▎WuXiEdited by Kant Content Team
Approximately $1.2 Billion: Day One Acquires Innovative ADC for the Treatment of Multiple Solid Tumors
Day One Biopharmaceuticals today announced that it has entered into an exclusive licensing agreement with MabCare Therapeutics to obtainInnovative Antibody-Drug Conjugate (ADC) Targeting Protein Tyrosine Kinase 7 (PTK7)The global exclusive rights for development, production, and commercialization of MTX-13 (excluding Greater China).
In April 2024, the U.S. FDA approved the IND application for MTX-13, which will be referred to as DAY301 in the future. In preclinical studies, DAY301 demonstrated anti-tumor activity against various solid tumors.DAY301 targets PTK7, a highly conserved, catalytically inactive transmembrane protein that is highly expressed in various adult cancers (including esophageal cancer, ovarian cancer, lung cancer, and endometrial cancer) as well as pediatric cancers (such as neuroblastoma, rhabdomyosarcoma, and osteosarcoma). The expression of PTK7 is limited in normal tissues or organs, making it an ideal target for ADC therapy development.
According to the terms of the agreement, MabCare will receive an upfront payment of $55 million and is eligible for additional development, regulatory, and commercial milestone payments of up to $1.152 billion. Day One anticipates dosing the first patient in the fourth quarter of 2024 or the first quarter of 2025.
Potential First-in-Class! Small Molecule Therapy Submits New Drug Application
KalVista Pharmaceuticals announced todayA New Drug Application (NDA) for the oral plasma kallikrein inhibitor sebetralstat has been submitted to the U.S. FDA for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.
The NDA submission is based on previously disclosed clinical trial results, including data from the Phase 3 clinical trial KONFIDENT and the KONFIDENT-S extension trial. Sebetralstat achieved the primary endpoint in the Phase 3 trial.Both 300 mg and 600 mg doses demonstrated significantly faster symptom relief compared to placebo (300 mg p<0.0001, 600 mg p=0.0013). Symptom relief occurred at 1.61 hours (CI: 1.28, 2.27) for the 300 mg sebetralstat group and at 1.79 hours (CI: 1.33, 2.27) for the 600 mg group, compared to 6.72 hours (CI: 2.33, >12) for placebo.
The press release noted that, if approved,Sebetralstat will become the first oral on-demand treatment for HAE.The NDA submission includes patients aged 12-17, a group the company believes has particularly high unmet needs due to challenges with injectable medications. KalVista plans to initiate a pediatric trial (KONFIDENT-KID) in the third quarter of 2024, which, if successful, will expand patient coverage to include those aged 2-11 in the future.
Iambic Therapeutics Completes $50 Million Financing, Lead Drug Enters Clinical Development
Iambic Therapeutics today announced the completion of a $50 million Series B extension financing.The proceeds will be used to advance Iambic’s clinical and preclinical programs, including IAM1363, a highly selective, blood-brain barrier-penetrant HER2 inhibitor that inhibits both wild-type and oncogenic mutant HER2 receptors, currently in Phase 1/1b studies. The funding will also support the development of a potential “first-in-class” CDK2/4 inhibitor aimed at broadening the therapeutic window and addressing resistance in solid tumors such as breast cancer.
Iambic Therapeutics' candidate drug was discovered using its AI protein structure prediction and integrated drug design model.These technologies are integrated into a closed-loop, automated, high-throughput biological and chemical experimentation platform, delivering new biological insights weekly from thousands of molecular designs, thereby directly informing its AI models.
Developing Innovative Small Molecule Therapies for Immune Diseases, Sanofi Reaches Approximately $700 Million Collaboration
Belharra Therapeutics today announced a strategic collaboration with Sanofi to advance the discovery of innovative small-molecule immunology therapeutics.The collaboration will leverage Belharra's proprietary non-covalent chemical proteomics platform to screen and validate immunology targets designated by Sanofi.Belharra is expected to receive an upfront payment and short-term milestone payments of up to $400 million, along with research, development, and commercial milestone payments, totaling approximately $700 million.
Belharra's platform aims to provide broad and unbiased chemoproteomics screening capabilities.The platform utilizes a computationally designed library of non-covalent drug-like molecules to identify proteins that bind to specific molecules and the precise binding sites on target proteins through photoaffinity chemistry.All screening is conducted in a natural cellular environment. With this approach, Belharra can reveal binding pockets for protein-small molecule or protein-protein interactions in any cell type, providing insights for discovering new drugs targeting hard-to-target protein targets as well as innovative protein targets.
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[1] Day One Expands Pipeline with Potential First-in-Class Clinical-Stage Antibody Drug Conjugate (ADC) Targeting PTK7 in Solid Tumors for Adult and Pediatric Cancers. Retrieved June 18, 2024, from https://ir.dayonebio.com/news-releases/news-release-details/day-one-expands-pipeline-potential-first-class-clinical-stage[2] Intra-Cellular Therapies Announces Positive Topline Results in Second Phase 3 Trial Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive Disorder. Retrieved June 18, 2024, from https://www.globenewswire.com/news-release/2024/06/18/2900311/30597/en/Intra-Cellular-Therapies-Announces-Positive-Topline-Results-in-Second-Phase-3-Trial-Evaluating-Lumateperone-as-Adjunctive-Therapy-in-Patients-with-Major-Depressive-Disorder.html[3] Iambic Therapeutics Closes $50 million Series B Extension to Broaden its Pipeline of AI-Discovered Clinical Oncology Programs. Retrieved June 18, 2024, from https://www.iambic.ai/post/iambic-therapeutics-closes-50-million-series-b-extension-to-broaden-its-pipeline-of-ai-discovered-clinical-oncology-programs[4] Belharra Therapeutics Announces Strategic Collaboration with Sanofi to Advance Discovery of Novel Small Molecule Therapeutics for Immunological Diseases. Retrieved June 18, 2024, from https://belharratx.com/press-releases/belharra-therapeutics-announces-strategic-collaboration-with-sanofi-to-advance-discovery-of-novel-small-molecule-therapeutics-for-immunological-diseases/[5] KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for Hereditary Angioedema. Retrieved June 18, 2024, from https://www.businesswire.com/news/home/20240618507569/en
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