FDA re­jects Kala's dry eye drug; Trou­bled In­sys finds a buy­er (of some as­sets) in Hik­ma

Kala Phar­ma­ceu­ti­cals, one of the pletho­ra of biotechs that trace their roots to the pro­lif­ic lab at MIT led by Bob Langer, on Thurs­day dis­closed that its ex­per­i­men­tal drug for short-term dry eye re­lief did not pass muster with the FDA. Last year, the com­pa­ny post­ed mixed da­ta from two stud­ies — STRIDE 1 and STRIDE 2. Kala $KALA is now bank­ing on the on­go­ing STRIDE 3 study to re­verse its for­tunes. It ex­pects STRIDE 3 to read out by the end of the year, and to re­sub­mit its mar­ket­ing ap­pli­ca­tion the first half of 2020.

While dis­ap­point­ing, the CRL is not com­plete­ly un­ex­pect­ed, COO Todd Baze­more said. The com­pa­ny had ini­ti­at­ed STRIDE 3 last year at the ad­vice of the FDA, and is con­fi­dent that they have now got­ten the in­clu­sion/ex­clu­sion cri­te­ria right by screen­ing out pa­tients with un­sta­ble symp­toms. Once they have the da­ta, he added, they can re­file an NDA un­der a type 2 sub­mis­sion, which en­tails a 6-month in­stead of 12-month re­view.

Point­ing to No­var­tis‘ re­cent $5.3 bil­lion pur­chase of Shire’s Xi­idra — whose ap­proval process in­spired Kala to take its chances the first time — Baze­more em­pha­sized the po­ten­tial of KPI-121: “There’s so few prod­ucts in this cat­e­go­ry, it’s a huge un­tapped cat­e­go­ry in which on­ly about a mil­lion and a half of the 30 mil­lion pa­tients are cur­rent­ly be­ing treat­ed with a pre­scrip­tion prod­uct.”

→ Em­bat­tled In­sys, en­gulfed in lit­i­ga­tion and fi­nan­cial­ly starved, has found a buy­er for its unit-dose nasal and sub­lin­gual spray man­u­fac­tur­ing equip­ment, as well as two pipeline prod­ucts — nalox­one nasal spray and ep­i­neph­rine nasal spray — in UK-based Hik­ma. “Hik­ma is the largest sup­pli­er of gener­ic nasal sprays in the US and we have been look­ing for ways to build up­on our strong man­u­fac­tur­ing plat­form and ex­pand our prod­uct port­fo­lio,” said Hik­ma’s pres­i­dent of gener­ics Bri­an Hoff­mann in a state­ment.

→ Los An­ge­les biotech BioVie, which in April post­ed pos­i­tive da­ta from a small study test­ing its in­fu­sion ther­a­py for se­ri­ous com­pli­ca­tion of ad­vanced liv­er cir­rho­sis, on Thurs­day amend­ed the terms of its im­pend­ing IPO. The com­pa­ny now plans to raise $15 mil­lion by of­fer­ing 1.3 mil­lion shares for $11.44/share, the as-con­vert­ed last close of its shares on the over-the-counter mar­ket. The com­pa­ny, which plans to list un­der the sym­bol BIVI, had pre­vi­ous­ly filed to of­fer 1.3 mil­lion priced at $11.88/share.

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.

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.

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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.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Gilmore O’Neill, Editas Medicine CEO

Ed­i­tas re­ports ear­ly-stage da­ta from two pa­tients in sick­le cell dis­ease

One company is moving forward in its bid to make a cell therapy for sickle cell disease viable — and after previous setbacks, including a hold earlier this year, execs are touting some really early data.

Editas Medicine announced Tuesday morning that it had positive safety and efficacy data from two patients in a Phase I/II trial investigating EDIT-301, a cell therapy candidate that Editas developed. Safety was measured in both patients, and efficacy data are from only the first patient dosed.

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