News briefing: Exelixis rolls the dice with 2 ADC deals tied to $35M cash upfronts; A rare antibiotic win for prominently-backed Spero – Endpoints…

Posted: September 12, 2020 at 12:49 pm

Catalents Redwood Bioscience subsidiary is taking the lead role in developing ADCs for Exelixis $EXEL. In one of 2 deals announced this morning, Exelixis is turning to Catalent to do the discovery work on the ADCs, which will employ their SMARTag site-specific bioconjugation platform technology using antibodies out of the biotechs pipeline.

Catalent gets $10 million upfront to trigger the deal, with Exelixis holding worldwide development rights on anything it chooses.

In a separate ADC development deal, Exelixis is turning to NBE-Therapeutics for another pact that could steer more product candidates its way. In this deal Exelixis is paying $25 million upfront to get a 2-year alliance underway.

Exelixis is pursuing both internal drug discovery and external business development approaches to build a pipeline with the potential to make a difference for patients with cancer, saidPeter Lamb, the CSO at Exelixis. John Carroll

Back in the days when investors thought there was still good business to be made in antibiotics, Spero raised a fair bit of capital: a $30 million Series A and B led by Atlas Ventures, a $51.7 million Series C led by GV, and a $77 million IPO. In 2018, they received an up to $54 million contract with BARDA too.

The market for antibiotics has since soured, but that cash has allowed Spero to get through Phase III with its lead drug. And on Tuesday they announced positive results, showing in a 1,372-person study that their oral antibiotic tebipenem was non-inferior to the approved IV antibiotic ertapenem in treating patients with complicated urinary tract infections and acute pyelonephritis.

The drug, said trial investigator Keith Kaye, will give cUTI patients a new oral option after evolving microbiotic resistance had left them with only the IV drug.

Due to the increasing prevalence of antibiotic-resistant bacteria, many patients with cUTI now receive intravenous antibiotics as their only available treatment option, Kaye, who is also director of research in the division of infectious diseases at the University of Michigan Medical School, said in a statement. The much-anticipated data from this head-to-head comparison against an IV standard-of-care carbapenem antibiotic suggest that in many instances oral, outpatient treatment of these complicated bacterial infections is a viable option.

Spero CEO Ankit Mahadevia said it would be the first oral cUTI drug approved in 26 years. The company said it plans to start a rolling NDA and complete it by the second quarter of 2021.

An approval would be a major boon to any biotech, but when it comes to antibiotics, regulatory success doesnt necessarily translate into commercial success. Melinta and Achaoegen are well proof of that. Jason Mast

A UK-based biotech is buying outright a software developer in Brooklyn, NY, in order to bring artificial intelligence to its diagnostics tools.

APIS Assay Technologies announced the acquisition of Beogenomics on Friday, hoping to use data-mining processes to identify biomarker targets in oncology, as well as inflammatory, autoimmune and infectious diseases. The technology from Beogenomics, which has been developing both on-prem and secure cloud-based data analysis solutions, will help support the launch of a new proprietary service line. APIS mainly works in R&D and diagnostics, developing new tests for the prediction, prevention, and diagnosis of disease from discovery to regulatory approval.

The companys business model focuses on three aspects: biomarker diagnostics development, molecular diagnostic contract development, and applied bioinformatics. Max Gelman

Intravacc, a Dutch vaccines company, landed an up to $9.4 million contract from NIAID to develop a vaccine for enterovirus D68, a respiratory virus that can cause paralysis and has become increasingly common in America, Europe and Asia over the last few years.

The small biotech, which also has programs for RSV, gonorrhea and of course Covid-19, will develop an inactivated virus vaccine in Vero cells. The contract is for early product selection through Phase I. Jason Mast

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News briefing: Exelixis rolls the dice with 2 ADC deals tied to $35M cash upfronts; A rare antibiotic win for prominently-backed Spero - Endpoints...

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