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.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by Jan. 1, 2028.

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