Acceleron Pharma, Inc.

The appointments of Dr. Karen Smith and Dr. Luke Walker to the Board bring extensive operational and clinical development experience to support corporate and pipeline strategyPHILADELPHIA, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced the appointments of Karen Smith, MD, PhD, MBA, LLM and Luke Walker, MD, to its Board of Directors. “Karen and Luke’s vast experience and proven leadership in the biopharmaceutical industry are tremendous assets for Context at this pivotal stage of our growth," said Martin Lehr, CEO of Context Therapeutics. “Karen’s extensive oncology drug development, regulatory, and strategy experience will be invaluable as Context continues to advance its pipeline. Luke brings an extensive track record in oncology drug development, including recent experience developing T cell engaging bispecific antibodies.” Mr. Lehr continued, “These additions supplement our ongoing effort to build Context into a leading oncology company and advance potential best-in-class T cell engaging bispecifics.” Dr. Karen Smith is a biopharmaceutical thought leader with over 20 years of experience bringing drugs into the clinic and through commercialization. She has been a key contributor to the successful development of multiple approved products in several therapeutic areas, including oncology (Herceptin, Vyxeos), rare disease (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox), neuroscience (Abilify) and anti-infectives (Teflaro). Previously, she was Global Head of Research & Development and Chief Medical Officer of Jazz Pharmaceuticals. Earlier in her career, Dr. Smith held senior leadership roles at Allergan, AstraZeneca, and Bristol Myers Squibb. Previously, Dr. Smith served on the Board of Directors of Antares Pharma (acquired by Halozyme for $960 million), Acceleron Pharma (acquired by Merck for $11.5 billion), Mariana Oncology (acquired by Novartis for $1 billion upfront), and Sucampo Pharmaceuticals (acquired by Mallinckrodt for $1.2 billion). Dr. Smith currently serves on the Board of Directors of Aurinia Pharmaceuticals, Capstan Therapeutics, Sangamo Therapeutics, and Skye Bioscience. Dr. Luke Walker has more than 20 years of clinical development experience as both an executive and board member. Most recently, he was the Chief Medical Officer of Harpoon Therapeutics, an oncology-focused biopharmaceutical company where he was responsible for oversight of all aspects of clinical development programs using Harpoon’s TriTAC T-cell engager platform, which was acquired by Merck in 2024 for $680 million. Previously, Dr. Walker was Vice President of Clinical Development at Seagen, where he was the global development lead for Tukysa (tucatinib) through the program’s successful completion of a pivotal registrational trial and successful regulatory approvals. Earlier, Dr. Walker was Senior Vice President of Clinical Development at Cascadian Therapeutics, which was acquired by Seagen in 2018 for $614 million. Dr. Walker began his career as a practicing medical oncologist and hematologist at Providence Regional Medical Center and with the Everett Clinic. Dr. Walker currently serves on the Board of Directors of Zentalis Pharmaceuticals. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. The Company is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics, including CTIM-76, a Claudin 6 (CLDN6) x CD3 bispecific antibody, and CT-95, a Mesothelin (MSLN) x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the new appointments to support the Company and the advancement of its product candidates; (ii) the ability of the Company to become a leading oncology company; (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) the ability of our product candidates to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (v) the likelihood data will support future development of our product candidates, and (vi) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. Investor Relations Contact:Jennifer Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com

Merck & Co’s – known as MSD outside of the US and Canada – pulmonary arterial hypertension (PAH) therapy has been granted approval by the European Commission (EC). Winrevair (sotatercept) has been authorised for use in combination with other pulmonary arterial hypertension (PAH) therapies to improve exercise capacity in adults with World Health Organization (WHO) functional classes two to three. About 30,000 people in the EU are living with PAH, a progressive disorder in which the blood vessels in the lungs thicken and narrow. This blocks the blood flow through the lungs, which raises blood pressure and results in a significant strain on the heart. Merck’s Winrevair, which is administered as a single injection once every three weeks, is now the first and only activin signalling inhibitor therapy for PAH approved in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the phase 3 STELLAR trial, which compared Winrevair to placebo, both taken alongside background standard of care therapies in adult patients with PAH. The Winrevair combination led to a statistically significant and clinically meaningful improvement in the study’s primary endpoint of six-minute walk distance, and on multiple secondary outcome measures, including reduction in the risk of death or clinical worsening. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, described the approval as “an important step” for PAH patients. “Winrevair is the first therapy targeting the activin signalling pathway. We are proud to bring this innovative treatment to more patients and remain committed to further investigating the potential of Winrevair in areas where there are unmet needs in the management of PAH,” Koglin added. The authorisation comes five months after Winrevair was approved by the US Food and Drug Administration, also to treat PAH in adults. Merck gained access to the drug in 2021 through its $11.5bn acquisition of Acceleron Pharma. Rob Davis, current chairman and chief executive officer, Merck, said when the deal was first announced: “Acceleron’s innovative research has yielded an exciting late-stage candidate that complements and strengthens our growing cardiovascular portfolio and pipeline and holds the potential to build upon Merck’s… legacy in cardiovascular disease.”

Five months after Merck & Co. won FDA approval for its first-in-class pulmonary arterial hypertension (PAH) treatment Winrevair (sotatercept), the activin signalling inhibitor has cleared another milestone — securing a green light in Europe. Following a positive recommendation from the bloc’s drug advisory committee issued in June, the European Commission on Monday approved Winrevair to be used in combination with other PAH therapies to improve exercise capacity in adult PAH patients with WHO Functional Class II to III.In addition to its regulatory wins, Winrevair has also found early commercial success. The drug brought in $70 million in US sales for the second quarter, ahead of estimates of around $60 million. During its financial earnings presentation in late July, Merck noted that about 40% of the product’s revenue was attributable to doses administered to patients, with the remainder due to distributors building inventory in support of increasing demand.Winrevair was acquired through the pharma’s $11.5-billion purchase of Acceleron Pharma in 2021.Mortality reductionSimilar to the US approval, Monday’s EU clearance was based on data from the Phase III STELLAR trial. According to Marc Humbert, director of the Pulmonary Hypertension Reference Center at Université Paris-Saclay, the study’s results support the use of Winrevair in combination with other PAH therapies as “a new standard of care” treatment for adults with PAH.The trial randomised 323 patients to receive a subcutaneous injection of Winrevair every three weeks, or placebo. Those who received Winrevair in addition to existing therapy saw a significant improvement in exercise capacity, measured by the six-minute walk distance (6MWD). Patients on Winrevair walked an average of 40.8m farther at 24 weeks than those on placebo.The drug also reduced the risk of death or clinical worsening by 82%, a secondary outcome that has set Winrevair apart from existing PAH therapies.A FirstWord poll of US cardiologists and pulmonologists found that more than half of responding physicians would be likely to, or would definitely, prescribe Winrevair, though 64% stated they are concerned about the drug’s safety profile and monitoring requirements due to its potential to increase haemoglobin and lead to erythrocytosis, as well as decrease platelet count and lead to severe thrombocytopenia. For more on that poll, see Physician Views Results: Merck & Co.’s Winrevair looks like a winner, but its clean label hasn’t banished safety concerns.