Francesco Maria Lavino, F2G CEO

Sofinno­va, For­bion back $70M push across fin­ish line for rare an­ti­fun­gal treat­ment

As the for­mer glob­al brand leader of Mer­ck’s an­ti­fun­gal busi­ness, Francesco Maria Lavi­no knows his facts: There are on­ly three class­es of an­ti­fun­gals.

But F2G, the biotech where he’s now CEO, is con­fi­dent that it can soon bring a fourth an­ti­fun­gal class to the mar­ket. And it’s closed $70 mil­lion in new fi­nanc­ing to get there.

The com­pa­ny has yet to un­veil da­ta from its open Phase IIb study in pa­tients with rare and re­sis­tant molds — it plans to do so at a con­fer­ence in Oc­to­ber — but the re­sults are ap­par­ent­ly pos­i­tive enough to ce­ment an FDA fil­ing by the end of the year. The agency has al­ready grant­ed its com­pound, named olo­rofim, des­ig­na­tions as a break­through ther­a­py, qual­i­fied in­fec­tious dis­ease prod­uct and or­phan drug.

Lavi­no, a self-de­scribed “com­mer­cial per­son,” joined F2G more than a year ago and, work­ing out of New York City, has been build­ing out a team in the US to pre­pare for mar­ket launch some­time next year pend­ing FDA ap­proval. The biotech keeps its R&D op­er­a­tions in Man­ches­ter, UK, and has a small of­fice in Vi­en­na, bring­ing the to­tal head­count to about 55.

For­bion and Sofinno­va co-led the round, which fol­lows a re­cent Eu­rope and Asia deal with Sh­iono­gi that al­ready poured $100 mil­lion cash in­to F2G’s bank, with promis­es of more in mile­stones.

Nan­na Lüneborg

Nan­na Lüneborg, For­bion gen­er­al part­ner, re­mem­bers do­ing due dili­gence on the com­pa­ny more than a decade ago while she was still at No­vo Hold­ings. For her, the draw to F2G is “straight­for­ward.” Rare fun­gal in­fec­tions like in­va­sive as­pergillo­sis typ­i­cal­ly af­fect can­cer pa­tients whose im­mune sys­tems are com­pro­mised from treat­ment, and drug-drug in­ter­ac­tions mean ex­ist­ing an­ti­fun­gals can­not be used to­geth­er with many of the stan­dard-of-care can­cer treat­ments these days.

“A lot of pa­tients don’t have any suit­able treat­ment op­tions,” she said. She is join­ing F2G’s board along­side Sofinno­va’s Joe An­der­son.

So while F2G will en­cour­age doc­tors to use an azole when it’s ap­pro­pri­ate, Lavi­no be­lieves olo­rofim will have a siz­able role to play in sal­vage — with a price to re­flect that.

“We are not try­ing to dis­place gener­ic drugs that work,” he said. “We are say­ing when you re­al­ly have no op­tion, this is a drug that could save your pa­tient’s life.”

The com­pa­ny is con­duct­ing a sep­a­rate Phase III head-to-head com­par­ing olo­rofim to an ex­ist­ing op­tion dubbed Am­Bi­some. The cash re­serves could al­so fund life­cy­cle man­age­ment, Lavi­no added, such as de­vel­op­ing an in­haled ver­sion of olo­rofim. Fur­ther down the line, the CEO sees F2G po­ten­tial­ly bring­ing in more drugs.

“At the mo­ment we don’t want to be — we don’t be­lieve we will be an an­ti-in­fec­tive com­pa­ny ac­tu­al­ly, we want to be a rare dis­ease com­pa­ny,” he said.

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

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.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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