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Clinical Catch-Up: August 17-21

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It was a relatively quiet week for clinical trial news. Here’s a look.

COVID-19-Related

Organicell Regenerative Medicine partnered with Alternative Research Associates and Larkin Hospital in Miami to initiate a Phase I/II trial of Zofin for COVID-19. So far five patients have been treated with Zofin under the FDA’s eIND Program. The company’s products are derived from perinatal sources and manufactured to retain naturally occurring microRNAs.

Appili Therapeutics was cleared by the FDA to proceed with an expanded Phase II trial in the U.S. to evaluate favipiravir against COVID-19 outbreaks in long-term care facilities. Favipiravir is a Japan-based therapy developed and regulated for prevention of pandemic influenza outbreak under the brand name Avigan.

Pfizer and BioNTech released additional Phase I data from their ongoing U.S. trial of BNT162b2 (B2), their mRNA-based vaccine against COVID-19. The vaccine has otherwise advanced into a Phase II/III trial. The companies had released preliminary data on the vaccine on July 1, but that was for a different vaccine than the one they are taking into a 30,000-patient Phase III trial. The companies were originally testing four variations of their vaccine, each with a different combination of mRNA format and target antigen. The preliminary data announced on July 1 were for BNT1621b1 (B1). But on July 28, they announced they had selected BNT162b2 to take into larger studies.

The data describes key safety and immunogenicity data from the U.S. Phase I study for BNT162b. At the 30-microgram dose, seven days after the second dose, the vaccine elicited a neutralizing geometric mean titer (GMT) 1.6 times the GMT of the same panel, showing strong immunogenicity in younger and older adults. This is a way of comparing the immune responses. Also, B2 (as compared to B1) created fewer adverse events in participants than B1. The immune responses were similar between the two vaccine candidates.

Russia reported that its recently “approved” vaccine, Sputnik V, will be tested on more than 40,000 people. And yes, it does seem backwards to approve a drug for use before you begin Phase III testing in a broader population. The Russian Direct Investment Fund indicates the vaccine, which was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, will be tested at more than 45 medical centers.

Non-COVID-19-Related

UNITY Biotechnology reported that the 12-week results from its Phase II study of UBX0101 in moderate-to-severe painful osteoarthritis (OA) of the knee failed to show improvement over placebo. As such, they do not plan to continue to progress the drug into pivotal trials and will shift the company’s focus, in the near-term, to ongoing programs for ophthalmologic and neurologic diseases.

UBX0101 is a p53/MDM2 interaction inhibitor. In the Phase II study, 183 patients with moderate to severe painful OA of the knee were split to receive placebo, 0.5 mg, 2.0 mg or 4.0 mg of UBX0101 by way of a single intra-articular injection. However, at the 12-week readout, there was no statistically significant difference between those receiving the drug and patients receiving the placebo in change of baseline in WOMAC-A, a measurement of pain in OA.

Precigen dosed the first patient with PRGN-2009, its first-in-class, off-the-shelf investigational immunotherapy using its AdenoVerse platform, which is designed to active the immune system to recognize and target HPV+ solid tumors. The Phase I part of the trial will use 3+3 dose escalation to evaluate the therapy’s safety as a monotherapy and to determine the appropriate dose for a Phase II trial.

Aligos Therapeutics dosed its first patient in a Phase Ia/b trial of ALG-010133 for chronic hepatitis B. The drug is a proprietary oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer (STOPS) molecule that decreases viral S-antigen levels.

Poseida Therapeutics paused enrollment in its Phase I clinical study of P-PSMA-101 in prostate cancer after the death of a patient. The patient was diagnosed with metastatic castrate-resistant prostate cancer and had failed previous treatments. The patient died of hepatic failure. P-PSMA-101 targets prostate-specific membrane antigen (PSMA) on metastatic castration-resistant prostate cancer cells. The direct cause of the patient’s death has not yet been determined.

Intravacc published the results of its Phase I trial of its candidate Respiratory Syncytial Virus (RSV) vaccine. It showed excellent induction of immunogenicity in healthy adults 18 to 50 years of age after nasal administration.

AngioDynamics enrolled the first patient in its PATHFINDER I: Post-Market Registry, a pilot study to evaluate the safety and efficacy of the Auryon Auterectomy System in the real-world treatment of de novo, re-stenotic, and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with Peripheral Artery Diseases (PAD).

Alzheon was awarded a $47 million grant over five years from the U.S. National Institute on Aging (NIA), part of the National Institutes of Health. The grant is to assist with a Phase III clinical trial of ALZ-801. ALZ-801 is an oral molecule that blocks the development of neurotoxic soluble amyloid oligomers. The clinical trial will evaluate ALZ-801 in 300 patients with early AD and the APOE4/4 genotype.

ViiV Healthcare, an HIV company majority owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, announced findings from the Phase IIIb STAT study. It evaluated Dovato (dolutegravir/lamivudine) for rapid initiation of treatment after diagnosis in adults with HIV-1. The drug was found to be effective and well tolerated in this setting.

Audentes Therapeutics announced that a third patient had died in the ASPIRO clinical trial of AT132 in X-linked Myotubular Myopathy (XLMTM). The study is currently on a clinical hold. XLMTM is a serious, life-threatening neuromuscular disease marked by extreme muscle weakness, respiratory failure and early death. The immediate cause of death in the third patient was gastrointestinal bleeding.

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