Enfortumab Vedotin-ejfv

Experienced CEO brings deep oncology drug development and corporate strategy experience to Corrixr's board as the company advances CXR101 toward the clinic NEWARK, Del.--(BUSINESS WIRE)--Corrixr Therapeutics, a pre-clinical genetic medicine company targeting lung, head & neck, and esophageal squamous cell carcinomas, today announced the appointment of Nancy Whiting, PharmD, as Chair of the Board of Directors, succeeding Janice E. Nevin, M.D., MPH. The transition follows Dr. Nevin’s announcement that she will retire from ChristianaCare effective September 1, 2026. Dr. Nevin will remain on Corrixr’s board, as will Jenn Schwartz, who will succeed her as President and CEO of ChristianaCare, continuing ChristianaCare’s role as Corrixr’s founding institutional investor and partner. Dr. Whiting has served as CEO of Recludix Pharma for the past 5 years and brings an extensive track record across all phases of drug development, including over 15-years at Seagen, where she made significant contributions in her roles of Executive Vice President of Corporate Strategy and Executive Vice President of Clinical Development. She steps into the Chair role at a pivotal moment as Corrixr advances CXR101 toward IND filing and first-in-human proof-of-mechanism trials. “Nancy brings to the board the extensive oncology development and commercial experience Corrixr needs as it moves toward the clinic,” said Janice E. Nevin, M.D., MPH, President & CEO of ChristianaCare. “It has been an honor to chair Corrixr’s board as ChristianaCare’s founding institutional investor and partner, and to help guide the company from its origins at the Gene Editing Institute to this point.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “I’m thrilled to take on the Chair role at such a pivotal moment for the company,” said Nancy Whiting, PharmD. “Having spent my career bringing transformative oncology medicines through development and into the hands of patients, I see that same potential with Corrixr. I’m grateful to Janice for her leadership in building this board and look forward to working with her, Hilary, and the rest of the Corrixr team.” “Nancy’s appointment as Board Chair, strengthens Corrixr’s leadership at a pivotal moment as we advance toward the clinic,” said Hilary M. Malone, Ph.D., Chief Executive Officer of Corrixr. “I am deeply grateful to Janice Nevin for her vision, leadership and unwavering support of Corrixr, and I look forward to working with Nancy and Jenn Schwartz to build on that foundation and drive the company forward.” Corrixr is developing CXR101 to eliminate NRF2, a transcription factor consistently hyperactive in squamous cell cancers, directly at its genetic source. Unlike small-molecule approaches that attempt to inhibit NRF2 protein activity, CXR101 acts upstream, disrupting the mechanism that sustains squamous cell tumor survival without the toxicity associated with systemic exposure. Delivered locally via ionizable lipid nanoparticles, the approach collapses tumor survival, proliferation, immune evasion, and metabolic reprogramming in a single intervention. About Nancy Whiting, PharmD Nancy Whiting, PharmD, is the Chief Executive Officer of Recludix Pharma and has an established track record across all phases of drug development. Dr. Whiting is a 15-year veteran of Seagen, where she most recently served as Executive Vice President of Corporate Strategy, holding broad responsibility for corporate strategy and planning, strategic alliances and partnerships, investor relations, corporate communications, and information technologies. She previously served as Executive Vice President of Late Stage Development, Senior Vice President of Clinical Development and Medical Affairs, and Head of Experimental Medicine. During her tenure at Seagen, Dr. Whiting played a central role in the development and regulatory approval of ADCETRIS for lymphoma, PADCEV for bladder cancer, TUKYSA for breast cancer, TIVDAK for cervical cancer, and several other pipeline compounds. Prior to transitioning to the pharmaceutical industry, Dr. Whiting practiced as a Clinical Oncology Pharmacist at the Seattle Cancer Care Alliance. She completed her undergraduate training at the University of British Columbia and received her PharmD from the University of Washington and completed a residency in clinical pharmacy practice at Vancouver General Hospital. Dr. Whiting is a member of the American Society of Clinical Oncology, the American Society of Hematology, and the European Society of Medical Oncology. She serves on the Board of Directors of Caribou Biosciences, Boundless Bio, and Biocom California. About Corrixr Therapeutics Corrixr Therapeutics is a genetic medicine company developing breakthrough treatments for squamous cell carcinomas of the lung, head & neck, and esophagus, among the deadliest and treatment-resistant cancers in the world. Corrixr's lead program, CXR101, targets NRF2, a transcription factor consistently hyperactive in squamous tumors that drives tumor survival. Using a proprietary CRISPR-based gene editing approach, CXR101 ablates NRF2 directly at the genetic source, with no reliance on small molecule binding, dismantling the biological mechanism these tumors cannot live without while aiming to reduce the burden patients experience with conventional therapies. Learn more at corrixr.com . Contacts Media: Jennifer Hanley 347-819-0402

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy. Full prescribing information for Keytruda, Keytruda Qlex, and Padcev will be posted on Drugs@FDA. Efficacy was evaluated in KEYNOTE-B15/EV-304 (NCT04700124), an open-label, randomized, active-controlled, multicenter trial in 808 patients with previously untreated MIBC who were candidates for radical cystectomy with pelvic lymph node dissection and were eligible for cisplatin-based chemotherapy. Patients were randomized (1:1) to receive neoadjuvant pembrolizumab and enfortumab vedotin-ejfv followed by surgery followed by adjuvant pembrolizumab and enfortumab vedotin-ejfv or to neoadjuvant gemcitabine and cisplatin followed by surgery. The major efficacy outcome measure was event-free survival (EFS) assessed by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. The trial demonstrated statistically significant improvements in EFS and OS in patients treated with perioperative pembrolizumab and enfortumab vedotin-ejfv compared with neoadjuvant gemcitabine and cisplatin. Median EFS was not reached (NR) (95% CI: NR, NR) in the pembrolizumab with enfortumab vedotin-ejfv arm and was 48.5 months (95% CI: 43.3, NR) in the gemcitabine with cisplatin arm (hazard ratio 0.53 [95% CI: 0.41, 0.70]; p-value 0.0029). The overall safety profile of pembrolizumab with enfortumab vedotin-ejfv in KEYNOTE-B15/EV-304 was similar to that observed in prior trials of this combination in urothelial cancer. The prescribing information for pembrolizumab includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. The prescribing information for enfortumab vedotin-ejfv includes warnings and precautions for skin reactions, hyperglycemia, pneumonitis/interstitial lung disease, peripheral neuropathy, ocular disorders, infusion site extravasation, and embryo-fetal toxicity. For patients who are cisplatin-eligible, the recommended pembrolizumab dose for neoadjuvant treatment is 200 mg IV every 3 weeks or 400 mg IV every 6 weeks administered in combination with enfortumab vedotin-ejfv 1.25 mg/kg (up to a maximum of 125 mg for patients ≥ 100 kg) IV on Days 1 and 8 of a 21-day cycle for 4 cycles for a total duration of 12 weeks of neoadjuvant treatment. In the adjuvant phase, enfortumab vedotin-ejfv is continued for 5 additional cycles, every 3 weeks in combination with pembrolizumab, administered either as 200 mg IV every 3 weeks for 13 cycles or 400 mg IV every 6 weeks for 7 cycles. The duration of the combination of pembrolizumab and enfortumab vedotin-ejfv in the adjuvant setting is 15 weeks and the overall duration of adjuvant therapy, including pembrolizumab as a single agent, is 39 weeks. Administer pembrolizumab after enfortumab vedotin-ejfv when given on the same day. For dosage and administration information for pembrolizumab and berahyaluronidase alfa-pmph given in combination with enfortumab vedotin-ejfv, refer to the Keytruda Qlex prescribing information. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada (HC), Switzerland’s Swissmedic (SMC), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), and the Israel Ministry of Health (IMOH). The application reviews are ongoing at the other regulatory agencies. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application five weeks ahead of the FDA goal date. This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. The content above comes from the network. if any infringement, please contact us to modify.