Daniela Salvemini. Saint Louis University

MPM backs new biotech in the hunt for non-opi­oid painkiller

A new MPM Cap­i­tal-backed com­pa­ny is join­ing the search for a bet­ter way of treat­ing chron­ic pain.

Six years af­ter its qui­et birth out of a St Louis lab, BioIn­t­er­vene un­veiled an MPM-led $30 mil­lion Se­ries A fund­ing round to take its lead drug, BIO-205, in­to hu­man proof-of-con­cept stud­ies. They an­nounced a new CSO too: Charles Co­hen, a neu­ro­science vet­er­an of Mer­ck, Bay­er, Ver­tex and most re­cent­ly Xenon.

BIO-205 “demon­strates pro­found ac­tiv­i­ty in mul­ti­ple mod­els of neu­ro­path­ic and in­flam­ma­to­ry pain as both a sin­gle agent and in com­bi­na­tion with mor­phine and gabapentin,” Co­hen said in a state­ment. “If we can re­pro­duce these da­ta in our clin­i­cal tri­als, BIO-205 has the po­ten­tial to ame­lio­rate tremen­dous suf­fer­ing while al­so play­ing a key role in ad­dress­ing the opi­oid epi­dem­ic.”

You can add BioIn­t­er­vene to the grow­ing num­ber of biotechs search­ing for new meth­ods of pain re­lief – a long-dor­mant hunt that’s picked up in the wake of the opi­oid abuse epi­dem­ic. Some of that re­search has fo­cused on re­pur­pos­ing NSAIDs such as ac­eta­minophen. More com­mon­ly, though, re­searchers have looked for new neur­al path­ways.

That in­cludes groups like Xenon, who have fo­cused on in­hibit­ing the NaV1.7 sodi­um re­cep­tor – al­though Roche and Bio­gen both aban­doned their NaV1.7 pro­grams in 2018 amid clin­i­cal fail­ure. Eli Lil­ly-part­nered Cen­trex­ion is us­ing a com­pound found in chili pep­pers that tar­gets the TR­PV1 re­cep­tor. Still, oth­ers have tried to find bet­ter opi­oids based on a con­cept called bi­ased ag­o­nism. Most of the work is ear­ly-stage.

BioIn­t­er­vene comes out of Saint Louis Uni­ver­si­ty pro­fes­sor Daniela Salvem­i­ni’s work on the A3 adeno­sine re­cep­tor (A3AR). The four dif­fer­ent adeno­sine re­cep­tors had long been in­ves­ti­gat­ed for the roles they may play in can­cer, in­flam­ma­tion and im­mune-re­lat­ed dis­eases.

But in 2012 Salvem­i­ni be­gan pub­lish­ing work sug­gest­ing that an A3AR ag­o­nist could “turn off” pain sig­nals from the spinal cord. In 2014, she formed BioIn­t­er­vene to de­vel­op that work in­to treat­ments of chron­ic pain.

The ag­o­nists are the­o­rized to work by restor­ing a form of neu­ro­trans­mis­sion called GA­BA sig­nal­ing that is dis­rupt­ed in cer­tain forms of pain. Over the 6 years lead­ing up to the Se­ries A, Salvem­i­ni pub­lished an­i­mal stud­ies show­ing the ag­o­nist’s po­ten­tial to treat the pain from can­cer drugs and oth­er caus­es.

Neu­ro­path­ic pain has been a par­tic­u­lar­ly thorny area for drug de­vel­op­ers, with the few ex­ist­ing drugs com­ing with sig­nif­i­cant side ef­fects. Salvem­i­ni has in­sist­ed their re­cep­tor can curb pain with­out the side ef­fects.

“The pro­tec­tive ef­fect of A3AR ag­o­nists in sev­er­al mod­els of chron­ic neu­ro­path­ic pain in­clud­ing that caused by wide­ly used chemother­a­peu­tic agents does not de­sen­si­tize over time with con­stant drug ex­po­sure, and there is no risk of ad­dic­tion,” she wrote in a 2015 note in Ex­pert Opin­ion on Ther­a­peu­tic Patents. 

BioIn­t­er­vene will fo­cus first on pain, but they’re ex­plor­ing one oth­er ther­a­peu­tic area: neu­rode­gen­er­a­tion. There are few de­tails yet but Salvem­i­ni pub­lished a patent in No­vem­ber for us­ing A3 ag­o­nists to ame­lio­rate mi­to­chon­dr­i­al in­jury.

That’ll make two ar­eas of high un­met med­ical need for the young biotech – two that have en­snared a long list of biotechs be­fore them.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.