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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

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The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.