Molecular Partners AG

Molecular Partners is changing the protocol in an early-phase to allow higher and more frequent dosing. Molecular Partners has identified “suboptimal exposure” to its tetra-specific T-cell engager as the potential cause of the limited response rate in its early-phase trial, prompting the Swiss biotech to change the protocol to try to dial up the impact of the compound.The candidate, MP0533, features six binding domains. Three of the domains engage CD33, CD123 and CD70 on the target tumor cells. One domain targets CD3 to engage T cells, and the final two domains are there to prolong the half-life of the candidate in circulation. Molecular Partners picked the tumor targets to kill cancer cells that express two or more antigens while sparing healthy, single-expressing cells. Investigators are testing the candidate in a phase 1/2a study that is enrolling patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndrome. As of July 29, the biotech had seen four clinical responses in the 28 patients treated in the first six dose cohorts.Philippe Legenne, M.D., fresh from his appointment as Molecular Partners’ permanent chief medical officer, walked through the interim data on an earnings call Tuesday. After discussing the number of responses, Legenne concluded that the company “need[s] to have more than that to be completely satisfied and to qualify that we would unlock the potential of that compound.” Molecular Partners has identified “suboptimal exposure” as a barrier to realizing the full potential of the candidate. That observation led the biotech to prepare to change the protocol to allow higher and more frequent dosing in pursuit of improved response rate, depth of response and durability. Investigators are now enrolling patients in the eighth dose cohort and could go up to the eleventh dose level.“What we hope is that we are going to ... reduce the tumor ... burden. We see that we have more responses in the lower tumor burden than in the higher,” Legenne said. “We also want to avoid by design having chronic exposure, because we are also conscious of that concept of T-cell exhaustion. So we wouldn't want to be continuous all the time. Then the question is how little is enough.”One outstanding question is whether increasing the dose will improve the responses. Molecular Partners saw one complete response on the fourth dose and one case of morphologic leukemia-free state at the third, fifth and sixth doses. The biotech is still collecting data on the seventh dose, but, at this stage, there is no clear dose response. 

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced the appointment of Nicolas Leupin, M.D., Ph.D., MBA to the role of Chief Medical Officer. Dr. Leupin brings a proven track record of leadership and accomplishment in the biotechnology and pharmaceutical industries, as well as extensive experience as a medical oncologist and educator. At Novocure, Dr. Leupin will oversee medical affairs, medical safety, and clinical development operations as the company advances its clinical pipeline and prepares to treat an expanded patient population. “It is a pleasure to welcome Dr. Leupin to Novocure as our new Chief Medical Officer,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Nicolas brings a wealth of knowledge and experience from some of the most innovative oncology companies in the world, as well as a dedication to patients that is core to Novocure’s mission. I am confident that his expertise will be instrumental as Novocure enters its next chapter, treating patients with aggressive tumors of the brain, torso and abdomen.” “I am thrilled to join Novocure’s executive leadership team and contribute to the innovation and expansion of this novel modality, Tumor Treating Fields therapy,” said Dr. Leupin. “2024 is a critical year for Novocure with multiple opportunities on the horizon and I am excited to be joining a company with such strong capabilities and aspirations to materially advance patient care.” Before joining Novocure, Dr. Leupin served as the Chief Medical Officer at Molecular Partners, a clinical-stage biopharmaceutical company, where he led the development of multiple designed ankyrin repeat protein therapeutics. Prior to his time at Molecular Partners, Dr. Leupin served as the Chief Medical Officer at Argenx, a leader in the development of therapeutic antibodies, and was instrumental in the development of Vyvgart and other compounds. Before moving into executive leadership, Dr. Leupin held a number of clinical development leadership roles at Celgene in the myeloma and lymphoma programs. Dr. Leupin earned his M.D. at the University of Bern, his Ph.D. from the UBFC-Université in France, and an MBA from Jones International University in the U.S. Dr. Leupin is a board certified medical oncologist with a specialty in hematological oncology. He has co-authored high-impact papers in peer-reviewed scientific journals, and is dedicated to educating the generation of oncologists through his continuing work as a lecturer of Tumor Biology at the University of Bern. Dr. Leupin will assume the clinical and medical responsibilities held by Pritesh Shah, Novocure’s former Chief Growth Officer. As previously announced, Mr. Shah resigned his position as an executive officer effective January 1, 2024 and has agreed to become a Senior Advisor to the Chief Executive Officer in a non-executive capacity. “I would like to thank Pritesh for his dedication and leadership over the 12 years,” said Asaf Danziger. “Pritesh has been at Novocure since the beginning of our commercial business and helped shape and build our business from scratch. I am very grateful to Pritesh and wish him a lifetime of happiness.” About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer. Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter. Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. View source version on businesswire.com: Contacts Investors & Media: Ingrid Goldberg 610-723-7427 investorinfo@novocure.com media@novocure.com Source: Novocure View this news release online at:

European life sciences investment firm Medicxi on Thursday said it raised $400 million, becoming the latest biotech-focused venture firm to boost its capital reserves so far this year.The firm will use the new funds to continue investing in “asset-centric“ biotechs, or companies focused on one or two experimental medicines rather than broad drugmaking platforms. This is its fourth fund.One of the largest firms of its kind in Europe, Medicxi announced its new fund after several of its portfolio companies were acquired. Over the past year, skin drug developer Villaris Therapeutics was bought by Incyte, autoimmune startup MiroBio sold to Gilead and obesity drug startup Versanis Bio was picked up by Eli Lilly.Those acquisitions provided the firm with a fast return on its investments. For instance, Medicxi joined with Atlas Venture and Aditum Bio to invest $70 million into Versanis in 2021. The biotech was sold to Lilly less than two years later in a deal that could be worth as much as $1.9 billion. Both MiroBio and Villaris were formed in 2019 and acquired in 2023.This new fund consolidates Medicxis position as a key operating platform for scientific entrepreneurs and drug hunters and is deliberately sized for our investment model, Francesco De Rubertis, Medicxis co-founder, said in a statement.Previously known as Medicxi Ventures, the firm launched out of Index Ventures in 2016 with backing from GSK and Johnson & Johnson.Its portfolio includes a number of public companies, such as Centessa Pharmaceuticals, Molecular Partners and Minerva Biosciences. Others, such as Genmab and Phathom Pharmaceuticals, have successfully developed marketed medicines.Medicxi joins other biotech investors, such as Westlake Village Biopartners and SR One, in closing new funds this year. New firms, such as Dimension and Cure Ventures, have also raked in hundreds of millions of dollars to support young biotech companies.Overall, venture firms raised approximately $163 billion in 2022, and invested nearly $31 billion into biotech and pharma companies last year, according to the National Venture Capital Association. '