Yer­voy in­ven­tor's on­col­o­gy start­up Pi­o­nyr gets $62M for tu­mor-fight­ing tech

An on­col­o­gy com­pa­ny co-found­ed by one of the in­ven­tors of Yer­voy has closed a $62 mil­lion round to push its an­ti-tu­mor tech to­wards the clin­ic.

Steve James

The start­up, called Pi­o­nyr Im­munother­a­peu­tics, is de­vel­op­ing an­ti­body ther­a­peu­tics that boost the body’s im­mune re­sponse at the site of the tu­mor. New En­ter­prise As­so­ci­ates led the round, along with new in­vestors Sofinno­va and Vi­da Ven­tures. Ex­ist­ing back­ers in­clud­ing Or­biMed joined the round.

Pi­o­nyr’s tech, which the com­pa­ny calls “Myeloid Tun­ing,” at­tempts to re­bal­ance the tu­mor mi­croen­vi­ron­ment to fa­vor im­mune-ac­ti­vat­ing myeloid cells. Es­sen­tial­ly, the an­ti­body will tar­get and de­stroy the myeloid cells that sup­press the body’s nat­ur­al tu­mor-fight­ing im­mune re­sponse, leav­ing the im­mune-ac­ti­vat­ing myeloid cells alive and strong. Pi­o­nyr’s CEO Steve James tells me the com­pa­ny plans to test this ap­proach in com­bi­na­tion tri­als with check­point in­hibitors and as a stand­alone treat­ment. In an­i­mals, the drug has proven to boost the per­for­mance of check­point in­hibitors.

Max Krum­mel

The com­pa­ny should have a pret­ty good idea of how they might im­prove the per­for­mance of a check­point in­hibitor. Af­ter all, Pi­o­nyr was co-found­ed by Max Krum­mel, the UC San Fran­cis­co pro­fes­sor who co-in­vent­ed the first check­point ­– Bris­tol-My­ers Squibb’s Yer­voy.

James said the com­pa­ny be­gan look­ing for next-lev­el treat­ment op­tions back in 2015, when the com­pa­ny was found­ed. Back then, fo­cus­ing on myeloid cells was pi­o­neer­ing. To­day, how­ev­er, “myeloid” has be­come a bit of a buzz­word in on­col­o­gy, with lots of com­pa­nies queu­ing up the area for R&D.

“You’re find­ing a num­ber of Big Phar­mas have grav­i­tat­ed to the idea,” James said. “They’ve re­al­ized that you can’t have 50 check­point in­hibitors on the mar­ket. There has to be a new ap­proach that could work as an en­hance­ment to check­point in­hibitors or open up ar­eas they’re not get­ting good re­spons­es in.”

In fact, Bris­tol-My­ers it­self has a pro­gram that in­volves elim­i­nat­ing myeloid cells. The phar­ma gi­ant paid Five Prime $350 mil­lion up­front two years ago to part­ner on the an­ti­body pro­gram called colony stim­u­lat­ing fac­tor 1 re­cep­tor (CSF1R), which re­cent­ly shared dis­ap­point­ing da­ta from a com­bo tri­al with Op­di­vo.

James said the BMS pro­gram doesn’t tar­get im­muno-sup­pres­sive myeloid cells like Pi­o­nyr’s tech­nol­o­gy does, but rather tar­gets mul­ti­ple myeloids.

“It will be in­ter­est­ing to see how their broad­er mech­a­nism of ac­tion will play out in clin­i­cal tri­als,” James said.

James wouldn’t dis­close which can­cers Pi­o­nyr will be tak­ing on, but did say the com­pa­ny was in sev­er­al pre­clin­i­cal tri­als and ex­pects INDs in 2019.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.