On September 6, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported positive preliminary safety and efficacy data from an ongoing Phase 1/2 clinical trial of CK-101 (also known as RX518), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being evaluated in advanced non-small cell lung cancer (NSCLC) (Press release, Checkpoint Therapeutics, SEP 6, 2018, View Source [SID1234529736]). The data will be presented on Monday, Sept. 24, at 10:30 a.m. ET in a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer in Toronto.

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"These preliminary data demonstrate CK-101 is well-tolerated at the doses tested while also demonstrating encouraging anti-tumor activity, particularly in treatment-naïve EGFR mutation-positive lung cancer patients," said Melissa L. Johnson, M.D., Associate Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, PLLC, and study chair of the Phase 1/2 trial.

"The data to date demonstrate CK-101’s potential to be a highly effective mutant-selective EGFR inhibitor with the potential for a differentiated safety profile," said James F. Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "We look forward to continuing to advance CK-101 towards a pivotal Phase 3 trial next year, positioning CK-101 to potentially be only the second third-generation EGFR inhibitor to enter the market."

The first-in-human, multicenter trial is evaluating CK-101 in NSCLC patients with EGFR mutations and other advanced malignancies (NCT02926768). Following dose escalation ranging from 100 mg to 1,200 mg/day in patients with any solid tumor where targeted EGFR was deemed reasonable, a first doseexpansion cohort was enrolled at 400 mg twice daily in patients with a confirmed diagnosis of either (1) EGFR mutation-positive advanced or metastatic NSCLC without prior exposure to EGFR-TKI therapy, or (2) T790M-positive advanced or metastatic NSCLC with disease progression on previous EGFR-TKI therapy. There was no limit on the number of prior lines of systemic therapy patients received prior to entering the study.

Key Data from the Abstract
As of June 2018, 37 patients had been treated with CK-101 in dose escalation and dose-expansion cohorts
and were evaluable for safety.
• No dose limiting toxicities (DLTs) or treatment
• The most common drug-related treatment-emergent adverse events (>10%) included nausea
(16%), diarrhea (14%), lacrimation increased (14%) and vomiting (11%).
In dose-expansion, 19 EGFR mutation-positive NSCLC patients were treated with CK-101 at a dose of 400
mg twice daily and were evaluable for response (RECIST v1.1). Eight patients achieved a partial response
(7 confirmed, 1 pending). Additional efficacy findings include:
• In eight treatment-naïve patients, six patients (75%) achieved a partial response.
• In six patients with brain metastases present at baseline, three patients achieved a partial
response.
• Higher drug exposures were associated with a higher response rate with a confirmed objective
response rate (ORR) of 55% (6/11) in patients achieving a maximum serum concentration (Cmax)
greater than 400 ng/mL.
• 100% (19/19) disease control rate was observed, with 84% (16/19) of patients experiencing target
lesion reduction versus baseline.
• Median duration of response and progression-free survival were not reached as of the data cutoff.
Enrollment in the trial is ongoing to identify the optimal dose to maximize therapeutic effect.

Oral Presentation
Details of the oral presentation at the IASLC 19th World Conference on Lung Cancer are as follows:
Title: CK-101 (RX518), a Third Generation Mutant-Selective Inhibitor of EGFR in NSCLC: Results of
an Ongoing Phase I/II Trial
Date / Time: Monday, Sept. 24, 2018 at 10:30am
Session: Novel Therapies in ROS1, HER2 and EGFR
Presenter: Melissa L. Johnson, M.D., Associate Director, Lung Cancer Research, Sarah Cannon
Research Institute at Tennessee Oncology, Nashville, Tenn.

The full abstract can be found on the conference website and is also available on the Publications page in
the Pipeline section of Checkpoint’s website, www.checkpointtx.com.

About CK-101
CK-101 (also known as RX518) is an oral, third-generation, irreversible kinase inhibitor against selective mutations in the EGFR gene. Activating mutations in the tyrosine kinase domain of EGFR, such as L858R and exon 19 deletion, are found in approximately 20 percent of patients with advanced non-small cell lung cancer (NSCLC).

Compared to chemotherapy, first-generation EGFR inhibitors significantly improved objective response rate and progression-free survival in previously untreated NSCLC patients carrying EGFR mutations. However, tumor progression could develop due to resistance mutations, often within months of treatment with first-generation EGFR inhibitors. The EGFR T790M "gatekeeper" mutation is the most common resistance mutation found in patients treated with first-generation EGFR inhibitors. The mutation decreases the affinity of first-generation inhibitors to EGFR kinase domain, rendering the drugs ineffective. Second-generation EGFR inhibitors have improved potency against the T790M mutation, but have not provided meaningful benefits in NSCLC patients due to toxicity from also inhibiting wild-type EGFR. Third-generation EGFR inhibitors are designed to be highly selective against both EGFR-TKIsensitizing and resistance mutations, with minimal activity on wild-type EGFR, thereby improving tolerability and safety profiles.

Checkpoint Therapeutics is developing CK-101 for the treatment of NSCLC patients carrying the susceptible EGFR mutations. These include the EGFR T790M mutation in second-line NSCLC patients, as well as the EGFR L858R and exon 19 deletion mutations in first-line NSCLC patients. Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK‐101, which it acquired from NeuPharma, Inc., in 2015.

On September 6, 2018 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported the pricing of its underwritten public offering of $150,000,000 of American Depositary Shares ("ADSs") representing ordinary shares of the Company (Press release, Zai Laboratory, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366260 [SID1234530327]).

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Zai Lab sold 7,500,000 ADSs at a price of US$20.00 per ADS. Each ADS represents one ordinary share of Zai Lab. The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $150,000,000. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the public offering price, less underwriting discounts and commissions. The offering is expected to close on September 10, 2018, subject to customary closing conditions.

J.P. Morgan, Citigroup, Jefferies and Leerink Partners are acting as joint book-running managers for the offering.

A registration statement on Form F-1 relating to the securities sold in this offering has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. Copies of the registration statement related to this offering can be accessed through the SEC’s website at www.sec.gov.

This offering is being made only by means of a prospectus. A final prospectus, when available, may be obtained from: (i) J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or email: [email protected], (ii) Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146 (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-821-7388, or by email at [email protected] or (iv) Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: 1-800-808-7525 ex. 6132 or email: [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 5, 2018 Zetagen Therapeutics, Inc., a private, US-based biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported its award of a $300,000 (USD) grant from the National Cancer Institute of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, SEP 5, 2018, View Source [SID1234643681]). The grant will be used for a Phase I validation study of the Company’s proprietary, drug-eluding implant called ZetaMet (Zeta-BC-003). ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic being developed to suspend tumor growth and regrow bone.

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"We are pleased that the National Cancer Institute, through this award, has recognized the potential ZetaMet (Zeta-BC-003) may hold for treating metastatic bone lesions," said Nikhil Thakur, MD, CMO of Zetagen Therapeutics, Inc. "Osteolytic metastases are among the most challenging of cancers to treat as they both destroy bone and cause debilitating pain in patients."

The grant is part of the Small Business Innovation Research Program (SBIR), a three-phase award system created by the Federal Government for small businesses to engage in research and development that has the potential for commercialization and public benefit. Zetagen exclusively licensed its platform technology from the State University of New York in 2016. The Company’s Phase I validation study will begin in Q4 2018.

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.

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"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.

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.