Longevity investment bulletin: Therini Bio, Calico, Alchemab and more

The latest longevity updates from our investment news desk.

Therini lands $36 million to combat neurodegenerative disease

Fibrin-targeted therapeutics company Therini Bio closed a $36m Series A financing round to treat inflammatory neurodegenerative and retinal diseases, bringing the total amount raised by the company to $62m. The round was co-led by Dementia Discovery Fund, MRL Ventures Fund, Merck‘s therapeutics-focused corporate venture fund, Sanofi Ventures, and SV Health Investors’ Impact Medicine Fund.

New investor Eli Lilly also joined the round, with all existing investors including Alzheimer’s Drug Discovery Foundation (ADDF), Dolby Family Ventures, and Foundation for a Better World.

“We are thrilled to announce a top-tier investor syndicate, which will allow us to advance our groundbreaking work in developing fibrin-targeted therapies for diseases driven by chronic inflammation,” said Dr Michael Quigley, CEO of Therini Bio. “This funding will enable us to accelerate the development of our lead antibody program targeting inflammatory fibrin in neurodegenerative and retinal diseases. We look forward to advancing our first candidate, THN391, into clinical trials, and expect to announce key safety and proof of mechanism clinical data by the end of 2024.”

In 2021, Therini was awarded a $3m non-dilutive funding grant from the National Institute on Aging (NIA), which will provide $1m of preclinical research funding to advance the company’s Alzheimer’s disease program each year through 2024.

Calico doses first patients in brain disease trial

Alphabet’s longevity biotech subsidiary Calico Life Sciences announced that the first participant has been dosed in a Phase 1b clinical trial evaluating its investigational drug as a potential treatment for Vanishing White Matter (VWM) disease.

Individuals with VWM disease commonly have symptoms such as impaired muscle movement, cognitive decline, and seizures. While symptoms often begin to appear between ages 2 and 6, the disease can present at any age. The disease course is chronic and progressive, and stressors such as fever, infection, and mild head trauma may cause episodes of rapid deterioration. There is currently no cure and no treatment approved for VWM disease.

“Since our founding, Calico has been focused on generating new scientific insights on biology relevant to aging and translating those insights to develop drug candidates for potential patient benefit,” said Dr Arthur D Levinson, founder and CEO of Calico. “[This compound] is an encouraging outcome of this approach and we are pleased to advance this clinical study in vanishing white matter disease. We are grateful to all the participants in this important trial and are hopeful that [it] will demonstrate its potential as a treatment for this devastating condition.”

Alchemab reveals Huntington’s data

Antibody discovery company Alchemab Therapeutics presented data on a potential first-in-class disease modifying therapeutic for Huntington’s Disease at the annual CHDI Huntington’s Disease Therapeutics Conference.  Alchemab’s innovative, target agnostic discovery platform, which combines data analysis of hundreds of millions of individual antibodies with classical laboratory-based drug discovery techniques, has discovered antibodies which bind to multiple extracellular forms of mutant Huntingtin and lead to the uptake of Huntingtin by microglia.

The data includes the outcome of work showing that Alchemab’s antibodies are highly effective at immunodepleting high molecular weight HTT species and reducing the seeding potential of HTT aggregates isolated from R6/2 mouse model brains.

“For the first time today, we are showing data on our potential first-in-class therapeutic for Huntington’s disease, and it is an excellent example of the way we are turning drug discovery on its head,” said Jane Osbourn, Chief Scientific Officer at Alchemab. “Our unique approach of identifying shared B–cell antibodies from cohorts of people who show resilience to neurodegenerative disease is allowing us to rapidly identify novel targets and further build our exciting pipeline.”

Twinn.health launches age-related disease detection platform

Health technology company Twinn.health announced the launch of its AI-driven imaging platform, which aims to revolutionize the early detection of age-related diseases. The platform, built on over a decade of research at Imperial College London, leverages advanced AI algorithms to analyze MRI data and provide risk assessments for common causes of frailty up to 10 years earlier than current methods.

Twinn.health’s platform is the first of its kind to use MRI data for risk assessment in the context of frailty. It identifies chronic age-related diseases earlier than traditional molecular signals, making it a powerful tool for early intervention and prevention. The platform has been validated through a retrospective clinical study involving 400 patients and three radiologists, with promising results.

“Twinn.health’s AI-powered platform offers a game-changing solution for age-related disease detection and management,” said Dr Wareed Alenaini, founder and CEO of Twinn.health. “Our mission is to unlock the true potential of imaging data to improve health outcomes and prevent multiple diseases with a single MRI scan.”

Mesoblast lands $40m private placement

Allogeneic cellular medicine company Mesoblast (Nasdaq: MESO) announced the completion of a global private placement raising approximately US$40 million, net of transaction costs. Proceeds will be used to fund the launch and commercialization of the company’s lead product, remestemcel-L, in the treatment of children with steroid-refractory acute graft versus host disease. This is subject to US FDA approval of Mesoblast’s resubmitted Biologics License Application.

The funds will also be used to initiate patient enrolment in a Phase 3 clinical trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease.

“We appreciate the strong support from our major shareholders as we look forward to commercializing our platform technology and bringing the first FDA approved treatment to children with life-threatening SR-aGVHD,”said Dr Silviu Itescu. CEO of Mesoblast.

HCW Biologics secures $26m asset-backed loan

Immunotherapy company HCW Biologics (NASDAQ: HCWB) has entered into a $26.25 million development line of credit agreement. This five-year, non-amortizing loan, collateralized with real estate assets, provides project financing for the buildout of the company’s new headquarters and manufacturing facility.

Funds formerly earmarked for this purpose will be redeployed for clinical development, including multiple Phase 2 clinical trials in cancer indications to continue to evaluate the company’s injectable, bifunctional fusion protein molecule for reduction of senescence, and a Phase 1b clinical study in an autoimmune disease.

“This financing provides us with a cash runway well into 2025 and the ability to continue to execute our strategy on multiple levels,” said Dr Hing C Wong, founder and CEO of HCW Biologics. “With this financing, we now have the necessary funding for the mid-phase clinical development programs of our lead product candidate without going to the equity markets for capital during a time when market conditions are not favorable – especially for biotech.”

Synartro gets OA trial go-ahead

Swedish life sciences company Synartro has been granted approval to start a Phase 1/2a first-in-human clinical study of its investigational drug candidate in patients with symptomatic knee osteoarthritis. The trial is planned to start turn of the year 2023/2024.

The candidate is a joint injection treatment targeting knee OA, which has a unique binding that enables a slow release of the active substance, with expectations of a prolonged reduction of inflammation and pain relief. Local administration means systemic side effects are reduced.​

“We are excited to announce that we have obtained approval from the Swedish MPA and Swedish Ethical Review Authority to start the first clinical trial,” said Mia Brundin, CEO of Synartro. “This is a great milestone for Synartro and for the development of SYN321 as a treatment for symptomatic knee OA, and the result of the Synartro team’s hard work and commitment.”

Celularity shifts focus to next-generation NK cell therapy

Placental-derived cell therapy company Celularity (Nasdaq: CELU) announced preliminary results from its Phase 1 trial of its investigational unmodified natural killer cell therapy for acute myeloid leukemia (CYNK-001). Based on preliminary analysis of the Phase 1 trial data, this trial will now be closed to further enrollment as Celularity refines the trial design for subsequent studies with a next-generation, genetically modified, NK product candidate (CYNK-301).

“In a very challenging clinical environment of treatment-resistant disease, where the optimized cellular immunotherapy regimen has yet to be determined, this trial has given us valuable insight into our unmodified NK-cell therapy, CYNK-001, as well as how we should identify those AML patients who might benefit most from therapy and the best approach to modifying NK cells in order to optimize their efficacy in treating AML,” said Dr Adrian Kilcoyne, Celularity’s Chief Medical Officer. “As we look to the future, these results, as well as recent important learnings from the broader scientific community, will support the development of CYNK-301, Celularity’s next-generation genetically modified NK cell therapy candidate in AML.”

Humacyte partners with JDRF on diabetes

Bioengineered tissue and organ company Humacyte (Nasdaq: HUMA) partnered with JDRF International to advance the development of Humacyte’s Biovascular Pancreas product candidate in type 1 diabetes.

Humacyte’s BVP is designed to deliver insulin-producing islets using Humacyte’s investigational tissue-engineered blood vessel, the Human Acellular Vessel. JDRF will provide Humacyte with funding to support the development and testing of the BVP.

“We are proud to be collaborating with JDRF, one of the leading organizations in the world focused on T1D research,” said Dr Laura ​​Niklason, founder and CEO of Humacyte. “Humacyte’s HAV technology, combined with insulin-producing islets, may constitute a groundbreaking development in the treatment of T1D in the future. Successful development of the BVP could improve the lives of millions of patients, and their families, who are suffering with this chronic and debilitating disease.”

VeriSIM partners with Clarivate

Drug development AI company VeriSIM Life announced a partnership with Clarivate to help researchers make early and accurate predictions about compound safety and efficacy. Together, the companies aim to provide pharmaceutical and biotech companies with R&D insights to de-risk and accelerate drug discovery and avoid late-stage failures during clinical trials.

“This collaboration will enable Clarivate customers to access VeriSIM’s powerful virtual drug development engine and deep expertise with our biosystem simulations,” said Dr Jo Varshney, CEO of VeriSIM Life. “Our goal is to help our clients bring their therapies from bench to bedside faster and more efficiently.”

BioAge to present brain aging data

Longevity biotech company BioAge Labs announced that it will provide updates on the company’s progress in novel target identification and drug development in the brain aging area at upcoming conferences in the US and UK.

The BioAge platform has implicated multiple mechanisms in brain aging, including chronic activation of the NLRP3 inflammasome and declining apelin pathway activity. BioAge is developing a novel class of CNS-penetrant NLRP3 inhibitors for neurodegenerative and neurosensory disorders associated with aging, and its apelin receptor agonist BGE-105 for multiple indications.

“Brain aging can lead to devastating neurological conditions, which affect millions of people every year,” said Dr Kristen Fortney, CEO and co-founder of BioAge. “Our discovery platform reveals biological drivers of cognitive decline that could be targeted with novel therapeutics to prevent, slow, or reverse neurodegeneration across the full continuum of disease, from early stages to established dementias. We are excited to share our innovative clinical vision and strategies with partners and investors at leading conferences this quarter.”