Sec­ond dose of Sophiris' prostate can­cer drug proves fu­tile, shares crash

Fol­low­ing a pa­tient death that was ruled un­re­lat­ed to the study drug, Sophiris Bio con­tin­ued test­ing a sec­ond ad­min­is­tra­tion of its ex­per­i­men­tal drug in pa­tients with prostate can­cer who re­spond­ed well to the first round of dos­ing. That faith was in vain, as re-treat­ment with the drug, top­salysin, failed to con­fer ad­di­tion­al ben­e­fit in the Phase IIb study, oblit­er­at­ing the San-Diego-based com­pa­ny’s shares $SPHS af­ter the bell on Mon­day.

Pre­vi­ous­ly, the biotech had re­port­ed that 10 out of 37 pa­tients with lo­cal­ized prostate can­cer in the tri­al demon­strat­ed a clin­i­cal re­sponse six months fol­low­ing a sin­gle ad­min­is­tra­tion of top­salysin — and that 6 of those 10 re­spon­ders ex­pe­ri­enced com­plete ab­la­tion of their tu­mor. On Mon­day, the com­pa­ny up­dat­ed its re­sults from the mid-stage tri­al say­ing that the 10 re­spon­ders who re­ceived a sec­ondary ad­min­is­tra­tion of the drug did not de­rive ad­di­tion­al ben­e­fit, ac­cord­ing to a tar­get­ed biop­sy con­duct­ed on them six months af­ter re-treat­ment.

Shares of the com­pa­ny, which said it was for­mu­lat­ing a de­sign for a Phase III study for sub­mis­sion to US and EU reg­u­la­tors, cratered about 40% af­ter-mar­ket.

In June, the com­pa­ny tem­porar­i­ly halt­ed sec­ondary dos­ing in pa­tients who had re­spond­ed well to the first ad­min­is­tra­tion of the drug, af­ter a pa­tient sud­den­ly died. By Au­gust, Sophiris said it would re­sume dos­ing af­ter re­searchers con­clud­ed the drug had not caused the death.

Mark Em­ber­ton

On Mon­day, lead study in­ves­ti­ga­tor Mark Em­ber­ton said that “tak­ing in­to ac­count the ob­served ef­fi­ca­cy and safe­ty pro­file to date fol­low­ing a sin­gle ad­min­is­tra­tion, we be­lieve urol­o­gists would wel­come a treat­ment like top­salysin for men with clin­i­cal­ly-sig­nif­i­cant lo­cal­ized prostate can­cer.” Mean­while, the com­pa­ny did not pro­vide any de­tails on re­ac­tion to the sec­ond dose, oth­er than to say it had not in­tro­duced any ad­di­tion­al ben­e­fit.

Top­salysin is de­signed to be ac­ti­vat­ed on­ly by en­zy­mat­i­cal­ly-ac­tive prostate spe­cif­ic anti­gen (PSA), which is over­pro­duced in pa­tients with prostate can­cer. The drug is be­ing de­vel­oped as an op­tion for pa­tients to de­lay or even pre­vent ag­gres­sive surg­eries such as rad­i­cal prosta­te­c­to­my, which comes with sex­u­al side-ef­fects and uri­nary in­con­ti­nence. The drug’s safe­ty pro­file could po­ten­tial­ly al­low it to po­si­tion it­self be­tween non-in­va­sive ther­a­peu­tic op­tions and in­va­sive sur­gi­cal pro­ce­dure, while al­so re­duc­ing or pre­vent­ing the off-tar­get ef­fects, HC Wain­wright’s Joseph Pant­gi­nis wrote in a note last month.

Oth­er than skin can­cer, prostate can­cer is the most com­mon can­cer in Amer­i­can men, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.