Encouraging early efficacy in CAR T naïve lymphomas in azer-cel Phase 1b trial

On October 28, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first efficacy results from the CAR T-naïve niche indication portion of its ongoing Phase 1b trial of azer-cel (azercabtagene zapreleucel) — an off-the-shelf, allogeneic CD19 CAR T therapy being evaluated across a spectrum of B-cell lymphomas.

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Of six evaluable CAR T-naïve patients (patients with no previous CAR T treatment), five (83%) achieved an overall response including three (50%) complete responses. The result of the sixth patient’s follow-up scan is pending.

A total of ten patients have been treated in this cohort thus far, with further results to come upon patient follow-up. These initial results encompass several rare lymphoma subtypes, notably WM, MZL and PCNSL — areas of significant unmet clinical need where no CAR T products are currently approved.

Azer-cel continues to demonstrate a manageable safety profile consistent with previously reported results in relapsed diffuse large B-cell lymphoma (DLBCL). Importantly, enrolment into the CAR T-naïve expansion is proceeding significantly faster than the earlier CAR T-relapsed DLBCL cohort, reflecting the substantial clinical demand and investigator enthusiasm for an allogeneic approach.

Imugene has an FDA Type C meeting in November to discuss pivotal study design options for azer-cel in CAR T-relapsed DLBCL, while also advancing the CAR T-naïve program to generate a broader evidence base across additional indications, including rare lymphomas to expand registrational options.

Chief Executive Officer Leslie Chong said "We are encouraged by these early signals of efficacy in the CAR T-naïve population, with at least five of the first six evaluable patients responding to treatment. As best responses can be seen up to 90 days or more after treatment, we look forward to further data on the depth and durability of these outcomes. Enrolment in this portion of the trial is proceeding at a remarkable pace, positioning us to explore an expedited development pathway for azer-cel."

In the CAR T relapsed DLBCL portion of the same Phase 1b study, azer-cel has achieved an 81% overall response rate to date, including multiple complete and partial responses, with several patients remaining in durable remission beyond a year. Patients in this cohort had typically failed an average of three prior lines of therapy, including autologous CAR T. These findings reinforce azer-cel’s potential as an allogeneic alternative for patients who relapse following existing CAR T treatments and complement the strong early data now emerging in the CAR T-naïve setting.

(Press release, Imugene, OCT 28, 2025, View Source [SID1234657074])

BeOne Medicines to Present at Upcoming Investor Conferences

On October 28, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported it will participate in fireside chats at two upcoming investor conferences:

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Guggenheim Second Annual Healthcare Innovation Conference on Monday, November 10, 2025 at 9:30 am EST; and
Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 4:00 pm GMT/11:00 am EST
Live webcasts of these events can be accessed from the investors section of the Company’s website at View Source, View Source, View Source Archived replays will be available on the Company’s website.

(Press release, BeOne Medicines, OCT 28, 2025, View Source/news/beone-medicines-to-present-at-upcoming-investor-conferences/2a85b5e9-db56-4488-b325-acec8a08ff0a [SID1234657075])

Nurix Therapeutics Announces Closing of $250.0 Million Registered Offering of Common Stock

On October 27, 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 closing of its previously announced underwritten registered offering of 24,485,799 shares of its common stock at a purchase price of $10.21 per share. The gross proceeds to Nurix from the offering were $250.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix.

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"The successful completion of this offering not only allows Nurix to accelerate our implementation of pivotal trials in chronic lymphocytic leukemia (CLL), but it also enables us to move more decisively to explore the use of bexobrutideg in autoimmune disease, which could unlock a new dimension of therapeutic potential of the BTK degradation mechanism," said Arthur T. Sands, M.D., Ph.D., president and CEO of Nurix. "We are very fortunate to be strongly supported in our mission to advance novel medicines for patients with cancer and autoimmune disease by a fantastic group of both current and new investors."

The offering included 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 acted as joint book-running managers for the offering. Oppenheimer & Co. Inc. and Robert W. Baird & Co. Incorporated acted as lead managers.

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

The securities were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-280117) previously filed with the Securities and Exchange Commission ("SEC") and declared effective on June 11, 2024. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov.

A copy of the final prospectus supplement and the accompanying prospectus relating to this offering 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 a 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 27, 2025, View Source [SID1234657034])

ORIC® Pharmaceuticals Presented Preclinical Data at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics Supporting Best-in-Class Potential of ORIC-944 to Treat Patients With Prostate Cancer and Other Solid Tumors

On October 27, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported posters at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) highlighting preclinical data that further illustrate the potential for ORIC-944, a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, to treat prostate cancer and various other solid tumors.

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"These preclinical data underscore the potential of ORIC-944 to overcome resistance not only in prostate cancer but in other solid tumors and highlight that the therapeutic potential of PRC2 inhibition may be maximized in combination with inhibitors of key tumor drivers, including AR inhibitors and KRAS inhibitors," said Lori Friedman, PhD, chief scientific officer. "Based on these data and clinical findings to date, we continue to believe ORIC-944 is a potential best-in-class PRC2 inhibitor with potential in both castration-resistant and castration-sensitive prostate cancer, as well as multiple other tumor types."

Key findings of posters presented at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper):

PRC2 inhibition enhances AR inhibitor response to delay treatment relapse in castration-sensitive prostate cancer by restricting adaptation of tumor cells in preclinical studies

ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with androgen receptor (AR) inhibition, synergistically impaired tumor growth, significantly improved survival and extended the duration of response to AR inhibitors in vivo by restricting cellular plasticity and delaying prostate tumor adaptation in castration-sensitive prostate cancer (CSPC).
Transcriptional effects induced by combining ORIC-944 and AR inhibitors were comparable across all AR inhibitors tested (i.e., darolutamide, apalutamide or enzalutamide), and consistent with transcriptional effects of mevrometostat and AR inhibitor combination.
Mechanistically, ORIC-944 in combination with AR inhibition in CSPC was linked to increased luminal cell state, and the restriction of lineage adaptation through reduced chromatin accessibility at binding sites of transcription factors associated with lineage diversification and cell plasticity such as FOXA, HNF1A and ONECUT2. These results were reproduced with mevrometostat and AR inhibitor combination and are consistent with what was previously reported in preclinical studies of CRPC.
PRC2 inhibition enhances KRAS inhibitor response to delay treatment relapse in KRAS-mutant preclinical lung and colorectal cancer models

ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with KRAS inhibition, significantly improved efficacy and progression-free survival in KRAS G12C mutant non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models, demonstrating that PRC2 inhibition can deepen and extend responses by preventing or delaying resistance to KRAS inhibition.
PRC2 activity is increased in tumors from KRAS-mutant NSCLC and CRC patients, and transcriptional analysis from in vivo studies of CRC demonstrated that PRC2 inhibition drives tumor cell differentiation.
ORIC-944 combined with the KRAS inhibitor adagrasib, regressed 100% of tumors in KRAS-mutant adenocarcinoma and squamous NSCLC xenograft models in vivo. The combination also prevented adagrasib tumor relapse and extended progression-free survival in a KRAS G12C adenocarcinoma NSCLC xenograft model.

About ORIC-944
ORIC-944 is a potent and selective allosteric PRC2 inhibitor via EED subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement, and a favorable safety profile. ORIC-944 continues to further demonstrate a potential best-in-class profile with positive interim PSA response data generated in an ongoing Phase 1b trial in combination with ERLEADA (apalutamide) and in combination with NUBEQA (darolutamide) for prostate cancer (NCT05413421).

(Press release, ORIC Pharmaceuticals, OCT 27, 2025, View Source [SID1234657035])

Rakovina Therapeutics Showcases Potent AI-Developed ATR Inhibitors with CNS Penetrance at AACR-NCI-EORTC International Conference

On October 27, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV)(FSE: 7JO0) reported the successful presentation of new data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 23–27 in Boston, Massachusetts. The Company’s poster, titled "Novel ATR inhibitors with CNS penetrance developed by artificial intelligence," highlights promising results from its AI-driven kt-5000AI drug discovery program for Ataxia telangiectasia and Rad3-related protein serine/threonine kinase (ATR) inhibitors for cancer therapy.

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Through its collaboration with Variational AI, Rakovina Therapeutics utilized the Enki generative AI platform to identify novel small-molecule candidates predicted to meet a defined target product profile for CNS-penetrant ATR inhibition. Data presented at the conference confirm that multiple lead compounds achieved this profile, demonstrating potent ATR inhibition together with clear evidence of central nervous system exposure.

While multiple ATR inhibitors are in development globally, none have yet demonstrated meaningful central nervous system penetration. Rakovina’s kt-5000AI program is advancing next-generation, AI-designed ATR inhibitors with confirmed CNS exposure, potentially extending the benefits of ATR-targeted therapy to patients with primary brain tumors and brain metastases, where effective treatments remain limited.

In cell-based assays, multiple compounds demonstrated:

>50% inhibition of ATR activity below 200 nM;
potency exceeding reference compounds such as ceralasertib, tuvusertib, and elimusertib;
equal selectivity across the PIKK kinase family compared to reference compounds; and
metabolic stability following incubation with human liver microsomes
In in vivo pharmacokinetic studies, lead compounds demonstrated:

measurable drug concentrations in both plasma and brain tissue following intraperitoneal dosing at 5 mg/kg, indicating CNS penetration; and
good tolerability after single-dose administration, supporting continued optimization and preclinical development
"Presenting at AACR (Free AACR Whitepaper)-NCI-EORTC is an opportunity to highlight Rakovina’s progress in translating AI-discovered compounds into preclinical validation to the scientific community," said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "ATR is a central regulator of DNA damage repair and a validated target across multiple tumor types. Developing ATR inhibitors capable of penetrating the blood–brain-barrier could expand treatment options for patients with primary brain tumors and brain metastases, areas where few effective therapies exist."

(Press release, Rakovina Therapeutics, OCT 27, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-showcases-potent-ai-developed-atr-inhibitors-with-cns-penetrance-at-aacr-nci-eortc-international-conference [SID1234657036])