Saturday, December 3, 2022


Biotechnology News Magazine

Gates Biomanufacturing Facility Announces Manufacture of Recombinant Protein – Alzheimer’s Disease Vaccine for Institute for Molecular Medicine’s Clinical Trials

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Imago BioSciences Announces First Participant Dosed in Investigator-Sponsored Phase 1 Study of Bomedemstat in Combination with Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia

Venetoclax is a BCL-2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for treatment of several hematologic cancers, including in combination with azacytidine for elderly patients with AML unable to tolerate the standard of care.

Acer Therapeutics Announces $1.5M Private Placement

The proceeds from the private placement will be used by Acer Therapeutics for working capital and general corporate purposes and, together with Acer’s existing cash and cash equivalents, are expected to be sufficient to fund the Company’s anticipated operating and capital requirements through the fourth quarter of 2022.

AC Immune’s Alzheimer’s Disease Vaccine-candidate ACI-35.030 Selected for Further Development

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “The selection of ACI-35.030 for further development is a significant step for this collaboration. Early clinical testing showed that ACI-35.030 was generally well tolerated and induced specific activity against the pathological species of Tau, including the neurotoxic pTau and enriched paired helical filaments (ePHF) species, both of which are closely implicated in Alzheimer’s disease (AD).

TransCode Therapeutics Announces eIND Submission to US FDA for Planned First-in-Human Clinical Trial in Patients with Advanced Solid Tumors

The planned clinical trial is to evaluate TransCode’s lead therapeutic candidate, TTX-MC138, in cancer patients with advanced solid tumors. ​TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode Therapeutics believes that TTX-MC138 could be used as a treatment for many of these cancers.

The Gates Biomanufacturing Facility (GBF) has announced the successful completion of the full cycle manufacturing of the recombinant Bulk Drug Substance (BDS) of the anti-Tau vaccine, AV-1980R, in collaboration with the Institute for Molecular Medicine (IMM), California.

IMM selected GBF as its exclusive cGMP-grade BDS manufacturing partner supporting clinical supply for IMM’s recombinant protein vaccines, including AV-1980R. As a result of this work, AV-1980R Drug Substance can be used for phase 1 and phase 2 clinical trials in humans. This work was financed through funding provided by the U.S. National Institute on Aging (NIA).

Abnormal Tau aggregation into neurofibrillary tangles is the hallmark of different tauopathies – neurodegenerative disorders that include Alzheimer’s Disease (AD). Until now, AD therapeutics have mostly focused on the treatment of already diseased patients. AV-1980R vaccine targets Alzheimer’s Disease (AD) and other Tau aggregation-associated neurodegenerative conditions by providing outstanding levels of antibody protection against harmful forms of Tau protein that may lead to disease.

Dr. Michael AgadjanyanProfessor and Vice President of IMM commented, “But once pathology begins and neurons are damaged, it becomes impossible to stop the disease. Now, with the help of cGMP-grade AV-1980R manufactured by GBF, [IMM has] a highly immunogenic preventative vaccine that could induce significant levels of antibodies inhibiting aggregation of Tau in cognitively unimpaired people [who are] at risk of AD and halt the disease onset.”

Huntington Potter, PhD, Professor of Neurology, Director of Alzheimer’s Disease Program at the Linda Crnic Institute for Down Syndrome, and Director of the CU Alzheimer’s and Cognition Center at the University of Colorado Anschutz Medical Center maintains, “It is becoming increasingly clear that targeting Alzheimer amyloid deposits and their formation is not, alone, an effective approach to halting or reversing Alzheimer’s disease. New therapeutics are needed. The development and manufacture of a Tau vaccine is one of the most promising approaches and might be used either alone or in combination with the anti-amyloid antibodies currently in clinical trials. I congratulate GBF on this important milestone.”

All vaccines developed by IMM are based on the proprietary MultiTEP platform technology, recently licensed to its commercial entity, Nuravax, which demonstrated therapeutic efficacy and immunogenicity in various species of transgenic animal models of AD, including non-human primates.

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