The Antibody Society’s Post

Featured highlights from today's Efortless Update: [Clinical Trials] 07/18 「AVEO Oncology's phase 3 Trial of TiNivo-2 Fails Primary Endpoint in Advanced RCC, Provides Efficacy at Standard Monotherapy Dose 」 07/18 「Alkeus Pharmaceuticals, Inc. shares interim TEASE-3 study data at the 42nd American Society of Retina Specialists Meeting」 07/18 「Abliva AB's FALCON Study Continues with KL1333 for Primary Mitochondrial Disease; Market Advancement Expected in 2024」 [Deals] 07/18 「Meitheal Pharmaceuticals, Inc. Pharmaceuticals Acquires North American Rights for CONTEPO from Nabriva Therapeutics plc, Gearing Towards Antibiotic Development」 07/18 「ME Therapeutics and NanoVation Therapeutics™ collaborate on mRNA-based drug trials using LNP technologies under a new material transfer agreement」 [Regulatory] 07/19 「EMA accepts marketing authorisation application for GSK's Blenrep for relapsed or refractory multiple myeloma treatment based on DREAMM-7 and DREAMM-8 trial results」 07/19 「Bristol Myers Squibb's Opdivo and Yervoy treatment for hepatocellular carcinoma validated by EMA for review based on CheckMate - 9DW trial results」 same day : ( ↑ NYSE: BMY | +0.5% ) 07/19 「ONO PHARMACEUTICAL CO., LTD. submits marketing authorization application to EMA for cancer therapy vimseltinib after MOTION phase 3 study results」 View the full newsletter contents for free via the link in the comments.

Innovent Biologics Announces Primary Endpoint Met in the Phase 3 Clinical Trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in Treating Thyroid Eye Disease and Plans to Submit NDA to the NMPA. RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye (the percentage of subjects with a reduction in proptosis of ≥2 mm from baseline in the study eye without deterioration ≥ 2 mm increase of proptosis in the fellow eye) was significantly higher in subjects treated with IBI311 than in subjects treated with placebo: 85.8% vs. 3.8%, with a difference of 81.9% (95% CI: 69.8% to 93.9%, P < 0.0001). https://lnkd.in/ezBNneM6

Garadacimab is now in regulatory review in both US and EU! CSL today announced the FDA has accepted the company's BLA for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the EMA has accepted the submission for CSL's MAA for garadacimab. Garadacimab is a recombinant monoclonal antibody targeting activated FXII (FXIIa), a plasma protein that initiates the kallikrein-kinin cascade of HAE attacks. Regulatory submissions are supported by data from the pivotal, multicenter, randomized, double-blind, parallel-group VANGUARD trial, which evaluated the efficacy and safety of garadacimab as a prophylactic treatment for patients with HAE. Results from VANGUARD were published in The Lancet in April 2023. If approved, it would become the first treatment for HAE in the U.S. and EU to target FXIIa. In addition, patients will have the benefit of an auto injector (pre-filled pen) for convenient administration. https://lnkd.in/eUuBssDw

[Clinical Trials] Teva Pharmaceuticals Pharmaceutical's first-in-human trials of TEV-'574 engages TL1A and maintains safety in asthma informs continued IBD and asthma research https://lnkd.in/d6P-8ZB4 ViiV Healthcare's phase 3 interim data of Cabenuva reveals efficacy for HIV patients facing treatment adherence challenges https://lnkd.in/d3ek97ys [Deals] HOX Therapeutics Ltd Enters Strategic Collaboration with Vernalis for Oncology Drug Candidate Development https://lnkd.in/d7kMCt6a ImmVirX and Innovent Biologics Sign Strategic Collaboration to Conduct phase 1 Trials of Oncolytic Virus IVX037 in Combination with Sintilimab for Ovarian Colorectal and Gastric Cancer https://lnkd.in/dgn9b4Xd ONO PHARMACEUTICAL CO., LTD. and Epsilon Molecular Engineering Inc. enter strategic collaboration for development of humanized VHH antibody candidates https://lnkd.in/d-XXunP2

Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational claudin (CLDN) 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy approved for this patient population in the U.S. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a new target action date of November 9, 2024. In the U.S., it was estimated that 26,890 people will be diagnosed with gastric cancer and 10,880 will die from the disease in 2024. Since early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, gastric cancer is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor's origin to other body tissues or organs. The five-year relative survival rate for patients at the metastatic stage is 7%. Moitreyee Chatterjee-Kishore, Ph.D., MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas: "Astellas is committed to introducing new targeted therapies for hard-to-treat cancers. Those living with advanced gastric or GEJ cancer often face great unmet needs, and the FDA acknowledgment of the zolbetuximab BLA resubmission brings us one step closer to offering this important treatment option to eligible patients in the U.S. facing this deadly disease." #gastriccancer #GEJ #targetedtherapy #zolbetuximab #Astellas #ScienceFirstForPatients #ChangingTomorrow

☝ FDA-Approved Drugs Encapsulated by Lipid-Based Nanoparticles In 2018, the FDA approved Alnylam Pharmaceuticals' siRNA drug Onpattro (Patisiran), the first drug to use LNPs as the drug delivery system. As of late 2020, several mRNA vaccines for SARS-CoV-2 use LNPs as their drug delivery system, including both the Moderna COVID-19 vaccine (uses its own proprietary ionizable cationic lipid) and the Pfizer–BioNTech SE COVID-19 vaccines (licensed an ionizable cationic lipid from Acuitas Therapeutics, Inc.) Following the approval of Patisiran, LNP-based siRNA delivery is now of significant interest for the development of the next siRNA formulation. Recently, a number of siRNA-encapsulated LNPs were reported for the treatment of intractable diseases such as cancer, viral infection, inflammatory neurological disorder, and genetic diseases. Its only a matter of time before this list is much longer.... I'd love to hear about other approved (or nearing approval ⏳ ) LNP encapsulated drugs ❓ Table Ref: Chi Zhang et al, 2022 Modification of Lipid-Based Nanoparticles: An Efficient Delivery System for Nucleic Acid-Based Immunotherapy #lipidnanoparticles #LNP #fdaapproval #mrnalnp #sirna #sirnadelivery #nonviraldelivery #mirna #mrna #vaccines #patisiran #RNAi

#fda 👉🏼FDA Launches Pilot Program (Support for clinical Trials Advancing Rare disease Therapeutics-START) to Help Further Accelerate Development of Rare Disease Therapies. ▪️ Applications for the START program will be open from Jan. 2 to March 1, 2024. Sponsor participation concludes upon achieving a major regulatory milestone. ▪️ The FDA is intensifying its commitment to accelerate the release of rare disease treatments by seeking input from stakeholders to identify knowledge gaps and create accessible resources. You can find the article here: https://lnkd.in/dTuCBBb8 ##cellandgenetherapy #raredisease #usfda

The development of Complement Inhibitors has been growing rapidly over the years, and it has proved to be one of the breakthroughs in various therapeutic areas. Till now, approximately nine complement inhibitor’s have been approved across various geographies. SOLIRIS, CINRYZE, and BERINERT are some of the older approved Complement Inhibitors, while AVACOPAN, ENJAYMO, and EMPAVELI are listed in recent developments. In order to sustain their momentum and seize market opportunities, prominent pharmaceutical and biotech companies like Regeneron, UCB, Roche, Iveric Bio, An Astellas Company, Achillion Pharmaceuticals, Inc., Novartis, and several others are actively engaged in the Complement Inhibitors Market. Get more detailed insights into the evolving market landscape of Complement Inhibitors, at: https://lnkd.in/ecUzsSmR #healthcare #biotechnology #lifesciences #pharmaceuticalindustry #pharmaceutical #marketresearch #marketforecast #markettrends #consulting #healthcareconsulting #consultingservices #marketforecast

Cessation Therapeutics, Inc. announced that CSX-1004, an investigational anti-fentanyl monoclonal antibody, was well-tolerated across the entire dose range, with no dose-limiting toxicities, in a Phase 1 study and that a Phase 2 study is planned. In the Phase 1a randomized, placebo-controlled, single ascending dose study (NCT06005402), 32 healthy subjects were enrolled. Four doses of CSX-1004 were tested sequentially, beginning with the lowest dose: 1.0, 3.0, 10 and 30 mg/kg. Eight subjects in each cohort were randomized to receive CSX-1004 or placebo in a 3:1 ratio. After each cohort completed dosing, a Safety Monitoring Committee reviewed the blinded data to approve escalation to the next higher dose. A Phase 2a proof-of-concept study is planned that will evaluate the ability of CSX-1004 to block the respiratory depressant effects of fentanyl in repeated challenges over 28 days in healthy volunteers and patients with Opioid Use Disorder. #mabs https://lnkd.in/ekNPhsYj

🧬 Biopharma Bite Sized News 🍗 Nov 20th - 24th 2023 Drug approvals, top-line data & public offerings… Ascendis Pharma  European Commission approved YORVIPATH® (palopegteriparatide) on Nov 20, 2023 for the treatment of Chronic Hypoparathyroidism. Vertex Pharmaceuticals  On Nov 23, 2023, the European Commission approved KAFTRIO® in combination with Ivacaftor for the treatment of children with Cystic Fibrosis ages 2 through 5. Calliditas Therapeutics & Everest Medicines China NMPA announced on Nov 24, 2023, the approval of Nefecon® for the treatment of primary IgA nephropathy. Jaguar Health Top-line data announced from pivotal Ph 3 OnTarget trial evaluating Crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Zevra Therapeutics & Acer Therapeutics Inc. Completed acquisition of Acer Therapeutics. Reviva Pharmaceuticals Announced closing of $30M offering. --- 👋 I'm Dominic Vacchiano, Co-founder of BiopharmIQ by Amp. We maintain biopharma data to help with your sales/BD activities. 📰 Each week we share clinical/regulatory news in an easy to digest format. #biotech #biopharma