Prelude Therapeutics的动态

My favorite oncology and hematology news of the week: ? Merck & Co released the unfortunate, but not surprising, news that its TIGIT asset, vibostolimab, is failing in resected high-risk melanoma and this particular clinical program will be discontinued. Vibostolimab joins a long list of TIGIT failed trials. https://lnkd.in/ezfRVdzY ? Novo Nordisk ($NVO) to submit NDA later in 2024 for its factor IX/X bispecific Mim8 (denecimig). The Phase III FRONTIER 2 trial showed great results in prophylaxis of hemophilia A patients older than 12. Competition with first-to-market Hemlibra is expected to be tough and in the absence of a head-to-head comparison neither drug can claim superior efficacy. https://lnkd.in/ekBE8gwK ?? It is no surprise that emotional distress was found to affect the response to immune checkpoint inhibitors in NSCLC. I cannot imagine having lung cancer and not being under very high emotional distress... The authors did a good job of balancing variables but potential confounders were stage and metastases.https://tinyurl.com/y42wa48m ? Amgen's Imdelltra (tarlatamab) became the first BiTe approved for lung cancer. The FDA awarded accelerated approval for 2L+ SCLC based on a 40% response rate seen in the DeLLphi-301 trial. https://lnkd.in/eX6mmZim

Congratulations to BeiGene for the FDA approval of Tevimbra (tislelizumab) to treat advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody (mAb) which minimizes binding to macrophage Fcγ receptors, thus facilitating the patient’s immune cells to recognize and fight tumors. Esophageal cancer is the sixth most common cause of cancer fatalities in the world, with over two-thirds of patients having advanced or metastatic disease at the time of diagnosis. Several clinical trials have taken place for use as both a monotherapy and in combination with other regimens, and over 750,000 individuals prescribed. ? Read the press release here: https://lnkd.in/djDr4xyY ? #Biointron #Antibodies #Immunotherapy #PharmaNews #FDA #Oncology

#pancreaticcancer #clinicalendpoint #drugefficacy #ctdna #liquidbiopsy An interesting partnership between Lisata Therapeutics, Inc. and Haystack Oncology, a Quest Diagnostics company, to evaluate the efficacy of a new drug in clinical trial. The MRD (minimal residual disease) test, developped by Haystack Oncology, "will be used to detect circulating tumour DNA (ctDNA) in a clinical study evaluating a Lisata's drug (certepetide) in patients with metastatic pancreatic cancer. The serum ctDNA levels will be measured at multiple points and will be used as an exploratory endpoint to assess the therapeutic effect of certepetide". Information published by Medical Device Network https://lnkd.in/dkm3BsbA

Dr. Abdul Moiz Khan, Dr. Inas Abuali, Dr. Hannah Abrams, Dr. Ivy Raino, and Dr. Pauline Funchain cover the 2023 Precision Oncology Summit's discussion on Tumor-Agnostic FDA Approvals and Melanoma as a Paradigm for Precision Immuno-Oncology in their recent article. According to their review, "The issues encountered in the development of [tumor agnostic drugs] are unique, and novel trial designs, such as basket trials, may provide optimal setting of testing these drugs." They also emphasize in the case of adjuvant pembrolizumab stage II melanoma, whose recurrence free survival cannot be identified based on traditional subgroup analysis, that "This is where genomic markers such as tumor mutational burden (TMB) and neo-antigen load have a value as they correlate with the response to immunotherapy." Find out more about the data behind these discoveries by clicking the link here ? https://lnkd.in/gCxnGiPU

The 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) was held in Chicago from May 31 - June 4, 2024. Overall ASCO was perhaps the year in which the dominant theme moved on from IO (Immuno-oncology)?to ADCs (Antibody-Drug Conjugates). Here are some notes from my side: - “Antibody Drug-Conjugates: Does Target Expression Matter?” that is: target expression matters, but may not be clinically relevant and when it matters depends on type of ADC, target histology, and availability of treatment options. - TROP-2 ADCs are likely to be preferred in EGFR wild type NSCLC due to the relatively high response rate observed in all comers, KOLs at ASCO made an argument for continued development of AbbVie’s Teliso-V (c-MET, MMAE payload). - In the P3 trial for Nivolumab in combination with human cytotoxic T-lymphocyte antigen 4 as a first line therapy for liver cancer (hepatocellular carcinoma), the Checkmate 9DW trial demonstrated superiority over standard treatments Lenvatinib and Sorafenib. - Eli Lilly's Abemaciclib, a CDK4/6 inhibitor and a rival to Ribociclib, seeks a bigger share of the market as a second line therapy in combination with endocrine therapy to improve PFS for patients with HR+/HER2 breast cancer. - Osimertinib data in the Phase 3 LAURA trial (unresectable, Stage III EGFRm NSCLC) in which the drug demonstrated a highly positive PFS bene?t - The oral presentation on petosemtamab in 1L r/m HNSCC grabbed all the attention. - The poster on acasunlimab's phase 2 in NSCLC - BioNTech's PM8002 - The presentation on the HB200

Amgen's tarlatamab-dlle, a CD3xDLL3 bispecific, received FDA accelerated approval for extensive-stage small cell lung cancer. This breakthrough marks the first T cell engager for solid tumors, a field where CAR-T cell therapy is still struggling. This success also represents a resurgence for the DLL3 target. AbbVie has dumped its DLL3 targeting ADC drug Rova-T after several trial failures. By the way, our society's official journal, Antibody Therapeutics (2022 CiteScore: 6.4) calls papers regarding Cell Therapies and Cell Engagers against Cancer. The deadline for the submission is December 24, 2024. You are welcome to know more details via the following website. https://lnkd.in/esh6_s2h #bispecific #antibody #mab #tcellengager #antibody #antibodies #lungcancer #oncology

I read today that AstraZeneca and Daiichi Sankyo's Enhertu has achieved FDA clearance as the first tumor-agnostic HER2-directed ADC approved for treating HER2-positive solid tumors, regardless of their anatomical location. While this is great news for a broader patient population, and particularly patients with unresectable or metastatic HER2-positive solid tumors who now have a second treatment option, this is approval is also representative of a paradigm shift - using a biomarker like HER2 instead of tissue type to guide the use of a targeted cancer therapy. It exemplifies a change we all believe in - of more personalized medicinal approach in oncology. Enhertu's accelerated approval underscores both the demand for innovative oncology therapies and the urgent need to expedite access to promising treatments for patients. It's a trend that gives us at #Fareva more opportunities to leverage our expertise with increasingly potent cytotoxic payloads and exciting new ADC projects in our sterile manufacturing spaces. Congratulations to the dedicated teams at AstraZeneca and Daiichi Sankyo. In the trendy, arguably oversaturated ADC space, Enhertu is truly a standout product. ?? #ADC #antibodydrugconjugates #enhertu #astrazeneca #daiichisankyo #averyrants #cytotoxic #HER2 #deruxtecan #sterilemanufacturing #CDMO https://lnkd.in/gqeaywtR

Discover the challenges and hopes of small molecule immuno-oncology therapies with insights from Dr Allan Jordan, Sygnature's VP of Oncology Drug Discovery on: ?? Challenges faced by small molecule immuno-oncology therapies targeting IDO, TDO, and A2a receptors in clinical trials. ?? Renewed hope with promising early trial data for STING pathway agonists, HPK-1 inhibitors, and Cbl-B inhibitors. ?? How success in small molecule immuno-oncology relies on clinical data, patient stratification, and understanding the tumour microenvironment. Read more in our latest blog: https://lnkd.in/eiqugsRk #smallmolecule #immunooncology #drugdiscovery

Personalised cell therapies in oncology hold the potential to make cancer treatment more effective and with fewer side effects. They enable patients to be treated individually, targeting their specific cancer. However, developing a personalised medicine, such as a BCMA-targeted CAR-T cell therapy, can require extensive training, preparation and certification. Read this Q&A with Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine, on European Pharmaceutical Review to learn about the major benefits and current challenges of CAR-T cell therapies: https://lnkd.in/ginskib2 #Oncology #PersonalisedMedicines #CellTherapies #ExecutiveSearch

Cervical Cancer Breakthrough: FDA Fully Approves TIVDAK? for Treatment Pfizer and Genmab have received full approval from the FDA for their antibody-drug conjugate, TIVDAK, for the treatment of recurrent or metastatic cervical cancer. The approval was based on positive results from a Phase 3 clinical trial, which showed a clear overall survival benefit compared to traditional chemotherapy. TIVDAK is the first antibody-drug conjugate to statistically significantly extend overall survival for patients with cervical cancer. The approval is expected to influence further research and development in the field of cervical cancer treatment. Safety precautions include warnings for ocular toxicity and other adverse reactions. The approval is a significant step forward in addressing the high unmet medical needs in cervical cancer treatment. For more details please click the link! https://lnkd.in/ds_-ZJnH #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical