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January 14, 2020 Bioscience Notebook 

Azitra, Bayer ink partnership to develop natural skin care products

PHOTO | Pixabay.com
By Natalie Missakian 

Pharma giant Bayer is teaming up with a Farmington biotech in hopes of creating new natural skin-care products that leverage the benefits of skin-friendly bacteria. 

Azitra Inc., which is expanding and relocating to Branford this spring, announced the joint development agreement with the German life-sciences conglomerate on Friday. If successful, the collaboration could lead to a future licensing deal, Azitra said.  Financial terms of the agreement were not disclosed.

Azitra’s R&D focuses on the skin microbiome, the millions of bacteria and other microorganisms that inhabit the human skin. Recent studies suggest some of these organisms can play a crucial role in protecting the skin and helping it to recover from conditions such as acne, rosacea and eczema. 

Bayer Consumer Health President Heiko Schipper said the microbiome offers “a promising platform” for developing and commercializing the kinds of natural skin-care products that “more and more people are looking for.”

“As Bayer is committed to the development of science-based consumer health products through our own research as well as external partnerships, we’re delighted to collaborate with Azitra,” said Schipper in a statement.

Under the agreement, Bayer and Azitra will use the startup’s proprietary panel of  Staphylococcus epidermidis strains to identify candidates suitable for skin-care products, the companies said. In turn, Bayer, whose skin-care brands include Solarcaine and A&D Ointment, will provide topical formulations “with excellent skin compatibility and sensorial performance” to deliver the beneficial bugs.

The companies said they are exploring medicated skin-care products for sensitive, eczema-prone skin as well as treatments for skin diseases such as atopic dermatitis.

Bayer will also consider the potential of Azitra’s genetically-modified bacteria for use in other consumer health areas, such as nutritionals and digestive health, Azitra said.

“We are strongly committed to the potential of the microbiome to provide significant benefits for improved skin health and appearance, and by working together with Bayer I am confident we can deliver on the promise of this technology,” Azitra CEO Richard Andrews said in a statement. 

Founded in 2014 by Yale scientists, Azitra closed on a $14 million Series A funding round last fall. Now housed at the UConn’s Technology Incubator Program (TIP) accelerator in Farmington, the company plans to relocate to a 12,000-square-foot lab and office facility in Branford by April 1. 

It expects to begin clinical trials on its first drug candidate, which targets a skin rash associated with cancer treatment, later this year. 

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ReNetX Bio’s experimental drug to reverse damage from spinal cord injuries has won a “Fast Track” designation from the U.S. Food & Drug Administration.

The designation makes the New Haven biotech, spun out of Yale, eligible for more frequent interactions with the FDA and can potentially accelerate the regulatory review process.  

Under a program to bring new medicines to patients faster, the FDA awards the label to drugs that treat serious or life-threatening conditions and fill an unmet medical need.

In a statement, ReNetX CEO Erika Smith said the FDA’s designation “recognizes the high unmet medical need in patients with [spinal cord injury].” 

ReNetX’s drug, AXER-204, works by blocking certain proteins that inhibit the regrowth of neurons. Current treatment for spinal cord injury consists primarily of physical and occupational therapy. There is no approved treatment to restore sensory or motor function, according to ReNetX. 

The FDA has previously labeled the drug a “Breakthrough Therapy,” indicating it could offer substantial improvement over available treatments.  

The drug is currently in a Phase 1-2 clinical trial, with results expected in 2021.

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Alexion Pharmaceuticals is eyeing the deadly neuromuscular disease ALS as the next target for its newly approved drug Ultomiris, the successor to its blockbuster Soliris.

Alexion said Tuesday it plans to enroll 350 patients in a 50-week global study of the drug to test its effectiveness in treating amyotrophic lateral sclerosis, also known as Lou Gehrig’s Disease. Current treatments are mostly palliative.

“Given the significant need for new and improved treatments for ALS, we are committed to advancing this clinical program with urgency,” Alexion’s head of R&D John Orloff, MD, said in a statement. 

Alexion said it submitted an investigational new drug application for Ultomiris in ALS with the FDA late last year. The Phase 3 trial is expected to begin this quarter.

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Connecticut serial entrepreneur Per Hellsund’s oncology startup Cybrexa Inc. has replaced its lead drug candidate with a new compound it believes will have a smoother path to regulatory approval.

Cybrexa said its new flagship drug, CBX-12, can be more effective as a standalone therapy than its predecessor, CBX-11, which works best in combination with chemotherapy. The company, which announced the change late last week, had planned to launch clinical trials on CBX-11 early this year. 

“Based on recent findings from preclinical studies of CBX-11, we have decided to prioritize CBX-12,” a spokeswoman said in an email to New Haven BIZ. 

“The value proposition for CBX-11 is dependent upon its synergy with DNA-damaging chemotherapy,” the email said. “This requires a combination therapy clinical development program, which can be a less straightforward (and more expensive) path to reaching patients as quickly as possible.”

Like CBX-11, the new drug uses Cybrexa’s alphalex technology, which deposits cancer-fighting agents directly into tumor cells while sparing healthy tissue. But CBX-12 features a potent anti-cancer drug known as topoisomerase I inhibitor, while CBX-11 uses a PARP inhibitor.

The new compound, which leverages the same class of drugs as the recently approved new breast cancer treatment Enhertu, demonstrated strong efficacy and a solid safety profile in preclinical studies, Cybrexa said.

The company expects to publish preclinical data on CBX-12 by June and advance it into clinical trials by 2021. 

“CBX-12 has tremendous potential to change the treatment paradigm in multiple solid tumors,” said CEO Hellsund in a statement. “We are committed to moving this program rapidly into the clinic, and ultimately benefit as many patients as possible.”

Contact Natalie Missakian at news@newhavenbiz.com

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