This week's Lab Notes has items on two key developments for a Bala Cynwyd biotech company, a new CEO at a Villanova drug developer, and a medical device company's FDA designation for a product it is developing.
Here is the roundup:
Larimar Therapeutics (NASDAQ: LRMR)
The Bala Cynwyd biotechnology expects to close a $70 private stock offering on Friday.
Larimar, led by CEO Dr. Carole Ben-Maimon, is selling nearly 22.23 million shares of common stock at $3.15 apiece, which is equal to the company's closing price on Sept.13.
Deerfield Management and other undisclosed life science investors are participating in the offering.
Larimar has granted underwriters a 30-day option to purchase an additional 3,333,750 shares to cover over allotments. If exercised in full, the amount raised by the stock offering would grow to $80.5 million.
The company plans to use the proceeds to support the clinical development of CTI-1601, its lead new drug candidate which is being developed as a potential treatment for Friedreich's ataxia, and for working capital and general corporate purposes, including research and development expenses.
Friedeich's Ataxia is an inherited disease that causes progressive damage to the nervous system and movement difficulties. An estimated 15,000 people in the U.S. and Europe are afflicted with the disorder.
Earlier this week, Larimar received notice from the Food and Drug Administration that the agency was lifting a clinical hold it had on the company's testing of CTI-106. The move clears the way for the company to initiate a Phase 2 dose exploration trial of the new drug candidate, which Larimar expects to begin during the fourth quarter of this year.
The clinical hold was initiated last year after Larimar informed the agency of mortalities which occurred at the highest dose levels in a 26-week non-human primate toxicology study designed to support extended dosing of patients. At the time of the initial notice, Larimar had no interventional clinical trials with patients enrolled or enrolling.
The FDA maintained the clinical hold in February.
Prolifagen Therapeutics
The Villanova biotech startup focused on developing medicines for cardiac regeneration has appointed a new chief executive.
M. Alexander Shaw was named CEO and will lead Prolifagen's efforts to develop new medicines to prevent development of heart failure in patients with large myocardial infarctions. Shaw was previously chief operating officer at Nuventra Pharma Sciences of Durham, North Carolina, where he co-led the clinical pharmacology consulting firm until its sale last year to Cato SMS.
He succeeds Claudine Bruck, who co-founded Prolifagen in 2016 and led the company through its initial pre-clinical studies of its microRNA therapeutic, miR-302. Bruck will remain with the company as chair of its board of directors.
Shaw's "drug development expertise along with his experience in running and growing a business makes him a perfect fit for leading Prolifagen as it begins to bring it's therapeutics through pre-clinical studies and into the clinic" Bruck said.
Curvebeam AI
The Hatfield medical technology company said its diagnostic software product OssView has received Breakthrough Device Designation from the FDA.
OssView calculates a structural fragility score, which determines bone microstructural deterioration, as a clinical aid to help medical provides determine bone fragility and fracture risk in females over the age of 70. OssView is investigational only, and is not available for sale in the U.S.
The goal of the FDA's Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices that provide for more effective treatment or diagnosis of irreversibly debilitating diseases by accelerating their development, assessment, and review — while preserving the statutory standards for premarket approval or clearances.
The current standard of care to determine fragility fracture risk in patients is bone mineral density measurements obtained via dual energy X-Ray. Such bone mineral density measures the amount of bone; but it does not measure the breakdown of three-dimensional bone architecture.
"There is a clear need for an improved clinical aid to help clinicians more effectively assess bone health and prevent fractures," said Greg Brown, CEO of CurveBeam.
The structural facility score produced by CurveBeam's OssView is calculated from a high resolution peripheral quantitative computed tomography scan of the wrist. The test helps a doctor identify patients with osteopenia or normal bone density with fracture risk so treatment can be given to prevent fragility fractures.
Earlier this month, CurveBeam signed a definitive merger agreement with an Australian medical software company — which the companies described as a precursor to an initial public offering sometime next year.
Quick Hits
Fort Washington antibiotics developer Nabriva Therapeutics (NASDAQ: NBRV) instituted a 1-for-25 reverse stock split of its ordinary shares of common stock. The reserve split was approved by the company's stockholders in August.… Onconova Therapeutics (NASDAQ: ONTX) of Newtown said updated data from an investigator-sponsored Phase 1/2a trial of oral rigosertib, along with the checkpoint inhibitor nivolumab, showed "an early and encouraging signal of efficacy" in patients with a certain type of advanced, non-small cell lung cancer. The ongoing trial's principal investigator is Dr. Rajwanth Veluswamy, an assistant professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai in New York City.… Precision-oncology company Fore Biotherapeutics of Philadelphia presented new data for its lead drug candidate, FORE8394, that it said provides evidence of durable anti-tumor activity and patient benefit in BRAF-mutated cancers. Matthew Ros, Fore's CEO, said the company is on track to initiate a global Phase 2 trial for FORE8394 next quarter.… EpiVario, a Philadelphia biotech company developing novel therapeutics for memory-related psychiatric disorders, was awarded a grant of nearly $260,000 from the National Institute on Alcohol Abuse and Alcoholism to advance research on its proprietary small molecule inhibitors designed to reduce alcohol craving responses and help people with alcohol use disorder prevent relapse.
