Thomas Cannell, Sesen

FDA re­jects Sesen Bio's blad­der can­cer pitch, send­ing shares spi­ral­ing back to pen­ny stock ter­ri­to­ry

Sesen Bio re­ceived some bad news Fri­day af­ter­noon that it said was “un­ex­pect­ed,” briefly slash­ing shares by more than 80% and be­low $1 for the first time in near­ly a year.

The biotech re­port­ed it re­ceived a CRL from the FDA re­gard­ing its blad­der can­cer can­di­date Vicineum, an an­ti­body-drug con­ju­gate ac­quired in the com­pa­ny’s buy­out of Toron­to-based Viven­tia back in 2016. Trad­ing was halt­ed for about an hour on Fri­day, with Sesen en­ter­ing the halt at about $6 per share and emerg­ing bat­tered with a $0.86 stock price.

Ahead of the clos­ing bell, Sesen shares re­cov­ered mod­est gains to close at $2.11, down 57% from Fri­day’s open. Ex­pec­ta­tions had swirled among in­vestors lead­ing up to the PDU­FA date, sched­uled for next Wednes­day, as Sesen’s stock price rose about 43% from Thurs­day’s open to Fri­day’s halt.

“We are deeply dis­ap­point­ed by this un­ex­pect­ed re­sult, and it is an un­for­tu­nate day for pa­tients suf­fer­ing from BCG-un­re­spon­sive NMIBC,” CEO Thomas Can­nell said in a state­ment. “We re­main ded­i­cat­ed to our mis­sion to save and im­prove the lives of pa­tients by bring­ing new treat­ment op­tions to pa­tients, and we in­tend to work close­ly with the FDA to un­der­stand next steps.”

Sesen de­scribed the rea­son for the CRL as a com­bi­na­tion of man­u­fac­tur­ing is­sues and re­quests for more da­ta and sta­tis­ti­cal analy­ses. The Cam­bridge, MA-based com­pa­ny plans to meet with the FDA “as soon as pos­si­ble” and said reg­u­la­tors pro­vid­ed rec­om­men­da­tions for how to boost the da­ta pack­age.

Vicineum us­es a re­com­bi­nant fu­sion pro­tein at­tached to a ge­net­i­cal­ly en­gi­neered pep­tide, with re­searchers aim­ing to tar­get spe­cif­ic anti­gens on the sur­face of tu­mor cells to treat can­cers. The FDA had giv­en Sesen pri­or­i­ty re­view for the pro­gram back in Feb­ru­ary, with Can­nell say­ing at the time Sesen un­der­stood the agency’s guid­ance “very clear­ly” and “found the re­view process to be col­lab­o­ra­tive and en­gag­ing.”

Sesen had sub­mit­ted da­ta from an open-la­bel Phase III study that en­rolled 133 pa­tients with high-risk, BCG-un­re­spon­sive non-mus­cle in­va­sive blad­der can­cer.

The pa­tients had pre­vi­ous­ly been on BCG im­munother­a­py, and the most re­cent da­ta came from 93 in­di­vid­u­als whose can­cer had not spread from the blad­der in­to the mus­cle or oth­er tis­sue. Sesen re­port­ed that 39% of those pa­tients achieved a com­plete re­sponse af­ter three months, with fol­low-ups at six, nine and 12 months see­ing CRs of 28%, 21% and 15%, re­spec­tive­ly.

Vicineum had giv­en Sesen new life af­ter a for­mer lead pro­gram failed twice and was sub­se­quent­ly li­censed out to Roche. But Fri­day’s news sent Sesen back in­to deep pen­ny-stock ter­ri­to­ry, and it re­mains to be seen how or whether the biotech plans to re-work its datasets and CMC is­sues to the FDA’s lik­ing.

In an­tic­i­pa­tion of a po­ten­tial ap­proval, Sesen had been launch­ing sig­nif­i­cant com­mer­cial ef­forts over the last sev­er­al months, ef­forts that ramped up in re­cent weeks and now may need to be paused. The biotech re­port­ed it had com­plet­ed hir­ing about 60 new sales reps at the end of Ju­ly — rep­re­sent­ing 97% of its sales force — and hired a new as­sis­tant gen­er­al coun­sel and chief com­pli­ance of­fi­cer as the cal­en­dar turned to Au­gust. As re­cent­ly as Ju­ly 14, Sesen paint­ed a pos­i­tive pic­ture fol­low­ing a meet­ing with the FDA.

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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.