Sri Kosuri, Octant CEO

Syn­thet­ic bi­ol­o­gy biotech nets three-hit com­bo in new fi­nanc­ing, Bris­tol My­ers deal and first CSO

A Bay Area biotech an­nounced three new de­vel­op­ments that have been in the works in re­cent months, hop­ing that all have a strong chance at pro­pelling the com­pa­ny for­ward.

The first and newest de­vel­op­ment is the fi­nanc­ing, as Oc­tant — head­ed up by for­mer UCLA pro­fes­sor Sri Ko­suri and found­ed in 2017 — raised $80 mil­lion in a Se­ries B round. It’s the biotech’s largest round to date, and more than dou­bles all its past fundrais­ing com­bined, bring­ing its to­tal fi­nanc­ing so far to $115 mil­lion. Ko­suri told End­points News that the fund­ing gives Oc­tant, which cur­rent­ly has around 50 em­ploy­ees, a cash run­way of two to three years.

While the round was led by biotech VC Catalio Cap­i­tal Man­age­ment, pre­vi­ous and new in­vestors hopped on­to the round, in­clud­ing Bris­tol My­ers Squibb, Allen & Co., 50 Years VC and An­dreessen Horowitz Bio Fund.

Ram­sey Hom­sany

As for what the com­pa­ny plans to do with that mon­ey, co-founders Ko­suri and Ram­sey Hom­sany said that their goal is three-pronged over the next few years: push their two lead­ing drug can­di­dates in­to the clin­ic, scale the size and ca­pa­bil­i­ty of their plat­form any­where from five- to ten­fold and start de­vel­op­ing an­oth­er five to 10 new drug can­di­dates.

So far, Oc­tant’s two lead can­di­dates, still in pre­clin­i­cal de­vel­op­ment, go af­ter au­to­so­mal dom­i­nant re­tini­tis pig­men­tosa — a rare form of blind­ness marked by dam­age to the reti­na — and re­cep­tors linked to me­tab­o­lism and obe­si­ty, re­spec­tive­ly. Ko­suri said that Oc­tant has no de­fin­i­tive time­frame for when it ex­pects to have the drugs in clin­i­cal tri­als.

Oc­tant’s plat­form fo­cus­es on syn­thet­ic bi­ol­o­gy, en­gi­neer­ing small mol­e­cules and test­ing them through hu­man cell lines, bi­o­log­i­cal as­says and ma­chine learn­ing soft­ware.

Sec­ond­ly, Bris­tol My­ers de­cid­ed to team up with Oc­tant in a mul­ti-year col­lab­o­ra­tion deal. While Ko­suri de­clined to give fi­nan­cial specifics, it had been in the works for close to a year and was fi­nal­ized in De­cem­ber. Ko­suri added that the deal was un­re­lat­ed to Bris­tol My­ers’ in­vest­ment in the afore­men­tioned Se­ries B.

The part­ner­ship with Bris­tol My­ers is us­ing Oc­tant’s tech­nol­o­gy to, as Ko­suri put it, sys­tem­at­i­cal­ly test thou­sands of amino acids in hu­man cell lines, go­ing through as many mu­ta­tions as pos­si­ble. Oc­tant and Bris­tol My­ers will ap­ply the tech­nol­o­gy to a set of un­spec­i­fied im­munol­o­gy tar­gets.

Rick Ar­tis

And the fi­nal change for the biotech is on the per­son­nel side. Oc­tant brought on its first chief sci­en­tif­ic of­fi­cer, Rick Ar­tis, and added bio­chemist Feng Zhang to its sci­en­tif­ic ad­vi­so­ry board. Ar­tis, who orig­i­nal­ly start­ed out as a re­searcher at Syn­tex and Genen­tech, worked at Elan, Cho­rum and An­nex­on be­fore com­ing to Oc­tant Bio. Ko­suri told End­points that Oc­tant want­ed Ar­tis’s ex­per­tise in com­pu­ta­tion­al chem­istry.

“We def­i­nite­ly want­ed more drug de­vel­op­ment ex­per­tise in the com­pa­ny. You know, we clear­ly need­ed it, es­pe­cial­ly as the mol­e­cules that we were run­ning in ear­ly dis­cov­ery days are kind of mov­ing to­wards larg­er an­i­mal stud­ies and mov­ing to­wards the clin­ic. But we al­so want­ed some­one with ex­per­tise in this new kind of small mol­e­cule and drug dis­cov­ery plat­form,” Ko­suri said.

The CEO added that Ar­tis got con­nect­ed with Oc­tant through Mark Mur­cko, the found­ing CSO at Dew­point Ther­a­peu­tics. Mur­cko al­so hap­pens to be on the board at Oc­tant, and knew Ar­tis through grad school, with both of them get­ting their PhDs at Yale in or­gan­ic chem­istry.

Ko­suri al­so said he and Zhang have known each oth­er for a few years — and Ko­suri thought that Zhang would be a great ad­di­tion to Oc­tant’s syn­thet­ic bi­ol­o­gy work and help guide the com­pa­ny for­ward in that space.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.