On October 27, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer.

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"We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer, a devastating disease with limited therapeutic options and representing a large unmet medical need," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "RAS driver mutations are present in nearly all pancreatic cancer cases, underscoring the urgent need for innovative therapies that target this critical driver of disease progression."

Daraxonrasib is being studied in a global Phase 3 clinical trial, RASolute 302, in patients with second line metastatic pancreatic ductal adenocarcinoma (PDAC). The company has also announced plans to initiate two additional Phase 3 clinical trials in pancreatic cancer: a trial for first line treatment in patients with metastatic PDAC and a trial for adjuvant treatment in patients with resectable PDAC.

Orphan Drug Designation is awarded by the FDA on behalf of selected investigational drugs to encourage the development of therapies for rare diseases, which are defined as conditions affecting fewer than 200,000 individuals in the United States. This designation provides sponsors with several incentives, including tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity following approval.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations2. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%3.

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

(Press release, Revolution Medicines, OCT 27, 2025, View Source [SID1234657037])

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])

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])

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])

On October 27, 2025 GSK plc (LSE/NYSE: GSK) and Syndivia, a private biotechnology company focused on next-generation ADCs, reported an agreement granting GSK exclusive worldwide rights to develop and commercialise a preclinical ADC for mCRPC.

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Approximately 1.4 million men worldwide are diagnosed with prostate cancer each year and approximately 10-20% develop advanced disease, castration resistance with metastases, within five years.1 For patients whose cancer has advanced to mCRPC, targeted treatment options are limited, and standard of care options may be difficult to access in community practice settings, and can be poorly tolerated with modest efficacy outcomes. Survival rates for these patients are low, with a 5-year survival rate of approximately 30% and a median survival of approximately two years.2,3,4

The novel ADC, which utilises Syndivia’s next-generation GeminiMab conjugation technology, has shown enhanced anti-tumour activity and an encouraging safety profile, demonstrating best-in-class potential. In preclinical studies, the ADC was effective at shrinking tumours without causing a proportional increase in significant side effects, even at higher doses. This ADC could provide a targeted treatment directly to the tumour, currently a gap in available therapies, along with a more easily accessible treatment in the community practice setting for mCRPC.

GSK is developing an innovative pipeline that spans ADCs with distinct antigens and payloads, next-generation small molecules, and T-cell engagers. These diverse approaches, such as GSK’227 and this novel ADC, enable GSK to advance potential therapeutic options across various stages and types of prostate cancer.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: "Prostate cancer represents a significant health burden and an emerging area of growth for GSK, where targeted therapies are urgently needed in metastatic castration-resistant settings. The addition of this ADC builds on GSK’s growing portfolio and strengths in tumour-targeted technologies, including GSK’227, our B7-H3-targeting ADC."

Sasha Koniev, Chief Executive Officer, Syndivia, said: "We are proud that GSK will advance this programme on a global scale. This agreement underscores the value of our GeminiMab ADC platform and the opportunity to bring a promising new therapy to patients with pressing unmet medical needs."

Financial considerations
Under the terms of the agreement, Syndivia will receive an upfront payment as well as success-based development and commercial milestone payments up to a total of £268 million. They will also receive tiered royalties on future product sales worldwide. GSK will assume full responsibility for the development, manufacturing, and worldwide commercialisation of the ADC program.

(Press release, GlaxoSmithKline, OCT 27, 2025, View Source [SID1234657033])