3 Things In Biotech, June 18: Some More Good Heme News!

Includes: ATRA, BGNE, BLRX
by: Zach Hartman

BioLineRx gives a favorable look at their heme transplant recovery treatment.

BeiGene updates on its BTK inhibitor program.

Atara glimpses strong results in its customized cell therapy.

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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.

BioLineRx gives a favorable look at their heme transplant recovery treatment

Company: BioLineRx (BLRX)

Therapy: BL-8040

Disease: Bone marrow transplantation

News: BLRX presented findings from its phase 2 study involving the CXCR4 antagonist BL-8040 in patients undergoing stem cell transplantation for blood cancer. The primary endpoint of the study was the rate of collecting a specific number of hematopoietic stem cells from donors. In all, 19 of the 21 patients who received one of two doses of BL-8040 achieved this endpoint. Donated bone marrow engrafted in a median of around 13 days, and the therapy was well tolerated overall.

Looking forward: These findings are promising for this stem cell mobilization technique, as currently donors have to undergo almost a week of treatment with a colony stimulating factor to help boost the number of stem cells they can donate. This is associated with significant potential toxicity and discomfort, and the potential life-threatening toxicity is unacceptable for patients who do not have cancer. The engraftment findings here suggest that BL-8040 achieves comparable results, but in a single dose of the agent, instead of over many days.

BeiGene updates on its BTK inhibitor program

Company: BeiGene (BGNE)

Therapy: Zanibrutinib

Disease: Various B-cell malignancies

News: BGNE provided an update on the development of their BTK inhibitor zanibrutinib, an agent analogous to ibrutinib and acalabrutinib, in the management of various heme malignancies. This coincided with data presentations at EHA describing the use of zanibrutinib in mantle cell lymphoma and Waldenstrom's macroglobulinemia. Patients experienced high response rates in both diseases. The company intends to submit its first marketing applications later this year in 2018 to the Chinese authorities.

Looking forward: I continue to feel strongly about BGNE as a company one will regret ignoring. Currently, they're taking a beating partly on the news that Bristol-Myers (NYSE:BMY) got their PD-1 drug approved in China, a first for the entire class. But they have a cache of drugs that have a strong chance of approval in a market largely untapped by Western pharmaceutical companies. These findings are continued signals that BGNE is going to achieve something special with their lines of agents from classes that have been used in America for years now.

Atara glimpses strong results in its customized cell therapy

Company: Atara Biotherapeutics (ATRA)

Therapy: Tabelecleucel

Disease: Epstein-Barr virus (EBV)-positive cancers

News: ATRA presented findings from a phase 1/2 study involving tabelecleucel in patients with rituximab-refractory EBV-positive lymphoma at EHA 2018. ATRA divulged that response rates ranged from 50% to 69% in lymphoma following hematopoietic cell transplantation or solid organ transplantation, respectively. In the latter patient group, median overall survival was 21.3 months, and this endpoint had not been reached in the patients with lymphoma after heme transplantation. In patients who achieved a response, over 80% were alive after 3 years.

Looking forward: These are important findings for a study addressing a major problem for patients. Viral reactivation can be a serious complication in these patients who need to undergo some form of substantial immunosuppression. However, as we know, certain viruses can cause cancer, as well, such as EBV. So we need as many treatment options as we can get. Cell therapy may be extremely well positioned to attack this problem, as the virus will make very specific antigens that can be targeted. This helps to explain the favorable results shown at EHA! I think this could be a signal for an important line of development for ATRA and tabelecleucel.

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