This week's life sciences industry news includes a biopharmaceutical company's new CEO and new direction, a progress report from a company developing treatments for rare skin disorders, a medical device company's expanding product line, and more.
Here's the roundup:
TFF Pharmaceuticals
The biopharmaceutical company, which has operations in New Hope, Bucks County, and Fort Worth, Texas, is moving in a different direction under its new leadership.
Dr. Harlan Weisman, who earlier this month was named TFF's permanent CEO, outlined his strategy for the company in a recent investor call.
During that call, Weisman noted investors have to date largely perceived TFF as a technology platform company, whose core mission was to license its technology to large pharma and biotech companies.
"Moving forward, as TFF transitions to its next phase, our core mission is to develop and bring to market high-value products from our own pipeline based on our thin film-freezing technology," he said.
TFF's film-freezing technology allows existing compounds and new chemical entities to be transformed into dry powder formulations, exhibiting what the company describes as "unique characteristics and benefits" that can be administered at lower doses compared to oral drugs and reduce unwanted toxicities and side effects.
"We don't expect that our new product development strategy focus will limit the upside potential from TFF's ongoing partnerships, and [we] fully anticipate that our partners will continue to evaluate our technology," Weisman said, "but the overarching emphasis is now being placed on value-creating activities which TFF has direct control over — specifically the advancement of our proprietary drug candidates. As a company, we simply cannot put our future in the hands of others, waiting on decisions that may or may not culminate in a formal transaction, particularly when we have clinical-stage assets that hold such tremendous potential."
TFF has two lead drug candidates in the clinic: voriconazole inhalation powder, for invasive pulmonary aspergillosis (a severe fungal infection), and tacrolimus inhalation powder, a prophylaxis for organ rejection in lung transplants. Both experimental therapies are in mid-stage clinical testing.
Palvella Therapeutics
The Wayne biopharmaceutical company focused on rare genetic skin diseases reported progress on the development programs for its lead new drug candidate: Qtorin rapamycin.
Palvella said it has completed enrollment in clinical studies that are investigating Qtorin for the treatment of individuals with pachyonychia congenita and microcystic lymphatic malformations, as well as for the prevention of basal cell carcinomas in individuals with Gorlin Syndrome.
There are currently no FDA-approved therapies or preventions for the three conditions.
“The rapid enrollment of our three ongoing clinical studies reflects the urgent unmet need in each of these diseases," said Wes Kaupinen, founder and CEO of Palvella.
Palvella said it expects to announce Phase 3 trial results from the pachyonychia congenita study in mid-2023. Results from the Phase 2 microcystic lymphatic malformation study are expected next month. Phase 2 study results for the Gorlin Syndrome trial are expected in the second quarter of 2023.
The company's research team, led by Dr. Braham Shroot, developed Qtorin as a therapy that can penetrate the deep layers of the skin to locally treat a broad spectrum of serious, rare genetic skin diseases.
Palvella last month closed a Series D financing valued at up to $37.7 million to accelerate the development and support commercialization of Qtorin.
Tela Bio
The Malvern medical technology firm said this week it has launched two additional, larger configurations of its OviTex LPR device.
Initially commercialized in 2018, OviTex LPR is designed specifically for use in minimally invasive hernia repair procedures. The company's OviTex reinforced tissue matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
“Since inception, a key design principle for OviTex has been to provide a platform that can be used for all hernia indications and surgical techniques,” said Antony Koblish, CEO of Tea Bio (NASDAQ: TELA). “The new larger configurations will help drive broader utilization in robotic and laparoscopic procedures.”
Quick Hits
The King of Prussia-based Center for Breakthrough Medicines, a contract development and manufacturing organization, has entered into a manufacturing agreement with Virion Therapeutics of Newark, Delaware. The agreement covers Virion's checkpoint modifier clinical development programs, including its experimental VRON-0200 immunotherapy for patients with chronic hepatitis B virus infection. … Verrica Pharmaceuticals (NASDAQ: VRCA) of West Chester raised $32.5 million this week from the sale of common stock and pre-funded warrants. The company plans to use the proceeds from the offering for the commercial launch of VP-102, if the new drug candidate is approved as a treatment for a skin disorder known as molluscum contagiosum. Molluscum contagiosum, an infection caused by a poxvirus, is a common and highly contagious skin disease characterized by lesions or growths that can appear anywhere on the body. The condition afflicts more than 6 million people in the United States. … The board of directors at Warrington-based Windtree Therapeutics (NASDAQ: WINT) approved a 1-for-50 reverse stock split. The company expects the action will bring Windtree into compliance with Nasdaq's $1 minimum bid price requirement.
