AACR21: Bristol Myers looks to build Opdivo’s case in early cancer with full data in pre-surgical NSCLC

April 10, 2021 08:30 AM EDTUpdated April 11, 12:07 PM

AACR21: Bristol Myers looks to build Opdivo's case in early cancer with full data in pre-surgical NSCLC

Kyle Blankenship

Checkpoint inhibitors have completely changed the landscape of metastatic, unresectable cancer since their introduction. But one remaining frontier is in patients whose tumors can still be removed, and Bristol Myers Squibb thinks it has a case to be made for PD-1 blocker Opdivo in that setting.

Bristol Myers’ Opdivo given as a neoadjuvant combination with chemo posted a 24% pathological complete response (pCR) rate for patients across the PD-(L)1 expression spectrum with non-small cell lung cancer compared with just 2.2% for chemo alone, according to late breaking Phase III data from the CHECKMATE-816 study presented Saturday at the virtual AACR annual meeting.

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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

Tom Avery

Scientific and Medical Affairs Specialist, Medical Devices

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

August 11, 2022 07:26 AM EDT

Financing

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

Max Gelman

Senior Editor

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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August 10, 2022 08:25 AM EDT

Editor's note

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

Nicole DeFeudis

Editor

Amber Tong

Senior Editor

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.

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Bernat Olle, Vedanta Biosciences CEO

August 11, 2022 07:30 AM EDT

People

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

Amber Tong

Senior Editor

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

August 11, 2022 07:16 AM EDT

FDA+

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

Amber Tong

Senior Editor

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).

August 10, 2022 07:33 AM EDTUpdated 2 hours ago

Pharma

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

Amber Tong

Senior Editor

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)

August 10, 2022 08:36 AM EDT

R&D

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

John Carroll

Editor & Founder

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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Boston, MA, USA

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Illustration: Kim Ryu for Endpoints News

August 9, 2022 07:00 AM EDTUpdated 08:48 AM

R&D

In Focus

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

Lei Lei Wu

News Reporter

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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August 10, 2022 02:24 PM EDTUpdated 02:52 PM

Pharma

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

Nicole DeFeudis

Editor

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.