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.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.