An Update on NextGen Class of 2019: Allogene, Gossamer and Viela

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Each year, BioSpace evaluates biotech startups for the last year and applies an algorithm that includes funding, collaboration, the state of their pipeline and editorial awards for innovation. These become the "Nextgen Bio Class of…" top life sciences startups to watch.

Although it’s probably unfair to look at the NextGen Bio “Class of 2019” so soon, we thought we to would see how a few of our picks were doing. And it’s obvious they were good choices.

Allogene Therapeutics. Hitting the number one spot, South San Francisco-based Allogene Therapeutics had launched with a $300 million Series A venture round in April 2018 with investors that included Pfizer and Gilead Sciences. The company is working on something that is a bit of a Holy Grail in immuno-oncology—off-the-shelf products.

Currently, CAR-T products are individualized to the patients. A cancer patient’s T-cells are collected, sent to the company’s laboratory where they are engineered to specifically target certain tumor markers, then infused back in the patient, where they become a living therapy, growing immune cells that attack the cancer. Off-the-shelf or allogeneic CAR-T therapies would derive from healthy patients and would not require back-and-forth and customization.

At launch, Allogene had access to 16 preclinical CAR-T licenses that Pfizer licensed from Cellectis and Servier. In January 2019, Allogene’s ALLO-501 was cleared by the U.S. Food and Drug Administration (FDA) to begin a clinical trial in relapsed/refractory non-Hodgkin lymphoma (NHL). In February, the company leased a 118,000-square-foot cell therapy manufacturing plant in Newark, California to manufacture its AlloCAR T therapy.

In June 2019, the FDA cleared the company’s IND for ALLO-175 in patients with r/r multiple myeloma. The Phase I part of the UNIVERSAL trial will also include ALLO-647 as part of the lymphodepletion regimen.

In September, the company inked a collaboration deal with Stanford University to investigate a novel nucleic acid delivery system, which Allogene believes can advance its AlloCAR T therapy program. Two months later, in November, the company signed a development deal with Toronto-based Notch Therapeutics to develop universally compatible, allogeneic T-cell therapies. The collaboration and license deal is to research and develop induced pluripotent stem cell AlloCAR products for initial application in NHL, leukemia and multiple myeloma. The two companies will create allogeneic cell therapy candidates from T-cells or natural killer (NK) cells using Notch’s Engineered Thymic Niche (ETN) platform.

Gossamer Bio. Launched in 2018, San Diego-based Gossamer Bio was number two on our list. The company launched with $100 million in Series A financing, followed six months later with a $230 million Series B financing. The company focuses on immunology and fibrosis, inflammation and immuno-oncology.

In February 2019, Gossamer launched its initial public offering (IPO), raising about $317.5 million. In November, the company presented research at a number of scientific meetings, including the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, National Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, and the American Heart Association (AHA) Scientific Sessions.

Also in November, Gossamer inked a clinical collaboration deal with Merck to evaluate Gossamer’s GB1275, a first-in-class oral modulator of CD11b, and Merck’s checkpoint inhibitor Keytruda in advanced solid tumors. The Phase I/II trial, KEYNOTE-A36, launched in the U.S. and UK.

At this time, Gossamer has three ongoing Phase II clinical trials and three ongoing Phase I trials in various diseases, including eosinophilic asthma, chronic rhinosinusitis, chronic spontaneous urticaria, pulmonary arterial hypertension, inflammatory bowel disease and cancer.

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Viela Bio. Launched in 2018, Viela Bio spun out of MedImmune and in February 2018, closed a Series A financing worth $282.3 million. The company focuses on severe inflammation and autoimmune diseases by targeting shared critical pathways. It launched with three clinical and three preclinical drugs from MedImmune, including inebilizumab, for neuromyelitis optica.

In January 2019, the company’s N-Momentum pivotal trial of inebilizumab hit its primary and key secondary endpoints in neuromyelitis optica spectrum disorder. It showed a 77% reduction in the risk of developing an NMOSD attack in the patients with the drug as a monotherapy compared to placebo. In April, the FDA granted the drug Breakthrough Therapy Designation.

In May, Viela entered a collaboration deal with Hansoh Pharmaceutical Group to develop and commercialize inebilizumab in China for NMOSD, as well as other possible inflammation/autoimmune and hematologic malignancy indications. The deal could hit more than $220 million-plus tiered royalties on net sales. In June, the company closed a $75 million Series B raise, bringing its total capital raised to more than $300 million. In August, the FDA accepted the company’s Biologics License Application for inebilizumab for neuromyelitis Optica Spectrum Disorder.

In October, the company closed its IPO, raising about $172.6 million. Not long after, it signed a collaboration deal with Mitsubishi Tanabe Pharma Corporation to develop and commercialize inebilizumab in nine Asia regions for NMOSD. Viela received an upfront $30 million licensing fee with additional milestone payments.

Then in December, Viela dosed the first patient in its Phase IIb trial of VIB4920 for Sjogren’s syndrome. VIB4920 is a fusion protein that binds to CD40L, blocking T-cell interaction with CD40-expressing cells.

Check out BioSpace's 2020 top life sciences startups and previous NextGen Bio classes:

NextGen Bio "Class of 2020."

NextGen Bio "Class of 2018."

NextGen Bio "Class of 2017."

NextGen Bio "Class of 2016."

NextGen Bio "Class of 2015."

 

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