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SpringWorks Therapeutics Announces Appointment of Saqib Islam as Chief Executive Officer

On September 5, 2018 SpringWorks Therapeutics, a clinical-stage rare disease and oncology company focused on sourcing and developing innovative treatments for underserved patient populations, reported that the company’s Board of Directors has appointed Saqib Islam as chief executive officer (Press release, SpringWorks Therapeutics, SEPT 5, 2018, View Source [SID1234529295]). Mr. Islam, who previously served as chief financial and chief business officer at SpringWorks Therapeutics, will also join the Board of Directors.

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"After a thorough and thoughtful search process, we are pleased to appoint Saqib as SpringWorks Therapeutics’ inaugural CEO and a member of our Board. Saqib has demonstrated exceptional leadership in building SpringWorks and brings to bear a broad set of skills and experiences that will enable our future success. With Saqib as CEO, we are extremely well positioned to execute on our multiple initiatives to deliver promising science to underserved patient populations," said Daniel S. Lynch, Executive Chairman of SpringWorks Therapeutics.

Mr. Islam has led SpringWorks Therapeutics’ key business operations and strategic corporate planning activities since the company’s launch in September 2017. He joined SpringWorks Therapeutics from Moderna Therapeutics, where he served as chief business officer and oversaw global strategic planning, corporate development and business development. Prior to Moderna, Mr. Islam served as executive vice president, chief strategy and portfolio officer at Alexion Pharmaceuticals. Mr. Islam has over 25 years of international business management experience and an extensive background in the healthcare banking sector, having held managing director positions in the investment banking divisions of Morgan Stanley and Credit Suisse Securities. He received a bachelor’s degree from McGill University and a J.D. from Columbia Law School, where he was a Harlan Fiske Stone Scholar.

"I joined SpringWorks Therapeutics because I saw a unique opportunity to build a company centered around the ambition of developing transformative medicines for severe diseases that do not currently have a cure, starting with our two lead development programs for patients with desmoid tumors and neurofibromatosis type 1, two rare and devastating tumors," said Mr. Islam. "I am honored to have the opportunity to lead SpringWorks and am very pleased to have assembled an experienced management team comprised of leaders who share our mission-driven approach to serving patients, each of whom will play a critical role in advancing and building upon the great work that has been done thus far."

Experienced Leadership Team

SpringWorks Therapeutics has built a team of highly talented executives with deep industry experience and a proven track record in their respective areas of expertise.

Jens Renstrup, M.D., MBA, Chief Medical Officer: Dr. Renstrup is responsible for developing and driving execution of the clinical development programs and oversees medical affairs. He has extensive experience building medical affairs organizations at pharmaceutical and biotech companies, shaping early- to late-stage development pipelines, and a proven track record accelerating time to market and new drug approvals. Prior to joining SpringWorks Therapeutics, Dr. Renstrup served as senior vice president and head of global medical affairs at Alexion Pharmaceuticals and vice president and head of global medical affairs at GSK Vaccines. Earlier in his career, Dr. Renstrup served in progressive leadership positions at Merck & Co, and he started his career at IPSEN Scandinavia A/S. Dr. Renstrup holds an M.D. and specialist medical degree in anesthesiology and intensive care medicine from the University of Copenhagen, as well as an MBA from the Copenhagen Business School.
Badreddin Edris, Ph.D., Chief Business Officer: Dr. Edris is responsible for corporate strategy, business development and capital formation for the company. His professional experience spans private and public equity investing, company formation and operations, corporate and business development, and strategic and product planning in the biotechnology industry. Prior to joining SpringWorks Therapeutics, Dr. Edris was an investment and operating professional on the private equity team at OrbiMed, where he was involved in deal sourcing, evaluation and execution, as well as post-investment strategic and operational support for biotechnology companies across a range of therapeutic areas and stages of development. Dr. Edris also co-founded and held operating roles at two OrbiMed portfolio companies, Silverback Therapeutics (where he was chief business officer) and Edgewise Therapeutics (where he was chief operating officer). Before OrbiMed, Dr. Edris was a management consultant at Bain & Company, where he collaborated with global pharmaceutical and biotechnology companies on a range of strategic and operational projects. Dr. Edris received his Ph.D. in genetics from Stanford University, where he was an NSF research fellow.
L. Mary Smith, Ph.D., Senior Vice President, Clinical Research and Development: Dr. Smith is responsible for designing and running the clinical development programs for SpringWorks Therapeutics. Prior to joining SpringWorks Therapeutics, Dr. Smith was the executive vice president of gene therapy at Bamboo Therapeutics, a wholly owned subsidiary of Pfizer, where she led several key gene transfer programs for rare genetic diseases. Prior to joining Bamboo, Dr. Smith was the vice president of product development at United Therapeutics, with responsibility for biological development in oncology, as well as regenerative medicine and virology. Dr. Smith holds a Ph.D. in microbiology/immunology from the University of New Hampshire and received her post-doctoral training at Emory University.
Michael Greco, J.D., General Counsel and Secretary: Mr. Greco is responsible for the company’s legal and compliance functions. He is an experienced legal executive who previously served as senior vice president of law and corporate secretary for Alexion Pharmaceuticals. He joined Alexion shortly prior to the launch of Alexion’s first and lead product and during his tenure assumed positions of increasing responsibility in the company’s legal department. In his most recent role, he was responsible for overseeing corporate governance initiatives, public reporting and securities compliance and corporate transactions. He was also responsible for managing the legal department’s corporate, R&D, business development and employment law legal teams. Prior to Alexion, Mr. Greco was a corporate attorney at Wiggin and Dana LLP and Bingham McCutchen LLP (now Morgan Lewis). Before law school, Mr. Greco served in the U.S. Army Corps of Engineers. Mr. Greco received a J.D. from Suffolk University Law School and a Bachelor of Science degree from the United States Military Academy, West Point.
Lisa Sinclair, Head of Program and Alliance Management: Ms. Sinclair is responsible for portfolio management and alliance development with the company’s biopharmaceutical partners, including the collaboration with Pfizer. Ms. Sinclair brings significant experience in driving the delivery of medicines from IND through approval in top-tier global biopharmaceutical companies and has a proven track record of accelerating medicines to key decision points in rare diseases. Prior to joining SpringWorks Therapeutics, she served as vice president of R&D strategy, portfolio and project management at Alexion Pharmaceuticals, where she led the development and execution of the five-year R&D strategic plan across multiple disease franchises and built portfolio and project management capabilities that supported pipeline speed, growth and value. Prior to Alexion, Ms. Sinclair was vice president of R&D portfolio and performance at AstraZeneca, where she was accountable for transforming global portfolio management across R&D and implemented R&D therapeutic area planning, portfolio prioritization, resource management, and performance metrics and analytics. Prior to AstraZeneca, she held various roles of increasing responsibility at Pfizer. Ms. Sinclair received a bachelor’s degree in business from the University of Vermont.
Kim Diamond, Head of Communications and Investor Relations: Ms. Diamond is responsible for the company’s internal and external communications strategy and investor relations. She has significant experience across the biopharmaceutical industry, including an established track record of launching rare disease therapies and broad therapeutic area expertise in oncology, hematology, nephrology, neurology and metabolic disorders. Prior to joining SpringWorks Therapeutics, Ms. Diamond served as executive director of corporate communications at Alexion Pharmaceuticals, where she was responsible for global external communications, including company reputation and branding, global product launches, and digital communications. Prior to Alexion, Ms. Diamond was director of corporate communications at OSI Pharmaceuticals, and she also held roles of increasing responsibility in the healthcare practice of Edelman earlier in her career. Ms. Diamond received a bachelor’s degree from Middlebury College.

Spectrum Pharmaceuticals Announces Release of Poziotinib Abstract as Part of the IASLC 19th World Conference on Lung Cancer

On September 5, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported new interim poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer (NSCLC) study which appeared in an online abstract as part of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (Press release, Spectrum Pharmaceuticals, SEPT 5, 2018, View Source [SID1234529294]). The interim results, which include data from the EGFR cohort and, for the first time, the HER2 cohort, are preliminary and based on data through May 3, 2018. More robust and updated data will be presented in an oral session on September 24 at the conference in Toronto, Canada.

"These results add to a growing body of evidence supporting the role of poziotinib in patients with EGFR and HER2 exon 20 mutations, and are a real advance for these patients for whom no targeted therapies have been effective so far," said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center. "I am highly encouraged by these results and the evolution of poziotinib data. Our study is the single largest data set in this high unmet need patient population and I am excited to present updated data during an oral session at the IASLC World Conference on Lung Cancer."

Data appearing in the abstract were current as of May 3, 2018. 40 patients of the 50 patient EGFR cohort had data available for the efficacy analysis. In the 40 patients, poziotinib continued to show robust efficacy with an objective response rate (ORR) of 58% in this heavily pre-treated population. Median progression free survival (PFS) was 5.6 months (95%-CI 5.06-NA). The disease control rate was 90%. In the HER2 cohort the ORR was 50% and the disease control rate was 83%. The most common adverse events were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. Updated data will be presented at the conference and will include data into September.

"We are thrilled with the data presented in the abstract and look forward to a more robust data set on September 24th," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Additionally, we believe the treatment potential of poziotinib may go well beyond the previously treated lung cancer setting. We are actively expanding the poziotinib clinical program to explore poziotinib in new areas including first-line treatment of NSCLC, treatment of other solid tumors with EGFR or HER2 mutations, and combination therapies."

Spectrum Pharmaceuticals will be hosting a live webcast on September 24 following the oral presentation.

Abstract: A Phase II Trial of Poziotinib in EGFR and HER2 exon 20 Mutant Non-Small Cell Lung Cancer

Background

Insertions/mutations in exon 20 of EGFR and HER2 occur in ~1% and ~3% of all lung adenocarcinomas, respectively. These alterations are characterized by primary resistance to approved tyrosine kinase inhibitors (TKIs) with response rates of <12%. We have previously shown that exon 20 insertions restrict the size of the drug-binding pocket, limiting binding of large inhibitors. However, poziotinib can circumvent these steric changes and is a potent inhibitor of EGFR and HER2 exon 20 mutants (Robichaux et al. Nat Med). Herein, we report the results of an investigator-initiated study of poziotinib in EGFR and HER2 exon 20 mutant NSCLC (NCT03066206).

Methods

Patients ≥18yrs with locally advanced/metastatic NSCLC bearing mutations/insertions in EGFR or HER2 exon 20 (except EGFR T790M) were eligible. Unlimited prior systemic and targeted therapies were permitted. Poziotinib 16mg PO daily was administered until progression, death, or withdrawal. The primary endpoint was objective response rate (ORR) based on RECIST v1.1. Response was evaluated every eight weeks. A Bayesian design was used with a plan to enroll patients in cohorts of 10 and to terminate the study if ORR was ≤20%. Secondary endpoints included disease control rate (DCR); progression-free survival (PFS); overall survival; and safety.

Results

As of May 3, 2018, the planned EGFR cohort of 50 patients was fully enrolled, and 40 patients were evaluated for response. Median age was 55yrs (range 29-78). 65.1% of patients had received at least two prior lines of therapy for metastatic disease. 60% of patients had ≥grade 3 adverse events; most common were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. One patient stopped the treatment due to grade 3 skin rash. The ORR at eight weeks was 58% (95%-CI 40.9-73.0) and the DCR was 90% (95%-CI 76.3-97.2). Among 23 patients who achieved partial response, 15 responses were confirmed, five responses were unconfirmed, and three patients are pending confirmation. Responses were observed in 8/13 (62%) patients that were previously treated with TKI. Median PFS was 5.6mo (95%-CI 5.06-NA). Furthermore, 13 patients were enrolled in the HER2 cohort. Observed toxicities were similar to the EGFR cohort except one case of grade 5 pneumonitis, assessed to be possibly drug related. Twelve patients were evaluated for response with an ORR of 50% (95% CI 21.1-78.9) at eight weeks and a DCR of 83%.

Conclusion

The trial exceeded the stopping boundary of ORR of 20%. In a heavily pre-treated population with EGFR and HER2 exon 20 mutant NSCLC, poziotinib provides a high ORR, an encouraging PFS, and a manageable toxicity profile.

Conference Call Details:

Monday, September 24, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 1993267
International: (973) 796-5077, Conference ID# 1993267

The conference call will also be webcast live. To access the webcast and additional documents related to the call, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source

For interested individuals unable to join the call, a replay will be available from September 24, 2018 @ 7:00 p.m. ET/4:00 p.m. PT through October 1, 2018, until 7:30 p.m. ET/4:30 p.m. PT.

Domestic Replay Dial-In: (855) 859-2056, Conference ID# 1993267
International Replay Dial-In: (404) 537-3406, Conference ID# 1993267

About Poziotinib

Poziotinib is a novel, orally available Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize worldwide excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 insertion mutations currently consists of a Phase 2 investigator-initiated study at The University of Texas MD Anderson Cancer Center and a Phase 2 pivotal, Spectrum-sponsored, multi-center, global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe.

BeiGene to Present Data on Anti-PD-1 Antibody Tislelizumab at the IASLC 19th World Conference on Lung Cancer (WCLC) in Toronto

On September 5, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present data on its investigational anti-PD-1 antibody tislelizumab at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC), which takes place September 23-26 in Toronto, Canada (Press release, BeiGene, SEPT 5, 2018, View Source;p=irol-newsArticle&ID=2366246 [SID1234529293]). Discovered by BeiGene, tislelizumab is being studied as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumors and hematologic cancers.

Poster Presentations:

Title: Tislelizumab Combined with Chemotherapy as First-Line Treatment in Chinese Patients with Advanced Lung Cancer
Session 1: JCSE01 – Perspectives for Lung Cancer Early Detection
Location: Room 202 BD
Date: Sunday, September 23
Time: 07:30-11:15 EDT
Presenter: J. Wang

Poster: P1.04-36
Session 2: P1.04 Immuno-oncology
Date: Monday, September 24
Time: 16:45-18:00 EDT
Presenter: J. Wang

Title: Preliminary Results with Tislelizumab in Chinese Patients with Non-Small Cell Lung Cancer (NSCLC)
Poster: P2.04-29
Session: P2.04 Immuno-oncology
Date: Tuesday, September 25
Time: 16:45-18:00 EDT
Presenter: Y-L. Wu

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

Syndax to Present at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer

On September 5, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that data from the PD-(L)1 refractory non-small cell lung cancer (NSCLC) cohort of ENCORE 601 will be presented at the upcoming International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) being held September 23-26, 2018 in Toronto, Canada (Press release, Syndax, SEPT 5, 2018, View Source [SID1234529292]). ENCORE 601 is a Phase 1b/2 trial evaluating the efficacy and safety of entinostat, the Company’s class I selective HDAC inhibitor, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, across multiple cohorts of PD-(L)1 treatment-naïve and pre-treated cancers, including NSCLC, melanoma and microsatellite stable colorectal cancer.

The accepted abstract is available on the World Conference on Lung Cancer website at View Source Updated data will be presented at the conference.

Presentation Details

Title: Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy
Presenter: Matthew D. Hellmann, M.D., Memorial Sloan Kettering Cancer Center
Track: Advanced NSCLC
Session: OA05 – Clinical Trials in IO
Presentation Number: OA05.01
Date and Time: September 24, 2018 1:30 – 1:40 PM ET

Exelixis to Present at the Morgan Stanley Global Health Care Conference on September 12, 2018

On September 5, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the Morgan Stanley Global Health Care Conference taking place September 12-14 in New York, NY (Press release, Exelixis, SEPT 5, 2018, View Source;p=irol-newsArticle&ID=2366220 [SID1234529291]). The Exelixis presentation is scheduled for 1:05 PM EDT / 10:05 AM PDT on Wednesday, September 12, 2018.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.