Molecular Templates, Inc. engages in the discovery, development, and commercialization of biologic therapeutics for the treatment of cancers and other serious diseases. It utilizes its proprietary biologic drug platform to design and generate engineered toxin bodies, or ETBs. The company was founded by Eric E. Poma, Jean Gariépy, and Leigh Revers in 2001 and is headquartered in Austin, TX.
相关临床试验
12
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2000
进行中（未招募）
3
25.0%
No Longer Available
1
8.3%
终止
7
58.3%
撤回
1
8.3%
暂无批准数据
- CRO acquisitions mid-trial create a 60-90 day high-friction period where TMF completeness can slip from 85-90% to below 70%, directly impacting FDA inspection readiness. - When sponsors are acquired after R&D downsizing, sites face 60-120 days of operational uncertainty with frozen budgets, unanswered invoices, and absent CRA contacts. - ICH E6(R3) and 21 CFR Part 312.52 require documented transfer-of-obligations agreements; sites must demand written confirmation of IND sponsor continuity during any transition. - Vertical integration of MSO and CRO functions under one parent entity raises GCP governance concerns that regulators are increasingly scrutinizing for monitoring independence.
- Hinge Bio has appointed three seasoned biotech executives to key leadership positions to advance its GEM-DIMER platform through clinical development. - The company published preclinical data in Scientific Reports demonstrating that HB2198, a novel anti-CD19/CD20 bispecific antibody, achieves durable depletion of memory B cells in vivo. - HB2198 is designed to treat B cell-mediated autoimmune disorders including systemic lupus erythematosus and is expected to enter clinical trials in the second half of 2025. - The therapeutic candidate demonstrated greater than 99% B cell depletion in preclinical studies, offering potential advantages over CAR-T therapies without associated toxicities.
- Calidi Biotherapeutics has appointed Eric Poma, Ph.D., as its new CEO effective April 22, 2025, succeeding Allan Camaisa who will continue to serve on the company's Board of Directors. - Dr. Poma brings over 30 years of biopharmaceutical industry experience, including a strong track record of raising capital and securing strategic partnerships, having previously raised over $250 million in equity financing at Molecular Templates. - Calidi is advancing its RTNova platform of stem cell-based oncolytic virotherapies, with preparations underway for a dose escalation trial of CLD-201 in adult patients with solid tumors.
