Mike Narachi gets a $19M shot at a new ap­proach to gene ther­a­py — and he has an­oth­er big mar­ket in mind

Mike Narachi is back at the helm of a start­up biotech. And once again he’s tak­ing on a big tar­get mar­ket — with the help of a ven­ture syn­di­cate that has at­tract­ed some of the top cor­po­rate in­vestors in the in­dus­try.

Narachi, you may re­call, steered Orex­i­gen through some huge de­vel­op­ment chal­lenges to join a group of new weight loss drugs that de­buted on the mar­ket. He sur­vived the de­vel­op­ment risk and an ini­tial FDA re­jec­tion, won a close­ly-watched ap­proval and sol­diered on to com­mer­cial­iza­tion. And that’s where he and the team were de­ci­sive­ly de­feat­ed — along with the oth­ers that tried and failed to find a niche for them­selves.

Now that Orex­i­gen has been sold for parts, the ex­pe­ri­enced biotech vet has jumped back in­to the game with a $19 mil­lion launch round for South San Fran­cis­co-based Co­da Bio­ther­a­peu­tics. 

At Co­da, the small team — less than 10 staffers — is work­ing on a new ap­proach that in­volves gene ther­a­py. They’re en­gi­neer­ing a neu­ro­trans­mit­ter re­cep­tor with plans to de­liv­er it in a gene via a vi­ral vec­tor de­liv­ery ve­hi­cle tar­get­ed at er­rant neu­rons. Cor­rect­ing those neu­rons should be enough to ad­dress chron­ic neu­ro­path­ic pain — pro­vid­ed they can be prop­er­ly mod­u­lat­ed by a drug that can be used to ac­ti­vate or de­ac­ti­vate the gene ther­a­py.

Joe Glo­rioso

The sci­ence comes out of the lab of Joe Glo­rioso, a pro­fes­sor in the De­part­ment of Mi­cro­bi­ol­o­gy and Mol­e­c­u­lar Ge­net­ics at the Uni­ver­si­ty of Pitts­burgh School of Med­i­cine.

That’s a sim­ple plan to ex­plain, but seems dev­il­ish­ly com­pli­cat­ed to de­liv­er for the 19 mil­lion Amer­i­cans who suf­fer from the con­di­tion.

“The first aim is build a plat­form ap­proach to dis­eases not ad­dressed by cur­rent tech­nol­o­gy,” Narachi tells me. The $19 mil­lion, he says, should get them a can­di­date some­time next year, with an aim to be in the clin­ic in 2021. And that team of his will dou­ble un­der the A round.

“I think we’re fo­cused on build­ing this plat­form and then lever­ag­ing against clin­i­cal in­di­ca­tions where gene ther­a­py is in­ad­e­quate,” he adds. “The first aim is build a plat­form ap­proach dis­eases not ad­dressed by cur­rent tech­nol­o­gy.”

So what did he learn from Orex­i­gen that can help him now?

Pa­tient en­gage­ment, he replies. Through it all, the work was about pa­tient re­cruit­ment, clin­i­cal tri­als and then com­mer­cial­iza­tion, scram­bling to build an on­line sales chan­nel. It’s all valu­able ex­pe­ri­ence, he says, for what lies ahead.

He has some promi­nent sup­port­ers for this next stage of his ca­reer.

Lead in­vestors MPM Cap­i­tal and Ver­sant Ven­tures were joined in the round by Astel­las Ven­ture Man­age­ment and No­var­tis.


At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Philip Dormitzer

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

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

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.