Claire Mazumdar (L) and Ryan Cohlhepp (Bicara)

Backed by In­di­an biosim gi­ant Bio­con, bis­pecifics play­er Bicara de­buts with $40M and sol­id tu­mors on the radar

Best known state­side for its biosim­i­lars pact with My­lan, In­di­an gener­ics play­er Bio­con has long run a much small­er R&D unit for in-house on­col­o­gy drugs. Now, with at least one of those can­di­dates show­ing promise, Bio­con is prop­ping up a US-based biotech to get things off the ground.

Claire Mazum­dar

Bio­con will shell out $40 mil­lion and spin off bis­pe­cif­ic an­ti­body play­er Bicara — head­quar­tered in Cam­bridge, MA — which is cur­rent­ly test­ing its lead com­pound along­side Mer­ck’s Keytru­da against sol­id tu­mors, the com­pa­ny said Mon­day.

Bicara’s lead can­di­date, an EGFR/TGFβ-trap bis­pe­cif­ic an­ti­body dubbed BCA101, en­tered Phase I/II test­ing in Ju­ly in the US and Cana­da for pa­tients with ad­vanced EGFR-dri­ven sol­id tu­mors who have not re­spond­ed to stan­dard of care.

BCA101 works by tar­get­ing both EGFR pro­teins on the sur­face of cells and al­so “trap­ping” TGFβ — a mul­ti­func­tion­al cy­tokine im­pli­cat­ed in im­mune sup­pres­sion — in the tu­mor mi­croen­vi­ron­ment. Bicara is test­ing the bis­pe­cif­ic as a so­lo ther­a­py and in com­bi­na­tion with Keytru­da for pa­tients pre­vi­ous­ly treat­ed with chemother­a­py, im­mune check­point in­hibitors or tar­get­ed ther­a­pies, the biotech said. The com­pa­ny ex­pects to launch the dose-es­ca­la­tion phase of that study in the back half of the year.

See­ing an on­col­o­gy spin­off from Bio­con may strike US mar­ket watch­ers as odd giv­en its rep­u­ta­tion for biosims. But ac­cord­ing to CEO Claire Mazum­dar, the In­di­an multi­na­tion­al has long been ded­i­cat­ing re­sources to its R&D branch.

“For as long as they’ve been around, (Bio­con has had) a ded­i­cat­ed R&D group fo­cused on nov­el an­ti­bod­ies and nov­el large mol­e­cules,” Mazum­dar said. “The idea was to build out a sep­a­rate com­pa­ny to re­al­ly get the re­sources and at­ten­tion it de­served with the idea that build­ing the lead­er­ship team in the US and bring­ing the clin­i­cal de­vel­op­ment to the US would be a re­al­ly great strat­e­gy. We very much view Bio­con as our lead strate­gic in­vestor, and they’re re­al­ly in­ter­est­ed in bring­ing the mol­e­cule with us side by side and as far as we can bring it.”

Ryan Cohlhepp

In a work­ing arrange­ment per­haps well suit­ed for the pan­dem­ic, Bicara’s ex­ec­u­tive team is housed in Cam­bridge, with a re­search team work­ing un­der con­tract from Bio­con back in Ban­ga­lore. It’s an un­usu­al set­up for a nim­ble, ear­ly-stage biotech but one mod­eled on Big Phar­ma’s glob­al set­up and well suit­ed for Bicara’s mis­sion, COO Ryan Cohlhepp told End­points News.

“It’s a unique sit­u­a­tion for a Cam­bridge start­up, but it’s not nec­es­sar­i­ly unique in the Big Phar­ma mod­el,” Cohlhepp said. “What we’re do­ing is tak­ing those mod­els — sort of the best of Bio­con — and think­ing through the site head mod­el, how we’re go­ing to be able to build the cul­ture be­tween the two or­ga­ni­za­tions, tak­ing the in­no­va­tion of a Cam­bridge start­up and lever­ag­ing some of the work prac­tices of a multi­na­tion­al.”

The Ban­ga­lore team cur­rent­ly sports 65 sci­en­tists work­ing across the de­vel­op­ment spec­trum, Mazum­dar said. The wet labs there are work­ing on build­ing Bicara’s bis­pecifics pipeline, and Mazum­dar said that team is on track de­spite the 10-hour time zone dif­fer­ence from its lead­er­ship team.

“Mov­ing in­to a re­mote and vir­tu­al world, we were very well set up to do that when Covid hit and de­spite the pan­dem­ic we’ve been able to achieve some re­al mile­stones along the way,” Mazum­dar said.

The com­pa­ny scored its first IND in Feb­ru­ary 2020 right as the pan­dem­ic was tak­ing off and dosed its first pa­tient at MD An­der­son Can­cer Cen­ter in Hous­ton in Ju­ly, just as the virus locked down the city.

“De­spite the fact we haven’t been able to go see the team all the time in In­dia, our CSO would say we’re mov­ing with the ur­gency that we want to have,” she said.

Mazum­dar, a for­mer founder at Rheos Med­i­cines and Third Rock se­nior as­so­ciate, is joined by a se­nior lead­er­ship team that in­cludes Cohlhepp, an­oth­er Rheos vet­er­an who for­mer­ly worked with Take­da On­col­o­gy. The com­pa­ny’s sci­ence will be led by CSO Seng-Lai “Thomas” Tan, a vet­er­an of El­star Ther­a­peu­tics and For­ma Ther­a­peu­tics, while blue­bird bio and Pfiz­er vet­er­an Liviu Nicules­cu will take the clin­i­cal lead as CMO.

Ki­ran Mazum­dar-Shaw

The com­pa­ny’s board fea­tures Bio­con founder Ki­ran Mazum­dar-Shaw — al­so Claire Mazum­dar’s aunt — as well as F. Stephen Ho­di, a Har­vard pro­fes­sor and Dana-Far­ber Can­cer In­sti­tute pro­fes­sor, and Nils Lon­berg, for­mer­ly VP of on­col­o­gy bi­ol­o­gy dis­cov­ery at Bris­tol My­ers Squibb.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

From left: James Brown, Michael Chambers, John Ballantyne

Alde­vron founders back a biotech start­up that's look­ing to end the moral de­bate over cell lines once and for all

For millions of Catholics around the world, the development of new vaccines to combat Covid-19 has sparked a moral dilemma. All the approved vaccines in use relied — in some fashion — on cell lines that were derived from aborted fetal tissue.

While church leaders accepted the vaccines and recommended their use to end the pandemic, a number also highlighted their preference for the mRNA vaccines from Pfizer/BioNTech and Moderna over the J&J and AstraZeneca shots, which they noted were more heavily dependent on cell lines that they found morally objectionable.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”