Yumanity chairman Tony Coles (L) and CEO Richard Peters

UP­DAT­ED: 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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

Endpoints Premium

Premium subscription required

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

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

Endpoints Premium

Premium subscription required

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

Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.

FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it's free.