Prevail InfoWorks’ Post

#News: BioNTech SE (22UAy.DE), and its partner Duality Biologics said on Monday they initiated a late-stage trial testing their #precisiondrug against a certain type of #breastcancer, taking on a rival partnership between AstraZeneca (AZN.L), and Daiichi Sankyo, Inc. Sankyo (4568.T). #COVID19 #vaccine maker #BioNTech, which is renewing its focus on its traditional roots in #oncology, said in a joint statement with China's Duality that their drug would be tested on women with a certain type of advanced breast cancer with low levels of a #cellsurfacereceptor known as #HER2. HER2 is a common mechanism of tumour growth that has been targeted by established drugs such as Roche's (ROG.S), #Herceptin. Partners Astra and Daiichi have taken the concept further with their leading drug #Enhertu, based on the #antibodydrugconjugate technology, a type of #highprecision #chemotherapy. That drug is expected by analysts to generate several billions of dollars in annual revenue, mainly because the drug has been approved to treat a larger population of HER2-type breast cancer patients to include women with low levels of the receptor. Read more from Reuters 👇🏼

Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADC Day One Biopharmaceuticals is offering MabCare Therapeutics up to $1.2 billion for exclusive licensing rights to an antibody drug conjugate (ADC) taking aim at solid tumors in both adults and kids. Day One has paid out $55 million upfront for development and commercialization rights to DAY301—originally known as MTX-13—excluding the Greater China area, where MabCare is based. In turn, MabCare has the chance to bank an additional $1.15 billion in development and commercial milestones, plus single-digit royalties. DAY301 is an ADC targeting protein-tyrosine kinase 7 (PTK7), which is overexpressed in esophageal, ovarian, lung and endometrial cancers among adults, as well as in neuroblastoma, rhabdomyosarcoma and osteosarcoma in children. https://lnkd.in/eAJKNKYJ

We look forward to disclosing first-in-patient clinical data at coming ASCO. CS5001 is antibody-drug conjugate (ADC) targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 is uniquely designed using LCB’s proprietary tumor-cleavable linker and pyrrolobenzodiazepine (PBD) prodrug. Only after enter the tumor cells, are the linker and prodrug cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. This double safety measure effectively reduces systemic toxicity associated with traditional PBD payloads, leading to a better safety profile and a larger therapeutic window.

BioNTech SE and Duality Biologics announced that their next-generation #endometrialcancer drug candidate received the #FDA's #BreakthroughTherapy designation. This crucial development, driven by positive Phase 1/2 study results, accelerates the drug's review process, offering hope to #endometrial #cancer patients. #BNT323/DB-1303 elicited an unconfirmed objective response rate of 58.8% and an unconfirmed disease control rate of 94.1% in 17 evaluable patients. https://lnkd.in/dtW4aEyu

Genmab to Acquire ProfoundBio for $1.8 Billion Danish #drugmaker Genmab has agreed to buy privately-owned US #biotechnology company ProfoundBio for $1.8 billion. ProfoundBio develops novel ADCs and ADC technologies for the treatment of certain cancers, including ovarian #cancer and other FRα-expressing solid tumors. With the transaction, Genmab will broaden its mid- to late-stage clinical pipeline and complement its suite of proprietary technology platforms, the company said. The #acquisition will give Genmab worldwide rights to ProfoundBio’s ADC portfolio, which consists of three clinical and multiple preclinical programs including Rina-S, a potential best-in-class, clinical-stage, FRα-targeted, Topo1 ADC, currently in Phase 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FRα-expressing solid tumors. In addition, Genmab expects the combination of ProfoundBio's novel ADC technology platforms with its proprietary antibody platforms to create new opportunities for the generation and development of novel anti-cancer drugs. Read more on #CMI online: https://lnkd.in/eF_SDMg4

The treatment landscape of Head and Neck Cancer (HNC) is expected to undergo a positive shift in the coming years. The emerging pipeline for HNC patients consists of various early-stage drugs and late-stage drugs. While the American Society of Clinical Oncology (ASCO) 2023 annual meeting is close, pharma and biotech giants, namely Merck Group, Innovent Biologics, Shanghai Junshi Biosciences Co Ltd, and others are looking at this opportunity to present their data readouts for different cancers, including Head and Neck Cancer. Visit to take a look at the key abstracts set to be presented at the conference by major pharma and biotech giants: https://lnkd.in/d59QWrBn #ASCO23 #MedicalConference #conference2023 #asco23 #clinicaltrials #clinicalresearch #healthcare #business #cancertherapy #cancercommunity #asco2023 #pharma #pharmaceutical #CancerResearch #Oncology #headandneck #headandneckcancer

VVD-214/RO7589831: A Covalent Allosteric WRN Helicase Inhibitor Stemming from Chemoproteomics Screening | https://lnkd.in/gx362NyS With Vividion Therapeutics, Inc. and Novartis publishing back-to-back articles today in Nature Portfolio on their respective WRN programs, targeting WRN is clearly a hot pursuit! VVD-214/RO7589831 is an oral covalent, reversible, and allosteric inhibitor of WRN helicase discovered by the San Diego-based biotech Vividion Therapeutics, Inc. and being developed by Roche, for tumors marked by microsatellite instability (MSI) and/or mismatch repair deficiency (dMMR). WRN has emerged as a synthetic lethal target in cancers exhibiting MSI. Despite the use of immune checkpoint inhibitors as a therapeutic option for MSI tumors, such as anti-PD1, anti-CTLA4 monotherapies, and combination therapies, treatment resistance remains a significant challenge. Vividion Therapeutics, Inc. has utilized its trailblazing chemoproteomics platform to discover and develop novel treatment options for oncology targets, including VVD-214 which is currently being evaluated in a Ph. I trial in subjects with advanced solid tumors marked by MSI and/or dMMR. The structure and initial preclinical pharmacology data of WRN helicase inhibitor VVD-214 were recently disclosed at the New Drugs on the Horizon session at the AACR Annual Meeting 2024 in San Diego and published today in Nature Portfolio. This article highlights the discovery of VVD-214, its preclinical pharmacology, WRN as a hot synthetic lethal target, and Vividion Therapeutics, Inc.'s chemoproteomics platform workflow. Article | https://lnkd.in/gx362NyS

𝐁𝐢𝐨𝐂𝐢𝐭𝐲 𝐚𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐭𝐡𝐞 𝐟𝐢𝐫𝐬𝐭 𝐩𝐚𝐭𝐢𝐞𝐧𝐭 𝐝𝐨𝐬𝐞𝐝 𝐰𝐢𝐭𝐡 𝐢𝐭𝐬 𝐟𝐢𝐫𝐬𝐭-𝐢𝐧-𝐜𝐥𝐚𝐬𝐬 𝐂𝐃𝐇𝟑-𝐭𝐚𝐫𝐠𝐞𝐭𝐢𝐧𝐠 𝐀𝐃𝐂 𝐁𝐂𝟑𝟏𝟗𝟓 𝐢𝐧 𝐚 𝐏𝐡𝐚𝐬𝐞 𝟏 𝐓𝐫𝐢𝐚𝐥 BioCity Biopharma, a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders, today announced the dosing of the first patient in a Phase 1a/1b clinical trial of its first-in-class CDH3 antibody drug conjugate (ADC), BC3195 in China. The study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BC3195 in patients with locally advanced or metastatic solid tumors. BC3195 is a novel ADC targeting CDH3/P-cadherin, a calcium-dependent cell-cell adhesion glycoprotein highly expressed in a variety of malignancies, including lung, breast, gastric, ovarian, colorectal, and pancreatic cancers. CDH3 expression is low or undetectable in normal tissues, making it an ideal target for anticancer therapies, particularly ADCs. Currently, BC3195 is the only ADC targeting CDH3 in clinical development globally. In preclinical studies, BC3195 binds to cell surface CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted tumor cells as well as surrounding cells which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and strong antitumor activity with tumor growth inhibition of ≥100%. In addition to clinical trials being conducted in China, BC3195 has an active US IND. BioCity Biopharma expects to obtain preliminary clinical data on BC3195 by the end of 2023 from clinical trials in China as well as in the US. #clinicaltrials #cdh3 #healthcare #biopharmaceutical #therapeutic #treatment #china #antibody #cancer

Day One Biopharmaceuticals has entered into a $1.2 billion agreement with MabCare Therapeutics, a Chinese biotech from Shanghai, for the exclusive rights to DAY301, an innovative antibody-drug conjugate (ADC) targeting solid tumors. Key highlights: • Upfront Payment: $55 million • Potential Milestones: $1.15 billion • Royalties: Single-digit Having achieved FDA investigational approval, Day One is advancing towards phase 1 clinical trials. DAY301, originally known as MTX-13, targets PTK7, a highly conserved protein overexpressed in numerous adult and pediatric cancers, including esophageal, ovarian, lung, endometrial, neuroblastoma, rhabdomyosarcoma, and osteosarcoma. Unlike other ADCs, DAY301 focuses on PTK7, offering a unique approach. With the ADC field heating up, it will be interesting to see what impact DAY301 will have in this competitive landscape… This deal, which excludes Greater China for development and commercialization rights, comes amid the proposed BIOSECURE Act’s efforts to limit U.S.-China biotech collaborations by reducing dependency on Chinese firms due to national security concerns, raising the question: with this looming threat, will similar partnerships soon become impossible?

📢 FDA issued CRLs to Regeneron for odronextamab BLA in r/r follicular lymphoma & in r/r diffuse large B-cell lymphoma ➤ The only approvability issue is related to the enrollment status of the confirmatory trials. CRLs did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing ➤ Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program. CRLs indicate that the confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission ➤ CRLs underscore FDA policy to have confirmatory trials be up and running (at a minimum) in order for FDA to proceed to an accelerated approval. This evolution in Agency thinking is more akin to European CMA requirements and carries significant impact to any sponsors pursing an accelerated approval strategy. #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent #lymphoma https://lnkd.in/gzKanBTh