BCMA

Pfizer’s Elrexfio (elranatamab) has been recommended with managed access by the National Institute for Health and Care Excellence (NICE) to treat relapsed and refractory multiple myeloma in adults. The BCMA-directed bispecific antibody will now be available for use on the NHS in England via the Cancer Drugs Fund (CDF) while more evidence is collected about its effectiveness. Patients eligible for the drug will have received at least three lines of treatment, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody, and will have experienced disease progression on the last therapy. NICE’s final draft guidance, which comes less than two months after the Scottish Medicines Consortium accepted Elrexfio for use in the same patient population, was supported by positive results from the mid-stage MagnetisMM-3 study. After more than two years of follow-up, the objective response rate for patients on Elrexfio was 61%. Patients also demonstrated a median overall survival of 24.6 months, with a median progression-free survival of 17.2 months. Affecting approximately 5,000 people every year in England, multiple myeloma is an incurable cancer that develops from plasma cells in the bone marrow. The disease often affects several areas of the body and follows a relapsing-remitting pattern, meaning it usually returns after a period of remission and further treatment is required. Elrexfio is given as a subcutaneous injection and is designed to help the immune system recognise and kill cancer cells by binding to both BCMA, which is highly expressed in multiple myeloma, and CD3 receptors found on the surface of T cells. NICE estimates that just over 700 people in England are now eligible for the drug. The health technology assessment agency previously recommended Elrexfio in draft guidance, published in July, in which the drug was only recommended if pomalidomide plus dexamethasone would otherwise be offered Commenting on the latest decision, Ruhe Chowdhury, oncology medical director at Pfizer UK, said: “We are pleased that NICE has reviewed its earlier position and taken the decision to recommend [Elrexfio] without the pomalidomide plus dexamethasone restriction, meaning that more patients will now be able to access the treatment via the NHS rather than just a select few. “This is important considering the relapsing and remitting nature of the disease and the fact that patients continue to need additional options, especially as their cancer advances and stops responding to earlier lines of therapy.”

Presentations will summarize new preclinical data from brain-penetrant, pan-mutant B-Raf degrader program and recent clinical data from NX-5948 BTK degrader program Members of the Nurix management team also to participate in several expert panel discussions SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that members of the Nurix team will make oral presentations on Nurix programs and participate in several industry panel discussions at the 7th Annual TPD & Induced Proximity Summit, being held October 28–31, 2024, in Boston, MA. “The growing interest in the targeted protein degradation field underscores the immense therapeutic potential of this approach,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “As an early leader in this space, Nurix has developed a broad pipeline and established numerous successful collaborations. We are excited to share preclinical data from our previously undisclosed pan-mutant B-Raf selective degrader with CNS exposure along with a review of clinical data from our NX-5948 selective BTK degrader with updated case reports.” Presentation and Panel Participation Details: Presentations Title: An Orally Bioavailable, Brain Penetrant Pan-Mutant B-RAF Degrader for the Treatment of Primary & Treatment-Resistant Solid Tumors Presenting author: Ya-Wen Lu, Ph.D. Session: Track B: Preclinical : Unearthing Brand New Bifunctional Modes of Action & Achieving Potent, Selective ADME Preclinically Date and time: Tuesday, October 29th, at 11:30 AM ET Description: Nurix has developed a potent, selective, and orally bioavailable mutant-specific B-RAF degrader for use in oncology Potent anti-tumor activity observed in multiple CDX and PDX disease models representing Class I, Class II and Class III B-RAF mutations. Anti-tumor activity was also observed in the setting of CNS disease and treatment-resistance, suggesting the potential for utility across a broad range of solid tumor types Title: Clinical Activity of NX-5948 in CLL & NHL: A First-in-Class BTK Degrader Presenting author: Paula G. O’Connor, M.D., Chief Medical Officer, Nurix Morning Keynote Plenary Session: Advancing Bifunctionals Towards the First Approval with Clinical Data from Leaders in the Clinic Date and time: Wednesday, October 30th, at 9:00 AM ET. Description: NX-5948 is an investigational, orally bioavailable degrader of BTK that is currently being evaluated in relapsed or refractory B-cell malignancies and recently advanced into Phase 1b expansion cohorts. Emerging data continues to support the utility of BTK degradation in patients with relapsed or refractory CLL including those with CNS involvement and with tumors harboring BTK inhibitor resistance mutations Recent data demonstrates clinical activity in Waldenstrom’s macroglobulinemia (WM) Updated case reports will be presented The slides for these presentations may be accessed following their presentation at the 7th Annual TPD & Induced Proximity Summit, via links in the Scientific Resources section of the Nurix website. Panel Discussions CEO Think Tank: A Strategic Look at Targeted Protein Degradation & Induced Proximity Field Panelist: Arthur T. Sands, M.D., Ph.D., President and CEO Morning Keynote Plenary Session: Visions for the Future of TPD & Beyond: The CEO Perspective Date and time: Tuesday, October 29th at 9:30 AM ET Lessons Learned from a Major Strategic Partnership Deal for a Platform Panelist: Jason Kantor Ph.D., Chief Business Officer Closing Keynote Plenary Session: Preparing for the Future: Accelerating Strategy, Partnering & Investment for TPD & Beyond Date and time: Wednesday, October 30th at 4:10 PM ET Lessons Learned from a Major Strategic Partnership Deal for an Asset Panelist: Jason Kantor Ph.D., Chief Business Officer Closing Keynote Plenary Session: Preparing for the Future: Accelerating Strategy, Partnering & Investment for TPD & Beyond Date and time: Wednesday, October 30th at 4:55 PM ET About NX-5948 NX-5948 is an investigational, orally bioavailable degrader of BTK that is currently being evaluated in a Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies. Additional information on the Phase 1a/b clinical trial can be accessed at ( NCT05131022 ). About Nurix Therapeutics, Inc. Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts, including, but not limited to, statements regarding the planned timing for the provision of updates and findings from preclinical studies and clinical trials, including Nurix’s intention to present preclinical data and updated clinical reports at the 7th Annual TPD & Induced Proximity Summit, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks described under the heading “Risk Factors” in Nurix’s Quarterly Report on Form 10-Q for the period ended August 31, 2024, and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect Nurix’s business and results of operations, which could, in turn, have a significant and adverse impact on Nurix’s stock price. Nurix cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nurix undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events. Contacts: Investors Jason Kantor, Ph.D. Nurix Therapeutics, Inc. ir@nurixtx.com Elizabeth Wolffe, Ph.D. Wheelhouse Life Science Advisors lwolffe@wheelhouselsa.com Media Aljanae Reynolds Wheelhouse Life Science Advisors areynolds@wheelhouselsa.com

Plus, news about Verastem Oncology, Bright Minds Biosciences and Telix Pharmaceuticals: Aura Biosciences unveils early bladder cancer data: The Boston biotech shared that its light-activated drug led to four complete responses in five patients with low-grade non-muscle invasive bladder cancer. In high-grade NMIBC, the drug did not lead to complete responses, but two of three patients saw “visual tumor shrinkage” via a cystoscopy. Last month, Aura unveiled results in a rare eye cancer, the lead indication for its experimental drug that’s known as bel-sar for short. Aura’s shares $AURA jumped about 10% Friday morning. — Lei Lei Wu Poseida scores $15M milestone payment from Roche: Poseida received the milestone after Roche nominated a new dual CAR-T therapy per a 2022 deal. The therapy targets antigens expressed in hematologic malignancies, including multiple myeloma. The companies now have three programs in development, and their lead program is a CAR-T therapy targeting BCMA in the third-line multiple myeloma setting. — Katherine Lewin Verastem Oncology’s stock falls despite positive mid-stage data: In a Phase 2 trial, ovarian cancer patients taking avutometinib and defactinib saw median progression-free survival of 12.9 months, and those with the KRAS mutation had 22 months. The company said it plans to complete its NDA submission this month. Verastem’s stock $VSTM fell about 20% in after-hours trading on Thursday, with Mizuho analysts attributing the stock’s weakness to Verastem’s decision to first seek approval for patients with a KRAS mutation, and not those with wild-type KRAS. — Katherine Lewin Bright Minds Biosciences’ $35M private placement : The funds are set to go toward R&D expenses and general working capital. The company’s stock $DRUG soared about 70% on Friday following the announcement. Earlier this week, Bright Minds announced positive preclinical data for BMB-201, which showed that it outperformed morphine in efficacy. The company now plans to move the drug into clinical trials. — Katherine Lewin Telix Pharmaceuticals files for NASDAQ inclusion: The Australian radiopharma company said listing on the NASDAQ will increase interest from both US and global investors. Last month, Telix paid $230 million upfront to buy radioisotope manufacturer RLS Radiopharmacies. — Katherine Lewin