Tesaro shares skid low­er as As­traZeneca wows with PhI­II da­ta on PARP drug for ovar­i­an can­cer

As­traZeneca spelled out its im­pres­sive Phase III da­ta for Lyn­parza (ola­parib) pills, which will now line up against Tesaro’s ri­val PARP ni­ra­parib.

Pas­cal So­ri­ot

In a cen­tral, blind­ed re­view the drug achieved a me­di­an pro­gres­sion-free sur­vival rate of 30.2 months in germline BR­CA-mu­tat­ed, plat­inum-sen­si­tive, re­lapsed ovar­i­an can­cer pa­tients ver­sus 5.5 months for the place­bo arm. A sol­id suc­cess for As­traZeneca, which bad­ly needs to con­tin­ue to build up its on­col­o­gy group if CEO Pas­cal So­ri­ot ex­pects to achieve any­thing like the big turn­around he’s been promis­ing in­vestors for years.

The drug al­so achieved a sta­tis­ti­cal­ly sig­nif­i­cant re­sult in de­lay­ing the sec­ond pro­gres­sion or time to death, with the me­di­an rate not reached for Lyn­parza com­pared to 18.4 months for place­bo.

As­traZeneca got a jump on the PARP mar­ket with shaky ear­ly da­ta, which reined in its rev­enue po­ten­tial. The phar­ma gi­ant earned on­ly a bit more than $200 mil­lion on Lyn­parza last year, but ex­pects to in­crease that past the $1 bil­lion block­buster mark as it looks to broad­en its use as a main­te­nance ther­a­py in the US.

Tesaro $TSRO has been aim­ing at a di­rect show­down with As­traZeneca as it winds up for a like­ly near-term ap­proval on ni­ra­parib. Its re­duc­tion in risk com­pares close­ly to ola­parib, with a PFS rate that won’t look as good.

Tesaro’s ni­ra­parib da­ta high­light­ed a clear im­pact for the tar­get­ed drug in a pop­u­la­tion of germline BR­CA mu­ta­tion car­ri­ers, with a me­di­an PFS of 21 months in the drug group com­pared to 5.5 months in the con­trol arm — a 15.5-month ad­van­tage that will not com­pare well with Lyn­parza’s, which beat place­bo by slight­ly more than two years.

Sean Bo­hen

Tesaro’s shares skid­ded down 12.5% on the com­par­i­son. Clo­vis $CLVS, mean­while, which has had prob­lems of its own in de­vel­op­ing its new­ly ap­proved PARP Rubra­ca, saw its shares rise 6.9% as the horse race among all the PARPs looked tighter than ever.

Pfiz­er will look to join this group in the not too dis­tant fu­ture with its own piv­otal da­ta for a PARP — ta­la­zoparib — picked up in the $14 bil­lion Medi­va­tion ac­qui­si­tion.

“With these da­ta, we be­lieve it is very dif­fi­cult to chal­lenge the no­tion that the lead­ing PARPs (ni­ra­parib, ola­parib, ru­ca­parib, ta­la­zoparib) are more sim­i­lar than dif­fer­ent,” summed up Leerink’s Sea­mus Fer­nan­dez. “But fol­low­ing our con­ver­sa­tion with AZN, they are most fo­cused on the safe­ty and tol­er­a­bil­i­ty of ola­parib, which they be­lieve is a key area of dif­fer­en­ti­a­tion vs. ni­ra­parib.”

As­traZeneca R&D chief Sean Bo­hen said:

We are ex­treme­ly pleased with the re­sults from SO­LO-2, which sup­port the po­ten­tial ben­e­fit of LYN­PARZA tablets as a main­te­nance ther­a­py for pa­tients with re­lapsed ovar­i­an can­cer. The tablet for­mu­la­tion may of­fer pa­tients a re­duced pill bur­den for LYN­PARZA and a safe­ty pro­file that is gen­er­al­ly con­sis­tent with pre­vi­ous tri­als. We will work with reg­u­la­to­ry au­thor­i­ties to make LYN­PARZA tablets avail­able to pa­tients as quick­ly as pos­si­ble.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Saurabh Saha, Centessa CEO (BIO19)

One of 2021's star biotech play­ers flags an­oth­er big set­back for the pipeline

Two months after scuttling their lead drug, Centessa’s executive team is back with the latest in a series of setbacks that have tanked its stock and blown holes in its strategic lineup of biotech subs.

The company reported in its Q2 post today that it has decided to scrap ZF874 after a patient demonstrated elevated liver enzymes — a classic red safety flag — in a Phase I study for alpha-1-antitrypsin (A1AT).

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.