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Tuesday, July 14, 2020

FDA OKs J&J’s Tremfya for psoriatic arthritis

The FDA approves Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies’ Tremfya (guselkumab) for adult patients with active psoriatic arthritis, the first IL-23 inhibitor to receive the nod in the U.S. for these patients.
The FDA first approved Tremfya in July 2017 for adults with plaque psoriasis.

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10x Genomics launches next-gen immune profiling product for COVID-19

10x Genomics (NASDAQ:TXG) announces the commercial launch of its Chromium Single Cell Immune Profiling v2 product that, it says, extends the capabilities of the first version and is used by researchers to understand COVID-19 to advance science for the development of vaccines, antiviral drugs and clinical treatments related to SARS-CoV-2 infection.
According to the company, the v2 product provides a comprehensive approach to simultaneously examine cellular heterogeneity of the immune system, T and B cell repertoire diversity, and antigen specificity at single cell resolution. It also offers up to a 60% increase in gene detection sensitivity.
Shipments will begin at month-end.

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Fosun Pharma’s application for licensed COVID-19 vaccine product OK’d in China

The National Medical Products Administration has accepted clinical trial application of Shanghai Fosun Pharmaceutical for the COVID-19 vaccine product candidate BNT162b1 (the “Vaccine”), in-licensed from BioNTech (BNTX +8.9%).
The Vaccine candidate is a prophylactic biological product, aiming at the precaution of COVID-19 for people who aged 18 or above.
In March 2020, Fosun Pharma obtained the license from BioNTech to jointly develop the vaccine in China.

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Akebia launches vadadustat study in COVID-19 complication

Akebia Therapeutics (AKBA -0.2%) has initiated an investigator-sponsored study evaluating the use of vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19 infection.
The study will enroll up to 300 adult patients who have been hospitalized for hypoxemia due to COVID-19. Patients will be dosed with vadadustat or a placebo starting within 24 hours of hospital admission and continuing for up to 14 days.
This study is being conducted under a FDA IND application.

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XBiotech antibody shows potential for treating stroke-related brain injury

XBiotech (XBIT +2.6%) announces encouraging results from research conducted in Switzerland that supports the rationale of interleukin-1 alpha (IL-1⍺) blockade for reducing brain damage and neurological deficit after a stroke.
In a mouse model of cerebral ischemia (specifically, reperfusion injury), treatment with the company’s anti-human IL-1α antibody (after artery blockage but before resumption of blood supply) showed 36% less brain damage (reduction in reperfusion injury) compared to controls.
The company plans to advance the candidate into the clinic next year.
It sold bermekimab, an anti-human IL-1α antibody, to Johnson & Johnson in December 2019 for $750M upfront and up to $600M in milestones for use in dermatology. It retains all rights to develop IL-1⍺ inhibitors for all other potential indications.


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Biotech properties bright spot in U.S. real estate

While the COVID-19 pandemic pressures most of the U.S. real estate sector, including hotels, shopping centers and senior housing communities, it has stoked demand from life sciences companies developing vaccines and treatments for the respiratory infection due the need for laboratory space.
Last week, Alexandria Real Estate Equities (ARE +1.2%), the largest life sciences real estate investment trust in America, raised $1.1B via a new share offering which was significantly oversubscribed.
Other life sciences-focused real estate players are beefing up their coffers. Blackstone Group-owned BioMed Realty plans to add 2.5M sq. ft. (Boston, San Diego, Seattle) to its 11M sq. ft. portfolio.
In April, Toronto-based Brookfield Asset Management (BAM -0.2%) acquired a 50% stake in Harwell Campus, a 700-acre life sciences campus near the University of Oxford for more than  £200 million ($251 million).
Over-supply, as always, could spoil the party. Jason Kaufman, SVP at Silverstein Properties Inc., says, “This has been the institutional focus du jour. Now everyone who operates a loft-style building in New York City thinks they have a life-sciences building.”
Opportunists looking to cash in on the demand should be wary of the high costs and hidden complexities of space used for scientific and medical research, including the need for sophisticated ventilation and gas & water delivery systems. Alexandria founder and executive chairman Joel Marcus adds, “If you don’t know what you’re doing, you blow yourself up.”

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Albireo initiates late-stage study of Odevixibat in pediatric liver disease

Albireo Pharma (ALBO +1.9%) has enrolled first patient in global Phase 3 trial (BOLD) of odevixibat for biliary atresia, expanding the development of odevixibat to a second rare cholestatic liver disease indication.
Odevixibat selectively inhibits a protein called the ileal bile acid transporter (IBAT), which plays a key role in transporting bile from the liver to the colon.
200-subject trial’s primary efficacy endpoint is improvement in the proportion of patients who are alive and have not undergone a liver transplant after two years of treatment, compared to placebo.
Children in the treatment arm will receive odevixibat and escalate to 120 μg/kg orally once daily for 24 months.
In addition to the BOLD and PEDFIC 1 trials, Albireo is finalizing a third pivotal trial of odevixibat in Alagille syndrome and anticipates to initiate the trial by the end of 2020.

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