Paul Wotton, Obsidian CEO

A new clutch of biotech blue-chip­pers joins Ob­sid­i­an's quest to craft next-gen drugs with an 'on' switch

The brain­child of se­r­i­al biotech en­tre­pre­neur Michael Gilman, Ob­sid­i­an is hop­ing to bring some­thing new to the par­ty with “on-switch” tech­nol­o­gy for a range of po­ten­tial drug ap­pli­ca­tions. Ob­sid­i­an now has a new trea­sure chest to play with — and an IPO feels on­ly a fin­ger­tip away.

Ob­sid­i­an closed a $115 mil­lion Se­ries B with a new group of biotech blue-blood in­vestors join­ing the Cam­bridge, MA biotech’s al­ready stacked syn­di­cate of back­ers, the com­pa­ny said Thurs­day.

New in­vestors in­clude round leader The Col­umn Group Crossover Fund with par­tic­i­pa­tion from Pe­ter Kolchin­sky’s RA Cap­i­tal, Sur­vey Cap­i­tal, Cowen Health­care In­vest­ments, Deep Track Cap­i­tal, Lo­gos Cap­i­tal, Piv­otal BioVen­ture Part­ners, Sam­sara Bio­Cap­i­tal and Soleus Cap­i­tal. That mur­der­er’s row joins ex­ist­ing in­vestors At­las Ven­ture, Ver­tex Ven­tures HC,  Am­gen Ven­tures, and Bris­tol My­ers Squibb on board once again.

Ver­tex, who re­cent­ly signed a deal with Ob­sid­i­an to fold the biotech’s tech­nol­o­gy in­to reg­u­lat­ed gene edit­ing drugs, al­so joined in on the round.

On top of part­ner­ships with Ver­tex and Bris­tol My­ers, Ob­sid­i­an is ad­vanc­ing a lead tu­mor in­fil­trat­ing lym­pho­cyte (TIL) drug that has its eyes set on first-in-hu­man tri­als in metasta­t­ic melanoma af­ter an IND sched­uled for mid-2022. The drug, dubbed cy­toTIL15, is en­gi­neered to con­tain a mem­brane-bound IL-15 cy­tokine, mit­i­gat­ing the need for con­cur­rent sys­temic IL-2 ther­a­py, and what the biotech calls a drug-re­spon­sive do­main (DRD) that reg­u­lates its ac­tiv­i­ty.

The DRD acts as an ef­fec­tive “on switch” for the drug, with sci­en­tists able to mod­u­late ac­tiv­i­ty with FDA-ap­proved small mol­e­cules act­ing as the fin­ger on the switch. It’s a tech­nol­o­gy that CEO Paul Wot­ton said can cut the risk of tox­ic side ef­fects while of­fer­ing physi­cians a de­gree of per­son­al­ized con­trol over a pa­tient’s care.

That tech is promis­ing enough that both Bris­tol My­ers and Ver­tex have tak­en fly­ers on the biotech’s pipeline, hop­ing to add an on-switch for their cell and gene ther­a­pies. In Sep­tem­ber 2020, Bris­tol My­ers opt­ed in on one of Ob­sid­i­an’s can­di­date, an an­ti-CD40L cell ther­a­py, that is cur­rent­ly in pre­clin­i­cal stud­ies — “right be­hind” cy­toTIL15, Wot­ton told End­points News. The part­ners’ col­lab­o­ra­tion dates back to Jan­u­ary 2019.

For Ver­tex, the cys­tic fi­bro­sis gi­ant inked a deal with Ob­sid­i­an in April for $75 mil­lion up­front and re­search mile­stones and $1.3 bil­lion in biobucks to part­ner up on con­trolled CRISPR gene edit­ing drugs, part of Ver­tex’s mis­sion to ex­pand its flag­ship fran­chise in­to next-gen meds.

The drug cy­toTIL15 is a prod­uct of Ob­sid­i­an’s rel­a­tive­ly new col­lab­o­ra­tion with the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter in Hous­ton. The part­ners teamed up in No­vem­ber to de­vel­op that can­di­date and less than a year lat­er the drug is ap­proach­ing its mo­ment in the sun. While metasta­t­ic melanoma is the first tar­get, Wot­ton sees promise for cy­toTIL15 in oth­er sol­id tu­mors, in­clud­ing head and neck and cer­vi­cal can­cers to name a cou­ple.

“We elect­ed to go af­ter metasta­t­ic melanoma first be­cause it’s well char­ac­ter­ized, but I think the op­por­tu­ni­ty set for us a com­pa­ny goes well be­yond that,” he said.

It’s a busy slate for Ob­sid­i­an as it ad­vances its own in­ter­nal can­di­date while meet­ing the ex­pec­ta­tions of its big-name part­ners, but Wot­ton said the com­pa­ny is ready to keep its foot on the gas ped­al with a se­ri­ous crossover syn­di­cate back­ing up its ef­forts. And on that syn­di­cate, by the way, Wot­ton isn’t shy: Ob­sid­i­an will spend the next year — like­ly much short­er — scout­ing an IPO and clear­ly in­tends the com­pa­ny’s cur­rent back­ers to be big play­ers in that of­fer­ing.

“We want­ed to fo­cus specif­i­cal­ly on in­vestors who want­ed to par­tic­i­pate in a crossover,” Wot­ton said. “All of the funds that are in this trans­ac­tion were able to fund this as well as par­tic­i­pate heav­i­ly in an IPO process.”

As the clock ticks there, Ob­sid­i­an’s team ex­pects to ex­pand from its cur­rent work­force of 70 to more than 100 by the end of 2022. The com­pa­ny will al­so grow out of its cur­rent man­u­fac­tur­ing site — a 60,000 square-foot fa­cil­i­ty in Hous­ton — that will pro­duce ear­ly clin­i­cal ma­te­r­i­al in­to a fa­cil­i­ty in Bed­ford, MA, that will act as Ob­sid­i­an’s TIL home base through Phase II and be­yond.

That site will be up and run­ning in Q4 and will have 15 to 25 em­ploy­ees, Wot­ton said.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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Biohaven CEO Vlad Coric

Bio­haven turns out a dud in fa­tal neu­rode­gen­er­a­tive dis­ease, cast­ing doubt on drug's chances in ALS

With one migraine drug on the market, Biohaven has gone big with its next phase of growth, targeting major neurodegenerative diseases in Alzheimer’s and ALS. The former effort has already gone up in smoke, and a new failure elsewhere in the pipeline could now bode poorly for the latter.

Biohaven’s verdiperstat failed to outperform placebo in reducing the symptoms of patients with multiple system atrophy (MSA), a rare and fatal neurodegenerative disorder, according to a “focused analysis” of the drug’s Phase III trial in that disease toplined Monday.

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