Processing Your Payment

Please do not leave this page until complete. This can take a few moments.

March 31, 2020 Bioscience Notebook

Kleo partners with Korean firm on COVID drug; Medtronic shares IP on ventilator design to address shortage

IMAGE | Pixabay.com
By Natalie Missakian

New Haven biotech Kleo Pharmaceuticals Inc. said Tuesday it is collaborating with a South Korean company to advance a potential drug targeting COVID-19.

The Science Park-based startup said it was working with South Korea’s Green Cross LabCell (GCLC) on a treatment that would combine Kleo’s ARM (antibody recruiting molecule) technology with that company’s “natural killer” cell therapies.

Kleo, which typically specializes in cancer drugs, is one of several Connecticut bioscience firms to announce R&D on a COVID-19 drug or vaccine in recent weeks, joining Shelton’s NanoViricides, Meriden’s Protein Sciences and others.  

“As a physician trained in infectious disease, I was on the forefront of the HIV infection epidemic in the 1980s,” said CEO Doug Manion, MD,  in a statement. “We bear a responsibility to advance our anti-COVID-19 program as rapidly as possible to determine its utility in the fight.”

In February the U.S. Food & Drug Administration gave Kleo the green light to begin human testing on a drug for multiple myeloma, a type of blood cancer. The drug induces the body’s natural killer cells to recognize and destroy the cancer cells. 

Kleo said the same ARM technology can be used to rapidly develop a treatment for COVID-19 by redirecting a patient’s own antibodies for a therapeutic effect. 

The ARM would work first by acting as a neutralizing antibody to block direct binding of the virus to human cells. It would then enlist “immune effector cells” to eliminate viral particles and infected cells, the company explained.

Kleo said the drug would also produce a long-term “vaccination effect” by activating and expanding immune memory cells. 

Manion said the company’s ability to quickly tackle a COVID-19 treatment underscores a key feature of its compounds, which have been described as similar to biologics but faster and easier to design and produce.

Manion told New Haven BIZ in an email Tuesday morning that the company expects to begin preclinical testing on the drug this month and is working with the FDA to accelerate the timeline for human studies.

 * * *

Medtech giant Medtronic, which has a large manufacturing presence in North Haven, announced Monday it would publicly share the design specs for one of its ventilators in response to a global shortage.

As the pandemic intensifies in the U.S., the need for additional ventilators is crucial because many patients with severe COVID-19 need respiratory support to survive.

Medtronic said product and service manuals, design requirement documents, manufacturing documents and schematics for its PB 560 ventilator are now available at www.Medtronic.com/openventilator. Software code and other information will follow shortly, the company said.

The PB 560 is a compact, light and portable ventilator introduced in 2010 and sold in 35 countries, according to Medtronic.

It can be used in a range of care settings, and its technology and design makes it ideal for “manufacturers, inventors, startups and academic institutions seeking to quickly ramp up ventilator design and production,” the company said in a news release. 

“Medtronic recognizes the acute need for ventilators as life-saving devices in the management of COVID-19 infections,” said Bob White, the company’s executive vice president. “We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett 980 ventilators. But we also know we can do more, and we are.”

“By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19,” White added.

The Minnesota-based company manufactures ventilators at its Galway, Ireland facility.

* * *

Here’s another dose of good news for migraine sufferers: Biohaven Pharmaceuticals’ newly approved drug to stop migraine attacks in progress is effective at preventing them, too, according to clinical trial results the company shared Monday.

The New Haven biopharmaceutical firm said patients who took the drug, rimegepant, as part of a Phase 2-3 clinical trial reported fewer migraines per month compared to both a baseline and those taking a placebo. The difference from the placebo was statistically significant, Biohaven said.

Biohaven began selling the drug under the brand name Nurtec ODT earlier this month after it won FDA approval in February as an acute migraine treatment.

Based on the trial results, the company said it plans to ask the FDA later this year for permission to market the drug as a preventative therapy as well. 

“If successful in expanding our label for Nurtec ODT to include prevention, patients for the first time will have the convenience of one oral medication to treat their migraine across the spectrum instead of having to mix different acute and preventive medications,” said CEO Vlad Coric, MD, in a statement. Biohaven said it will also seek expanded approval of the drug in Europe.

The drug is part of a new class of migraine drugs known as CGRP receptor antagonists, which work by blocking a brain chemical that transmits pain. 

While most other CGRP drugs require injections, Biohaven’s dissolves in the mouth without the need for water. 

Patients enrolled in the trial who took the drug every other day had an average of 4.5 fewer migraine-days per month, compared to 3.7 fewer days in patients taking a placebo, Biohaven said. 

Coric said rimegepant is so far the only CGRP drug to demonstrate effectiveness in both stopping and preventing an attack.  

Officials hope that gives Biohaven an advantage over much larger competitors in a crowded migraine treatment market.

Meanwhile, Biohaven announced plans last week to advance its migraine nasal spray drug, vazegepant, into Phase 3 clinical trials after a promising meeting with federal regulators. Phase 3 trials are the final stage in the regulatory process for a new drug. 

* * *

Guilford’s Butterfly Network, maker of a pocket-sized ultrasound device, has named Laurent Faracci  its new CEO effective April 1.

Faracci spent more than 20 years with Reckitt Benckiser, a British consumer goods conglomerate, most recently as its executive vice president. 

Butterfly said Faracci joins the medtech company as it looks to accelerate its growth and help combat the impact of COVID-19.

“We find ourselves at a moment in time where the clinical utility of and necessity for mobile lung ultrasound is perhaps more important than ever before,” Faracci said in a statement. 

Faracci’s appointment as CEO also comes as the company plans to start marketing its product in Canada following an expedited regulatory approval as a result of the COVID-19 pandemic.

Butterfly announced its Butterfly IQ hand-held ultrasound received medical device licensing from Canadian health regulators on Friday. 

Officials said a point-of-care ultrasound can be useful for triaging and monitoring patients impacted by COVID-19.

“Given current constraints on health care, from timing to surge capacity, we are not going to be able to use some of the traditional assessments and treatment options,” said Adam Thomas, MD, an emergency physician in Victoria, British Columbia, in a news release. 

Founded in 2011 by Connecticut serial entrepreneur and genomics pioneer Jonathan Rothberg, Butterfly is one of seven companies housed in Rothberg’s Guilford-based 4Catalyzer bioscience accelerator. The Bill and Melinda Gates Foundation is among its major investors. 

* * *

New Haven’s Cybrexa Therapeutics announced Tuesday that it has appointed Arthur DeCillis, MD, acting chief medical officer as it prepares to begin human testing on its first cancer drug early next year.

DeCillis will oversee clinical trials for Cybrexa’s lead drug CBX-12, which targets solid tumors, as well as other clinical programs in Cybrexa’s portfolio, the Science Park-based biotech said.

DeCillis is currently president of DeCillis Consulting LLC, which provides consulting services to the pharmaceutical and biotech industries in the oncology space.

With previous roles at Novartis and Bristol-Myers Squibb as well as small biotech firms, DeCillis has more than 20 years experience in the industry and has worked on multiple oncology projects with more than $1 billion in sales, Cybrexa said.

“We anticipate quickly growing into a company with multiple clinical-stage programs, and Art’s leadership will be a critical part of this transition,” said Connecticut serial entrepreneur Per Hellsund, Cybrexa’s President and CEO. 

Contact Natalie Missakian at news@newhavenbiz.com

Sign up for Enews

Most Recent

Most Recent

0 Comments

Order a PDF