As­traZeneca’s PARP drug Lyn­parza eas­i­ly outscores chemo in PhI­II breast can­cer study

Sean Bo­hen, As­traZeneca

As­traZeneca ap­pears ready to start broad­en­ing the mar­ket for its PARP in­hibitor Lyn­parza. AS­CO or­ga­niz­ers picked the phar­ma gi­ant’s Phase III da­ta for HER-2 neg­a­tive metasta­t­ic breast can­cer for the Sun­day spot­light. And it’s not hard to see why.

The drug was linked with tu­mor shrink­age in 60% of the pa­tients with germline BR­CA1 or BR­CA2 mu­ta­tions tak­ing the drug, com­pared to 29% in the chemo group.

An­a­lyz­ing the lat­est da­ta on Lyn­parza, in­ves­ti­ga­tors found a 42% re­duc­tion in the risk of dis­ease pro­gres­sion or death.

The top line suc­cess was an­nounced back in Feb­ru­ary.

The da­ta give As­traZeneca $AZN a chance to get an ear­ly start over Clo­vis’ Rubra­ca and Tesaro’s Ze­ju­la in mov­ing be­yond the ovar­i­an can­cer mar­ket. The re­sults al­so un­der­score the phar­ma gi­ant’s grow­ing suc­cess in the can­cer field — cru­cial to its longterm turn­around plans — with the ap­proval of their PD-L1 drug Imfinzi (dur­val­um­ab) re­cent­ly and loom­ing re­sults for a com­bi­na­tion of that check­point with treme­li­mum­ab, a CT­LA-4 ther­a­py.

Notes As­traZeneca CMO Sean Bo­hen:

“The OlympiAD re­sults shared to­day mark the first time a tar­get­ed ther­a­py shows ben­e­fit over the cur­rent stan­dard of care for pa­tients with HER2-neg­a­tive gBR­CA-mu­tat­ed metasta­t­ic breast can­cer. This al­so rep­re­sents an im­por­tant mile­stone for Lyn­parza as this is the first pos­i­tive Phase III tri­al in which a PARP in­hibitor has shown a sig­nif­i­cant ben­e­fit for pa­tients out­side of ovar­i­an can­cer.”

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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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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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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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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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

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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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

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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