Vaxxinity CEO On Lecanemab Challenger, Migraine Buster And Lipid-Lowering Vaccine
COVID-19 Vaccine Superior To mRNA Vaccines?
Executive Summary
Among Vaxxinity’s immunotherapeutic vaccine candidates are one for Alzheimer’s that shows a 50% reduction in cognitive decline, another that shows superior durability than Pfizer and Moderna’s COVID-19 vaccines and one that could prevent migraines. Vaxxinity CEO speaks to Scrip about these and more in this interview
Dallas-based Vaxxinity Inc’s co-founder and CEO Mei Mei Hu and her team are developing peptide-based vaccines to treat or prevent chronic illnesses like cardiovascular disease and infectious ones like COVID-19.
Among the immunotherapeutic candidates are an anti-PCSK9, lipid-lowering vaccine that could cost less than statins and a possibly game-changing vaccine against Alzheimer’s which showed about 50% reduction in the rate of cognitive decline in Phase IIa trials.
Based on the same premise of clearing amyloids from Alzheimer’s patients’ brains as Eisai Co., Ltd./Biogen, Inc.’s amyloid protofibril-clearing antibody lecanemab, this novel amyloid β synthetic peptide vaccine will soon enter Phase IIb/III trials that “has potential to be a pivotal study”, Hu tells Scrip in this interview. (Also see "Rising Tide Lifts Many Ships In Wake Of Eisai/Biogen’s Lecanemab Readout" - Scrip, 28 Sep, 2022.) (Also see "Roche’s Alzheimer’s Drug Fails In Phase III Giving Eisai/Biogen A Clear Run" - Scrip, 14 Nov, 2022.)
Vaxxinity’s COVID-19 vaccine candidate, currently in Phase III studies globally, has shown a superior durability response than mRNA vaccines like those from Pfizer Inc./BioNTech SE and Moderna, Inc., she says. It’s expected to serve as a booster in developed countries and as a primary vaccine for those like Africa, she adds.
However, it’s arrangement with India’s Aurobindo Pharma Limited for manufacture of the vaccine to supply developing countries and UNICEF is definitely on the backburner, if not terminated. (Also see "Aurobindo’s Animal Health Acquisition, US Deceleration Surprise Analysts" - Scrip, 18 Aug, 2021.)
Meanwhile, a migraine vaccine candidate is expected to be the “first choice to prevent migraines given its convenient dosing and accessibility”, says Hu, who along with Lou Reese and Peter Diamandis formed the company which now has operations in Asia, Europe, Latin America and the US.
She joined her scientist mother, Chang Yi Wang in the family biotech business United Biomedical, Inc. post stints as a consultant at McKinsey and a lawyer. Vaxxinity was formed by combining two offshoots of United Biomedical – United Neuroscience and COVAXX - and is aiming to create a new class of medicines that harness the immune system, converting the body into its own "drug factory".
In this wide-ranging interaction, she spoke about when data readouts from these immunotherapeutic candidates can be expected and her plans to make them accessible. Whether or not the the vaccine against hypercholesterolemia will pass muster, unlike Ionis Pharmaceuticals, Inc./AstraZeneca PLC's ION449, remains to be seen. But Hu and her team are trying.
Time Stamps
00:08 Introduction
01:07 UB-311, the fast-tracked Alzheimer’s vaccine candidate
02:06 Timeline to launch
02:39 Lecanemab comparison
04:01 Possibility of Emergency Use Authorization (EUA)
04:54 Partnering for nasal delivery of vaccines
06:33 UB-312, the Parkinson’s candidate
07:40 Studies for Dementia with Lewy bodies (DLB), Multiple System Atrophy?
08:30 UB-313, the accessible migraine candidate
09:55 Phase I Readout Mid-2023
10:58 VXX-401 – Cheaper than statins?
12:40 PCSK9 targeted therapy
13:28 UB-612 – response more durable than mRNA, inactivated vaccines?
15:23 The deal with Aurobindo
16:52 A combined COVID-19 and flu vaccine?
17:30 Can gene therapies replace vaccines?
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