Novartis backs $30M round for cancer biotech; Bayer drug makes a ‘breakthrough’ at FDA
→ Ayala Therapeutics — which focuses on rare cancers that occur due to dysregulation of the Notch-activating pathway — has raised $30 million in a round of financing led by partner Novartis.
The funds, which also came from investors including SBI JI Innovation Fund, Israel Biotech Fund, aMoon and Harel Insurance & Finance Group, will be used to fuel the development of its lead drug, AL101. The pan-Notch inhibitor is currently being evaluated for adenoid cystic carcinoma (ACC) in a Phase II trial, and the company is also planning to investigate its use in a mid-stage study in triple negative breast cancer.
In 2017, Ayala inked a deal with Bristol-Myers Squibb $BMY to develop treatments for cancers with altered Notch genes. The following year, it joined forces with Novartis to develop and market another drug, AL102, in combination with BCMA-targeting agents for multiple myeloma patients.
The Israeli biotech raised $17 million in its first round of financing in April 2018.
→ The FDA granted Bayer’s Aliqopa (copanlisib) — used for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two other therapies prior — breakthrough therapy designation based on overall response rate (ORR) from its pivotal Phase II CHRONOS-1 study. The company says that it “is conducting two additional Phase III studies to evaluate the efficacy and safety of Aliqopa in combination with other therapies with iNHL (including MZL) who have relapsed following one or more prior therapies.”
→ German-based Bayer $BAYRY and Foundation Medicine $FMI are entering a global collaboration for the development and commercialization of NGS-based companion diagnostic tests, which help find a possible cancer treatment therapy via molecular information from a patient’s tumor genome. Bayer will also have access to FoundationOne CDx — Foundation Medicine’s sequencing based in vitro diagnostic device.
The first project that will be undertaken is developing a companion diagnostic for Vitrakvi (larotrectinib), the first and only TRK inhibitor approved in the US for adult and pediatric patients with “solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.”
→ AstraZeneca spinout Viela Bio has notched a commercial deal with seasoned Chinese pharma Hansoh centered around inebilizumab, the lead drug among six assets from the pharma giant. The anti-CD19 drug treats neuromyelitis optica spectrum disorder, a rare disease that affects the eye and spine. All told, the deal is worth up to $220 million including upfront and milestones.
→ The Parker Institute is embarking on a new research journey to find out why some patients develop autoimmune disorders following cancer immunotherapy. Together with two other nonprofits (dedicated to diabetes and healthcare respectively), it’s pledging $10 million over three years to support researchers at Yale, UCSF, Virginia Mason and Dana-Farber. The hope is to both advance cancer treatment and better understand how type 1 diabetes develops in general.
→ In 2015, Inovio joined forces with AstraZeneca’s $AZN MedImmune unit for $27.5 million upfront, as well as another potential $700 million in milestone payments — for the exclusive rights to Inovio’s immunotherapy, designed to target cancers caused by human papillomavirus (HPV), in addition to two additional DNA-based cancer vaccine products. On Wednesday, Inovio in a filing disclosed that MedImmune was retaining its rights to the HPV immunotherapy, MEDI0457 (previously called INO-3112), but walking away from the rest.