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Dynavax has appointed Kelly MacDonald as Senior VP and CFO. MacDonald will join the company effective March 1. CFO Michael Ostrach is retiring and has agreed to remain available as an advisor to the company thereafter. MacDonald joins Dynavax from Ironwood Pharmaceuticals where she held roles of increasing responsibility. In her final role at Ironwood MacDonald served as Chief Accounting Officer and Vice President, Finance.

Molecular Templates announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with MTEM's antigen seeding technology. ETBs enabled with AST have dual mechanisms of action that include the enzymatic destruction of ribosomes and the delivery of viral class I antigens into the targeted tumor to be processed and presented on its cell surface to induce an antigen specific immune response. MTEM expects to start dosing enrolled subjects in a first-in-human Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21. The Phase 1 study is planned as a multi-center, open-label, dose escalation and dose expansion trial in the United States and outside of the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment in the clinical trial. Following determination of the maximum tolerated dose or recommended Phase 2 dose, expansion cohorts are planned to study MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.

Atea Pharmaceuticals (AVIR) announced that it has expanded its senior management team with the appointments of Jayanthi Wolf, Ph.D., SVP of Regulatory Affairs and Jonae Barnes, SVP of Investor Relations and Corporate Communications. Wolf has had an extensive career in research and development at Merck (MRK) over a 19-year period. During her tenure at Merck, she served in a series of roles ranging from scientific to safety assessment and regulatory, with increasing responsibility in global regulatory affairs and clinical safety. Ms. Barnes served most recently as SVP, Investor Relations, Corporate Communications and Internal Communications at Sunovion.

Chiasma (CHMA) announced the hiring of John Doyle as its new CFO. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities to Mr. Doyle. Prior to joining Chiasma, Mr. Doyle served as VP of Finance and Investor Relations at Verastem (VSTM).

C4 Therapeutics announced that the U.S. Food and Drug Administration has cleared the company's investigational new drug application for its lead product candidate, CFT7455, an orally bioavailable MonoDAC targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma. The FDA has completed its 30-day safety review and granted approval for the company to proceed with the proposed Phase 1/2 clinical trial for CFT7455. The Phase 1/2 clinical trial will be an open-label, two-part dose-escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies. The Phase 1 portion of the trial will explore CFT7455 as a single agent in patients with relapsed or refractory multiple myeloma and non-Hodgkin lymphomas, and in parallel in combination with dexamethasone in R/R MM patients. Following the identification of an optimal dose, the Phase 2 expansion portion of the trial will enroll additional investigational arms including patients with MM, as single agent and in combination with dexamethasone, and as single agent in patients with mantle cell lymphoma and peripheral T-cell lymphoma, two subtypes of NHL. The trial will primarily investigate safety and tolerability, with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti-tumor activity of CFT7455.