Tucatinib

SOUTH SAN FRANCISCO, Calif. & LOS ANGELES & SAN DIEGO--( BUSINESS WIRE )--Biocom California, the association representing the California life science industry, today announced that it appointed Aliza Apple, Ph.D., a vice president of Catalyze360 AI/ML at Eli Lilly; Carolyn Ng, Ph.D., business unit partner at TPG Life Sciences Innovations; and Nancy Whiting, Pharm.D., president and CEO at Recludix Pharma, to its board of directors. Additionally, Tim Scott has assumed his role as CEO and president of Biocom California, and Sabrina Martucci Johnson, CEO at Daré Biosciences, has been appointed board chair. “Our new members’ expertise in drug discovery, clinical development and navigating the fundraising environment will complement the diverse perspectives of our current board,” said Tim Scott, president and CEO of Biocom California. “As the life science industry evolves, we continue to rely on the deep industry knowledge and key insights of our board of directors, helping shape our 2025 initiatives and ensure we meet the needs of our member companies and foster innovative progress throughout California.” Aliza Apple, Ph.D. is a vice president of Catalyze360 AI/ML at Eli Lilly. In this capacity, Dr. Apple leads the strategy, build and launch of Lilly’s external-facing AI/ML efforts for drug discovery. In her previous role at Lilly, Dr. Apple served as the COO and head of Lilly Gateway Labs West Coast, where she supported the local biotech ecosystem through early engagement and providing tailored offerings to meet their needs. Prior to Lilly, Dr. Apple served as a co-founder at Santa Ana Bio, a venture-backed precision biologics company focused on autoimmune disease, and as an advisor to the founders of Firefly Biologics. Prior to biotech, Dr. Apple was a partner in McKinsey & Co’s life sciences practice. During her nine years at McKinsey in New York and San Francisco, she collaborated with leaders from over 20 biopharma companies to develop their corporate and portfolio strategies, evaluate business development opportunities and improve their organizational effectiveness. Dr. Apple completed her Ph.D. in bioengineering at UC Berkeley and UCSF, and holds a bachelor of science in physics from Georgetown University. She completed a postdoctoral fellowship at Cornell Medical College supported by the NIH Kirschtein National Research Service Award. Carolyn Ng, Ph.D. is a business unit partner at TPG Life Sciences Innovations, where she is one of the founding senior leaders of the investment fund. She has spent the past decade of her career leading investments into transformative companies of early to mid-stage in different therapeutic areas. She currently serves on the board of directors of Adcendo, Mbrace Therapeutics and Bicara Therapeutics. Prior to joining TPG in 2021, Dr. Ng was a managing director at Vertex Ventures HC, a global healthcare and life sciences venture fund, where she co-headed the investment team. Dr. Ng has previously served on the board of directors for other promising public and private life sciences companies including Bicycle Therapeutics PLC, Boundless Bio, Obsidian Therapeutics, 28-7 Therapeutics, Epirium Bio, Nuvaira and a board observer to Visterra (acquired by Otsuka Pharmaceutical). Dr. Ng is a mentor to the Women in Bio Boardroom Ready Program. She also currently serves on the panel of the Singapore Therapeutics Development Review Panel, a funding scheme aimed at identifying high-value drug discovery and development projects from the public research community in Singapore. Prior to her investing career, Carolyn was a consultant at Deallus Consulting, a specialized life sciences strategy consulting firm where she collaborated with leaders of global biopharmaceutical companies. Dr. Ng holds a Ph.D. in cancer molecular biology from the National University of Singapore, where she was the recipient of the prestigious NGS, Integrative Sciences and Technology, Ph.D. scholarship, and patent holder of a novel small molecule nuclear receptor activator indicated for the treatment of neuroblastoma. Nancy Whiting, Pharm.D. is a president and CEO at Recludix Pharma. Previously, Dr. Whiting was a 15-year veteran of Seagen, formerly Seattle Genetics, and served as the executive vice president of corporate strategy, where she had the broad remit of corporate strategy and planning, strategic alliances and partnerships, investor relations, corporate communications and information technologies. During her tenure, she was also the executive vice president of late-stage development, senior vice president of clinical development and medical affairs, and head of experimental medicine. 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 currently serves on the board of directors of Caribou BioSciences and Boundless BioSciences. Dr. Whiting completed her undergraduate training at the University of British Columbia and received her Pharm.D. from the University of Washington. She also completed a residency in clinical pharmacy practice at Vancouver General Hospital. About Biocom California Biocom California is the leader and advocate for California’s life science sector. We work on behalf of more than 1,800 members to drive public policy , build an enviable network of industry leaders , create access to capital , introduce cutting-edge STEM education programs and create robust value-driven purchasing programs . Founded in 1995 in San Diego, Biocom California provides the strongest public voice to research institutions and companies that fuel the local and state-wide economy. Our goal is simple: to help our members produce novel solutions that improve the human condition. In addition to our San Diego headquarters , Biocom California operates core offices in Los Angeles and the San Francisco Bay Area , with satellite offices in Sacramento , Washington, D.C. and Tokyo . Our broad membership benefits apply to biotechnology, pharmaceutical, medical device, genomics and diagnostics companies of all sizes, as well as to research universities and institutes, clinical research organizations, investors and service providers. For more information on Biocom California, please visit our website at www.biocom.org . Connect with us on LinkedIn , Facebook and X .

Enhertu is one of six marketed products that AZ expects could reach more than $5 billion global sales at peak. Daiichi Sankyo and AstraZeneca are padding the case for their antibody-drug conjugate Enhertu with new data demonstrating the medicine’s worth in patients whose cancer has spread to the brain.The partners unveiled positive results from the phase 3b/4 DESTINY-Breast12 study, which saw Enhertu chart substantial overall and intracranial clinical activity in a large clutch of patients with HER2-positive metastatic breast cancer who have brain metastases and received two or less lines of therapy in the metastatic setting.The data on the antibody-drug conjugate (ADC) were simultaneously published in Nature Medicine and presented as a late-breaking presentation at the 2024 meeting of the European Society for Medical Oncology (ESMO) Friday.The results won’t drive a new indication for Enhertu given that the drug’s current label doesn’t exclude patients with brain metastases. But data on those particular patients, which was previously limited, now add to a growing body of evidence around Enhertu’s merit. On the trial’s primary progression-free survival (PFS) endpoint—which measures the time a patient lives without their disease getting worse—Enhertu yielded a 12-month PFS rate of 61.6% in patients with brain metastases at baseline, AZ and Daiichi said in a release. Further, patients with brain metastases showed a central nervous system (CNS) 12-month PFS rate of 58.9%.The results were consistent across patients with stable and active brain metastases, the partners added.Specifically, those with stable brain metastases achieved a 12-month PFS rate of 62.9% on Enhertu and a 12-month CNS PFS rate of 57.8%. Alternately, patients with active brain metastases had a 12-month PFS rate of 59.6% and a 12-month CNS PFS rate of 60.1%.The 12-month PFS for patients with brain metastases in DESTINY-Breast12 was roughly in line with the 72% observed in an exploratory analysis of a small group of similar patients enrolled in DESTINY-Breast03 that got Enhertu its approval in previously treated HER2-positive breast cancer, the trial investigators noted in the Nature Medicine study.Being able to show some CNS activity could help Enhertu in its competition with Pfizer’s small-molecule drug Tukysa, which was obtained in the New York pharma’s acquisition of Seagen.In the phase 2 HER2CLIMB study conducted in patients with heavily pretreated HER2-positive breast cancer, Tukysa's combination with chemo and trastuzumab delivered a median CNS PFS of 9.6 months in patients with active brain metastases, or 13.9 months in those with stable brain metastases.Up to 50% of patients with HER2-positive metastatic breast cancer see their disease spread to the brain over time, in turn significantly impacting quality of life and disease outcomes, Dana-Farber’s Nancy Lin, M.D., who served as the principal investigator for DESTINY-Breast12, pointed out in a statement.“Treating brain metastases in patients with breast cancer is challenging as there are few effective treatment options,” Mark Rutstein, global head of oncology development at Daiichi, said in a separate statement. “Building on previous studies, these results show Enhertu can provide strong overall and intracranial clinical activity and support its potential role in treating patients with active or stable brain metastases.”The data boost comes as Enhertu's sales growth has slowed down in recent months. In July, Daiichi and AZ reported combined Enhertu sales of $893 million for 2024’s second quarter, reflecting a scant 1.6% sequential increase from the first three months of the year. Even still, AZ’s oncology business chief Dave Fredrickson at the time said the British drugmaker expects Enhertu to return to “more robust sequential growth” in the second half of the year.Enhertu is one of six marketed products that AZ expects could reach more than $5 billion in global sales at peak.