GSK poised to leap back in­to the on­col­o­gy mar­ket with more pos­i­tive be­lan­tam­ab mafodotin re­sults — but BC­MA ri­vals are swarm­ing in be­hind

Glax­o­SmithK­line took an im­por­tant step to­ward a key new ap­proval Mon­day night, post­ing their sec­ond pos­i­tive round of piv­otal da­ta for the BC­MA-tar­get­ing mul­ti­ple myelo­ma con­ju­gate be­lan­tam­ab mafodotin (GSK2857916). And with up­beat DREAMM-2 da­ta, they’ve filed for an ap­proval with hopes of get­ting a pri­or­i­ty re­view for their “break­through” drug can­di­date.

But af­ter the stel­lar rounds of new da­ta in the BC­MA field at ASH a few days ago, don’t ex­pect a tremen­dous lev­el of ex­cite­ment to greet them over the out­come.

To be sure, a 31% over­all re­sponse rate among 97 very sick pa­tients with 3 com­plete re­spons­es in the bunch is like­ly enough to war­rant an FDA OK — giv­en reg­u­la­tors’ track record when it comes to pa­tients and op­tions. But the re­sults leave open the ques­tion of what the long-term com­mer­cial prospects can be as GSK makes its way back in­to the on­col­o­gy mar­ket af­ter a long and painful ab­sence.

Me­di­an du­ra­tion has not been es­tab­lished yet.

For ‘7916, the new da­ta batch marks a sig­nif­i­cant drop from the 60% ORR in DREAMM-1, though in­ves­ti­ga­tors note that this new tri­al in­clud­ed a much sick­er set of pa­tients with dwin­dling op­tions. At ASH we al­so saw a CAR-T from J&J that de­liv­ered a 100% re­sponse rate in the BC­MA field for mul­ti­ple myelo­ma. That came with a jaw drop­ping 69% com­plete re­sponse rate. Re­gen­eron im­pressed with its bis­pe­cif­ic REGN5458, while blue­bird and Bris­tol-My­ers Squibb lead the boom­ing BC­MA field, and now add their bis­pe­cif­ic CC-92369 to the list of am­bi­tious can­di­dates. The list goes on.

And out in front, Darza­lex con­tin­ues to make new progress in com­bi­na­tion with oth­er drugs for mul­ti­ple myelo­ma. At ASH Am­gen post­ed a 37% re­duc­tion in the risk of pro­gres­sion of mul­ti­ple myelo­ma for pa­tients treat­ed with a com­bi­na­tion of Kypro­lis and the block­buster Darza­lex from J&J and Gen­mab, com­pared to ei­ther alone.

Game over for GSK?

Not quite.

Ax­el Hoos

Ax­el Hoos, the GSK on­col­o­gy R&D chief who kept the flame of ear­ly-stage can­cer R&D burn­ing af­ter a big pipeline/com­mer­cial swap with No­var­tis, read­i­ly agrees that both the CAR-Ts as well as the bis­pecifics have a lot of ex­cit­ing da­ta be­hind them. They al­so have fur­ther to go in the clin­ic, he adds, and in CAR-T’s case, se­ri­ous cy­tokine re­lease syn­drome safe­ty is­sues as well as a con­tin­u­ing set of man­u­fac­tur­ing ob­sta­cles that con­tin­ues to drag back the pi­o­neers.

Move back to a con­ju­gate like theirs, Hoos says, and there are re­al ad­van­tages in scal­a­bil­i­ty and ac­cess that gives GSK a re­al shot at mak­ing a mark in the field — soon.

“We think we have a more po­tent agent and that should play out as you start com­bin­ing,” he adds, im­por­tant in a field where com­bi­na­tions are king. In the mean­time, every­thing from DREAMM-3 to DREAMM-10 are in the works, un­der­scor­ing a com­mit­ment to amp up their com­mit­ment to drugs that have po­ten­tial.

Armed with a break­through ther­a­peu­tic des­ig­na­tion at the FDA, and PRIME from the EMA, it’s like­ly that GSK won’t have to wait much longer be­fore it starts to put its toe back in the can­cer drug mar­ket. And with Luke Miels lead­ing the com­mer­cial charge fol­low­ing the Tesaro PARP buy­out, every­one at GSK knows they have a lot to prove as R&D chief Hal Bar­ron and CEO Em­ma Walm­s­ley take new steps to prove they’ve re­vived a stag­nant phar­ma R&D group.

Here we go.

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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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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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.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

David Hung, Nuvation Bio president and CEO (Nuvation Bio)

FDA places par­tial clin­i­cal hold on David Hung biotech af­ter cer­tain can­cer pa­tients ex­pe­ri­ence eye in­flam­ma­tion

Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung — of Medivation fame — has run into its first setback.

San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.