Alexander Zehnder, MD, MBA

+++ 𝗤𝟭 𝗿𝗲𝘀𝘂𝗹𝘁𝘀 𝟮𝟬𝟮𝟰 𝗮𝗻𝗱 𝗰𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝘂𝗽𝗱𝗮𝘁𝗲 +++ We started the year with good progress across our oncology pipeline and our commercialization activities. Some key events: 🔬 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆: We and our collaboration partner Duality Biologics dosed the first patient in a Phase 3 clinical trial with our #ADC candidate BNT323/DB-1303 in breast cancer patients, advancing towards BioNTech’s goal of ten or more potentially registrational trials running by the end of 2024. 🩹 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵: We are focusing on preparing for variant-strain adaptation of our COVID-19 vaccine to be ready for a commercial launch ahead of the upcoming 2024/2025 vaccination season, pending approvals. 🌎 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀: We appointed our General Manager Fatma Ocak for the U.S. in line with our commercial preparations to drive our first expected global #oncology product launch. 𝗟𝗶𝗻𝗸 𝘁𝗼 𝗣𝗥 𝗮𝗻𝗱 𝗳𝗼𝗿𝘄𝗮𝗿𝗱-𝗹𝗼𝗼𝗸𝗶𝗻𝗴 𝘀𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀: https://lnkd.in/ePDQiHbH  

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In the Newsweek article, "The Many Faces of Oncology”, our Co-Founder & CEO, Fabian Gerlinghaus, highlights a significant issue: 'About 20 percent of patients are dying on the waitlist even though they are eligible for approved cell therapies because the industry is unable to meet patient demand.' This is a medical emergency. Learn more about how Cellares' Cell Shuttle platform integrates and automates the entire cell therapy manufacturing process, reducing labor and space requirements by 90% and processing 16 cell therapies simultaneously. This industry 4.0 approach aims to meet global patient demand for these life-saving cell therapies. Read now: https://lnkd.in/gsYX84RB For more Cellares coverage, check out the 🔗 link in the comments!

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Our CEO, Hubertus von Baumbach, underscores in today's edition of Handelsblatt the critical role our votes play in shaping the future of Europe, especially amidst the current challenges. As a company deeply invested in life sciences and pharmaceutical R&D, we echo his call for strengthening European competitiveness in these fields. Let's use our votes to build a stronger, more innovative Europe. Learn more here: https://lnkd.in/enbXBV4n #EuropeanElections #VoteForEurope

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𝐑𝐨𝐜𝐡𝐞 𝐭𝐨 𝐟𝐚𝐬𝐭-𝐭𝐫𝐚𝐜𝐤 𝐰𝐞𝐢𝐠𝐡𝐭-𝐥𝐨𝐬𝐬 𝐩𝐢𝐥𝐥 𝐭𝐨 𝐜𝐨𝐦𝐩𝐞𝐭𝐞 𝐰𝐢𝐭𝐡 𝐫𝐢𝐯𝐚𝐥𝐬 Roche has announced plans to accelerate the production of a new weight-loss pill to vie with competitors like Eli Lilly and Novo Nordisk in the expanding obesity treatment market. Thomas Schinecker, CEO of Roche, conveyed to the Financial Times that the company anticipates its inaugural obesity drugs to hit the market much sooner than expected, potentially as early as 2028. The forthcoming offerings include a weight-loss injection slated for phase II trials and a pill that demonstrated a 6.1% weight reduction relative to a placebo over a four-week period. Following the acquisition of biotech firm Carmot last year for up to $3.1 billion, Roche is set to introduce several drugs under this deal, with details revealed for three key assets. Schinecker mentioned that the acquisition could yield approximately seven drugs, some still in early developmental stages. Last week's data publication regarding the pill caused Roche's stock to surge by 6% on that day, while impacting the shares of rival companies Novo Nordisk and Eli Lilly, raising concerns about Roche’s potential to challenge their market dominance. Analysts at Goldman Sachs have projected that the obesity drug market could exceed $130 billion by 2030, as various companies aim to launch their treatments. Despite this, Roche must bridge the gap with frontrunners who are developing more potent and effective treatments. For instance, Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro have led to 15% and 20% weight losses, respectively, in trials extending beyond a year. Other pharmaceutical firms, including Boehringer Ingelheim and Pfizer, are also in the race to develop obesity drugs, while US biotech Viking Therapeutics saw a 30% jump in shares after announcing progress to late-stage trials for its obesity pill. Schinecker highlighted that Roche’s pill is easier to scale up as it is synthetically produced, unlike the peptide-based drugs like those from Novo Nordisk. However, Emily Field from Barclays noted that it’s premature to determine if Roche can disrupt the advantage held by Novo and Lilly. Roche has recently streamlined its drug development pipeline, cutting 25% of underperforming drugs and focusing on a smaller selection of promising candidates, including those for obesity and Alzheimer’s diseases. This strategic shift allows for better allocation of resources towards more promising projects. Despite recent setbacks in research, including a failed lung cancer drug trial, Roche remains optimistic about its obesity drugs, potentially integrating them with other treatments for related conditions. Additionally, strong sales from other drugs like Vabysmo and Ocrevus have led Roche to upgrade its 2024 earnings forecast to the high single-digit range, up from the previously anticipated mid-single digit increase. FT, 30.7.24 #biopharma #insights

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Thoughtful commentary from my former Lumanity (Cello BioConsulting, Defined Health) colleague Joel Sandler, Ph.D. It will be very interesting to see how all this plays out in terms of therapeutic index, ease of use, manufacturing, and value (clinical benefit versus price) between CAR-T, cell engagers, cancer vaccines, next gen IO antibodies and maybe oncolytic viruses. #immunooncology #immunotherapy #cancer #oncology

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🌍 Despite global efforts, 1 billion people worldwide continue to suffer from neglected tropical diseases, including #schistosomiasis. We are pleased to share that Merck KGaA, Darmstadt, Germany and the Pediatric Praziquantel Consortium have reached a new important milestone in the fight against this disease. After the positive scientific opinion by the European Medicines Agency in December 2023, the new pediatric treatment option for children aged 3 months to 6 years has now been included into the World Health Organization’s List of Prequalified Medicines. This step brings the new medication closer to the young patients in needs as it supports its equitable and sustainable access, and its adoption in and by the countries where schistosomiasis is endemic. We continue driving health equity through our innovations and products. This program showcases our commitment to improve health and well-being of people, including the youngest patients living in low-income countries 👉 https://lnkd.in/d8H--wJa #HealthEquity #BeatNTDs #GlobalHealth

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🎗 𝗕𝗶𝗼𝗡𝗧𝗲𝗰𝗵'𝘀 𝗛𝟭 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗠𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲𝘀 📣 We are advancing our oncology pipeline with mRNA as the centerpiece of our toolbox. In the first half of 2024, we presented encouraging data from our investigational mRNA-based cancer therapies, including BNT111 and BNT122. Additionally, we have progressed the development of immunomodulatory candidates, such as BNT327, which we believe are well-suited for combination therapies. We have continued to execute our combination therapy strategy by successfully initiating a trial evaluating the antibody candidate BNT327 in combination with the investigational ADC BNT325. 🌟🧬 More news from H1/2024 in our PR (incl. forward-looking statements): https://lnkd.in/edJXDHc9 #BioNTech #mRNA #CancerTherapy #Oncology

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#News: Bayer and Evotec have updated the focus of their strategic collaboration to develop #precisiontreatments for #cardiovasculardiseases (CVDs). Financial terms were not disclosed.   The collaboration aims to identify and validate #noveltargets, with the goal of building a portfolio of precision #cardiologytherapeutics by leveraging #Evotec's disease modelling capabilities using human #inducedpluripotentstemcells (iPSCs). #iPSCs provide unique opportunities to identify new disease mechanisms and pathways for novel treatments. Under the terms of the agreement, both companies will contribute drug targets and a comprehensive set of high-quality technology platforms.   Bayer and Evotec will share responsibilities during the preclinical development of potential clinical candidates. Bayer will be responsible for any subsequent clinical development and commercialization.   “This development takes our long-standing collaboration with Evotec to a new level, and has the added benefit of lessons learned from working together the past 12 years,” said Juergen Eckhardt, M.D., Head of Business Development & Licensing at Bayer’s Pharmaceuticals Division. “We remain committed to develop innovative therapies for patients in need and to tackle the high burden of cardiovascular disease.”
 Read more from Contract Pharma 👇🏼

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𝐑𝐨𝐜𝐡𝐞 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝐈 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐂𝐓-𝟑𝟖𝟖 𝐢𝐧 𝐎𝐛𝐞𝐬𝐢𝐭𝐲 𝐚𝐧𝐝 𝐓𝐲𝐩𝐞 𝟐 𝐃𝐢𝐚𝐛𝐞𝐭𝐞𝐬 Roche (SIX: RO, ROG; OTCQX: RHHBY) Roche announced positive results from the Phase I trial of CT-388, a dual GLP-1/GIP receptor agonist for obesity and type 2 diabetes. A once-weekly injection of CT-388 over 24 weeks resulted in significant weight loss in obese adults compared to placebo. The mean placebo-adjusted weight loss was 18.8% (p < 0.001). At week 24, 100% of CT-388 treated participants lost >5% of their weight, 85% lost >10%, 70% lost >15%, and 45% lost >20%. The treatment was well tolerated, with mild to moderate gastrointestinal-related adverse events. “We are very pleased with the significant and clinically meaningful weight loss seen with CT-388,” said Levi Garraway, M.D., Ph.D. Levi Garraway, Roche’s Chief Medical Officer. “These results are highly encouraging for further development of CT-388 for obesity and type 2 diabetes, highlighting its potential as a best-in-class therapy.” Obesity, affecting over four billion people globally, poses significant health challenges, including type 2 diabetes, cardiovascular diseases, and chronic kidney disease. CT-388, an incretin-based medicine, aims to regulate blood sugar and reduce appetite by activating GLP-1 and GIP receptors. An additional cohort from the Phase I trial will evaluate CT-388 in obese patients with type 2 diabetes over 12 weeks, with results expected in the second half of 2024. #ClinicalTrials #Obesity #Type2Diabetes #Biotechnology #Pharmaceuticals #MedicalResearch #GLP1 #GIPReceptor #IncretinTherapy #HealthcareInnovation #WeightLoss #DiabetesManagement

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𝐑𝐨𝐜𝐡𝐞'𝐬 𝐂𝐓-𝟑𝟖𝟖 𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐬 𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐢𝐧 𝐎𝐛𝐞𝐬𝐢𝐭𝐲 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Roche has announced promising results from a Phase Ib trial of its dual GLP-1/GIP receptor agonist, CT-388, designed for treating obesity and type 2 diabetes. Over 24 weeks, participants receiving weekly CT-388 injections achieved a significant placebo-adjusted weight loss of 18.8%. Additionally, 100% of participants experienced over 5% weight loss, with 70% losing over 15% and 45% over 20%. The treatment also normalized glycemia in all pre-diabetic participants. CT-388 showed a favorable safety profile, with side effects consistent with its drug class. These findings highlight its potential as a leading therapy in obesity and glucose control. Further trials, including one focusing on obese patients with type 2 diabetes, are ongoing. Dr. Levi Garraway, Roche’s Chief Medical Officer, emphasized the significant and meaningful weight loss achieved, underlining CT-388's potential as a best-in-class therapy for obesity and diabetes. Given the global obesity crisis, affecting over four billion people and burdening healthcare systems, CT-388 could be a crucial development in addressing this urgent health challenge. CT-388 targets the GLP-1 and GIP receptors, which help regulate blood sugar and appetite. Its unique dual-targeting approach minimizes receptor desensitization, potentially leading to prolonged effectiveness. Roche plans to release further data from ongoing trials in the second half of 2024. With the obesity market projected to grow to $100 billion by 2030, CT-388 positions Roche as a strong competitor against Novo Nordisk and Eli Lilly. Further trials are ongoing, with additional data expected later this year. Source: Roche, Financial Times 16.5.24 #biopharma #insights #glp1 Roche's CT-388 Achieves Breakthrough in Obesity Treatment

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Rare diseases do not mean ‘rare’ symptoms to manage. For people living with generalized pustular psoriasis (#GPP) and their loved ones, the burden of the disease on their lives is tremendous, spreading across their entire lifetime. The CHMP positive opinion is another milestone for people living with GPP, offering continuous treatment to potentially help them prevent, as well as resolve debilitating flares.   GPP is a chronic and heterogenous disease, often leading to isolation and anxiety about future flares. The possibility of managing the condition, including stopping flares before they happen and reducing painful skin symptoms, means people living with the disease will have predictability and control in their lives.   I’d like to congratulate everyone involved – the Boehringer Ingelheim teams, scientists, healthcare professionals, and of course the GPP community, who inspire us every day in our pursuit of a flare-free future. This reiterates our commitment to address high unmet needs in rare diseases across therapy areas. #Dermatology https://lnkd.in/dfs5_HKf

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AbbVie breaks ground on a new central research building, “LUnA” (LUdwighafens neue Arbeitswelt) and is investing approximately €150 million in its second largest R&D location worldwide. A state-of-the-art research and laboratory building is being built on the main campus and will be home to more than 300 researchers and scientists. The facility will be built with modern and sustainable infrastructure features, creating flexible working conditions that enable greater scientific exchange between different areas of research and implement automation and digital research capabilities. “For AbbVie Germany, the new construction of our 'LUnA' research building is much more than a €150 million investment in cutting-edge infrastructure. It is a promise for the future of AbbVie science and innovation. We are creating attractive working conditions for our top scientists and attracting new talent so that we can conduct cutting-edge research at our site in the long term,” explains Martin Gastens, VP, biologics drug product development and managing director R&D, AbbVie Germany. "The German state of Rhineland-Palatinate is on track to become one of the leading hubs for biotechnology and life sciences. We support research, promote its translation, and continue expanding the footprint. As the Government of the Federal State of Rhineland-Palatinate, we are proud of this additional investment made by AbbVie, and the trust which yet another large pharmaceutical company has placed in our state." said Rhineland Palatinate’s Minister President Malu Dreyer. “Our Ludwigshafen site serves as a center of excellence for both research and development and pharmaceutical manufacturing and will play a critical role in AbbVie’s future growth,” said Azita Saleki-Gerhardt, Ph.D., executive vice president, chief operations officer. "This new expansion represents the proud continuation of our decades-long partnership with Germany – where we have invested approximately €250 million euros since 2020.” “LUnA will offer our researchers in Ludwigshafen the most modern working conditions and, thanks to its structure, will further strengthen scientific exchange between different areas of research,” explains Thomas Hudson, MD, senior vice president, global research, chief scientific officer, AbbVie. “I am particularly looking forward to seeing how we will further develop the future of laboratory automation and digital research in Ludwigshafen in our pursuit of discovering and developing breakthrough medicines for patients.” The groundbreaking ceremony was attended by distinguished guests including Rhineland Palatinate Minister President Malu Dreyer; Mario Brandenburg, Parliamentary State Secretary to the Federal Minister of Education and Research in Germany; Jutta Steinruck, Lord Mayor of the City of Ludwigshafen, as well as global AbbVie representatives. The research building is expected to be completed in 2027. #AbbVieGermany #research #innovation #AbbVie 👉 https://news.abbvie.com

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There is no denying that Europe is facing significant healthcare challenges – from an ageing population and a rise in chronic diseases, to health inequalities and low investment. Research has shown Europe is falling behind in attracting life sciences investment and suffers from inequity when it comes to delivering the end product – treatment innovations – to patients in a timely way. However, I firmly believe all is not lost and in the middle of these challenges lies opportunity. With the new EU Parliament term under way, we must continue to build the momentum towards a sustainable healthcare ecosystem that is fit for the future. Supporting pro-innovation policies that foster scientific research, smooth regulatory processes and access to medicines, is one key aspect. Another is transformative approaches to address public health literacy and combat misinformation within communities. For the greatest impact, the two must go hand-in-hand.  With this in mind, I was excited to see EFPIA - European Federation of Pharmaceutical Industries and Associationsissued a call to the new parliament to make the region a world-leader in life sciences once again. Possible solutions to help us take on these challenges include the creation of an EU Office for Life Sciences and a dedicated Competitiveness strategy for European Life Sciences. Consideration of these kinds of collaborative solutions are key to delivering the European healthcare system we all want to see. Over the next five year term I believe Europe can once again become a global leader in life sciences – driving economic growth and most importantly improved health outcomes for all. #LifeSciences #Equity

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In the pharmaceutical development's evolving landscape, medical affairs have never been more critical, especially with complex therapies needing complex clinical trials. By integrating robust data analytics and regulatory expertise, medical affairs professionals are best equipped to address the complexities of clinical trials, ensuring compliance and the integration of valuable patient insights from the outset. Integrating medical affairs from early development stages is crucial, as it optimizes trial design and patient recruitment while ensuring that trials reflect patient needs and real-world conditions more. Medical affairs' early involvement is essential to reshaping the drug development process, increasing efficiency and patient outcomes. https://lnkd.in/evQscsBi

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Roche has shared positive phase 3 results for its Columvi (glofitamab) in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   The STARGLO trial has been evaluating Columvi against rituximab, both in combination with gemcitabine plus oxaliplatin (GemOX), in DLBCL patients who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.   Affecting approximately 160,000 people worldwide every year, DLBCL is the most common form of non-Hodgkin lymphoma.   According to Roche, around 40% of people living with the condition will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.   The trial met its primary endpoint of overall survival (OS) after demonstrating that patients treated with Columvi plus GemOx lived significantly longer, showing a 41% reduction in the risk of death compared to rituximab in combination with GemOx, with the safety of the combination being consistent with the safety profiles of the individual medicines.   The Columvi combination also met its key secondary endpoint of progression-free survival (PFS), with a 63% reduction in risk of disease worsening or death versus rituximab plus GemOx.   In a follow-up analysis, the Columvi combination showed continued benefit in both primary and secondary endpoints, with a median OS of 25.5 months and 58.5% of patients experiencing complete response (CR), compared to 12.9 months and 25.3% in the rituximab combination group, respectively. Read more: https://lnkd.in/eNcn2wYH  Stay in touch with all the leading stories, events and opportunities by subscribing to our LinkedIn Newsletter:https://bit.ly/3RbdKtc or joining some of the largest groups most relevant to you: https://bit.ly/4caKquL (A-Z list)

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European regulatory authority adopts a positive opinion for an update of the Wegovy® label to reflect risk reduction of major adverse cardiovascular events Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with established cardiovascular disease (CVD) and either overweight or obesity (initial BMI ≥27 kg/m2) without diabetes.

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