Bay­er’s block­buster pipeline promis­es bro­ken by a PhII set­back for top can­cer drug

Bay­er tout­ed its ex­per­i­men­tal can­cer drug ane­tum­ab rav­tan­sine as a $2 bil­lion-plus peak earn­er in the mak­ing for the phar­ma com­pa­ny. And it just flopped in its first mid-stage study — this one fo­cused on rare cas­es of mesothe­lioma.

Wern­er Bau­mann, Bay­er CEO

Bay­er will de­tail the da­ta lat­er, but in­ves­ti­ga­tors say the drug flunked a Phase II study with a pri­ma­ry end­point of pro­gres­sion free sur­vival. The drug is al­so cur­rent­ly in 6 oth­er ear­ly stage stud­ies for a va­ri­ety of tu­mor types.

The drug has caused con­sid­er­able head scratch­ing among some of the an­a­lysts who fol­low this com­pa­ny, as well as some of the big in­vestors.

“Bay­er is feel­ing a cer­tain eu­pho­ria about the pipeline prod­uct ane­tum­ab, which I can’t com­pre­hend at the mo­ment,” Markus Manns, who helps man­age as­sets at Union In­vest­ment GmbH, told Bloomberg last year.

Look­ing to as­sure the mar­kets that its phar­ma busi­ness wouldn’t lan­guish as it pur­sued Mon­san­to, Bay­er had pre­dict­ed that its pipeline in­clud­ed 6 drugs — veri­ciguat, finerenone, vi­laprisan, BAY-1841788, ane­tum­ab rav­tan­sine and co­pan­lis­ib — with 6 bil­lion eu­ros in peak sales.  Ane­tum­ab was Ex­hib­it A in that case.

Michael Schmidt at Leerink not­ed:

Ane­tum­ab is an an­ti­body-drug con­ju­gate (ADC) di­rect­ed against mesothe­lin, com­pris­ing an an­ti­body de­vel­oped by Mor­phosys and uti­liz­ing IMGN’s ADC tech­nol­o­gy. IMGN could po­ten­tial­ly earn tiered mid-sin­gle dig­it (4-7%) roy­al­ties on ane­tum­ab sales, but this is not re­flect­ed in our mod­el or Street es­ti­mates.

Bay­er seems ready to plow ahead.

“Based on the avail­able da­ta, we re­main com­mit­ted to fur­ther eval­u­at­ing the util­i­ty and safe­ty of ane­tum­ab rav­tan­sine across mul­ti­ple tu­mor types with sig­nif­i­cant un­met med­ical need,” said Robert La­Caze, an EVP at Bay­er.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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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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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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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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Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.