Yumanity chairman Tony Coles (L) and CEO Richard Peters

Fol­low­ing deep cuts, Yu­man­i­ty strikes a deal to sell drugs to J&J, hands the keys to Genen­tech-part­nered Kine­ta

Yu­man­i­ty has found that “strate­gic al­ter­na­tive” it start­ed search­ing for ear­ly this year as its share price shriv­eled, forc­ing deep staff cuts.

The suf­fer­ing biotech has agreed to sell off most of its pipeline — in­clud­ing a par­tial­ly-held Phase I Parkin­son’s drug, dubbed YTX-7739, and un­part­nered dis­cov­ery-stage neu­ro­science prod­uct can­di­dates — to J&J for $26 mil­lion in cash. And it’s ex­e­cut­ing a re­verse merg­er with the pri­vate biotech Kine­ta, which will wind up with the pub­lic list­ing and Yu­man­i­ty’s Mer­ck-part­nered ALS/fron­totem­po­ral lo­bar de­gen­er­a­tion pro­gram.

YTX-7739 marks Janssen’s first clin­i­cal-stage Parkin­son’s as­set, a com­pa­ny spokesper­son told End­points News in an email. The drug caught the Big Phar­ma’s eyes be­cause of its “po­ten­tial to be the first oral-dis­ease mod­i­fy­ing ther­a­py in PD.” Janssen doesn’t in­tend to test it be­yond PD, at this time, un­like the orig­i­nal own­er’s am­bi­tions of po­ten­tial­ly test­ing the drug in glioblas­toma mul­ti­forme and oth­er dis­eases.

In the re­verse merg­er, Kine­ta will end up with 85% own­er­ship of the com­bined op­er­a­tions with its new name on the mar­quee from now on. The fu­ture of the new Kine­ta is ex­pect­ed to be sup­port­ed by a PIPE fi­nanc­ing of undis­closed amount from Growth & Val­ue De­vel­op­ment Inc.

Yu­man­i­ty was found­ed by the late Su­san Lindquist — an MIT pro­fes­sor and ex­pert in pro­tein fold­ing who died in 2016 — and Tony Coles about eight years ago, amid great hopes for their R&D ap­proach to some tough dis­ease. But it didn’t play out as they had hoped it would.

Yu­man­i­ty’s bat­tered stock $YMTX jumped 50% be­fore the open­ing bell Mon­day, to $2.12 apiece, but it’s still well be­low the $16 lev­el that Yu­man­i­ty trad­ed at a year ago. The biotech had $17.5 mil­lion in cash and in­vest­ments as of March 31.

Shawn Iado­na­to

“We are ex­cit­ed that our lead clin­i­cal-stage neu­rol­o­gy as­set and un­part­nered as­sets will con­tin­ue to be de­vel­oped and we are very en­thu­si­as­tic about Kine­ta’s in­no­v­a­tive on­col­o­gy pipeline,” Yu­man­i­ty CEO Richard Pe­ters said in a press re­lease.

The new Kine­ta will be led by Kine­ta’s ex­ecs: CEO Shawn Iado­na­to and Pres­i­dent Craig Philips.

Yu­man­i­ty pre­vi­ous­ly merged with cys­tic fi­bro­sis de­vel­op­er Pro­teosta­sis Ther­a­peu­tics in 2020, but the com­pa­ny’s stock cratered about 91% over the course of 2021 as the biotech strug­gled to ce­ment its turn­around sto­ry.

Craig Philips

Now, in its lat­est merg­er, Yu­man­i­ty will be a shell of it­self as the fo­cus will land on Kine­ta’s pre­clin­i­cal im­munother­a­py as­set known as KVA12.1, which is slat­ed to en­ter hu­man tri­als in the fourth quar­ter of this year, the com­pa­nies said on an in­vestor call Mon­day. The drug will even­tu­al­ly be test­ed in com­bi­na­tion with oth­er ther­a­pies across NSCLC, col­orec­tal and ovar­i­an can­cers.

A CD27-tar­get­ed mon­o­clon­al an­ti­body will en­ter a Phase I study in the fourth quar­ter of 2023, and IND-en­abling stud­ies will be­gin around the same time for a CD24-tar­get­ed mAb, the com­pa­nies said in the in­vestor pre­sen­ta­tion.

Kine­ta has been through mul­ti­ple changes over the years. The Seat­tle biotech once thought about mak­ing RIG-I ag­o­nist an­tivi­rals for the Zi­ka virus around the time of the 2016 Rio Olympics. It al­so want­ed to de­vel­op a vac­cine ad­ju­vant sys­tem for the flu. The biotech al­so went in­to the clin­ic for Las­sa fever and neu­ro­path­ic pain.

Kine­ta had se­cured $15 mil­lion up­front and had the po­ten­tial to reel in an­oth­er $505 mil­lion from Pfiz­er in a De­cem­ber 2018 deal.

“We sold the RIG-I pro­gram to Pfiz­er and are no longer in an ac­tive col­lab­o­ra­tion,” a Kine­ta spokesper­son told End­points News in an email.

An­oth­er Big Phar­ma deal came through in a $359 mil­lion tie-up signed with Roche’s Genen­tech in April 2018. The col­lab­o­ra­tion ex­pand­ed in Oc­to­ber 2020 for a new non-opi­oid for chron­ic pain. A Genen­tech op­tion on the Phase I as­set, KCP506, is on the cal­en­dar for the sec­ond half of 2023, Kine­ta said in the in­vestor pre­sen­ta­tion.

Last month, Yu­man­i­ty al­so agreed to ter­mi­nate its 30,000 square-foot lab­o­ra­to­ry lease in Boston. The lease was sched­uled to end in 2028, but that will now hap­pen on Ju­ly 31.

This sto­ry was up­dat­ed to cor­rect the name of the pres­i­dent of the new, com­bined Kine­ta, and in­clude com­ments from Janssen.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

Endpoints Premium

Premium subscription required

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

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

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

Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,800+ biopharma pros reading Endpoints daily — and it's free.

Doug Williams, departing Codiak BioSciences CEO

Co­di­ak files for Chap­ter 11 bank­rupt­cy as most ex­ec­u­tives head for the ex­it

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.

Simeon George, SR One CEO

Ven­ture in­vest­ing with­out the GSK tie-up? Sime­on George and the SR One team score a $600M fund to pave the way for­ward

Over the past year, Simeon George has seen the market chill for biotech, scrambled a crisis team through a harrowing weekend as SVB’s collapse threatened companies in its portfolio and forced them to rework their timeline on support and to rethink his syndicates.

And the CEO is still coming back with a new fund at SR One that is substantially larger than the first they assembled in their breakaway move from the investment arm role they played at GSK.

Endpoints Premium

Premium subscription required

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

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.