Ear­ly-stage can­cer biotech nails $85M C round; Flem­ming Orn­skov's Gal­der­ma scores 'break­through' sta­tus

Zen­tal­is Phar­ma­ceu­ti­cals just nabbed an $85 mil­lion round from a syn­di­cate that in­cludes Ma­trix Cap­i­tal, Viking Glob­al In­vestors, Red­mile Group, Far­al­lon Cap­i­tal, Per­cep­tive Ad­vi­sors, Sur­vey­or Cap­i­tal and Even­tide As­set Man­age­ment. Their lead drug is ZN-c5, which is cur­rent­ly in Phase I/II tri­als. The biotech de­scribes that drug as a “po­ten­tial best-in-class oral Se­lec­tive Es­tro­gen Re­cep­tor De­grad­er for es­tro­gen re­cep­tor-pos­i­tive, HER2-neg­a­tive (ER+/ HER2-) breast can­cer.”

Zen­tal­is scored a part­ner­ship with Pfiz­er last year that match­es their CDK 4/6 Ibrance with their ear­ly-stage drug. The C round brings Zen­tal­is’s to­tal take to $147 mil­lion.

→ Der­ma­tol­ogy com­pa­ny Gal­der­ma, which months ago se­cured the ser­vices of for­mer Shire chief Flem­ming Ørn­skov as CEO, on Mon­day scored the FDA’s break­through sta­tus for nemolizum­ab, a ther­a­py un­der de­vel­op­ment to treat pru­ri­tus as­so­ci­at­ed with pruri­go nodu­laris, a rare chron­ic skin con­di­tion char­ac­ter­ized by thick skin nod­ules cov­er­ing large body ar­eas. 

→ Months af­ter scor­ing $56 mil­lion in fresh fund­ing, UK-based Healx is shar­ing its AI-based drug dis­cov­ery plat­form with Boehringer In­gel­heim, to help the Ger­man drug­mak­er ex­plore new in­di­ca­tions for the ex­ist­ing as­sets in its ar­se­nal.

→ Ger­many’s Al­giax Phar­ma­ceu­ti­cals has gar­nered a €5.5 mil­lion round. The biotech is fo­cused on the de­vel­op­ment of GA­BA(a) re­cep­tor mod­u­la­tors for neu­ro­path­ic pain. Oc­ci­dent and an undis­closed Ger­man fam­i­ly of­fice led this round, which will be used to fu­el a Phase IIa study named “CURE“ for its lead com­pound AP-325.

→ Life sci­ences ven­ture firm Ep­i­darex Cap­i­tal is launch­ing a new biotech fund called Ep­i­darex Ex­eed. WSJ Pro re­port­ed in March that Ep­i­darex Cap­i­tal had raised over $100 mil­lion for a new fund fo­cused on ear­ly-stage as­sets. In their re­lease to­day Ep­i­darex called the new ven­ture “a ther­a­peu­tic dis­cov­ery en­gine” and said it would ap­ply seed fund­ing and man­age­ment to “trans­form break­through life sci­ence in­no­va­tions in­to in­vestable as­sets over a pe­ri­od of 12-18 months.”

On­cono­va Ther­a­peu­tics — which picked up a few mil­lion in cash to fund the Phase III pro­gram for its lead drug, rigosert­ib, back in Mayhas col­lab­o­rat­ed with In­cep­tua Med­i­cines Ac­cess, a sub­sidiary of Icep­tua Group, to make avail­able in­tra­venous rigosert­ib via a pre-ap­proval ac­cess pro­gram in se­lect­ed coun­tries across the world. A pre-ap­proval ac­cess pro­gram al­lows for ex­per­i­men­tal agents in de­vel­op­ment to be made avail­able up­on re­quest of a physi­cian or a pa­tient for ap­pro­pri­ate pa­tients for whom no al­ter­na­tive treat­ment op­tion ex­ists in their coun­try.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.