A busy, buzzy Vertex finds a high-profile partner in the RNA-drugging world to launch a fresh discovery effort

Bill Haney, Skyhawk co-founder and CEO (Dave Pedley/Getty Images for SXSW)

December 22, 2020 08:30 AM ESTUpdated 10:50 AM

A busy, buzzy Vertex finds a high-profile partner in the RNA-drugging world to launch a fresh discovery effort

John Carroll

Editor & Founder

As Vertex began zeroing in on launching its big combo for cystic fibrosis, the oft-lauded biotech started to selectively snap up new technologies that promised to break the therapeutic mold on the way some diseases are treated.

There was the Semma buyout, looking for a cure for diabetes. There was a deal with CRISPR Therapeutics that just produced some landmark data on curing sickle cell disease. They bought Exonics, with a gene editing approach to curing Duchenne muscular dystrophy.

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Healthcare Disparities and Sickle Cell Disease

Frank Lee

CEO of Forma Therapeutics

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

September 20, 2021 01:15 PM EDTUpdated 02:06 PM

Bioregnum

Exclusives: Eli Lilly out to crash the megablockbuster PD-(L)1 party with 'disruptive' pricing; reveals cancer biotech buyout

Paul Schloesser

Editorial Intern

John Carroll

Editor & Founder

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

September 20, 2021 07:55 AM EDT

People

Fresh off FerGene's meltdown, David Meek takes over at Mirati with lead KRAS drug racing to an approval

Kyle Blankenship

Managing Editor

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

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Senior Analyst, Oncology

Brass Tacks Health

Remote

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September 20, 2021 05:57 PM EDTUpdated 06:24 PM

FDA+

FDA hands accelerated nod to Seagen, Genmab's solo ADC in cervical cancer, but combo studies look even more promising

Kyle Blankenship

Managing Editor

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

September 20, 2021 11:09 AM EDT

Cell/Gene Tx

Zolgensma patent spat brews between Novartis and Regenxbio as top Novartis gene therapy exec departs

Zachary Brennan

Senior Editor

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

September 20, 2021 10:12 AM EDTUpdated 02:59 PM

R&D

In Focus

As Bayer, Novartis stack up their radiopharmaceutical data at #ESMO21, a key debate takes shape

Amber Tong

Senior Editor

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

September 20, 2021 08:11 AM EDT

Financing

Continuity and diversity: Rafaèle Tordjman's women-led VC firm tops out first fund at $630M

Amber Tong

Senior Editor

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

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Senior Scientific Research Analyst

American Association for Cancer Research

Philadelphia, PA, USA

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September 20, 2021 07:30 AM EDT

R&D

Mirati triumphs again in KRAS-mutated lung cancer with a closely watched FDA filing now in the cards

Kyle Blankenship

Managing Editor

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

September 18, 2021 09:05 AM EDTUpdated 7 hours ago

R&D

AstraZeneca, Daiichi Sankyo's ADC Enhertu blows away Roche's Kadcyla in second-line advanced breast cancer

Kyle Blankenship

Managing Editor

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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