A veteran oncology startup crew is making a very serious bet that they’ve found the key to unlocking the promise of oncolytic viruses

Clodagh O’Shea (Salk)

January 5, 2021 06:00 AM ESTUpdated 07:03 AM

A veteran oncology startup crew is making a very serious bet that they’ve found the key to unlocking the promise of oncolytic viruses

John Carroll

Editor & Founder

Five years ago, when Amgen ushered the oncolytic virus T-Vec over the finish line at the FDA, 2 things seemed completely clear in short order.

One was that an important new avenue in cancer therapy had been opened up, finding a clean shot at solid tumors while recruiting an immune system attack to “mop up” cancer cell survivors. The other was that any of a number of upstart rivals following that path could do a lot better.

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August 7, 2022 08:02 AM EDTUpdated 7 hours ago

R&D

Pharma

UPDATED: In a fresh disappointment, Amgen spotlights a major safety issue with KRAS combo

John Carroll

Editor & Founder

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Addressing the ‘Capacity Crunch’ with a Scalable Platform Process Approach

Brianna Barrett

Ph.D., Associate Director, Technical Sales, Forge Biologics

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

August 6, 2022 06:00 AM EDT

Weekly

A $5B Pfizer buyout? Amgen, Gilead headline M&A Thursday; Alnylam's ATTR sweep; Andrew Lo's rare disease quest; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

August 3, 2022 12:13 PM EDT

Bioregnum

Pharma

George Yancopoulos says he's on the trail of the holy grail: ‘This could represent the next breakthrough for immunotherapy’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

August 5, 2022 12:02 PM EDTUpdated 12:55 PM

Deals

Breaking: Pfizer in hot pursuit of a $5B buyout of Global Blood Therapeutics — report

John Carroll

Editor & Founder

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

August 4, 2022 08:00 AM EDTUpdated 01:59 PM

R&D

UPDATED: Amgen chief Bradway nabs a rare disease player in $4B buyout as the M&A tempo accelerates

John Carroll

Editor & Founder

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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David Hallal (L) and George Daley (Hallal photo: Bertrand Guay/AFP via Getty Images)

August 4, 2022 11:00 AM EDT

People

Startups

Cell/Gene Tx

David Hallal's ElevateBio launches new company to 'disrupt' off-the-shelf cell therapy, but provides few other details

Max Gelman

Senior Editor

David Hallal’s ElevateBio is launching a new company Thursday as it looks to continue making its mark in the cell and gene therapy spaces. But Hallal is also keeping his cards close to the vest, preferring to toe the line between bombast and mystique rather than going all-in in one direction.

The new company comes out of a partnership with Boston Children’s Hospital and research from George Daley, the dean of Harvard Medical School. The triumvirate claims to have found a way to design better off-the-shelf cell therapies using new methods discovered in Daley’s Boston Children’s Hospital lab (Harvard is not involved in the collaboration).

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ENDPOINTS CAREERS

Senior Project Manager

CAI

Boston, MA, USA

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(AP Photo/Richard Vogel, File)

August 5, 2022 01:51 PM EDT

R&D

Pharma

Manufacturing

US declares monkeypox a national health emergency, as new drugmakers consider entering vaccine race

Tyler Patchen

News Reporter

Kyle LaHucik

Associate Editor

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

August 5, 2022 01:30 PM EDT

Pharma

Biohaven touts surge in Nurtec sales ahead of Pfizer takeover

Nicole DeFeudis

Editor

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.