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BIOBIZ: Pfizer’s migraine nasal spray gets FDA approval; Olema Oncology cuts staff by 25%; Ansa Biotechnologies creates world’s longest DNA oligonucleotide; Indaptus doses first patient


Pfizer has announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.

“The FDA approval of ZAVZPRET marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer in a press statement.  Pfizer picked up zavegepant in its $11.6 billion acquisition of Biohaven, which also included Nurtec ODT and a preclinical portfolio of CGRP drugs last year.

In a press statement, Olema Oncology will let go of a quarter of its workforce, as well as two top executives, as the biotech works on an experimental breast cancer drug. As a result of the restructuring, Olema’s workforce will be reduced by approximately 25%, affecting employees across research, early development, and general and administrative functions. Chief Business Officer Kinney Horn will be departing the company, and Cyrus Harmon, Ph.D., co-founder of Olema, will step down from his role as the Chief Research Officer and remain a member of Olema’s Board of Directors.

This week, Ansa Biotechnologies, Inc announced the successful de novo synthesis of the world’s longest DNA oligonucleotide ever reported to be produced in a single synthesis. The 1005 base sequence encodes a key part of an AAV vector used for gene therapy development and contains complex features, including strong secondary structures and high GC content, which are extremely challenging to synthesize using conventional methods that require assembly of shorter oligonucleotides.  According to Daniel Lin-Arlow, Ph.D., CEO and co-founder of Ansa Biotechnologies. “Our extremely long Ansamer oligonucleotides will enable us to manufacture genetic constructs for researchers much faster, more reliably, and with fewer sequence limitations than what is currently possible.”

NYC-based Indaptus Therapeutics dosed their first patient with INDP-D101. The treatment, INDP-D101 is the Company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors. “Following dosing of our first subject in INDP-D101, we are optimistic regarding our expectations for this part of the trial,” said Michael Newman, Ph.D., the Company’s founder and chief scientific officer. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity.

AnHeart Therapeutics published the clinical trial design of TRUST-II, a global Phase 2 clinical study of taletrectinib in ROS1-positive non-small cell lung cancer and other solid tumors, in the peer-reviewed medical journal, Future Oncology. The paper, “TRUST-II: A global phase II study of taletrectinib in ROS1-positive non-small cell lung cancer and other solid tumors,” describes the rationale and design of TRUST-II, a global Phase 2 study of taletrectinib in patients with locally advanced/metastatic ROS1+ NSCLC and other ROS1+ solid tumors.

“Many patients develop resistance to first-generation inhibitors such as crizotinib within two years of treatment due to progression in the brain or emergence of secondary mutations such as G2032R,” said Dr. Misako Nagasaka, lead author, a medical oncologist at the University of California Irvine in a press statement. “There is a significant unmet medical need for a next-generation ROS1 inhibitor, such as taletrectinib, which is potent against secondary mutations and effectively treats brain metastases while maintaining a favorable safety profile.”

Artax Biopharma has added Andre Hoekema, Ph.D., to the Company’s Board of Directors as the Company is currently evaluating AX-158 in clinical trials.  AX-158 is the Company’s first-in-class, oral small molecule investigational immunomodulating agent that selectively acts at the T-cell receptor to lower self-antigen triggered cytokines, a known cause of autoimmune disease. Importantly, AX-158 has the potential to treat multiple T-cell-mediated diseases without causing immunosuppression.

According to Joseph Lobacki, Artax Biopharma’s Chief Executive Officer, “Dr. Hoekema’s expertise will be of significant value to the Company as we seek to bring our promising first-in-class, oral, non-immunosuppressive treatment option forward for the benefit of autoimmune patients.”