Early-stage cancer biotech nails $85M C round; Flemming Ornskov’s Galderma scores ‘breakthrough’ status

December 9, 2019 10:55 AM EST

Endpoints Staff

Early-stage cancer biotech nails $85M C round; Flemming Ornskov's Galderma scores 'breakthrough' status

→ Zentalis Pharmaceuticals just nabbed an $85 million round from a syndicate that includes Matrix Capital, Viking Global Investors, Redmile Group, Farallon Capital, Perceptive Advisors, Surveyor Capital and Eventide Asset Management. Their lead drug is ZN-c5, which is currently in Phase I/II trials. The biotech describes that drug as a “potential best-in-class oral Selective Estrogen Receptor Degrader for estrogen receptor-positive, HER2-negative (ER+/ HER2-) breast cancer.”

Zentalis scored a partnership with Pfizer last year that matches their CDK 4/6 Ibrance with their early-stage drug. The C round brings Zentalis’s total take to $147 million.

→ Dermatology company Galderma, which months ago secured the services of former Shire chief Flemming Ørnskov as CEO, on Monday scored the FDA’s breakthrough status for nemolizumab, a therapy under development to treat pruritus associated with prurigo nodularis, a rare chronic skin condition characterized by thick skin nodules covering large body areas.

→ Months after scoring $56 million in fresh funding, UK-based Healx is sharing its AI-based drug discovery platform with Boehringer Ingelheim, to help the German drugmaker explore new indications for the existing assets in its arsenal.

→ Germany’s Algiax Pharmaceuticals has garnered a €5.5 million round. The biotech is focused on the development of GABA(a) receptor modulators for neuropathic pain. Occident and an undisclosed German family office led this round, which will be used to fuel a Phase IIa study named “CURE“ for its lead compound AP-325.

→ Life sciences venture firm Epidarex Capital is launching a new biotech fund called Epidarex Exeed. WSJ Pro reported in March that Epidarex Capital had raised over $100 million for a new fund focused on early-stage assets. In their release today Epidarex called the new venture “a therapeutic discovery engine” and said it would apply seed funding and management to “transform breakthrough life science innovations into investable assets over a period of 12-18 months.”

→ Onconova Therapeutics — which picked up a few million in cash to fund the Phase III program for its lead drug, rigosertib, back in May — has collaborated with Inceptua Medicines Access, a subsidiary of Iceptua Group, to make available intravenous rigosertib via a pre-approval access program in selected countries across the world. A pre-approval access program allows for experimental agents in development to be made available upon request of a physician or a patient for appropriate patients for whom no alternative treatment option exists in their country.

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2019 Trinity Drug Index Evaluates Actual Commercial Performance of Novel Drugs Approved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to capitalise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

January 23, 2020 10:32 AM ESTUpdated 9 hours ago

John Carroll

R&D

UPDATED: Eli Lilly’s $1.6B cancer drug failed to spark even the slightest positive gain for patients in its 1st PhIII

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Aymeric Le Chatelier, Ipsen

January 24, 2020 08:30 AM ESTUpdated 09:17 AM

John Carroll

R&D

A $1B-plus drug stumbles into another big PhIII setback -- this time flunking futility test -- as FDA hold remains in effect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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January 24, 2020 06:17 AM ESTUpdated 06:42 AM

Natalie Grover

R&D

Roche's checkpoint player Tecentriq flops in another bladder cancer subset

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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January 22, 2020 06:04 AM ESTUpdated 11:06 AM

John Carroll

Regulatory

UPDATED: FDA’s golodirsen CRL: Sarepta’s Duchenne drugs are dangerous to patients, offering only a small benefit. And where's that confirmatory trial?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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January 24, 2020 04:10 PM EST

Zachary Brennan

Pharma

Gilead claims Truvada patents in HHS’ complaint are invalid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

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Stephen Hahn, AP

January 23, 2020 08:56 AM EST

John Carroll

Bioregnum

Regulatory

The FDA has devalued the gold standard on R&D. And that threatens everyone in drug development

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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January 23, 2020 07:05 AM ESTUpdated 10:44 AM

John Carroll

R&D

UPDATED: New players are jumping into the scramble to develop a vaccine as pandemic panic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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