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