Action is in our genes
We make precision therapies that make genomic testing actionable for every patient.
Founder’s Letter | Q1 2021
Notes from the Trail
The journey towards our first summit, NRG1 fusions, is well underway. We closed out 2020 with the release of the first preclinical data in support of the Phase 2 CRESTONE study at the EORTC-NCI-AACR conference in October, and a $65M Series B financing in November. We were thrilled to finally be able to publicly share this data showing 50-100% tumor regressions following treatment with seribantumab specifically in NRG1 fusion PDX models, and grateful to see this excitement reflected by our expanded Series B investor syndicate led by venBio and Cormorant Asset Management.
While this data gives our team great confidence in the CRESTONE trial, we recognize that both our tumor-agnostic trial design and targeted focus on genomic driver alterations are still non-traditional approaches to drug development. In addition, we believe that in order for precision medicine to be a real option for every patient with cancer, many more drugs targeting rare genomic drivers like NRG1 fusions are needed.
We hope that our experiences can inspire and support others who are embarking on a similar drug development journey. Because of this, we have committed to documenting and sharing our insights along the way in a new series we’re calling “Trail Notes”. Here we hope to tackle everything from breaking down concepts and terms, to taking deep dives into technical challenges and sharing operational lessons. While each driver alteration may individually be rare, our combined efforts as part of a vibrant precision oncology community can enable a future where every patient’s cancer genomic test results in an actionable treatment decision.
2020 has been an incredibly successful launch year and it is with enthusiasm and great momentum that we enter into 2021. We’re on track for the planned CRESTONE interim analysis mid-year, and as well as a first look at early clinical data at a major conference this year. In support of our tumor-agnostic approach, we continue to expand our preclinical dataset in additional tumor types, with additional data coming out this year as well. In addition, we’re constantly evaluating promising candidates to expand our pipeline and look forward to embarking on the journey to our next summit!
Stay tuned, and get in touch – we’re always on the lookout for innovative collaborators and trailblazers to join us, and will be growing our Elevation family significantly this year!
With best wishes for a healthy and hopeful 2021,
It takes a team to reach the summit
We are experienced oncology drug developers united by a shared passion for identifying true precision therapies that will illuminate a clear treatment pathway for our patients.Join Our Team
Shawn M. Leland is the Founder and Chief Executive Officer of Elevation Oncology and currently serves as its Chief Business Officer overseeing all day-to-day operations. Shawn brings over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. Shawn has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Shawn has also served as an expert strategic consultant for Catenion providing guidance on portfolio management for pharmaceutical/biotech companies.
Shawn resides in Denver, Colorado and enjoys snowboarding, hiking and cycling.
Amy C. Cavers is an executive leader with more than 30 years of experience in medical affairs, clinical development and commercialization of therapeutics. Ms. Cavers was most recently Chief and SVP, Strategic Engagement and Innovation/Field Medical Team at Verastem Oncology. Prior to that she held the role of VP, Scientific Affairs at TG Therapeutics, Inc., a global biopharmaceutical company focused on the development of therapies in B-Cell malignancies for 5 years. Additional experience includes Senior Director, Scientific Strategy and Communications at Onyx Therapeutics, US Launch Lead for ixabepilone at Bristol Myers Squibb, Senior Director, Global Strategic Marketing at Millennium Pharmaceuticals and VP, Marketing at Celgene. Her experience in developing and bringing novel therapies to market includes high-profile clinical programs and launches, to include blockbuster drugs BOTOX, THALOMID, REVLIMID, VELCADE and KYPROLIS. She has developed a world-class global network and medical alliances through an innate ability to build extraordinary relationships internally and externally.
Ms. Cavers holds a Bachelor of Science degree in Animal Health Science from the University of Arizona.
Sheila Magil, PhD is a CMC and quality expert with more than 30 years of experience working closely with both large and small biopharmaceutical companies to bring novel drugs to patients. As a Principal Consultant with BioProcess Technology Consultants, Sheila has helped many companies implement upstream and downstream manufacturing processes, quality control testing and characterization, cGMP compliance, and validation of manufacturing processes and facilities. Sheila was most recently the Managing Director for BDO USA. Sheila has a proven track record of overseeing successful internal and external development activities and preparing a wide range of regulatory filings to the FDA and EMA including 510Ks, INDs, BLAs for biologics and cell and gene therapy related materials. Sheila received her BA in Chemistry from Carnegie Mellon University and a PhD in Biochemistry from the University of Minnesota.
Doug is a Medical, Clinical and Scientific Affairs leader with more than 20 years of oncology/hematology and cellular immunotherapy product development and commercialization experience. Over the past decade, Doug has built and led Clinical Operations, Medical Affairs, Regulatory and MSL teams to support phase I-III clinical development programs. Doug is the former Chief Clinical and Scientific Development officer of Global Biotechnology and Cancer Therapeutics (Roswell Park Cancer Center affiliate), Vice President of Medical and Clinical Affairs for Aprecia Pharmaceuticals and Argos Therapeutics. Doug previously worked with Axcelo MSL Solutions, The Navicor Group, Millennium Pharmaceuticals and Bristol Myers Squibb Oncology. Doug is a licensed Pharmacist and completed his BS in Pharmacy at Northeastern University College of Pharmacy and Allied Health.
Siera Talbott brings over 15 years of experience in industry and government-funded projects supporting rapid growth in biologic-based therapies. Siera’s roles mostly focus on Project Management, Product Development and Corporate Development. Siera loves creating structure out of chaos, distilling technical requirements into business outcomes and leading high-functioning teams.
Siera holds a Ph.D. in Cancer Cell Biology from West Virginia University (WVU). Her academic research focused primarily on how cancer cells evolve to become chemotherapy resistant. With an extreme fascination of protein signaling networks, Siera further worked on cell survival and toxicity from nanoparticle exposure for the National Institute of Occupational Safety and Health (NIOSH). Siera went on to setup two first-in-kind Bionano laboratories for WVU serving multiple academic departments, government and industry nearby. During this time, Siera also developed the Environmental Health & Safety program used by the School of Engineering.
As Director of Project Management at Argos Therapeutics (Durham, NC), Siera managed all the operational projects for commercial launch of an autologous cell therapy product for Renal Cell Carcinoma. Later, as Head of Product Launch & Operations for a French biotech company (Erytech Pharma, Lyon, FR), Siera led the expansion into the U.S., including the construction and startup of a GMP manufacturing facility in Princeton, N.J. In conjunction with expansion efforts, she has managed Global Supply Chain and Program Management.
As a contractor, Siera provided clients with CMC and operational strategy support to drive forward early stage companies to the next clinical phase. With many favorite things, she enjoys driving efforts focused on risk and change management, scenario planning and decision analysis.
Board of Directors
Steve Elms is a Managing Partner at Aisling Capital, a leading life sciences investment firm. Prior to joining Aisling, he was a Principal in the Life Sciences Investment Banking Group of Chase H&Q (formerly Hambrecht & Quist), where he was involved in over 60 financing and M&A transactions, helping clients raise in excess of $3.3 billion in capital. Prior to H&Q, Mr. Elms traded mortgage-backed securities at Donaldson, Lufkin & Jenrette. His previous healthcare sector experience includes over two years as a pharmaceutical sales representative for Marion Laboratories and two years as a consultant for The Wilkerson Group. Mr. Elms currently serves as a director of ADMA Biologics, Marker Therapeutics, Zosano Pharma and was previously Chairman of the Board of LOXO Oncology. He also serves on the INVO Board at Northwestern University. He received his M.B.A. from the Kellogg Graduate School of Management at Northwestern University and his B.A. in Human Biology from Stanford University.
Tim Clackson, Ph.D. is President, and EVP of R&D, of Xilio Therapeutics Inc, a privately held oncology company developing tumor-selective immunotherapies. Prior to Xilio, Tim was President of R&D and Chief Scientific Officer at ARIAD Pharmaceuticals, a global, commercial oncology company acquired by Takeda in 2017. During Tim’s 22-year tenure at ARIAD, he led the multi-disciplinary R&D team that internally discovered and developed five product candidates, including ICLUSIG (ponatinib), approved for the treatment of resistant CML/Ph+ALL, and ALUNBRIG (brigatinib), approved for ALK+ NSCLC. Earlier in his career, Tim was a postdoctoral fellow with Dr. James A. Wells at Genentech, where his studies on growth hormone receptor defined the now-established “hot spot” paradigm for how proteins interact.
Tim received his Ph.D. in Biology from Cambridge University for research conducted under Dr. Greg Winter at the MRC Laboratory of Molecular Biology into antibody engineering and the development of antibody phage display technology, subsequently commercialized by Cambridge Antibody Technology. He received his B.A. degree in Biochemistry from Oxford University. Tim serves a member of the boards of directors of Forma Therapeutics, Spring Bank Pharmaceuticals, and the Massachusetts Biotechnology Council (MassBio).
Richard Gaster, M.D., Ph.D., is a Partner at venBio with experience as a physician, entrepreneur, and life science investor. He currently serves on the board of Arrakis Therapeutics, Pharvaris, Aeovian Pharmaceuticals, NorthSea Therapeutics, Attralus, and Stargazer and served as a board observer for Akero Therapeutics and Harmony Biosciences. Prior to joining venBio, Richard served as the head of translational medicine at Pliant Therapeutics. As a key member of the initial management team, Richard participated in the formation and launch of Pliant Therapeutics from Third Rock Ventures. During his tenure at Third Rock Ventures, Richard was responsible for company creation to transform new areas of science into innovative drug discovery companies. He began his career as a resident physician in Harvard’s Plastic and Reconstructive Surgery Program. Richard has published numerous articles in top-tier peer-reviewed journals including Nature Medicine and Nature Nanotechnology, holds more than a dozen patents, and was named one of Forbes “30 Under 30” in Science and Healthcare. Richard holds a BSE in Bioengineering from the University of Pennsylvania where he graduated summa cum laude. He received his M.D. and Ph.D. in Bioengineering from Stanford University in the Medical Scientist Training Program.
Lori Hu is Managing Director at Vertex Ventures HC. Ms. Hu joined in 2015 to help establish the US office and manages global healthcare investments in biotech, medical devices and digital health. She manages a portfolio of over a dozen companies across two funds. Lori serves on the Board of Directors for Palleon Pharma, Blackthorn Therapeutics, Elevation Oncology and Kona Medical, and is a board observer for Ivantis and Moximed.
Before Vertex, Lori was an Associate Director for Business Development at Bristol-Myers Squibb, identifying and executing licensing and partnership transactions. She has also worked with SR One, the corporate venture capital arm of GlaxoSmithKline. Previously, she was a strategy consultant at Accenture, advising biopharmaceutical clients on strategic projects across the US and Asia.
Lori graduated with an MBA from The Wharton School, and MA in International Studies from the University of Pennsylvania where she was a Leonard Lauder Fellow. She also holds a BSE in Biomedical Engineering from Duke University. She is based in the Bay Area.
Shawn M. Leland is the Founder and Chief Executive Officer and currently serves as its Chief Business Officer overseeing all day-to-day operations. Shawn brings over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. Shawn has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Shawn has also served as an expert strategic consultant for Catenion providing guidance on portfolio management for pharmaceutical/biotech companies.
Shawn resides in Denver, Colorado and enjoys snowboarding, hiking and cycling.
Andy Phillips, Ph. D. is a Managing Director at Cormorant Asset Management, LP (“Cormorant”). Before joining Cormorant, Andy was the President and Chief Executive Officer of C4 Therapeutics, a company pioneering targeted protein degradation medicines. Prior to joining C4 Therapeutics, Andy was Senior Director, Center for Development of Therapeutics at the Broad Institute of MIT and Harvard, where he led overall therapeutic efforts and provided strategic leadership for a number of major partnerships. Previously, he was a Full Professor of Chemistry at Yale University and a Full Professor of Chemistry and Biochemistry at the University of Colorado.
Andy holds Ph.D. and B.Sc. Hons. degrees in Biochemistry and Chemistry from the University of Canterbury (Christchurch, New Zealand). His academic research and accomplishments have been recognized by a number of national and international awards including the ACS Cope Scholar Award.”
Colin Walsh, PhD is a Partner at Qiming Venture Partners USA, based in Los Altos, CA. Before joining Qiming, Dr. Walsh was a Vice President on the life science investment team at NanoDimension where he sourced, structured, and managed investments in biotech, biopharma, and platform companies. Dr. Walsh was an early employee at Precision NanoSystems (PNI), a 5AM Ventures backed biotech developing a suite of technologies to enable the development and manufacture of complex drug formulations. At PNI, he focused extensively on RNA- and DNA-based therapeutics, and held a variety of product and business development roles where he worked to define the strategy and direction of the business.
Dr. Walsh earned a Ph.D. from the UC Berkeley – UCSF Graduate Program in Bioengineering where he worked on novel delivery systems for RNA-based therapeutics as an NSF Graduate Research Fellow. He holds a Management of Technology certificate from the UC Berkeley Haas School of Business, and a dual BS with Honors in Chemical Engineering and Biochemistry from the University of Massachusetts, Amherst.
Dr. Walsh currently serves on the business advisory board for the Harvard Medical School Initiative for RNA Medicine. He is also an advisor to the Stanford SPARK program and the UCSF Catalyst program where he provides mentorship and support to student- and faculty-led translational research projects.
Scientific Advisory Committee
Dr. Kunkel holds more than two decades of experience in oncology and immunology drug development and commercialization. Dr. Kunkel currently serves on the Board of Directors of Curis, Inc., Nurix Therapeutics, ORIC Pharmaceuticals, and Maverick Therapeutics. She was previously the acting Chief Medical Officer at Loxo Oncology and subsequently served on their board. She also served as Chief Medical Officer at Pharmacyclics (acquired by AbbVie) and Proteolix, Inc. (acquired by Onyx Pharmaceuticals), where she contributed to the global approvals of cancer therapeutics IMBRUVICA® and Kyprolis®, respectively. She participates as a scientific advisor to multiple clients including Atreca, Jasper Therapeutics, Oncopeptides, Oryzon, Rain Therapeutics, and Enliven Therapeutics. Dr. Kunkel spent ten years in academic medicine and served as a faculty member at the Bone Marrow Transplant Unit in the Division of Hematology/Oncology at University of California, Los Angeles. She is board certified in internal medicine and held board certifications in hematology and oncology and holds a B.A. in biology from the University of California, San Diego.
Dr. Siraj M. Ali is a physician-scientist and VP of clinical development at EQRx, a Cambridge area biotechnology company. Previously, he led translational research efforts at Foundation Medicine where his group focused on identifying predictive biomarkers for targeted anti-neoplastic and cancer immunotherapies, which encompasses both work with basic cancer biology and exceptional responders. Siraj has co-authored more than 200 peer-reviewed manuscripts, which have accrued nearly 20,000 citations, in journals such as The Oncologist, JCO-Precision Oncology, Cancer Discovery, Journal of Clinical Oncology (JCO), and others. He has given invited and juried presentations at international conferences. Siraj serves as a reviewer for multiple life-sciences journals and is a member of a NIH study section focused on drug development for oncology.
Siraj earned his BS in Biophysics Phi Beta Kappa from the Johns Hopkins University and an MD-PhD program from Harvard Medical School supported by HHMI fellowships and the Medical Scientist Training Program. He completed residency training at the Beth Israel Deaconess Medical Center/Harvard Medical School in Boston and is board-certified in Anatomic Pathology.
Dr. Camidge’s main clinical and research interests are thoracic malignancies and developmental therapeutics. The discoveries he and his team have made have changed the standard of care for the treatment of lung cancer multiple times. He has authored over 200 academic publications, including in the Journal of Thoracic Oncology, Lancet Oncology, and New England Journal of Medicine. He has received numerous awards including the Bonnie J. Addario International Lectureship Award and The Lung Cancer Foundation’s Breath Away From The Cure Award. In 2017, 2018 and 2019, he was internationally recognized as a highly cited researcher ranked in the top 1% of all of Clinical Medicine by Clarivate Analytics Web of Science. He is the National Medical Director of the Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC), a member of the VIA Oncology Lung Cancer Pathways Committee and a past-member of the National Comprehensive Cancer Network Lung Cancer Committee.
Dr. Alexander Drilon is the Acting Chief of the Early Drug Development Service and a medical oncologist on the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center in New York. His research focuses on the development of targeted therapy for genomic subsets of lung cancer and other solid tumors, including cancers that harbor fusions involving ALK, ROS1, RET, and NTRK1/2/3, and MET exon 14 skipping alterations. He is a recipient of American Society for Clinical Oncology (ASCO)/Conquer Cancer Foundation Career Development and Young Investigator Awards, and grants from the International Association for the Study of Lung Cancer and the Lung Cancer Research Foundation. Dr. Drilon is also a member of the Editorial Board of ASCO University.
Professor Ou is board-certified in Internal Medicine (2020 renewal) and Medical Oncology (2023 renewal) by the American Board of Internal Medicine
He has published more than 180 peer-reviewed manuscripts (including New England Journal of Medicine, Lancet Oncology, Journal of Clinical Oncology, Cancer Discovery, Nature Medicine) primarily in the field in targeted therapy including resistance mechanisms to targeted therapy in lung cancer.
In particular, Professor Ou is one of the seven original principal investigators for the still ongoing phase I crizotinib trial that has led to the approval of crizotinib for the treatment of anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) and ROS1-rearranged NSCLC which is now currently investigating the activity of crizotinib in MET exon 14 altered NSCLC. Other clinical research that Professor Ou has involved in has led to the approval of afatinib in uncommon EGFR mutations, Alectinib and Lorlatinib for ALK TKI-refractory ALK+ NSCLC.
Currently first-in-human phase 1 trials that Professor Ou are conducting includes a 3G ROS1/2G NTRK TKI (Repotrecitnib), a next generation RET inhibitor (BlU667), RMC-4630 (SHP2 inhibitor) as a single agent or in combination, and MRTX849 (direct covalent allosteric KRAS G12C inhibitor). The newest target Professor Ou is involved in is targeting NRG1+ fusion malignancies. Professor Ou also actively collaborate with commercial sequencing companies to mine their database to investigate their database on resistance mechanisms and treatment outcome to targeted therapy and also identification of extremely rare actionable driver mutations.
Professor Ou is the editor-in-chief of Lung Cancer: Targets and Therapy and Associate editor of Journal of Thoracic Oncology, editorial board member for Annals of Oncology, Critical Reviews in Oncology/Hematology, Clinical Lung Cancer, and Translational Lung Cancer Research. He is a member of the scientific program committee for metastatic non-small lung cancer track for the American Society of Clinical Oncology (ASCO) (2016-2018).