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BioN­Tech and Re­gen­eron launch new melanoma col­lab; Har­bour Bio­Med finds in­cu­ba­tion part­ner

BioNTech and Regeneron have announced they are collaborating on a Phase II trial to study how the combination of the former’s BNT111 candidate with the latter’s Libtayo can treat melanoma.

The trial will enroll patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma. More details about the trial will be revealed at a later date, with the companies hoping to launch sometime in the fourth quarter.

Bris­tol My­ers Squibb and blue­bird bio re­turn to FDA; Take­da gets a break­through nod

More than two months after the FDA slammed Bristol Myers Squibb and bluebird bio with a suprise refuse-to-file on their  “ide-cell” CAR-T therapy, the pair of developers have resubmitted their application.

The new application comes just in time to keep the contingent value rights from the Celgene deal alive. The “ide-cell” was one of the therapies Bristol Myers picked up in the monster acquisition and one of three therapies that have to be approved by early next year to gain every Celgene shareholder $9. Mizuho analyst Salim Syed estimated that Bristol Myers would have to resubmit by July 31 — tomorrow — to get an FDA decision on time.

Trump, Big Phar­ma trade barbs over drug pric­ing EOs; BAR­DA gives Re­gen­eron $350M for Ebo­la drugs

Tensions between the White House and Big Pharma have ratcheted up after President Donald Trump announced four executive orders targeting the pharmaceutical industry. On Tuesday morning, the president fired off the latest public salvo, while Pfizer CEO Albert Bourla harshly criticized the directives in a call with investors.

Without providing evidence, Trump on Twitter accused pharma companies of airing television ads attacking him and, he says, falsely claim the policies would raise prescription drug prices for seniors. It was not clear to which ad or ads Trump was referring.

Ab­b­Vie backs an Ital­ian start­up fo­cused on au­toim­mune dis­eases; Bio­Th­eryX ad­vances AML drug with $35M D round

Italy’s Enthera Pharmaceuticals has grabbed a €28 million launch round to back its work on, laying bragging rights to the largest A round ever for an Italian biotech.

The company is using “nontraditional” tech to target autoimmune diseases, looking to re-establish stem cell capabilities in type 1 diabetes and inflammatory bowel disease.

Graziano Seghezzi, managing partner of Sofinnova Partners, co-seeded the company, with AbbVie stepping in to help out. This is AbbVie’s first investment in the Italian biotech scene.

Boehringer In­gel­heim beefs up vet port­fo­lio with GST buy­out; No­var­tis, Aus­tria to in­vest €150M in Eu­ro­pean man­u­fac­tur­ing deal

One year after the European launch of Arti-Cell Forte — a stem cell product used to treat lameness in horses — Boehringer Ingelheim has acquired Belgian veterinary biotech company Global Stem cell Technology (GST) with an eye to expanding its portfolio of animal health drugs.

Boehringer ranked as the world’s second largest animal health company in 2019, behind New Jersey-based Zoetis, with about €19 billion (or $21.7 billion) in total net sales. It initially partnered with GST in 2018, and the resulting Arti-Cell Forte was the first veterinary stem cell medicine to gain market authorization from the European Commission.

No­var­tis, Gilead, GSK grab pos­i­tive CHMPs; Menar­i­ni and Ra­dius sign up to $350M part­ner­ship

→ The CHMP may have given a thumbs down on SOBI’s $568 million rare disease drug, but they handed out several positive opinions, including:

Gilead and Galapagos’s JAK inhibitor filgotinib was recommended for moderate to severe rheumatoid arthritis. It will be known as Jyseleca should it be approved.
Novartis’s sickle cell drug Adakveo, meant to reduce the number of painful sickle cell crises, was recommended for approval.
Heron Therapeutics’ post-operative pain drug HTX-011 was recommended for approval, despite being slapped down by the FDA multiple times.
GlaxoSmithKline’s antibody-drug conjugate belantamab mafodotin was recommended. The anti-BCMA drug was recently recommended by an FDA advisory committee for approval in the US, despite concerns about safety and efficacy.

This week's wave of biotech IPO play­ers bumps up of­fer­ings and tar­gets big­ger har­vests of cash

It’s time for the latest round of biotech IPO news, which now focuses on the upsizing process ahead of the pricing.

→ For starters, we have Inozyme Pharma, a preclinical startup out of Boston that is now looking to raise $104 million by selling 6.5 million shares at $16 a pop. As Renaissance Capital notes, they had initially laid out plans to sell 5 million shares at $14 to $16 each.

→ Next up is South San Francisco-based Annexon, which bumped up its deal size by a hefty 29%. The biotech is now looking for around $200 million by selling 12.5 million shares at $15 to $16 per share.

Ayahuas­ca in­spires an­oth­er biotech start­up at ATAI; My­lan TB drug gets green light in In­dia

→ We have one more startup to add to the list before we call it a day. ATAI Life Sciences, which likes to dabble with psychedelics in developing new therapies, has another mind bender in the works. They’ve kickstarted a new company to delve into  formulations of N,N-dimethyltryptamine (DMT) —the active ingredient in ayahuasca — for new drugs to use in the mental health field. DMT acts as a partial agonist on a variety of 5-HT receptors, they say, which makes it a good candidate for patients not attracted to the potent brew featured on certain South American journeys. “These novel products are expected to simplify in-clinic administration and allow greater pharmacokinetic control of the psychedelic experience and its overall duration,” said Srinivas Rao, chief scientific officer of ATAI. “Patients may even be able to attend psychotherapy sessions later the same day.”

Pieris slammed with FDA hold; Bio­gen adds PhIV for Spin­raza

→ Boston-based Pieris $PIRS has been forced to hit the brakes on a slate of Phase I studies for its 4-1BB/HER2 fusion protein drug PRS-343 after the FDA hit the company with a partial hold. The biotech can continue to dose patients already in the studies, but can’t add patients until after it conducts “an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings.” The biotech says no adverse events were cited and still plans to launch their Phase II program for the drug later this year — provided the FDA can be satisfied.  “We also remain on track to present comprehensive data from both the monotherapy and atezolizumab combination phase 1 studies at a medical conference later this year,” says CEO Stephen Yoder. Their stock was down about 6% in morning trading Tuesday.

BMS gets the ball rolling on liso-cel in Eu­rope; BeiGene files Chi­na NDA for in-house PARP drug

→ The EMA has validated Bristol Myers Squibb’s marketing application for liso-cel, its CAR-T that’s been held up at the FDA. The move marks the beginning of the regulatory group’s drug review process. Bristol Myers reported back in May that the FDA had notified the company that US regulators needed an extra 3 months for their review, putting it in line for a mid-November PDUFA deadline. If the drug isn’t approved by the FDA before the end of the year, Celgene investors will lose their CVR picked up in the buyout. The drug had been developed by Juno before Celgene bought out the biotech.