The latest longevity updates from our investment news desk.
Stock markets rallied in the past week, with investors boosted by the IMF’s improved forecast for the global economy. It remains to be seen whether this latest rally heralds a genuine change in direction following last year’s sell-off, but there are indications that better days lie ahead for biotech and longevity investing.
Mesoblast resubmits to FDA
Cell therapy company Mesoblast (NASDAQ: MESO) announced it has resubmitted for FDA approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease. The move comes some two years after the therapy was rejected by the FDA and is based on “substantial new information” in terms of its efficacy.
“There is an urgent need for a therapy that improves the dismal survival outcome in children with SR-aGVHD,” said Dr Silviu Itescu, Chief Executive of Mesoblast. “Our team has worked tirelessly over the past two years to provide a comprehensive response to the FDA. We are grateful for the agency’s active dialogue and constructive feedback that will ensure a high bar is met in terms of product consistency and predictability of clinical outcomes.”
Endogena granted Fast Track status
Endogenous regenerative medicine company Endogena Therapeutics announced that its treatment for retinitis pigmentosa has received Fast Track designation from the FDA. Fast Track is a process designed to enable patients to benefit earlier from important new drugs for serious conditions.
The treatment takes a novel, small-molecule approach and selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve or restore visual function. This gene-independent treatment approach has significant advantages in retinitis pigmentosa and was granted orphan drug designation by the FDA in May 2021.
“This acknowledgement by the FDA of the potential of EA-2353 for RP gives hope for patients living with this devastating degenerative disease,” said Dr Matthias Steger, CEO of Endogena. “It is a significant milestone for our company, our investors, and gives recognition to our dedicated team at Endogena, who have been working for the past six years to reach this point.”
NeuroSense commences Phase 2 in Canada
Developer of neurodegenerative disease treatments NeuroSense Therapeutics (NASDAQ: NRSN) a announced the commencement of patient enrolment in Canada for the Company’s Phase 2b PARADIGM study of its combination therapy PrimeC for the treatment of ALS. Currently, over 50% of patients have been enrolled in PARADIGM with topline results expected in the second half of 2023.
“Our North American clinical development strategy got a boost from Health Canada, which approved our Phase 2b PARADIGM study to dose patients,” said Alon Ben-Noon, CEO of NeuroSense. “In the interest of treating and completing dosing of people living with ALS in an expedient and safe manner through PARADIGM, we’ve focused our North American recruitment in Canada.”
Cellvie bags $5.5 million
Therapeutic mitochondria transplantation startup Cellvie closed a $5.5 million financing round led by Taiho Ventures, with participation of existing investors, including Kizoo Technology Capital. Leveraging an approach developed at Harvard Medical School, the company will use the fresh capital to accelerate development of its technology platform, strengthen its team and further establish mitochondria manufacturing, ahead of a Series A round by the end of this year.
“While many companies need to conserve cash and slow down shortly before raising their next round of funding, we are now in the position to speed up and form an even stronger basis to immediately and efficiently put the Series A funding to work,” said Dr Alexander Schueller, co-founder and CEO of Cellvie.
Telocyte secures investment
Telomerase gene therapy developer Telocyte exclusively revealed to Longevity.Technology that it has secured new investment. While the identity of the new investor remains unknown, it appears that the company’s work is now funded through to clinical trials and potentially beyond.
“Ultimately, all age-related diseases are our targets, and luckily, we now have an investor who sees exactly that sort of potential,” said Telocyte founder Dr Michael Fossel. “They are basically willing to underwrite us to an unlimited degree to see if we can take this all the way to the clinic – not only for age-related neurodegenerative diseases and cardiovascular disease, but beyond that as well.”
Nightingale adds genetic risk information
Preventive health company Nightingale Health has combined its unique blood test results with genomic data in the latest release of its Livit by Nightingale Health mobile app. This follows the company’s acquisition of Finnish genetics-testing company Negen last year.
“By adding genetic risk information to Livit, we hope to help our users understand how both genetics and lifestyle are key to preventing common chronic diseases,” sais Jeffrey Barrett, Nightingale Health’s Chief Scientific Officer. “We created an intuitive way for the user to see if they can “beat their genes” by adopting lifestyle changes that reduce their risk compared to people with similar genetic background.”
Scholar Rock appoints CMO
Clinical stage biopharma company Scholar Rock (NASDAQ: SRRK) announced the appointment of Tracey M Sacco as Chief Commercial Officer. The company is focused on the treatment of serious diseases in which protein growth factors play a fundamental role.
Sacco will build and lead all commercial functions at Scholar Rock, including sales, marketing, market access, and commercial operations. Her first priority will be preparing the company for the potential commercial launch of apitegromab, the company’s Phase 3 investigational candidate for spinal muscular atrophy (SMA).