3 Things In Biotech, May 20: You Want Some Good News?

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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 a me too PARP inhibitor study in China

Company: BeiGene (NASDAQ:BGNE)

Therapy: Pamiparib

Disease: Platinum-sensitive recurrent ovarian cancer

News: BGNE announced that it has initiated a phase 3 clinical trial investigating a PARP inhibitor, pamiparib, as maintenance therapy for patients with recurrent ovarian cancer, similar to the approved therapies olaparib, niraparib, and rucaparib in the United States and Europe. This study is being conducted exclusively in China.

Looking forward: In America, there are 5 major PARP inhibitors approved or in development: Olaparib, rucaparib, niraparib, talazoparib, and veliparib. This one caught me by surprise, to be honest. I was simply not aware of it, and suddenly they're in phase 3! Sheesh...but that's the Chinese market for you, relatively opaque to many American onlookers like me. But this continues a growing wave. China is potentially a much bigger market, and American companies can't just waltz in and start marketing drugs. BGNE could get away with a very large chunk of market share if this phase 3 study is a success and leads to approval. And since I've started covering it last year, it's done nothing but grow!

I think it's time for you to take a serious look at BGNE!

Abeona Therapeutics shows off more promising data in wound healing

Company: Abeona Therapeutics (ABEO)

Therapy: EB-101

Disease: Epidermolysis bullosa

News: ABEO presented an update to its phase 1/2 trial data at the 21st Annual Meeting of the American Society for Gene and Cell Therapy. This study assessed the safety and efficacy of EB-101, a technique of grafting a patient's skin cells that have been modified to correct the defective COL7A1 gene to promote effective wound healing in patients with epidermolysis bullosa. This study met its primary endpoint of safety and tolerability, and there was a favorable signal of efficacy, as well, with 67% of the patients demonstrating at least 50% wound closure 12 months post-treatment.

Looking forward: These findings continue to build a very interesting picture of EB-101, with a clear trend toward long-term, persistent efficacy for the therapy. ABEO gave insight into the efficacy of the technique as far as 36 months out, where 6 out of 6 patients with this much follow-up had >50% wound closure. Overall, the results of this study bode about as well as I can imagine for a phase 1/2 trial, and I am now wondering if these data will be sufficient to move EB-101 very quickly through the regulatory channels.

Very interesting positive development for ABEO, worthy of a deeper look for your portfolio.

BioLine shows off a winner in AML at EHA

Company: BioLine Rx (NASDAQ:BLRX)

Therapy: BL-8040

Disease: Relapsed/refractory acute myeloid leukemia (AML)

News: BLRX announced that it will be giving a presentation of updated findings from its phase 2a trial investigating its CXCR4 antagonist BL-8040 in patients with relapsed/refractory AML at this year's European Hematology Association Annual Congress. The expansion dose of the drug, in combination with chemotherapy, led to median overall survival of 9.2 months in the dose expansion cohort of patients, which compares favorably with the 6.1 months expected with chemotherapy alone based on historical controls.

Looking forward: These data are very encouraging, although the use of historical controls should give you some pause when trying to draw firm conclusions about efficacy. However, relapsed/refractory AML is a very tough treatment setting, with generally poor prognosis for patients. If CXCR4 antagonism is an effective treatment strategy, I personally will be elated. Without a doubt, this study supports the ongoing development of BL-8040, and I won't be surprised if this is the first sign that the drug will eventually be approved.

Very interesting, and I think this should put BLRX on your radar.

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