3 Things In Biotech, June 13: Ripples, Transitions, And A Hint At Something Important

by: Zach Hartman

AbbVie's PARP inhibitor finally begins to make ripples.

Adaptimmune transitions their sarcoma program to GSK with good data.

GT Biopharma could be on to something in B-cell malignancies.

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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.

AbbVie's PARP inhibitor finally begins to make ripples

Company: AbbVie (ABBV)

Therapy: Veliparib

Disease: Small cell lung cancer (SCLC)

News: Researchers from MD Anderson published phase 2 findings in the Journal of Clinical Oncology describing the use of their PARP inhibitor veliparib, combined with standard chemotherapy (temozolomide) for patients with SCLC. Patients did not experience a progression-free survival benefit in the whole population. However, response rates were significantly improved (39% vs 14%). Furthermore, the researchers identified a potential biomarker, SLFN11, which corresponded with a significant improvement in progression-free and overall survival.

Looking forward: This is an interesting development for a drug that has had a lot of trouble getting off the ground. This is thought to be because veliparib has the weakest "PARP trapping" ability of the 5 major developmental or available inhibitors. While it hasn't been definitively shown that this is important, we have seen it play out in the difficulty to show benefit for ABBV's PARP inhibitor, generally. This study is important because it highlights a potential angle for the company to take, as it embarks on other exploratory studies combining veliparib and temozolomide.

Adaptimmune transitions their sarcoma program to GSK with good data

Company: Adaptimmune (ADAP) and GlaxoSmithKline (GSK)

Therapy: NY-ESO-1

Disease: Synovial sarcoma

News: ADAP announced the publication of its pilot phase 1/2 study in patients with synovial sarcoma. The trial concerned the use of engineered T cells, which showed encouraging response rate (50%), duration of response (30.9 weeks), and estimated median overall survival (just over 2 years). GSK exercised their option to license the therapy back in September, and the transition to them is ongoing.

Looking forward: The ability to generate a prolonged immune response in patients is quite encouraging, given that few standard options exist for this form of sarcoma (which makes up 5% of all sarcomas). With only 12 patients in the study, these findings are not going to be the deal-sealer for ADAP and GSK; they need to be confirmed in a larger trial. I imagine, though, that as soon as GSK get their hands on the tech, confirmatory trials will begin in relatively short order.

GT Biopharma could be on to something in B-cell malignancies

Company: GT Biopharma (OTCQB:GTBP)

Therapy: OXS-1550

Disease: Acute lymphoblastic leukemia

News: GTBP announced results from a preliminary review of their ongoing phase 1/2 trial involving the bispecific antibody-drug conjugate OXS-1550 in patients with non-Hodgkin lymphomas and acute lymphoblastic leukemia. Of the 13 patients enrolled so far, 7 have achieved some form of clinical benefit, either in the form of stable disease, partial response, or a complete remission after one month. Toxicity to date has been rather mild and manageable.

Looking forward: It would be premature to draw too much evidence out of this preliminary look into the data. However, compared with something like the TOWER study, we can see some signs of life for this all-in-one drug cocktail. We do not know from the release how heavily pre-treated the patients were, either, but given that new agents have been available for several years, it seems reasonable to presume that the patients have had quite a few courses of therapy. In that case, it's possible that this new drug could come to represent a major advance.

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