3 Things In Biotech, July 25: A Chinese Blitz Continues

by: Zach Hartman

BeiGene launches two big studies.

Apellis announces a nod from the FDA.

Celyad gets the go-ahead from the FDA to start a new CAR-T trial.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

BeiGene launches two big studies

Company: BeiGene (BGNE) and Celgene (CELG)

Therapy: Tislelizumab and pamiparib

Disease: Various

News: Over the past several days, BGNE has announced the start of several high-profile studies involving their versions of blockbuster agents like their PARP inhibitor pamiparib, which is being assessed in patients with gastric cancer as a maintenance treatment for patients who respond to chemotherapy. Then, they announced the initiation of a phase 3 trial in non-small cell lung cancer for their PD-1 inhibitor tislelizumab, which just showed favorable results in Hodgkin lymphoma, covered in yesterday's edition of 3 Things.

Looking forward: BGNE has made a lot of splash with their moves over 2018 with their iterations of these big drugs. The big difference maker is that they'll have near-exclusive access to a nearly untapped Chinese oncology market, in addition to holding their own in the other markets around the world. If this works out, then CELG's big licensing foray will look quite prescient.

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Apellis announces a nod from the FDA

Company: Apellis Pharmaceuticals (APLS)

Therapy: APL-2

Disease: Geographic atrophy

News: APLS announced that the FDA has granted Fast Track designation for their C3 complement inhibitor APL-2 for the treatment of geographic atrophy, an advanced for of age-related macular degeneration. This news precedes plans the company has to launch a pivotal trial in the disease with APL-2.

Looking forward: Fast Track designation is a good start for APL-2, and APLS needs to build some momentum as it continues a drift downward from the highs seen earlier this year. Back in January I recommended that the $20 price per share represented a significant gamble, as it is unclear whether APLS will be able to fund operations. This news is a positive, but I don't know that it will be enough to right the ship here.

Buy, sell, or hold? Locked

Celyad gets the go-ahead from the FDA to start a new CAR-T trial

Company: Celyad (CYAD)

Therapy: CYAD-101

Disease: Unresectable colorectal cancer

News: CYAD announced that the FDA has approved their IND seeking to begin trials with a non-gene edited allogeneic CAR-T cell product called CYAD-101. This technique makes use of off-the-shelf CAR-T cells that express an inhibitor of the signaling that leads to graft-versus-host disease, one of the deadliest complications of allogeneic transplantation. Patients with colorectal cancer will be the first to receive this therapy, in combination with chemotherapy for unresectable disease.

Looking forward: CYAD is building an exciting pipeline of therapies for various diseases, and this approval to move forward builds on that momentum. It's difficult to tell when we might see the earliest results from this study, since it has not yet begun to enroll patients. Possibly ASCO 2019 at the earliest, I would imagine, but it could take longer than that, even, if the trials do not get started soon.

Buy, sell, or hold? Locked

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