regulators including the U.S. Food and Drug Administration, the U.K Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency.

In an investor webcast at 8:00 a.m. ET, today, Wednesday, October 22, 2025, Nurix will provide a program update including a review of new preclinical data supporting the potential best-in-class BTK degrader profile of bexobrutideg and discuss the DAYBreak and planned Phase 3 confirmatory studies.

"The initiation of the DAYBreak study marks Nurix’s transition to a pivotal-stage company and a major milestone for bexobrutideg, which our data demonstrate has a potential best-in-class profile," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With the DAYBreak study underway, we are advancing the development of bexobrutideg and are one step closer to registration and commercialization."

The DAYBreak study will enroll patients with r/r CLL who have experienced disease progression following treatment with a covalent BTK inhibitor (cBTKi), a BCL-2 inhibitor (BCL-2i), and a non-covalent BTK inhibitor (ncBTKi). The DAYBreak study aims to evaluate bexobrutideg’s potential to address an unmet medical need in this patient population and generate data to support a potential Accelerated Approval submission.

Nurix plans to initiate a randomized confirmatory Phase 3 trial in the first half of 2026 in r/r CLL patients whose disease has previously progressed while receiving a cBTKi. This global Phase 3 confirmatory trial in patients treated in the second line or later setting will compare bexobrutideg monotherapy to an investigator’s choice of pirtobrutinib monotherapy (a ncBTKi), bendamustine + rituximab, or idelalisib + rituximab.

"The favorable safety profile observed at the 600 mg bexobrutideg dose allows us to optimize its therapeutic effect, providing patients the opportunity to regain control of CLL that has progressed or has failed to respond to other therapies," said Paula O’Connor, M.D., chief medical officer of Nurix. "With regulatory alignment, we are advancing a global registrational program intended to address a large unmet need for patients with relapsed or refractory CLL. We look forward to completing this pivotal Phase 2 study and our confirmatory Phase 3 trial as part of our comprehensive development plan designed to provide patients with a much-needed therapeutic alternative.

As an innovator in the field of targeted protein degradation, Nurix has generated significant data to support bexobrutideg’s potential best-in-class BTK degrader profile.

"During our upcoming conference call, we will share highlights from our latest, unpublished preclinical data demonstrating superior degradation potency, broad coverage of clinically relevant BTK mutations, and exquisite selectivity, which together set a high bar for this class of medicines," said Gwenn Hansen, Ph.D., chief scientific officer of Nurix. "These superior attributes strengthen our conviction that bexobrutideg may prove to be a clinically superior medicine for the treatment of patients with CLL and other B-cell driven diseases."

Investor webcast
Nurix will host an investor webcast today, October 22, 2025, at 8:00 a.m. EDT. A live webcast and replay of today’s event will be available on the Investors section of the Nurix website at View Source A copy of the materials to be presented at the Investor Update will be filed in an accompanying Form 8-K filing and may be found at View Source

(Press release, Nurix Therapeutics, OCT 22, 2025, View Source [SID1234656899])

On October 22, 2025 GemPharmatech, a global leader in preclinical research solutions and genetically-engineered mouse models, reported a collaboration with Memorial Sloan Kettering Cancer Center (MSK) to accelerate the discovery of new therapeutic antibodies.

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Through the non-exclusive agreement, researchers at Memorial Sloan Kettering will have access to GemPharmatech’s extensive preclinical service capabilities and resources, utilizing the NeoMab platform — a next-generation transgenic mouse model designed for rapid, efficient discovery of fully human therapeutic antibodies. The collaboration will help scientists at Memorial Sloan Kettering who are already tapping a wide range of leading-edge preclinical resources to further accelerate the development of fully human therapeutic antibodies against high-value targets and address urgent, unmet needs in cancer treatment.

"Our mission has always been to enable transformative biomedical research through innovative mouse models and technologies," said Dr. Xiang Gao, founder of GemPharmatech. "Collaborating with MSK on antibody discovery represents a powerful opportunity to combine scientific excellence with cutting-edge mouse models such as NeoMab. Together, we can accelerate the development of novel therapeutics that address some of the most urgent challenges in cancer treatment."

Part of the world’s largest library of genetically engineered mouse models (GEMMs), the immunoglobulin gene-humanized mouse model- NeoMab, carries the full variable gene repertoire of human heavy and kappa light chains, and regulatory elements, in a BALB/c background. This innovative design enables the rapid generation of diverse, high-affinity fully human antibodies without the need for time-consuming sequence humanization steps. By skipping this process, the collaboration aims to shorten antibody development timelines and reduce immunogenicity risks.

"This collaboration underscores our mission to provide the global research community with advanced platforms to accelerate innovations in drug discovery," said Dr. Brandy Wilkinson, Chief Executive Officer of GemPharmatech. "We are excited to be supporting MSK’s pioneering work in oncology research with the NeoMab platform. It is an honor to contribute to their scientific mission and to help advance antibody programs with the potential to transform therapies and improve patient outcomes worldwide."

(Press release, Memorial Sloan-Kettering Cancer Center, OCT 22, 2025, View Source [SID1234656915])

On October 22, 2025 Onco3R Therapeutics, a clinical-stage immunology and oncology biotech company dedicated to transforming patients’ lives with best-in-class medicines, reported that it will present preclinical data from its FGFR3, SMARCA2 and P53 Y220C small molecules programs in 3 posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston.

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"First generation precision medicines are often suboptimal in the clinic due to low target coverage, off-target toxicity and emergence of resistance. At Onco3R, our vision is to design best-in-class medicines to address the unmet needs left by first generation drugs and unlock the full potential of therapeutic targets" said François Gonzalvez, PhD, CSO and co-Founder of Onco3R Therapeutics.

"We are thrilled to present the first preclinical data from our lead oncology programs FGFR3, SMARCA2 and P53 Y220C. Each program has identified best-in-class molecules which offer the potential to deliver transformational efficacy and improved tolerability for patients. Our FGFR3 and SMARCA2 candidates, G-012 and G-141 respectively, have reached the optimum potency and selectivity profile to mitigate dose-limiting toxicities while maintaining maximum target coverage. This has translated into robust anti-tumor activity in vivo. The poster presentations will highlight data supporting the advancement of these two candidates towards the clinic, as well as the discovery of unique small molecule P53 reactivators."

"These compelling preclinical results further validate our patient-centric drug discovery approach, which integrates deep translational science with rational, structure-based and AI-augmented drug design", Pierre Raboisson, PhD, CEO and co-Founder of Onco3R Therapeutics said. "We look forward to advancing these two candidates and remain on track to initiate IND-enabling studies in mid-2026. The identification of these candidates, alongside the continued clinical progress of our SIK3 inhibitor O3R-5671 in autoimmune indications, reinforces Onco3R’s strong strategic position. With a robust pipeline and clear execution momentum, we are confidently advancing toward our next value-driving milestones."

Presentation details

Title: Discovery of Best-in-Class FGFR3 small molecule inhibitors with high isoform selectivity and activity against gatekeeper mutations

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: Sandrine Vendeville, PhD

Key findings from preclinical studies include:

G-012 demonstrated best-in-class potency and selectivity with favorable drug-like properties.

Based on translational modelling, the compound reached the optimal selectivity against other FGFR isoforms to mitigate off-target toxicity and maintain maximal target coverage.

G-012 showed robust anti-proliferative activity in FGFR3-driven cancer cells and induced significant tumor regression in vivo.

G-012 is currently advancing in 14 days toxicology studies.

IND-enabling studies are anticipated in mid-2026.

Title: Discovery of novel SMARCA2 small molecule inhibitors with best-in-class potency and selectivity for the treatment of SMARCA4-mutant cancers

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: Lijs Beke, PhD

Key findings from preclinical studies include:

G-141 combined best-in-class cellular potency and selectivity to allow optimal target coverage and unlock the full therapeutic potential of SMARCA2 inhibition.

The compound showed synthetic lethality in SMARCA4-deficient cells and induced robust anti-tumor activity in vivo without signs of SMARCA4-related toxicity.

G-141 showed favorable drug-like properties and is currently advancing in 14 days toxicology studies.

IND-enabling studies are anticipated in mid-2026.

Title: Discovery of a Best-in-Class small molecule p53 Y220C reactivator: Breaking through the potency ceiling

Session: Poster Session C

Session Date and Time: Saturday, October 25, 12:30-4pm

Presenting author: François Gonzalvez, PhD

Key findings from preclinical studies include:

Onco3R patient-centric drug discovery approach identified unique small molecule P53 reactivators with best-in-class cellular potency.

Onco3R leads exhibit the optimal potency and residence time to induce deep and sustain target engagement and fully unlock the tumor suppressive function of P53 in cells.

This translated into robust anti-proliferative activity in P53 Y220C mutant cancer cell lines (single digit nanomolar IC50s) and tumor regression in a Y220C P53 mutant xenograft model.

Further characterization of the lead candidates is ongoing.

(Press release, Onco3R Therapeutics, OCT 22, 2025, View Source [SID1234656951])

On October 22, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, reported the pricing of its underwritten registered offering of 24,485,799 shares of its common stock at a price of $10.21 per share. The gross proceeds to Nurix from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix, are expected to be $250.0 million. The offering is expected to close on or about October 23, 2025, subject to the satisfaction of customary closing conditions. All of the securities are being offered by Nurix.

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The offering includes participation from both new and existing investors including General Atlantic, Redmile Group, Braidwell LP, Deep Track Capital, Perceptive Advisors, Trails Edge Capital Partners and Vestal Point Capital, as well as other healthcare-dedicated funds.

J.P. Morgan Securities LLC, Jefferies LLC and Stifel, Nicolaus & Company, Incorporated are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. and Robert W. Baird & Co. Incorporated are acting as lead managers for the offering.

Nurix currently intends to use any net proceeds from this offering primarily to fund clinical development of its drug candidates, including the clinical development of bexobrutideg (NX-5948) in chronic lymphocytic leukemia (CLL) and for the exploration of potential autoimmune indications, to fund research and development activities to expand its pipeline and for working capital and general corporate purposes.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-280117) that was previously filed by Nurix with the Securities and Exchange Commission ("SEC") and declared effective on June 11, 2024. A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the prospectus supplement relating to the offering, when available, may be obtained from: J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388, or via email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or via email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Nurix, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Nurix Therapeutics, OCT 22, 2025, View Source [SID1234656901])

On October 22, 2025 Ipsen (Euronext: IPN; ADR: IPSEY) and ImCheck Therapeutics reported they have entered into a definitive share purchase agreement in which Ipsen will acquire all issued and outstanding shares of ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The anticipated acquisition is focused on the lead Phase I/II program ICT01 in first line acute myeloid leukemia (AML)3 patients who are ineligible for intensive chemotherapy. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

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Many AML patients are unable to tolerate intensive chemotherapy and must rely on lower-intensity options, which often deliver limited and short-lived benefit.2 This high-risk, unfit population continues to face a significant unmet medical need, highlighting the urgency for new therapies that can improve survival and quality of life.

"At completion, the acquisition of ImCheck Therapeutics presents an opportunity for us to expand our pipeline in oncology and reinforces our commitment to deliver transformative therapies to the people who need them most," said David Loew, CEO, Ipsen. "We feel confident that with the ICT01 promising data combined with Ipsen’s global development and commercialization expertise, we are well positioned to start a Phase IIb/III trial in 2026."

Interim data (n=45) orally presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 20251 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).2 ICT01 in combination with Ven-Aza was also shown to be well tolerated, underscoring ICT01’s potential as a novel immunotherapy to improve outcomes for patients with AML.

"We are thrilled to become part of Ipsen, a company whose ambition for transformative care matches our commitment to bringing innovative treatments to patients. This transaction recognizes groundbreaking science originating from French academia," said Pierre d’Epenoux, CEO, ImCheck Therapeutics. "It also highlights the exceptional work the ImCheck team and our partners have achieved to advance the understanding of butyrophilns and gamma delta T cells. Joining Ipsen will help us accelerate ICT01 toward registrational studies and commercialization. I remain grateful to the patients and investors for their contributions to furthering ImCheck’s pioneering science."

Transaction details
Under the terms of the agreement, through a wholly owned affiliate of Ipsen SAS, shareholders of ImCheck Therapeutics will receive a 350 million euros payment on a cash-free and debt-free basis at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones, for a total potential consideration up to 1 billion euros.

The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions including the expiration or termination of any required regulatory and governmental approvals under French and U.S. regulations.

Advisors
Allen & Overy Shearman (Paris) is acting as legal counsel to Ipsen. Centerview Partners is acting as exclusive financial advisor to ImCheck Therapeutics with Goodwin (London) and Dentons (Paris) acting as legal counsel.

About the EVICTION trial
EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of ICT01 in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About ICT01
ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, ICT01 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.

(Press release, Ipsen, OCT 22, 2025, View Source [SID1234656868])