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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

Seven years after founding Roivant Sciences as an upstart contender in the world of biotech creation, Vivek Ramaswamy and his recently anointed CEO Matt Gline are gliding into Nasdaq on the gilded wings of a cash-heavy SPAC.

In a carefully crafted SPAC pact aimed at wedding new investors at Montes Archimedes Acquisition Corp. with a syndicate of investors coming back to re-up for the next round of company building, they’ve assembled a fresh $611 million in financing for Roivant — $411 million held in trust from the investors in MAAC with a fresh $200 million from the syndicate.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.