Are­navirus­es. They’re small, they’re packed with tiny stolen ri­bo­somes that re­sem­ble grains of sand, they’re re­spon­si­ble for 300,000 to 500,000 hu­man in­fec­tions in West Africa each year, and, if a new Ger­man biotech has their way, they are go­ing to one day treat tu­mors.

Aba­los Ther­a­peu­tics launched to­day with $12 mil­lion in fund­ing to de­vel­op are­navirus­es it hopes can be used in im­munother­a­py for can­cer. The fund­ing was co-led by Boehringer In­gel­heim Ven­ture Fund (BIVF) and Gru­en­der­fonds Ruhr, with par­tic­i­pa­tion from NRW.BANK and High-Tech Gru­en­der­fonds (HT­GF).

CEO Mar­cus Kost­ka

Aba­los Ther­a­peu­tics CSO Jörg Vollmer told End­points News the plat­form stood out for its nim­ble­ness com­pared to oth­er on­colyt­ic virus ap­proach­es.

“We use the nat­ur­al adap­tion pos­si­bil­i­ty and prop­er­ties of the virus adapt­ed to the tu­mor cell,” Vollmer said. “So we are not re­strict­ed, re­al­ly.”

Aba­los is en­ter­ing an in­creas­ing­ly crowd­ed field of small biotechs and phar­ma gi­ants try­ing to lever­age virus­es and the body’s nat­ur­al de­fense sys­tem against them to treat can­cer. Over the last 3 years, As­traZeneca, Mer­ck, Boehringer In­gel­heim, Bris­tol-My­ers Squibb and J&J have inked deals of var­i­ous sizes with on­colyt­ic virus biotechs, with J&J putting up the largest fig­ure at $1.04 bil­lion.

Where­as im­munother­a­pies such as CAR-T re-en­gi­neer im­mune cells to see and tar­get tu­mors, like out­fit­ting a fight­er jet with in­frared or a sub with radar, on­colyt­ic virus­es work by light­ing up the tu­mor cells tar­gets. A virus that is de­signed to prop­a­gate pri­mar­i­ly through can­cer cells is in­ject­ed in­to a pa­tient. The body then car­ries out its nat­ur­al im­mune re­sponse to the virus, which hap­pens to be in can­cer cells.

Un­like oth­er on­colyt­ic virus­es — such as the her­pes-virus-based T-Vec from Am­gen, the first such ther­a­py ap­proved in the US — are­navirus­es don’t them­selves kill cells. Like in the Junin and Las­sa in­fec­tions that are­navirus­es can cause in hu­mans, the dam­age comes from the body’s im­mune re­sponse. In a po­ten­tial im­munother­a­py, that re­sponse would be di­rect­ed to can­cer cells.

Kost­ka told End­points News their plat­form was not anti­gen-spe­cif­ic and thus could be used to tar­get a wide range of can­cers.

Like much of vi­rother­a­py re­search, their work is pre­clin­i­cal. They said they are aim­ing for an IND in three years.

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
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Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.