Ab­b­Vie picks first Alzheimer's, Parkin­son's tar­gets in Mis­sion pact; Amarin files for Vas­cepa OK in Eu­rope

→ Back in 2018, Ab­b­Vie teamed up with pro­tein degra­da­tion ex­perts at Mis­sion Ther­a­peu­tics to fo­cus on deu­biq­ui­ty­lat­ing en­zymes, or DUBs, to tack­le Alzheimer’s and Parkin­son’s dis­ease. And to­day, the pact has reached its first mile­stone — with Ab­b­Vie choos­ing the pan­el of DUBs that will be pro­gressed for fur­ther char­ac­ter­i­za­tion and screen­ing ac­tiv­i­ties.

→ Af­ter emerg­ing from an ex­pert pan­el re­view last month with a unan­i­mous en­dorse­ment for their fish oil-based heart drug Vas­cepa — bod­ing well for their up­com­ing FDA re­view — Amarin has filed the drug for re­view by the EMA. The drug is al­ready ap­proved in the US for the treat­ment of el­e­vat­ed triglyc­erides, but the com­pa­ny is gun­ning to ex­pand the la­bel to in­clude the re­duc­tion of the in­ci­dence of heart at­tack and stroke in high-risk pa­tients.

Boston Bio­med­ical, a US sub­sidiary of Japan’s Sum­it­o­mo Dainip­pon Phar­ma, has sealed an on­col­o­gy re­search al­liance with Co­lum­bia Uni­ver­si­ty, Har­vard Uni­ver­si­ty and The Wis­tar In­sti­tute, gain­ing ac­cess to nov­el tar­gets and plat­form tech­nolo­gies emerg­ing out of the in­sti­tu­tions over the next five years.

→ Tai­wan-based Lu­mosa Ther­a­peu­tics an­nounced that the FDA has ac­cept­ed its IND ap­pli­ca­tion for their anal­gesic in­jec­tion, LT1001 — al­low­ing for the com­mence­ment of a bridg­ing study in the US. The drug, which con­tains a pro­drug of nal­buphine, is pitched as an abuse-free al­ter­na­tive painkiller amid an on­go­ing opi­oid cri­sis. The com­pa­ny an­tic­i­pates en­roll­ment to be com­plet­ed in the first half of 2020.

→ Al­though in­vestors of Puma Biotech­nol­o­gy were left fret­ting as Q1 sales of Ner­l­ynx fell short of Wall Street es­ti­mates, the com­pa­ny’s li­cens­ing part­ner Spe­cialised Ther­a­peu­tics Asia has re­ceived the green­light to mar­ket Ner­l­ynx in Sin­ga­pore by the Health Sci­ences Au­thor­i­ty (HSA). The drug is in­di­cat­ed for the ex­tend­ed ad­ju­vant treat­ment of adult pa­tients with ear­ly stage HER2-over­ex­pressed/am­pli­fied breast can­cer, to be giv­en af­ter ad­ju­vant ther­a­py fea­tur­ing Her­ceptin (trastuzum­ab).

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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News brief­ing: Com­pa­ny de­vel­op­ing 'mag­ic mush­room' treat­ment hits Nas­daq; Spring­Works en­ters spon­sored re­search agree­ment with Fred Hutch

Compass Pathways seeks to raise $127.5 million in an upsized IPO, by offering 7,500,000 shares priced at $17 apiece. The London-based company had initially filed for a $100 million IPO, according to its F-1 filing.

The company is researching psilocybin therapy, which combines psilocybin — a psychoactive ingredient found in some species of “magic mushrooms” — with psychological support to treat mental illnesses such as depression, anxiety and addiction. It plans on using IPO money to fund research and clinical development of its COMP360 psilocybin therapy.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

UP­DAT­ED: A mi­cro-cap with a po­ten­tial­ly promis­ing coro­n­avirus drug en­lists mask-skep­tic con­gress­man for DSMB

A small biotech that has talked up a potentially promising but unproven treatment for Covid-19 enlisted an unusual member for its study’s Data and Safety Monitoring Board: a sitting Republican congressman with close ties to the CEO and a history of mask skepticism.

NeuroRx, an Israeli biotech testing a lung inflammation drug in Covid-19 patients, tapped Maryland Rep. Andy Harris for the DSMB, Politico reported. Harris is an anesthesiologist but not a biostatistician, and he has questioned the CDC about a “cult of masks” in the US. Harris has known NeuroRx CEO Jonathan Javitt since the two worked at Johns Hopkins together over 20 years ago.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Leen Kawas, Athira

Seat­tle-based Athi­ra, aim­ing for tough Alzheimer's and Parkin­son's tar­gets, rais­es $204M for IPO

Following an $85 million Series B round back in June, Athira Pharma is set to become the third biotech in the last three days to go public Friday.

Athira raised $204 million for its IPO after pricing shares at $17 apiece, the high-point of its expected range. Initially pegging $100 million in financing, Athira said it offered 12 million total shares and will trade under the ticker $ATHA.

Now that Athira plans to hit the Nasdaq, there have been more than 50 biotech IPOs this year, more than the total from last year. Combined, the companies have raised more than $11 billion. Over half of those biotechs, including Athira, raised at least $200 million each.