Longevity investment bulletin: Mikra, Celmatix, LyGenesis and more

The latest longevity updates from our investment news desk.

Mikra study shows healthspan and lifespan improvements

Consumer longevity company Mikra Cellular Sciences completed its first foundational pre-clinical study aimed at understanding the effect of its CELLF supplement on healthspan and lifespan. Mikra partnered with InVivo Biosystems, an expert in CRISPR genome editing, to test whether CELLF could improve healthspan and protect against reactive oxygen species.

The researchers identified non-toxic concentrations of CELLF and found that it increased both lifespan and healthspan in animals, especially late in life. Additionally, researchers found that treatment with CELLF resulted in differential gene expression profiles, particularly affecting key members of established longevity pathways. It was also observed that CELLF had antioxidant properties and reduced the damage caused by exposure to pesticides in the study.

“We always intended our first pre-clinical study to pave the way for more iterations of CELLF and clinical studies,” said Faraaz Jamal, CEO of Mikra. “With these results, it’s clear that we have a winning product that has significant potential to improve one’s healthy years and I am excited to continue to strengthen our offering and develop on these truly remarkable results.”

Celmatix announces new PCOS program

Ovarian biology company Celmatix announced its latest drug program targeting melatonin receptors outside of the central nervous system (CNS). The therapeutic drug will address a gap in the market for effective first-line treatments for a range of women’s health indications, starting with Polycystic Ovary Syndrome (PCOS) and with the potential to expand into the treatment of endometriosis and menopausal symptoms.

The novel program has emerged from a decade-long multi-omics initiative at the company to understand the molecular and genetic mechanisms underlying ovarian health and conditions like PCOS. The Celmatix therapeutic program is focused on developing a novel melatonin receptor agonist compound with peripherally-preferred pharmacokinetics to increase therapeutic action at the target tissues, including the ovary, and minimize unwanted side effects like drowsiness.

“We are excited to not just be at the forefront of highlighting the importance of melatonin signaling for ovarian health and function but also pioneering the development of a novel melatonin receptor agonist that acts specifically in the periphery and not the brain,” said Celmatix CEO Dr Piraye Yurttas Beim. “We believe this drug has the potential to support ovarian health throughout a woman’s lifespan, beginning with treating the root causes of PCOS early in life and later through enabling healthier aging for women as their ovarian function declines through the menopause transition.”

LyGenesis partners with Imagine Pharma

Cell therapy company LyGenesis has partnered with Imagine Pharma to develop novel cell therapies for patients with type 1 diabetes. The research collaboration will leverage Imagine Pharma’s Type 1 Diabetes Activated Islet Progenitor Cells (T1D AIPCs) and LyGenesis‘ allogeneic cell therapy platform to develop therapies for type 1 diabetes.

Imagine Pharma announced its discovery of T1D AIPCs, a critical component for the potential treatment of T1D in the setting of an autologous cell transplantation, in June 2022. By utilizing Imagine Pharma’s AIPCs as the cell source, combined with LyGenesis’ use of the lymph node as a bioreactor to grow a functioning ectopic pancreas, the collaboration will enable rapid advancement of a preclinical proof of concept program for the potential treatment of type 1 diabetes.

“We’re thrilled to announce our collaboration with Imagine Pharma to utilize their unique cell-source with our use of endoscopic ultrasound engraftment of cell therapies into the lymph node for the treatment of diabetes,” said Dr Michael Hufford, CEO of LyGenesis. “With our lead cell therapy already in clinic for the treatment of end stage liver disease, Imagine Pharma’s AIPCs hold remarkable promise to rapidly advance our pipeline of therapies.”

Humacyte completes Phase 3 enrollment

Clinical stage biotech Humacyte (Nasdaq: HUMA), announced it has completed enrollment of its Phase 3 trial in hemodialysis access. The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease as compared to autogenous arteriovenous fistulas.

The Phase 3 trial, labeled V007, is a prospective, multi-center, randomized, comparative study in 240 hemodialysis patients suffering from ESRD in the United States. Enrolled individuals were randomly assigned to either the ​​HAV, or an AV fistula for hemodialysis. Efficacy assessments include useability of the conduit for dialysis at six and 12 months and a comparison of secondary patency, evaluated at 12 months. The rate of dialysis-related infections in both HAV and fistula subjects will also be tracked as a secondary endpoint.

“Completing enrollment in this Phase 3 trial brings us one step closer to our goal of providing vascular access for dialysis patients that is usable more quickly after implant and reduces reliance on catheters, compared to AV fistula procedures,” said Dr Shamik Parikh Chief Medical Officer at Humacyte. “We believe our regenerative medicine technology has the potential to transform the quality of care nephrologists are able to provide to their patients, and address the substantial failure rate and risk of infection associated with the current AV access options for hemodialysis.”

eGenesis and Karius join forces

Xenotransplantation company eGenesis and Karius, the world leader in liquid biopsy for infectious diseases, announced a partnership to develop infectious disease diagnostics for xenotransplantation. Through the partnership, Karius will leverage its platform to power the detection and quantification of pathogens with potential to occur in porcine organ donors.

Karius’ expanded platform for detection of microbial cell-free DNA will power the surveillance and diagnosis of potential infection in both the porcine organ donor and recipient, pre- and post-transplant. Karius and eGenesis will collaborate in the development of this expanded platform and plan to complete this work by early 2024.

“While we are taking numerous measures to ensure our porcine donors are free from infectious agents, the ability to broadly monitor for infection transmission between species is important for ensuring the safety of xenotransplantation,” said Dr Michael Curtis, CEO of eGenesis. “With our gene-editing technology, we have an unprecedented ability to engineer human compatible organs to address the organ shortage, and this partnership is a key step in our goal to make xenotransplantation safe.”

Biogen opts in on Denali’s Alzheimer’s program

Pharma giant Biogen (Nasdaq: BIIB) announced that it has exercised its option to license the Antibody Transport Vehicle program targeting amyloid beta from Denali Therapeutics (Nasdaq: DNLI). Accumulation of amyloid beta plaque in the brain is a defining feature of Alzheimer’s disease.

Using Denali’s ATV platform to cross the blood-brain barrier, the program is designed to increase brain exposure and target engagement of antibody therapeutics directed against amyloid beta.

“Recent progress with Aβ-directed therapeutic antibodies enables new treatment options for people living with AD, and clinical trial data have demonstrated that clearance of aggregated Aβ is associated with benefit for patients,” said Dr Joseph Lewcock, Chief Scientific Officer of Denali. “Our ATV:Aβ program is designed to safely increase exposure of the therapeutic antibody in the brain and potentially lead to improved efficacy and/or safety. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti- Aβ therapeutics.”  

Q1 2023 Report

Aviceda gets Phase 2 go-ahead

Clinical-stage biotech Aviceda Therapeutics announced FDA clearance for the IND relating to its lead asset for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This means the company can proceed with initiating Phase 2 clinical trials of AVD-104, expected to begin in Q2 2023.

AVD-104 is an intravitreal nanoparticle molecule with a unique dual mechanism of action for the treatment of GA through its modulation of critical inflammatory pathways via inhibition of the activity of retinal macrophages and repolarization of activated macrophages to their resolution state coupled with inhibition of complement cascade amplification.

“The FDA’s acceptance of our IND application to initiate the clinical evaluation of AVD-104 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with geographic atrophy and macular degeneration,” said Dr Mohamed Genead, CEO of Aviceda. “The AVD-104 IND clearance marks an important milestone for Aviceda as we continue our track record of execution as the leader in the glycome field. We are thrilled to advance the development of AVD-104 in the US and are working to rapidly enroll patients in the Phase 2 portion of the study. We look forward to presenting additional data later this year.”

Turn Bio boosts advisory board

Cell rejuvenation company Turn Biotechnologies announced the appointment of two preeminent physicians to the company’s Medical Advisory Board. Memorial Sloan Kettering Cancer Center (MSK) specialists Kevin J. Curran, MD, and Joseph Hai Oved, MD, MA, who are both board-certified in oncology and pediatrics, bring extensive experience in gene and cell therapy.

Their expertise will help Turn Bio, which is developing novel mRNA medicines for untreatable, age-related conditions, to expand research and development to use the company’s Epigenetic Reprogramming of Aging (ERA) technology to increase the efficacy of immunotherapies.

“We are thrilled to have Drs Curran and Oved as our founding immunology medical advisors,” said Anja Krammer, Turn Bio CEO. “Their clinical pedigrees and expertise will help us achieve life-saving advances in immunotherapy to improve patient outcomes and access to critical cancer treatments.”

Improving longevity literacy

LongeVC’s Sergey Jakimov on why it’s time to demystify the longevity industry and build a bridge from clinicians to the masses.

“It’s time for us to bring longevity science to the masses,” he told us. “While the sector has largely moved past misconceptions around magic potions and cure-all superfoods, the average person knows very little about longevity, or even biological aging in general. Throw terms like telomeres, epigenetic reprogramming and cellular rejuvenation into a presentation, and eyes will glaze over before you move past your outline slide. We need better education and awareness to reach more people.”

‘Good companies will continue to get funded’

A key player involved in orchestrating the recent seed round for Five Alarm Bio was o2h Ventures. The Cambridge-based investment firm specializes in biotech and FAB is the first longevity-specific investment it has made. To find out more about o2h and its first investment in longevity, we spoke to the managing partner of its therapeutics division, Sunil Shah.

o2h ventures is part of the o2h group of companies, which also includes contract research services and an incubator for biotech startups. The goal of the group is to nurture and invest in emerging life science and tech companies, spanning biotech, small molecule and biologics developers, digital health and software companies.