Ciba-Geigy AG

STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company’s Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. “Martin is a proven industry leader whose experience in developing and delivering novel treatments to patients in need is exceptional,” said Saqib Islam, Chief Executive Officer of SpringWorks. “His expertise in rare diseases and unique perspectives leading multiple Research and Development organizations across the globe will be extremely valuable to SpringWorks as we advance and expand our pipeline and execute on our mission to make a meaningful difference in patients’ lives. I am delighted to welcome Martin to the SpringWorks team.” “I am very pleased to join the SpringWorks Board and work with a group of talented and visionary leaders who are driven by a joint mission to develop and deliver transformative therapies for patients with devastating diseases,” said Dr. Mackay. “I believe SpringWorks is uniquely positioned to make a significant impact in therapeutic areas with tremendous potential, and it is an honor to bring my experience and knowledge to support the important work that SpringWorks is doing.” Dr. Mackay is a co-founder and Executive Chairman of Rallybio, a privately held clinical-stage biotechnology company focused on severe rare diseases that was incorporated in January 2018. Previously, Dr. Mackay was Executive Vice President, Head of Research and Development at Alexion from 2013 until 2017. Prior to joining Alexion, Dr. Mackay served as President, Research and Development at AstraZeneca from 2010 to 2013, where he led the R&D functions worldwide, including discovery research, clinical development, regulatory affairs, and key related R&D functions. From 1995 to 2009, he held various positions at Pfizer Inc., including Senior Vice President of Worldwide Development, where he was a member of the Executive Leadership Team and led a global organization tasked with advancing a portfolio of investigational medicines across a range of disease areas, and President, Head of Pfizer Pharmatherapeutics, R&D, where he oversaw all aspects of small molecule discovery and development across multiple therapeutic areas. From 1986 to 1995, Dr. Mackay worked at Ciba-Geigy (now Novartis) in the United Kingdom and Switzerland, and held various positions in academic research prior to that time. Dr. Mackay is currently a member of the Board of Directors of Charles River Laboratories and Novo Nordisk. He received a First-Class Honours Degree in microbiology from Heriot-Watt University and his Ph.D. in molecular genetics from the University of Edinburgh. About SpringWorks Therapeutics SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. OGSIVEO® (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, is the Company’s first FDA-approved therapy. SpringWorks also has a diversified targeted therapy pipeline spanning solid tumors and hematological cancers, with programs ranging from preclinical development through advanced clinical trials. In addition to its wholly owned programs, SpringWorks has also entered into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients in need. For more information, visit www.springworkstx.com and follow @SpringWorksTx on X (formerly Twitter), LinkedIn, and YouTube. Contacts: Kim DiamondVice President, Communications and Investor RelationsPhone: 203-561-1646 Email: kdiamond@springworkstx.com Samantha Hilson SandlerSenior Director, Investor RelationsPhone: 203-461-5501Email: samantha.sandler@springworkstx.com

People with chronic myeloid leukemia, a simmering cancer of the bone marrow, are often treated with one of several targeted drugs that, over the past two decades, have helped to substantially prolong survival from the disease.Study results revealed Friday suggest that Scemblix, the newest of those therapies, can be both safer and more effective, potentially supporting wider use of it as an initial treatment. The results are from a late-stage clinical trial run by Scemblixs maker, Novartis, and will be presented at the American Society of Clinical Oncologys annual meeting.In the trial, dubbed ASC4FIRST, Scemblix led to treatment responses in significantly more participants than did other targeted drugs, which included the mainstay therapy Gleevec as well as more recently introduced medicines. Additionally, more people given Novartis drug experienced whats called a deep molecular response, which over time can be considered a remission and allow treatment to be stopped.Study researchers also reported markedly favorable safety and tolerability for Scemblix, compared to Gleevec and the other so-called kinase inhibitors it was tested against.This combination of potency and safety may enable more patients to achieve treatment-free remission, the ultimate goal of CML therapy, said Timothy Hughes, the lead author of the ASC4FIRST study and an oncologist at the University of Adelaide, Australia, in a statement provided by ASCO.Scemblix is already approved in the U.S. and elsewhere for CML thats previously been treated with two or more kinase inhibitors. Based on the results of the ASC4FIRST trial, which Novartis in January said succeeded, the drugmaker has submitted for U.S. approval in people newly diagnosed with CML.If approved in the first-line setting, Scemblix would join Gleevec and three other kinase inhibitors that are currently available as first-line CML treatments. Their arrival in the 2000s and 2010s helped to triple the five-year survival rate for the disease, to roughly 70% among people diagnosed between 2012 and 2018, according to ASCO.Yet people with CML still cycle through different therapies, typically because their cancer develops resistance to treatment or side effects become intolerable.Patients with chronic myeloid leukemia often have to be on treatment for a very prolonged period, and more than 40% of patients who are newly diagnosed with CML fail to achieve the major molecular response after a year of treatment, said Oreofe Odejide, a medical oncologist at the Dana-Farber Cancer Institute, in a press conference held Wednesday under a publishing embargo. And then [some] also have to switch treatments because of adverse events.Fridays results indicate Scemblix may help on both fronts.The drug works differently than other kinase inhibitors approved before it, targeting a certain pocket on a mutant protein that drives CML proliferation. This difference might make Scemblix more selective in its binding and therefore less toxic, according to Jorge Cortes, director of the Georgia Cancer Center and an ASC4FIRST study investigator.Novartis designed its trial to compare Scemblix to available kinase inhibitors selected by participants treating physicians. Just over 400 adults with recently diagnosed, chronic-phase CML were enrolled and randomized to receive either Scemblix or the selected kinase inhibitor. (Along with Gleevec, approved first-line kinase inhibitors include the drugs Sprycel, Tasigna and Bosulif.)Results showed that, after 48 weeks, 68% of patients given Scemblix achieved a major molecular response, versus 49% of those on other kinase inhibitors. This laboratory measure looks at levels of mutant protein in the body. A major response means that levels are less than or equal to 0.1% on a so-called International Scale.Major molecular response predicts for better event-free survival, said Cortes, at the ASCO press conference. But probably more important is that it's a good predictor for the deep molecular responses in the long term, particularly the sustained deep molecular responses that make the patients eligible for considering treatment discontinuation.Nearly two-fifths of Scemblix-treated patients met the threshold for those deep molecular responses in the trial, compared to 21% of those on the other kinase inhibitors.Novartis also designed ASC4FIRST with a twist. Before patients were randomized to either the Scemblix or control groups, their physicians chose whether they would get Gleevec, which is typically used with older individuals, or one of the more potent, second-generation kinase inhibitors. For the main study analysis, Novartis then compared patients selected to receive Gleevec but randomized to Scemblix, to those who were randomized to the control group.Here, too, Scemblix outperformed. Major molecular responses were observed in 69% of Gleevec-selected patients who received Scemblix, versus 40% who went on to get one of the control drugs. This comparison was a main objective of the study.Patients were similarly grouped prior to randomization by whether they were selected for a second-generation kinase inhibitor, but the study wasnt powered to detect a statistical difference on that score.Its common for newer drugs to offer better efficacy or safety. But its rarer that theyre both safer and more potent. In ASC4FIRST, Scemblix was associated with lower rates of study discontinuation, dose adjustment or treatment interruptions than the comparator kinase inhibitors. And there were fewer side effects classified as medically significant with Scemblix than with either Gleevec or the second-generation drugs. The most common adverse events were low platelet and neutrophil counts.In its current labeling, Scemblix carries cautions about the risk of pancreatic toxicity, hypertension and cardiovascular toxicity.Scemblix has a nice balance of efficacy and tolerability, said Odejide. This is really poised to potentially change the management of first-line treatment of chronic myeloid leukemia.Researchers will continue to follow patients through 96 weeks, testing whether earlier molecular responses lead to better outcomes. Other studies will test progression-free survival or overall survival.For Novartis, the results position the company to extend a legacy in CML treatment. Gleevec, which had roots in the Swiss firm Ciba-Geigy, became a top-seller for Novartis, which also later developed Tasigna. Executives hope Scemblix can find similar commercial success.Our goal is to make this, over time, the leading CML treatment in the world, said Novartis CEO Vas Narasimhan on a recent earnings call. He added that Novartis has long patent protection on the medicine, which also may not be eligible for drug price negotiations in the U.S. since CML is a rare form of cancer. '

Giovanni Caforio, the former CEO of Bristol Myers Squibb, is set to become the next board chairman of Novartis, which on Tuesday proposed the pharmaceutical industry veteran as its pick to replace Joerg Reinhardt in the role next year.Reinhardt has served as Novartis chair since 2013 and plans to retire when his 12-year term ends in 2025. The appointment of Caforio will be put to Novartis shareholders at the companys annual general meeting. Announcement of the planned succession Tuesday came alongside first quarter earnings that beat Wall Street forecasts.Caforio spent two decades at Bristol Myers, rising through the ranks to become the companys CEO in 2015. Under his eight-year tenure as chief, Caforio oversaw a number of major acquisitions, most notably the $74 billion buyout of Celgene that greatly expanded Bristol Myers cancer drug business. More recently, the company agreed to pay $14 billion to acquire brain drug developer Karuna Therapeutics and its closely watched treatment for schizophrenia.He was replaced as Bristol Myers CEO by Chris Boerner in November.Reinhardt, meanwhile, started at Sandoz in 1982, joining Novartis via the 1996 merger of Sandoz and Ciba-Geigy. He held several executive positions, including chief operating officer and head of Novartis then vaccines and diagnostics division, before he was appointed board chair.During his time as chair, Novartis switched CEOsand underwent a significant transformation. The drugmaker sold its consumer business to GSK for $13 billion in 2018 and spun out its eye business Alcon.The company shed its long-held stake in Roche in 2021 and later restructured its workforce and drug pipeline. Last year the company spun out Sandoz, completing the last major step in current CEO Vas Narasimhans plan to focus Novartis on high-margin prescription pharmaceuticals. '