Nima Farzan, Kinnate CEO

Ki­nase in­hibitor spe­cial­ist Kin­nate launch­es Shang­hai sub­sidiary with $35M to mar­ket its pro­grams in Chi­na

A lit­tle more than five months af­ter go­ing pub­lic with a $276 mil­lion IPO, Kin­nate Bio­phar­ma is back rais­ing mon­ey — this time for a new sub­sidiary launch­ing in Chi­na.

The yet-to-be named com­pa­ny is launch­ing Thurs­day with a $35 mil­lion Se­ries A round, Kin­nate said, and it will be a joint ven­ture with some of Kin­nate’s pre­vi­ous in­vestors. Or­biMed Asia Part­ners, Or­biMed Pri­vate In­vest­ments and Fore­site Cap­i­tal are all help­ing es­tab­lish the com­pa­ny, with Kin­nate tak­ing the role as ma­jor­i­ty stake­hold­er.

Head­quar­tered in Shang­hai, the new­co will fo­cus on mar­ket­ing Kin­nate’s small mol­e­cule ki­nase in­hibitors in main­land Chi­na, Hong Kong, Macau and Tai­wan. Wenn Sun, the founder and pres­i­dent of the ge­nom­ic da­ta com­pa­ny Pre­ci­sion Med­i­cine Asia, has been ap­point­ed as ex­ec­u­tive chair.

CEO Ni­ma Farzan told End­points News that Kin­nate de­cid­ed to set up a whole new com­pa­ny for this ef­fort, rather than mar­ket the drugs them­selves at Kin­nate, be­cause of their pre­vi­ous deal­ings with Or­biMed. The con­nec­tions gained there en­abled the launch of an en­ti­ty that can more close­ly fo­cus on the more unique Chi­nese mar­ket.

“There’s dif­fer­ent rates of can­cer in dif­fer­ent pop­u­la­tions; for ex­am­ple, Chi­na has a very sub­stan­tial num­ber of lung can­cer epi­demi­ol­o­gy,” Farzan told End­points. “It’s not nec­es­sar­i­ly a dif­fer­ent type of can­cer, they just have more lung can­cer.”

Kin­nate has yet to hit the clin­ic for any of its pro­grams, though they’re on track to file an IND for their lead RAF in­hibitor some­time be­fore the end of June. The new joint ven­ture is ex­pect­ed to put this pro­gram, dubbed KIN-2787, at the top of its to-do list for Chi­nese com­mer­cial­iza­tion, much like Kin­nate it­self is do­ing glob­al­ly.

With re­gards to this pro­gram, Farzan said it would be tar­get­ing the Class II and III BRAF mu­ta­tions typ­i­cal­ly pre­sent­ing more fre­quent­ly in lung can­cers. RAF in­hibitors tar­get­ing Class I mu­ta­tions gen­er­al­ly skew more to­ward melanoma, which are more preva­lent in the US and al­ready have seen ap­proved drugs. There aren’t any drugs ap­proved for the lat­ter mu­ta­tion type, how­ev­er.

KIN-2787 is be­ing de­vel­oped for both lung can­cer and melanoma, as well as oth­er sol­id tu­mors, and pre­clin­i­cal da­ta will be pre­sent­ed next month as AS­CO. If every­thing goes well with the IND, Kin­nate says it’s plan­ning to launch a Phase I study in pa­tients with ad­vanced or metasta­t­ic sol­id tu­mors har­bor­ing BRAF gene al­ter­ations this year, eval­u­at­ing the can­di­date as a monother­a­py.

The sub­sidiary will al­so fo­cus on mar­ket­ing an­oth­er Kin­nate pro­gram in greater Chi­na, an FGFR in­hibitor can­di­date called KIN-3248. This pro­gram is be­ing de­vel­oped to treat in­tra­hep­at­ic cholan­gio­car­ci­no­ma, a can­cer of the bile ducts in the liv­er, and urothe­lial car­ci­no­ma, a can­cer of the blad­der lin­ing.

Farzan not­ed that Chi­na has not ap­proved any FGFR in­hibitors and hopes the Kin­nate sub­sidiary can pur­sue first-line treat­ment with KIN-3248.

There’s one oth­er un­named Kin­nate can­di­date in­volved where the new­co will have an ex­clu­sive li­cense for the re­gion. The com­pa­ny will al­so be able to de­vel­op oth­er pro­grams from the Kin­nate pipeline in the area, as well as can­di­dates from oth­er com­pa­nies in Chi­na and else­where.

Thurs­day’s launch is a step Farzan de­cid­ed to take even though none of Kin­nate’s pro­grams have been test­ed in hu­mans. But he said he’s con­fi­dent in the can­di­dates be­cause the modal­i­ties and tar­gets have been high­ly val­i­dat­ed with oth­er drugs.

“When you look at BRAF mu­ta­tions, these are clear onco­genic dri­vers and drugs that have been ef­fec­tive against these mu­ta­tions have shown clear clin­i­cal ad­van­tages,” Farzan said. “When you look at FGFR, sim­i­lar­ly val­i­dat­ed tar­get, there’s al­ready li­censed drugs pro­tec­tive against that tar­get … and then the pre­clin­i­cal da­ta that we’ve gen­er­at­ed does seem to be, when you look at oth­er drugs in this class, to be rel­a­tive­ly pre­dic­tive.”

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.

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In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

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GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

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Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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