Genentech's decision to terminate its partnership with Nykode Therapeutics on the VB10.NEO individualized cancer vaccine has left many in the industry surprised. While Nykode assures that the decision isn’t tied to the program's performance, it raises broader questions about portfolio prioritization and the future of personalized cancer vaccines. Insights and Impact ? - The termination reflects shifting priorities within Genentech and its broader portfolio management strategy, as seen with its recent consolidation of cancer research departments.?? - Personalized cancer vaccines remain a promising frontier, and Nykode is optimistic about finding new partners to advance VB10.NEO.?? - With the ongoing focus on mRNA vaccines, as seen in Genentech’s work with BioNTech, the field of individualized therapies continues to evolve rapidly.? Questions to Consider ? - How will this termination affect confidence in the viability of individualized cancer vaccine programs??? - What new collaborations or funding strategies might emerge to support VB10.NEO’s development??? - Could this signal a broader industry shift in how pharma prioritizes its oncology pipeline investments?? #CancerResearch #OncologyInnovation #PersonalizedMedicine #CancerVaccines #BiotechNews #Genentech #NykodeTherapeutics #Immunotherapy #PrecisionMedicine
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It’s an exciting time to be apart of Personalised Cancer Vaccine Drug Development as biopharma surge through pre-clinical / clinical trials, working to bring safe and efficacious individualised cancer vaccines to patients faster. See some recent highlights: ?? CureVac’s CVGBM Cancer Vaccine induced promising immune responses in Phase 1 study in Glioblastoma. ?? NEC Bio Therapeutics GmbH and AGC Biologics announced a partnership to advance the production of NECVAX-NEO1, an orally delivered, bacteria-based DNA vaccine designed to target patient-specific tumour antigens. ?? Imvax, Inc.’s leading candidate, IGV-001 for GBM is progressing into a Phase 2b trail after showing promising results in earlier phases. ?? Nykode Therapeutics’s VB10.16, a therapeutic cancer targeting HPV16, is undergoing clinical trials for several cancer types and they are also collaborating with Genentech to develop personalised cancer vaccines. You can hear first-hand from… CureVac: Dr. Myriam Mendila - CSO & Head of R&D NEC Bio Therapeutics: Heinz Lubenau - CEO Imvax: Mark A. Exley - CSO Nykode Therapeutics: Agnete Fredriksen - CSO …at our Personalised Cancer Vaccine Summit taking place in Boston this December. Uniting 60+ KOL’s in the space, you can network with and learn from the leaders in biopharma developing individualised cancer immunotherapy, allowing you to benchmark against your competitors and stay ahead of the curve. NOTE: Discounts of up to $600 on conference passes are only available until next Friday (11th Oct). #personalisedcancervaccine #individualisedimmunotherapy #immunooncology #cancervaccine #biopharma
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The article from the newsletter "MetaphysicalCells" provides an update on the progress of various companies in AI-powered drug discovery, highlighting key advancements and collaborations in the field. Key Companies and Updates: 1910 Genetics: Integrates AI with data streams to develop novel drug candidates. Announced collaboration with Microsoft’s Azure Quantum Elements to enhance their AI-driven drug discovery platform. Working on TYK2 inhibitors for various diseases. Seismic Therapeutics: Uses the IMPACT platform to optimize protein sequences. Announced an antibody license agreement with Integral Molecular and participation in upcoming scientific conferences. Focused on novel therapeutics for autoimmune diseases. AbCellera: Specializes in AI-powered antibody discovery. Signed collaborations with Prelude Therapeutics, Biogen, and others. Focused on T-cell engager programs for cancer therapy and other areas. BioXcel Therapeutics: Utilizes AI to find applications for existing drugs. Leading product IGALMI? treats agitation in schizophrenia and bipolar disorder. Involved in various clinical trials and has received significant funding for growth. Sinopia Biosciences: Focuses on metabolomics for data-driven drug discovery. Announced a lead clinical candidate for Parkinson’s disease. Received SBIR grant for oncology and immunology applications. RubrYc Therapeutics: Acquired by iBio, which uses AI to design better antibody drug candidates. Focused on immuno-oncology candidates and has new partnerships and acquisitions. Numedii: Uses big data to discover and de-risk new drug indications. Partnered with a drug delivery company for ulcerative colitis therapeutics. Envisagenics: AI-driven technology for RNA therapeutics discovery. Focused on breast cancer and other preclinical programs. Raised significant funding and announced new partnerships. Gritstone Bio: Develops tumor-specific cancer immunotherapies. Faced challenges with a personalized cancer vaccine trial. Continues to develop vaccines for solid tumors and HIV. Generate Biomedicines: Uses ML algorithms to generate novel protein sequences. Collaborates with Amgen and secured substantial funding. Developing programs in oncology and immunology. Biolojic Design: Creates AI-designed antibodies acting as functional switches. Partnered with Merck KGaA for multi-target drug discovery. Evaxion Biotech: Develops immunotherapies for cancer and infectious diseases using AI. Announced collaborations with MSD and presented data at ASCO. Focused on personalized cancer vaccines and has raised considerable funds. Additional News: CytoReason, Living Cell Technologies, BluMaiden, and Insilico Medicine announced significant advancements in AI drug discovery and funding.?https://lnkd.in/eDHSgMuu
AI-powered drug discovery: update (V)
marinatalamanou.substack.com
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Revolutionizing cancer treatment: the FDA embraces the future. ?? At the cutting edge of oncology, innovative cancer vaccines are moving from the realm of science fiction to clinical reality. Take Moderna and Merck's collaborative effort on mRNA-4157—an individualized vaccine forged by AI, set to rewrite oncology rulebooks. While the novel technology poses fresh regulatory challenges, the FDA declares readiness to tackle this uncharted territory. Peter Marks, championing the regulatory charge, affirms their position at the World Vaccine Congress. "We're open for business," he states, as we stand on the precipice of a new therapeutic era. Marks draws parallels between reviewing these vaccines and the established processes for CAR-T cell therapies, suggesting a path through the regulatory maze. But with AI at the helm, defining the next steps is complex. The confounding questions around how AI modifications may redefine products loom large, yet the FDA signals a willingness to adapt, to innovate. The FDA's flexibility finds its nexus in a potentially transformative 'platform technology' concept. Products sharing a technological backbone could see streamlined reviews, propelling them through the approval process with newfound efficiency. This readiness to evolve, to accommodate the rapid advancements in medical technology, is pivotal. With cancer vaccines like mRNA-4157 on the horizon, an FDA signal that they are equipped to face the future of cancer care head-on. #CancerVaccine #FDA #InnovationInOncology
'We're open for business': FDA's Peter Marks says agency ready to review novel cancer vaccines despite unknowns
fiercebiotech.com
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???? Longtime Exec email reveals new partnership data for Merck & Moderna's Keytruda cancer vaccine combo ??? It all starts with an encrypted email... In an encrypted email shared with BioSpace, a longtime biopharma executive made a compelling case for Moderna to sell its share of the investigational personalized cancer vaccine, mRNA-4157 (V940), to Merck. This novel mRNA-based therapy is currently being developed in a 50/50 partnership between the two companies, combined with Merck’s blockbuster cancer drug, Keytruda. Key Points: ?? mRNA-4157 (V940): An mRNA-based individualized neoantigen therapy developed jointly by Merck and Moderna. This innovative treatment is designed to trigger an immune response against cancer cells. ?? Current Collaboration: Merck and Moderna share development costs and potential profits equally. ?? Email Proposal: The anonymous email argues that selling Moderna’s share to Merck is a fiduciary responsibility to shareholders, given the potential market value and Merck’s upcoming patent cliff for Keytruda. ?? Merck’s Patent Cliff: Keytruda, which generated $25 billion in sales in 2023, will lose exclusivity in 2028, potentially causing a significant drop in revenue. The email suggests that the combination therapy could help Merck mitigate these future losses. ?? Financial Implications: Analysts agree that such a transaction could benefit both companies but note the complexities involved. For Moderna, selling its share could significantly boost its market cap and provide necessary funds for its other pipeline programs. ?? Market Potential: The vaccine has shown promising Phase II results, reducing the risk of death in melanoma patients by 49% compared to Keytruda alone. It is moving into Phase III trials for melanoma and non-small cell lung cancer. Analysts’ Views: ?? Hartaj S. believes the proposal is logical and could be beneficial, depending on Merck’s offer. ?? Myles Minter sees potential but notes that the commercial incentive for Merck might not be clear-cut without further data. The email’s author argues that a deal is a win-win for Merck, Moderna, and patients, emphasizing the urgency of making a meaningful deal before Keytruda’s patent cliff. The situation is evolving, and whether Merck and Moderna will take this step remains to be seen. For now, the collaboration continues to hold promise for advancing cancer treatment through innovative mRNA technology. Source : BioSpace ?? If you found this insightful, don’t forget to like and share! ——— I am Alexis - French pharmacist turned entrepreneur. My company BTHT is connecting senior industry experts, ex-payors, and KOLs with consultants and investors in Life Sciences and Healthcare for expert calls and senior advisory. ?? For more content like this Join 14K+ followers by clicking my name + follow ?? Join 1.3K+ subscribers to my newsletter ??
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WHAT IS A VACCINE, EXACTLY? WHY IS THIS CALLED: "VACCINE?" Adding Moderna’s in-development cancer vaccine to a standard treatment for melanoma dramatically reduces cancer survivors’ risk of death or recurrence, according to newly shared trial data. ... The challenge: To treat melanoma — the deadliest type of skin cancer — doctors typically start by surgically removing as much of the cancer as possible. They might then administer another treatment, such as chemo or radiation therapy, to kill any cancer cells they missed. (article attached) ... #vaccine #biomed #biotechnology #medicine #pharmaceutical #pharmacology #noderna.
Moderna’s mRNA cancer vaccine works even better than thought
freethink.com
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Could cancer vaccines be the next big breakthrough in immunotherapy? According to experts, these vaccines could be even more powerful than other immunotherapies and may even provide a preventative measure against certain malignancies. While the first therapeutic cancer vaccine was approved over a decade ago, interest in the space is growing as certain candidates enter late-stage clinical trials. Large pharma companies continue to focus on oncology R&D, with immunotherapies quickly becoming some of the best-selling products on the market. Scot Ebbinghaus, VP of Clinical Research at Merck, which is developing mRNA-4157/V940 in partnership with Moderna, notes that "it's definitely a competitive area," but competition is ultimately a good thing for patients. It makes companies work harder and smarter, as they carefully examine what their competitors are doing. Stay tuned as we continue to follow this exciting area of cancer research and its potential impact on patient outcomes. #cancervaccines #immunotherapy #oncologyresearch
Could Cancer Vaccines Be the Next Big Breakthrough in Immunotherapy? | BioSpace
biospace.com
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A Complete Guide of " ???????????? ?????????????????????????? ???????? ?????????????????? ?????????????????????? " [ PDF Guide ] ?????? ???????? ?????????? ???? ?????????????? ?????????????????? | ???????????????? ?????? ???????????? ?????????? ???? ???????? : ?https://lnkd.in/g2dwGYih This growth is due to rising awareness regarding cancer immunotherapy among physicians and patients, increasing investment by?#biotechnology?and pharmaceutical companies to develop cancer treatment, and the increasing prevalence of cancer globally. In addition, there is increasing interest in immunotherapies by pharmaceutical companies as they reduce the risk of cancer and show a reduction in tumor recurrence post-chemotherapy. Moreover, COVID-19 impacted all clinical trial studies however, cancer clinical research was the least impacted owing to the severity of these studies. ? The government announced a stay-at-home order to prevent the COVID-19 pandemic that caused disruption and restricted cancer testing and diagnosis, which led to a steep slowdown in referral and treatment for cancer immunotherapies. However, in the second half of 2020, due to the rising prevalence of cancer among people, drug discovery for its treatment started. According to ClinicalTrials.gov, the number of oncology clinical trials stopped in May 2020. However, from November 2020, the stopped clinical trials also resumed, and the COVID-19 vaccine rollout has not affected the trend. Among the elements promoting the expansion of clinical research firms is expertise in creating medications in particular therapeutic areas and performing?#clinicaltrials?in different geographic regions. Outsourced research tasks help maximize the resources and time used in the process. New leads are entering the market for cancer immunotherapy drug discovery outsourcing more quickly due to increased R&D initiatives. Launching advanced therapeutic options such as oncolytic viral therapies, cancer vaccines, HDAC inhibitors, and monoclonal antibodies are expected to create a future potential market. The market for cancer immunotherapy drug discovery outsourcing is growing due to fewer side effects, increased efficacy, and rising demand for the products. The rising investment in R&D by key players in cancer immunotherapy is one of the strategic initiatives adopted. Furthermore, there is an increasing focus on testing therapeutic options such as checkpoint inhibitors, tumor-infiltrating lymphocytes (TILs),?#immunomodulators, and chimeric antigen receptor (CAR) T-cell therapies for enhanced efficacy. This, in turn, is hindering the growth of the market.
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FDA review of?CANCER VACCINES using artificial intelligence (AI)???? For Moderna and Merck’s mRNA candidate mRNA-4157, AI dictates how the individualized vaccine should be formulated to attack cancer. The platform sequences a patient’s tumor and healthy tissue and then uses AI to capture the most relevant tumor-specific mutational signatures. Neoantigens identified this way form the basis of the vaccine construct, and the resulting proteins can be very different between individuals. The goal is to induce an immune response against tumors bearing those biomarkers. #cancer #alltimm
As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccine czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite unknowns.
'We're open for business': FDA's Peter Marks says agency ready to review novel cancer vaccines despite unknowns
fiercebiotech.com
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Diakonos Oncology?CFO?Anthony Baldor is at?#BIO24?this week to make a company presentation and meet with potential partners and investors. For those interested in learning more about Diakonos’ unique dendritic cell vaccines for cancer, we can be reached through the BIO ONE Partnering System. Mr. Baldor’s?company presentation takes place on Tuesday, June 4th at 3:00 pm PT?in Company Presentation Theater 2 at the San Diego Convention Center.?Mr. Baldor’s presentation will include a review of Diakonos’ highly differentiated double-loaded autologous dendritic cell vaccines for cancer, and an operational update on the company’s plans for growth, including clinical development outlook and expansion of its leadership team. Diakonos recently completed a Phase 1 trial of DOC1021, its lead vaccine for glioblastoma multiforme (GBM), and is planning a Phase 2 study. The US Food and Drug Administration has granted Fast Track and Orphan Drug status for DOC1021. Two other clinical trials are under way with dendritic cell vaccines targeting pancreatic cancer and angiosarcoma. “We are very excited about the results of our Phase 1 trial for GBM,” Mr. Baldor said. “Data observed to date give us great confidence in our dendritic cell vaccines and their potential to treat a broad range of solid tumor cancers, including the most deadly. Twelve month survival is currently at 90% for evaluable patients, and the therapy is well tolerated.” Diakonos’ dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that better harness a patient's immune system to target and eliminate cancer cells by initiating a natural immune response. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs when compared to leading cell therapy approaches. Visit our we?site:?diakonosoncology.com?to learn more. #cancerresearch #cancer #biopharma #clinicaltrials https://lnkd.in/dET5pqbD
Diakonos Oncology CFO Anthony Baldor to Provide Corporate Update at BIO International Convention In San Diego, June 3 - 6, 2024 - Diakonos
https://www.diakonosoncology.com
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Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy The company is paying China-based biotech LaNova Medicines $588 million for the same type of bispecific antibody drug that recently bested Keytruda in a clinical trial. Merck & Co. has bought into the kind of drug that has emerged as a top threat to its dominant cancer immunotherapy Keytruda. The company said Thursday it agreed to pay privately-held LaNova Medicines $588 million in cash for?worldwide rights to a cancer therapy called LM-299,?which is currently in Phase 1 testing in China. LaNova, which is based in Shanghai, could receive up to $2.7 billion in additional payments should the drug hit various development and sales milestones across multiple indications. The deal makes Merck the latest company to acquire a type of dual-pronged cancer immunotherapy that’s fast become a top target of drugmakers. These so-called bispecific therapies simultaneously home in on the proteins PD-1 and VEGF, which help tumors grow and evade detection from the immune system.? This year, one such drug, ivonescimab, from China-based Akeso and development partner Summit Therapeutics,?bested Merck’s Keytruda in a late-stage trial in lung cancer?— the first time that’s happened since Keytruda’s arrival a decade ago. Though the results came with notable limitations and are unlikely to support a U.S. approval, since then, an array of drugmakers have either?acquired?PD-1 and VEGF-targeting bispecifics or?built?new companies?around them. Just yesterday,?BioNTech agreed to pay $800 million?to buy biotech Biotheus, giving it a PD-1 and VEGF drug the companies have been co-developing. https://lnkd.in/eDMPzTiS
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