Israeli Startup Ayala Taking BMS Cancer Drug Into Phase II With $17m Financing
Executive Summary
Ayala Pharma, which launched in late 2017, has raised $17m via a series A financing round to propel its lead precision cancer therapy into Phase II – an asset it licensed from Bristol-Myers Squibb.
Ayala Pharma, an Israeli oncology company built around targeted cancer therapies licensed from Bristol-Myers Squibb Co., has raised $17m to take its lead asset into Phase II trials.
The emerging company, based in Rehovot, was founded in December 2017 and is backed by local investors Israeli Biotech Fund (which identified the BMS assets as a spinout opportunity), aMoon and Harel Insurance.
Ayala wants to shed new light on gamma secretase inhibitors. The company licensed two candidates from BMS at the end of last year that are in development for the treatment of cancers with altered Notch genes: BMS-906024 and BMS-986115.
As part of the deal, BMS received an upfront payment, became a shareholder of Ayala, and is eligible to receive certain development, regulatory, and sales-based milestones, as well as tiered annual net sales royalties. Ayala is responsible for all future development and commercialization of the two product candidates.
Ayala CEO Roni Mamluk told Scrip in an exclusive interview that the $17m – raised via a series A funding round – will take the company up to initial Phase II results for its lead asset. Ayala will start a Phase II trial for BMS-906024, a drug it considers to be a best-in-class gamma secretase inhibitor, before the end of 2018. The company expects to focus on metastatic adenoid cystic carcinoma (ACC) as a lead indication.
Roni Mamluk, CEO of Ayala Pharma
ACC, for which there is no approved treatment on the market, is an uncommon form of malignant neoplasm that arises within secretory glands, most commonly the major and minor salivary glands of the head and neck.
Mamluk said the product candidates were available because they did not fit with BMS's cancer strategy. Now the startup, which has 15 employees currently, is moving swiftly to get its operations off the ground. Ayala expects to report initial results for the first few patients from the open-label Phase II trial in the first half of next year.
Mamluk, who is the former CEO of Chiasma Inc. and still a member of its board of directors, said Ayala was already positioning clinical development of its lead drug for a US FDA filing. The company expects to target the US market first once it has data from later stage trials.
Mamluk added that as well as advancing its lead drug, it wants to license another product candidate soon. "We don't want to be a single-asset company," she said. The firm will also seek further funding in the near future – which is likely to include local and foreign investors.
Getting Traction In Precision Meds Market
Mamluk said Ayala's chair of the board, David Sidransky, a co-founder and managing partner of Israel Biotech Fund, had propelled the development of the new company and added weight to its standing in the competitive oncology development arena. Sidransky was previously vice chair of ImClone Systems until its acquisition by Eli Lilly & Co., and he holds chair and board member positions at several Nasdaq-listed biotech companies.
Ayala's chief exec said the company was able to raise $17m so quickly after its founding because of the "people involved and the potential to tailor its drug for precision cancer treatment."
BMS-906024 was developed as a Notch inhibitor for oncology indications and preclinical studies showed robust, broad-spectrum efficacy in traditional and PDX (Patient Derived Xenograft) models in T-cell acute lymphoblastic leukemia (T-ALL), triple-negative breast cancer, non-small cell lung cancer, colorectal and pancreatic carcinoma. In Phase Ib clinical studies carried out by BMS, given once a week by intravenous injection, the molecule displayed strong pharmacokinetic/pharmacodynamic attributes and was tolerable with manageable side effects in 205 cancer patients.
As well as a Phase II trial in ACC, Ayala will explore the use of BMS-906024 in other indications, such as triple-negative breast cancer.
Mamluk noted that the precision medicine market was being carved out by other, more advanced drug developers and that Ayala's cancer therapy would be able to slot in, if efficacy for the drug was replicated in further studies. She added that molecular testing panels already included Notch gene screening. She also noted that the drug would be more affordable than some of the other personalized cancer therapies that were coming to marketing. "We are not expecting CAR-T prices," she said.
Ayala's CEO is presenting the company at the upcoming MIXiii Biomed conference, Israel’s leading international life science conference and exhibition, held in Tel Aviv, May 15-17.