Israeli drug developer BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) announced last Thursday the full results of the trial of its treatment of pancreatic cancer, one of the deadliest and most difficult to treat types of cancer. In the trial, which involved 36 patients, BiolineRX's drug was tested in combination with leading immunotherapy drug Keytruda (pembrolizumab), marketed by Merck & Co., Inc. (MDS). BiolineRX's share price, which initially responded to the results with a jump of over 10%, reversed direction and wound up 12% lower than before the announcement, thereby pushing the company's market cap down to $26 million. The share has lost 68% of its value over the past year and 92% in the past five years.
The drug was tested on patients in the later stages of the disease who had already unsuccessfully undergone chemotherapy. Because of the rapid deterioration of patients in this condition, the efficacy of the treatment could be evaluated for only 22 of the patients in the trial. Seven of these patients (32%) experienced some improvement and the disease was stable in 10 of the patients, meaning that 77% of the patients responded positively to the treatment, compared with improvement in 17% of comparable patients and stable results in 52% of comparable patients with the prevailing form of chemotherapy. The results appear to be statistically significant. According to the company, the safety profile matches what is expected from chemotherapy treatments.
Is statistical success sufficient?
The trial was statistically successful, but the share's response does not reflect all of these benefits observed in the trial, for which there can be several reasons. For example, the market perceives this level of improvement as inadequate for bringing a new drug to market, especially for a young company that currently lacks the resources to do so.
BiolineRX began as a company for developing many drug projects initiated by Dr. Aharon Schwartz, then head of innovation at Teva Pharmaceuticals, together with Morris Lester. The partners in this venture were Teva, Pitango Venture Capital, Giza Venture Capital, Star Ventures, Hadasit Bio-Holdings, and the Jerusalem Development Authority. The company brought a number of products to advanced clinical trials, including a drug for treatment of schizophrenia and a polymer to help rebuild stronger heart muscle tissue following a heart attack. A number of unsuccessful licensing deals and trials, however, led to the current situation, in which BiolineRX has a single leading product - BL-8040, which it acquired from Israeli company Biokine Therapeutics. BiolineRX is developing the drug for a number of indications for cancer and stem cell mobilization in transplants.
The company has also undergone far-reaching changes in its ownership structure. From being owned mainly by Israeli funds and concerns, following offerings on the Tel Aviv Stock Exchange and Nasdaq and many other subsequent financing rounds, the leading shareholder in BiolineRX is now San-Francisco-based BVF Partners with a 15.8% stake, with most other shares in the company being held by the public.
Published by Globes, Israel business news - en.globes.co.il - on December 15, 2019
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