Surface Oncology in licensing deal with Glaxo for immunotherapy program

 

• Surface Oncology (NASDAQ:SURF) inks an agreement with GlaxoSmithKline (NYSE:GSK) for worldwide development and commercial rights to its preclinical program SRF813.
• Under the terms of the agreement, Surface Oncology will receive an upfront payment of $85M, potential milestone payments of $730M, as well as be eligible to receive tiered royalties on global net sales.
• “Furthermore, the economics of the transaction position us well to continue to drive the development of our wholly-owned clinical programs, SRF617 and SRF388, while also advancing SRF114, our CCR8 targeted program,” said Jeff Goater, CEO at Surface Oncology.
• “We believe this transaction is further validation of our strong immuno-oncology drug discovery capabilities.” he added.
• SRF813 is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells.
• https://seekingalpha.com/news/3645228-surface-oncology-shares-rise-7-on-licensing-deal-gsk-for-immunotherapy-program

FDA clears AlloVir's ALVR106 application in respiratory viruses

 

• The FDA has cleared AlloVir's (NASDAQ:ALVR) Investigational New Drug (IND) application for ALVR106, an allogeneic, off-the-shelf virus-specific T cell therapy designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV).
• The IND enables AlloVir to initiate a Phase 1/2 proof-of-concept study in allogeneic and autologous hematopoietic stem cell transplant (HSCT) patients with respiratory infections caused by RSV, influenza, PIV or hMPV. The study is expected to begin in 2021.
• https://seekingalpha.com/news/3645249-fda-clears-allovirs-alvr106-application-in-respiratory-viruses

Sigilon Therapeutics' MPS-1 gene therapy an Orphan Drug in U.S.

 

• The FDA grants Orphan Drug designation to Sigilon Therapeutics' (NASDAQ:SGTX) SIG-005 for the treatment of mucopolysaccharidosis type I (MPS-1), a rare inherited disorder in which the body cannot metabolized large sugar molecules called glycosaminoglycans due to a deficiency in an enzyme called IDUA which leads to organ and tissue damage.
• SIG-005 contains a human cell line genetically modified with a non-viral vector designed to express human a-L-iduronidase (IDUA), an enzyme which is missing or defective in patients with MPS-1. The IDUA enzyme is essential for the breakdown of glycosaminoglycans.
• The company anticipates to initiate a Phase 1/2 trial in this patient population in 2H of 2021.
• The Orphan Drug tag may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the U.S. following marketing approval.
• https://seekingalpha.com/news/3645257-sigilon-therapeutics-mpsminus-1-gene-therapy-orphan-drug-in-u-s

Rite Aid EPS beats by $0.45, beats on revenue, guides FY2021 outlook above consensus

 

• Rite Aid (NYSE:RAD): Q3 Non-GAAP EPS of $0.40 beats by $0.45; GAAP EPS of $0.08 beats by $0.58.
• Revenue of $6.12B (+12.1% Y/Y) beats by $280M.
• Adj. EBITDA margin rate down 60 bps to 2.3% vs. consensus of 1.8%.
• For FY2021, revenues to be between $23.9B-$24.2B vs. consensus of $23.46B, with same store sales increase of 3.5%-4.5%; Adjusted EBITDA to be between $490M-520M; Adjusted EPS to be between $0.45-$0.85 vs. consensus of -2.95.

• Press Release

• COVID vaccines are expected to arrive in drugstores like Rite Aid in early spring.

• https://seekingalpha.com/news/3645226-rite-aid-eps-beats-0_45-beats-on-revenue-guides-fy2021-outlook-above-consensus

Otonomy's OTO-413 shows clinical benefit in hearing loss study

 

• Otonomy (NASDAQ:OTIC) gains 10% in premarket on the heels of positive top-line results from Phase 1/2 trial evaluating OTO-413 in subjects with speech-in-noise hearing difficulty. Results include the 9 subjects from the OTO-413 high dose (0.3 mg) cohort with test results on both Day 57 and Day 85 and 8 placebo.
• The trial demonstrated that a single intratympanic injection of OTO-413 was well-tolerated across all dose cohorts, as well as showed therapeutic activity versus placebo across multiple clinically-validated speech-in-noise hearing (SIN) tests.
• 6/9 OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 0/8 for placebo.
• 3 out of 9 OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more different SIN tests vs. 0 in placebo.
• Improvements from baseline were also observed for multiple other exploratory endpoints and for OTO-413 in lower dose cohorts.
• On the safety front, no serious adverse events were reported and no patients who discontinued the trial due to an adverse event.
• Management held a conference call today at 8 a.m. ET, to review the results.
• https://seekingalpha.com/news/3645233-otonomys-otominus-413-shows-clinical-benefit-in-hearing-loss-study

Miragen in license pact with Xencor for tech to treat thyroid eye disease

 

• miRagen Therapeutics (NASDAQ:MGEN) inks an agreement to gain exclusive rights to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend Fc technology from Xencor.
• Under the terms of the license agreement, miRagen will be solely responsible for the activities and costs related to research, development, and if successful, commercialize the product candidates incorporating technologies licensed from Xencor.
•  Xencor will receive an upfront payment, payable in shares of common stock of miRagen, and is eligible to receive certain development and commercial milestone payments, as well as royalties.
• miRagen is developing multiple product candidates to treat patients who suffer from thyroid eye disease, the Company’s most advanced product candidate is intravenous VRDN-001 and VRDN-002 is a second-generation product candidate, distinct from VRDN-001, which incorporates half-life extension technology and is intended for subcutaneous administration.
• The company expects to file an IND applications for both VRDN-001 and VRDN-002 and to initiate a Phase 2 clinical trial of VRDN-001 by the end of 2021.
• https://seekingalpha.com/news/3645235-miragen-therapeutics-enters-license-pact-xencor-for-xtend-technology-to-treat-thyroid-eye

Teladoc Falls On Amazon Telehealth Report

 Teladoc Health 

TDOC 4.56% is falling with news out that Amazon.com AMZN 2.4% is entering the telehealth space.

What Happened: Business Insider is out with a report Wednesday that Amazon is working on efforts to build a national telehealth business.

The efforts would be geared toward big employers; Zillow Z 0.9% is one of the companies mentioned. 

Called Amazon Care, the service is partnering with Care Medical. Employers who are near Amazon headquarters could get online and in-person doctor visits as part of the plan. Employees elsewhere would get virtual offerings from the plan.

Amazon did not comment on the rumor and provided the following statement to Business Insider.

“We do not comment on rumor or speculation. Amazon Care is a healthcare benefit pilot for Amazon employees in the state of Washington.”

Why It’s Important: Shares of Teladoc are up over 130% in 2020. The company completed an $18.5-billion merger with rival Livongo Health. Teladoc is the largest pure-play telehealth company.

Shares of Teladoc are under pressure, as Amazon’s entry could put pressure on its market position. Amazon has a wide base of customers it could market to with a telehealth service.

In November, Amazon announced its plans for Amazon Pharmacy. This service would see drug delivery in 48 states, with discounts to Amazon Prime members.

https://www.benzinga.com/news/20/12/18817435/teladoc-falls-on-amazon-telehealth-report-what-investors-should-know