Longevity investment bulletin: XtalPi, Levolta, MetrioPharm and more

The latest longevity updates from our investment news desk.

AI drug discovery company inks $250 million Eli Lilly deal

Chinese AI-powered pharmaceutical technology company XtalPi announced an AI drug discovery collaboration worth up to $250 million in upfront and milestone payments with Eli Lilly. The collaboration will leverage XtalPi’s integrated AI capabilities and robotics platform to de novo design and deliver drug candidates for an undisclosed target.

XtalPi combines mutually informative AI dry lab algorithms with large-scale wet lab robotics to empower pharmaceutical innovation. XtalPi will work closely with the Lilly team to harness the power of its AI drug discovery solution to deliver a novel compound, which Lilly will pursue in clinical and commercial development.

“With a closed loop of AI and quantum physics algorithms working in sync with the data factory of large-scale robotics experiments, XtalPi is uniquely equipped to tackle challenging novel targets,” said Dr Jian Ma, CEO of XtalPi. “We are honored that Lilly has chosen XtalPi’s AI + robotics drug R&D platform as a partner in achieving more fruitful pharmaceutical innovation and bringing much-needed treatments to patients worldwide.”

Levolta out-licenses investigational OA drug

Clinical-stage US pharma company Levolta Pharmaceuticals has entered into an exclusive licensing and distribution agreement for its investigational osteoarthritis therapy VOLT01 with Saudia manufacturing company Tabuk Pharmaceuticals. VOLT01 is a patented novel combination drug that has shown promise in Phase 2 and Phase 2b/3 clinical trials in treating OA, which has no cure.

The deal is for the commercialization of VOLT01 in the Middle East and Africa region, excluding South Africa. Tabuk Pharmaceuticals, a fully owned subsidiary of Astra Industrial Group, will hold the marketing authorization and be responsible for registering, importing, and commercializing VOLT01 in the MEA region.

“We are excited to announce this partnership with Tabuk Pharmaceuticals, as it represents the next step in bringing the first disease modifying therapy for osteoarthritis to market,” said Richard P Becker, Jr, CEO of Levolta. “Our goal is to fill the global void in the treatment of osteoarthritis, which affects more than 32.5 million adults in the United States alone. Tabuk is the market leader in MEA and will be a valuable partner in fulfilling that mission.”

MetrioPharm gets FDA orphan drug nod

Inflammatory and infectious disease drug developer MetrioPharm announced that the US FDA has granted Orphan Drug Designation for its small-molecule metabolic modulator MP1032 for the treatment of Duchenne muscular dystrophy.

A genetic disorder characterized by progressive muscle degeneration, DMD is the most common form of muscular dystrophy, and shortens life expectancy significantly. Existing standard therapies consist of treatment with high dose corticosteroids for decades that lead to serious side-effects and can only slow disease progression.

MetrioPharm has conducted preclinical studies in cooperation with the patient organization Duchenne UK, which showed that MP1032 was able to enhance muscle strength, like the corticosteroid Prednisolone, but without the serious side effects of the latter.

“Currently, DMD cannot be cured, but it can be treated,” said Dr Wolfgang Brysch, CSO and co-founder of MetrioPharm. “These treatments have serious side effects that heavily impact patients’ quality of life. With MP1032 we aim to improve the tolerability of treatment while also further slowing down disease progression. Our goal is to improve both safety and efficacy in the long-term treatment of DMD patients.”

Aviceda doses first patient in macular degeneration trial

Next generation immuno-modulator company Aviceda Therapeutics announced the dosing of its first patient with AVD-104 in its Phase 2 SIGLEC Trial. This lead intravitreal asset is a novel glycan-coated nanoparticle, supported by a uniquely strong pre-clinical in vivo efficacy and safety profile, used for the treatment of geographic atrophy secondary to age-related macular degeneration.

Aviceda has developed a proprietary nanotechnology platform and an IND-cleared ophthalmic lead product. 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.

“AVD-104 is a potentially transformative targeted approach for patients with GA due to AMD,” said David Callanan, Chief Medical Officer of Aviceda. “AVD-104 attacks two fundamental processes in GA by modulating critical inflammatory pathways through the inhibition of retinal macrophage inflammatory activity and repolarization of activated macrophages to their resolution states, and, through inhibition of complement cascade amplification. Based on this dual mechanism and the exquisite selectivity and preclinical potency of AVD-104, we believe it could provide a profound benefit for patients in dire need of new therapies. We have designed our Phase 2 trial to move efficiently through dose escalation and to increase the chances of seeing early signals of clinical activity.”

Humacyte grows human blood vessels for wounded Ukrainian soldiers

Clinical stage biotech Humacyte (Nasdaq: HUMA) has been featured by WRAL News for growing human blood vessels to be used in severe trauma cases associated with the war in Ukraine.

Humacyte’s HAV is a universally implantable vascular conduit for use in vascular repair. It has shown a low rate of infection in clinical trials, making it well-suited for use in settings such as vascular trauma where wounds may be contaminated with foreign material. The HAV is designed to be available off-the-shelf and ready whenever surgeons need it, potentially saving valuable time and potentially improving patient outcomes in cases requiring urgent vascular repair.

“Humacyte’s tissue engineering platform is really revolutionary,” Laura Niklason, the company’s CEO told WRAL News. “After the Russians invaded in Ukraine last year, Humacyte began getting requests from surgeons in Ukraine asking if they could have access to the HAV to treat their wounded war fighters.”

Stealth Bio inks licensing deal with Pharmanovia

Mitochondrial dysfunction-targeting biotech Stealth BioTherapeutics announced an exclusive licensing agreement with Pharmanovia, a global lifecycle management healthcare company. Pharmanovia will commercialize elamipretide, Stealth’s lead investigational product candidate, in Europe and other key global territories for the treatment of Barth syndrome, an ultra-rare life-threatening cardiac condition caused by mitochondrial cardiolipin deficiency for which there are currently no approved treatments.

Elamipretide, an investigational mitochondrial protective agent which has been shown to improve mitochondrial structure and function through its interaction with cardiolipin, has completed Phase 3 development as a potential treatment for Barth syndrome. Under the terms of the agreement, Pharmanovia receives exclusive rights to commercialize elamipretide for the treatment of Barth syndrome in the European, the Middle East and Northern Africa.

“While we work with FDA toward a potential US approval pathway, we remain committed to expanding access to elamipretide to individuals living with Barth syndrome in Europe and beyond,” said Reenie McCarthy, Chief Executive Officer of Stealth. “As a global pharmaceutical company with a strong footprint in Europe and a resolute commitment to patients with rare diseases, Pharmanovia is an ideal partner to work with regulatory authorities in Europe and MENA to progress our shared goal of facilitating access to a potential first treatment option for this ultra-rare genetic cardiac condition.”

Adiso completes Phase 1b trial in ulcerative colitis

Chronic inflammatory disease-targeting biotech Adiso Therapeutics announced the completion of its Phase 1b clinical trial evaluating ADS051, an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation.

The randomized double-blind placebo-controlled study enrolled 24 moderately-to-severely active ulcerative colitis patients, all of whom completed the trial as planned over the 28-day treatment period. ADS051 was found to be safe and well-tolerated with each daily oral dose in all three dosing cohorts. The company intends to pursue a Phase 2 development program in late 2023.

“In this Phase 1b study in addition to safety, we evaluated measures of efficacy in patients with moderate to severe UC,” said Jessica Allegretti, Medical Director, Crohn’s and Colitis Center, Brigham & Women’s Hospital Boston. “ADS051 showed positive signals of pharmacologic activity and great promise to provide incremental benefit to patients beyond what is achieved with current therapies. Neutrophils are a hallmark of UC, and today’s therapies do not directly modulate neutrophil trafficking. Continued clinical development of ADS051 as a potential therapeutic with a differentiated mechanism of action is important given the significant unmet need for patients.”

Seal Rock out-licenses liver treatment to GENFIT

Kinase inhibitor developer Seal Rock Therapeutics announced it has entered into an out-licensing agreement with GENFIT for the development of an injectable formulation of SRT-015 for acute liver disease. Under the agreement, Seal Rock Therapeutics is eligible for payments up to €100 million, including regulatory, clinical, and commercial milestone payments, plus tiered royalties.

SRT-015, a highly optimized, second generation, liver-selective inhibitor of Apoptosis Signal-reducing Kinase 1. It is being developed by Seal Rock as a treatment for severe acute alcoholic hepatitis as well as orphan liver diseases and NASH.

“We’re excited to announce this licensing deal with GENFIT that will accelerate the development of an injectable formulation of our second-generation ASK1 inhibitor SRT-015 for ACLF, a liver disease with high unmet need,” said Neil McDonnell, CEO of Seal Rock Therapeutics. “At Seal Rock, we remain focused on initiating a Phase 2a trial of oral SRT-015 for severe alcoholic hepatitis. We will also continue development of our first-in-class LRRK2/ASK1 dual kinase inhibitors for Parkinson’s Disease and ALS.”

Greenstone Bio and Creative Medical complete first phase of IPSC program

Creative Medical Technology Holdings and Greenstone Biosciences have successfully completed the first phase of the companies’ collaborative program aimed at developing a next-generation induced pluripotent stem cell (IPSC) pipeline for the ImmCelz immunotherapy platform. The partnership focuses on leveraging cutting-edge technology to revolutionize cellular therapy.

The collaboration between Creative Medical Technology Holdings and Greenstone Biosciences aims to advance the field of regenerative medicine by developing an innovative IPSC pipeline for the ImmCelz immunotherapy platform. Through this partnership, both companies are dedicated to unlocking the full potential of IPSCs in treating various medical conditions.

According to Timothy Warbington, CEO of Creative Medical Technology Holdings, the completion of the first phase of the program marks a significant milestone in their joint effort to revolutionize the field of regenerative medicine.

“We are thrilled to have achieved this important milestone in our collaboration with Greenstone Biosciences,” he said. “This success underscores the strength of our partnership and the potential of our combined expertise.”

ChromaDex on climbing the intellectual property ladder

Two leading lights from longevity supplement company ChromaDex joined us to talk IP, explain why longevity supplement companies need a strong patent portfolio, types of patents applied for, and patenting GRAS compounds.

“To remain a pioneer in the NAD space, we feel it’s important to defend the inventions that we’ve worked so hard to protect, and take action to prevent infringement,” they told us. “A strong portfolio acts as a deterrent, gives you a competitive advantage and gives you the freedom to build the strongest product line.”

Eterna CEO on the potential of mRNA in cellular reprogramming

The CEO of mRNA cell engineering company Eterna Therapeutics joined us to talk about the vast array of gene editing and cell reprogramming technologies it has assembled. The company has gene-editing technologies that enable the deletion, insertion, and repair of DNA sequences in living cells. It also has cell-reprogramming technologies that enable the generation of clonal lines of pluripotent stem cells, which can be expanded and differentiated into a desired cell type for the development of regenerative cell therapies.

“Cell reprogramming is an area of research that has been very active over the last decade or so,” he told us. “But much of the work in the field of pluripotent stem cell research has relied on viral approaches or DNA-based approaches that we believe have some challenges when it comes to clinical translation and ultimately developing viable therapeutics that are actually going to help people. Eterna’s approach would not rely on those technologies, but instead be able to leverage proprietary non-viral, non-DNA based approaches, using mRNA.”