Clo­vis says it needs mon­ey af­ter re­verse split vot­ed down; Cin­Cor touts PhII da­ta for hy­per­ten­sion drug

Clo­vis On­col­o­gy needs a se­ri­ous leg up af­ter post­ing a $71.3 mil­lion net loss in Q2.

Ac­cord­ing to the com­pa­ny’s Q2 re­port, based on its cur­rent cash, cash equiv­a­lents and liq­uid­i­ty the com­pa­ny will need to raise ad­di­tion­al cap­i­tal in the near term to con­tin­ue go­ing on be­yond Feb­ru­ary of next year.

A pro­posed re­verse stock split of Clo­vis’ com­mon stock, which would have freed up more cap­i­tal, was not ap­proved at its an­nu­al meet­ing of stock­hold­ers. The com­pa­ny said in the re­port it is look­ing at oth­er sources of fund­ing such as strate­gic part­ner­ships or li­cens­ing arrange­ments for one or more of its prod­ucts or can­di­dates.

“With­out the ap­proval of an in­crease in au­tho­rized shares of com­mon stock, Clo­vis is not able to raise mean­ing­ful ad­di­tion­al cap­i­tal through pub­lic or pri­vate eq­ui­ty-based of­fer­ings. There­fore, the Com­pa­ny is cur­rent­ly ex­plor­ing al­ter­na­tives and strate­gies to in­crease the num­ber of shares that would be avail­able for is­suance to per­mit greater flex­i­bil­i­ty in rais­ing cap­i­tal through eq­ui­ty fi­nanc­ing trans­ac­tions, in­clud­ing the of­fer and sale of su­per-vot­ing mir­rored pre­ferred stock that has been uti­lized by peers in sim­i­lar sit­u­a­tions to sup­port ap­proval of such pro­pos­als where the ex­ist­ing votes of stock­hold­ers al­ready in­di­cate fa­vor­able sup­port,” the re­port said.

Clo­vis said it is cur­rent­ly in dis­cus­sions re­lat­ed to part­ner­ing on de­vel­op­ment and com­mer­cial­iza­tion rights to FAP-2286. How­ev­er, Clo­vis said it needs to com­plete some form of a com­bi­na­tion of its strate­gic ini­tia­tives and eq­ui­ty fi­nanc­ing to con­tin­ue.

Cin­Cor hits pri­ma­ry end­point for hy­per­ten­sion drug

Cin­Cor an­nounced topline re­sults and the com­ple­tion of its Phase II tri­al dubbed BrigHtn. The tri­al eval­u­at­ed bax­dro­stat, an al­dos­terone syn­thase in­hibitor for pa­tients with treat­ment-re­sis­tant hy­per­ten­sion.

The re­sults showed that bax­dro­stat hit its pri­ma­ry end­point for the re­duc­tion of sys­tolic blood pres­sure. This in­clud­ed a 20.3 mmHg SBP re­duc­tion at the 2 mg dose, or 11.0 mmHg place­bo-ad­just­ed de­cline (p < 0.0001).  For the 1mg dose, the com­pa­ny al­so hit its pri­ma­ry end­point post­ing a 17.5 mmHg SBP re­duc­tion (p = 0.0030).

“We be­lieve these da­ta rep­re­sent an im­por­tant sci­en­tif­ic break­through, sup­port­ing the po­ten­tial of bax­dro­stat to ef­fec­tive­ly emerge as a new mech­a­nism of ac­tion in the hy­per­ten­sion treat­ment par­a­digm and to po­ten­tial­ly be the first mean­ing­ful in­no­va­tion in the treat­ment of hy­per­ten­sion in decades. Treat­ment-re­sis­tant pa­tients rep­re­sent as many as 15 mil­lion adults in the Unit­ed States alone, and now Cin­Cor looks for­ward to open­ing a new era in hy­per­ten­sion in­no­va­tion,” said Marc de Garidel Cin­Cor CEO.

EQRx rolls out up­dat­ed da­ta for its PhI­II tri­al for small cell lung can­cer

EQRx showed up­dat­ed da­ta from its Phase III tri­al, called GEM­STONE-301, which eval­u­at­ed sug­e­mal­imab in non-small cell lung can­cer. The drug has po­ten­tial as con­sol­i­da­tion ther­a­py for peo­ple with ad­vanced, un­re­sectable Stage III non-small cell lung can­cer ac­cord­ing to Vince Miller, physi­cian-in-chief at EQRx.

“The in­clu­sion of pa­tients who had re­ceived se­quen­tial chemora­dio­ther­a­py in this tri­al is of par­tic­u­lar im­por­tance as pa­tients of­ten can­not tol­er­ate con­cur­rent chemora­dio­ther­a­py or can­not ac­cess it due to a va­ri­ety of fac­tors. There is cur­rent­ly no im­mune check­point in­hibitor ap­proved as a con­sol­i­da­tion op­tion for these pa­tients, es­ti­mat­ed to rep­re­sent as many as 25% of peo­ple with un­re­sectable Stage III non-small cell lung can­cer in the US,” Miller said.

The tri­al showed that sug­e­mal­imab had demon­strat­ed im­prove­ment in PFS com­pared to place­bo as con­sol­i­da­tion ther­a­py for pa­tients with Stage III NSCLC with­out dis­ease pro­gres­sion af­ter con­cur­rent or se­quen­tial chemora­dio­ther­a­py. The Me­di­an PFS was 10.5 months for sug­e­mal­imab and 6.2 months for place­bo with a p-val­ue of p=0.0012.

The com­pa­ny said that da­ta for over­all sur­vival, a sec­ondary end­point, was en­cour­ag­ing but had not ma­tured by the time the da­ta were post­ed.

Hutchmed reach­es pri­ma­ry end­point in PhI­II tri­al for col­orec­tal can­cer can­di­date

Hutchmed an­nounced on Sun­day that its glob­al Phase III tri­al, dubbed FRES­CO-2, which has been eval­u­at­ing the in­ves­ti­ga­tion­al use of fruquin­tinib, met its pri­ma­ry end­point of over­all sur­vival (OS) in pa­tients with ad­vanced, re­frac­to­ry metasta­t­ic col­orec­tal can­cer (CRC).

The FRES­CO-2 study in­ves­ti­gat­ed fruquin­tinib in pa­tients with metasta­t­ic CRC who had chemother­a­py, bi­o­log­ic agents, and who had pro­gressed on to TAS-102 and/or re­go­rafenib. The com­pa­ny said it reached a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival as well, but the com­pa­ny plans to present the de­tails of the tri­al at an up­com­ing med­ical meet­ing.

The FDA grant­ed a fast-track des­ig­na­tion for the can­di­date in June 2020.

“We are very hap­py to see the pos­i­tive out­comes of the FRES­CO-2 study which of­fers a po­ten­tial new treat­ment for pa­tients with ad­vanced metasta­t­ic col­orec­tal can­cer, where the un­met need is very high and pa­tients have lim­it­ed treat­ment op­tions,” said Marek Ka­nia, Hutchmed CMO.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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