Fritz Ger­ber, who led Roche for 2 decades, dies; ADC Ther­a­peu­tics tries again for an IPO, sets terms

Fritz Ger­ber, the 92-year-old ex-Roche CEO who steered the com­pa­ny to a ma­jor­i­ty stake in Genen­tech, has died. Ger­ber was CEO from 1978 to 1998, and chair­man for a few years af­ter that. The com­pa­ny cred­its him with tak­ing a lead­ing role in ac­quir­ing a ma­jor­i­ty stake in Genen­tech, a foun­da­tion­al move that led to the full buy­out 11 years ago. Deals to ac­quire PCR tech­nol­o­gy and the takeover of Boehringer Mannheim al­so set up a big play in di­ag­nos­tics, where Roche is a world leader to­day.

→ Can ADC Ther­a­peu­tics pull off an IPO in the mid­dle of a pan­dem­ic, af­ter try­ing and fail­ing ear­li­er? We’ll find out soon. The Eu­ro­pean biotech has set its range for an IPO at $16 to $18 a share, with plans to sell 7.3 mil­lion shares to in­vestors and up to $1.1 mil­lion shares to un­der­writ­ers. Al­to­geth­er they could reap as much as $151 mil­lion-plus, de­pend­ing on how it all shakes out. There has been a string of suc­cess­ful biotech IPOs since the pan­dem­ic hit hard in the US and Eu­rope, like­ly in­spir­ing a slate of com­pa­nies to brush off old fi­nanc­ing plans. ADC with­drew its IPO last fall, cit­ing “ad­verse mar­ket con­di­tions.”

→ The Re­gen­eron Ge­net­ics Cen­ter has struck a deal to col­lab­o­rate with the Uni­ver­si­ty of Col­orado’s Col­orado Cen­ter for Per­son­al­ized Med­i­cine. In the deal, Re­gen­eron will se­quence 450,000 DNA sam­ples and cor­re­spond­ing health records from de-iden­ti­fied pa­tients. Their work will help in­form trans­la­tion­al re­search projects as well as back bet­ter pre­scrib­ing rou­tines.

→ Is­raeli biotech Pro­tal­ix now has de­tailed late-stage da­ta to back up its pitch to mar­ket its en­zyme-re­place­ment ther­a­py for Fab­ry dis­ease. The BRIDGE study, a sin­gle-arm switch-over study eval­u­at­ing the safe­ty and ef­fi­ca­cy of the com­pa­ny’s pe­gu­ni­gal­si­dase al­fa (or PRX-102) in up to 22 Fab­ry pa­tients pre­vi­ous­ly treat­ed with Take­da’s agal­si­dase al­fa (Re­pla­gal), showed sub­stan­tial im­prove­ment in re­nal func­tion with the Pro­tal­ix drug. In pa­tients who switched from the Take­da ther­a­py to PRX-102 — the mean im­prove­ment was from ‑5.90 mL/min/1.73m2/year while on agal­si­dase al­fa to -1.19 mL/min/1.73m2/year on PRX-102 in all pa­tients.

Da­ta from with two oth­er Phase III stud­ies are still ex­pect­ed, but Pro­tal­ix and part­ner Chiesi are plan­ning to sub­mit an ap­pli­ca­tion to mar­ket PRX-102 un­der the ac­cel­er­at­ed ap­proval path­way, de­spite Covid-19 and oth­er in­ter­rup­tions.

→ New­port Beach, CA-based cell ther­a­py play­er jCyte has li­censed the ex-US rights for its lead pro­gram to Japan’s San­ten for $50 mil­lion up­front. Dubbed Jcell, the prod­uct con­sists of al­lo­gene­ic hu­man reti­nal prog­en­i­tor cells to treat re­tini­tis pig­men­tosa, where gene mu­ta­tions lead to pro­gres­sive de­gen­er­a­tion of the reti­na. The US biotech can tap in­to a $12 mil­lion con­vert­ible debt and $190 mil­lion in mile­stones.

Pascal Soriot (AP Images)

As­traZeneca, Ox­ford her­ald 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine, tout­ing eas­i­er dis­tri­b­u­tion, low­er price

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic.

With an average efficacy of 70%, the headline number may appear less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Biotech IPOs: New Steps to Suc­cess on the Road to Go­ing Pub­lic

By RBC Capital Markets

Key Points

2020 is on track to post the highest number of biotech IPOs in five years
COVID-19 has created a new roadmap for going public
Crossover investors are becoming even more active
Companies are going public with strong balance sheets

As the search for COVID-19 vaccines and therapeutics continues, investor interest in biotech IPOs has surged. 2020 is on track to post the highest number of biotech IPOs in five years.

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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CEO Matthew Kane (Precision BioSciences)

In an ap­par­ent R&D about-face, Eli Lil­ly part­ners with Pre­ci­sion Bio­Sciences on genome edit­ing in a deal worth up to near­ly $2.7B

As a large multinational corporation, Eli Lilly has their hands in boundless projects, from cancer and immuno-oncology to diabetes, psoriasis and Crohn’s disease. But Friday they signaled a shift in their R&D focus toward genome editing, leaping into a cutting-edge field CEO Dave Ricks had shied away from as recently as January 2019.

The big pharma is ponying up $100 million upfront to partner with Precision BioSciences, focusing initially on Duchenne muscular dystrophy and two other undisclosed in vivo targets. Lilly is also acquiring $35 million worth of the biotech’s stock, and has the option to develop three additional in vivo therapies.

The pri­ma­ry failed. The key sec­ondary failed. But this biotech still be­lieves it can win an FDA OK in ALS

Two years after the executive team at BrainStorm Cell Therapeutics decided to back off a controversial attempt to sell their stem cell therapy for ALS under the new ‘Right to Try’ legislation, the biotech is back with the top-line data from Phase III. And the data aren’t good.

Researchers say the drug — with a once-proposed price of $300,000 — failed the primary endpoint as well as the key secondaries on disease progression. But the executive crew still thinks it’s approvable. And in fact, the biotech also insists the FDA is eager to review it.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

It's of­fi­cial: Pfiz­er and BioN­Tech have sub­mit­ted their Covid-19 vac­cine to the FDA -- and the agency cir­cled a date for the ad­comm

Pfizer and BioNTech’s request for emergency authorization of its Covid-19 vaccine is now in the FDA’s hands. Regulators caught the application Friday afternoon in an open field dash to the goal line.

The agency immediately marked Dec 10 on the calendar for an advisory committee meeting to discuss the request. Pfizer and BioNTech first announced the submission was coming on Friday morning, and Pfizer CEO Albert Bourla confirmed the filing in a video statement later that afternoon. The “historic day,” as Bourla called it, came just 248 days after the pharma first announced plans to develop the candidate with BioNTech — a process which typically takes years.

News brief­ing: ADC gets a speedy FDA re­view for their DL­B­CL ther­a­py; Qi­a­gen teams with the world's new fa­vorite biotech

The transatlantic biotech ADC Therapeutics is getting a speedy review for its anti-body drug conjugate loncastuximab tesirine (Lonca), developed for relapsed or refractory diffuse large B-cell lymphoma.

ADC $ADCT said Friday morning that the FDA put their drug on the fast lane, providing a priority review for the drug with a May 21 PDUFA date. The biotech won over regulators with Phase II data that reflected an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1%.

Jen­nifer Zi­olkows­ki re­signs from CFO post at Sol­id Bio­sciences; Sean Bo­hen's Ole­ma On­col­o­gy adds San­dra Horn­ing to board of di­rec­tors

Jennifer Ziolkowski has decided to step down from Ilan Ganot’s team at Solid Biosciences “to pursue a new career opportunity,” according to an SEC document filed Friday. Ziolkowski will continue to be Solid’s CFO until Jan. 29, 2021. The day after she announced her resignation at the company, the Duchenne muscular dystrophy biotech entered into a consulting agreement with Danforth Advisors, at which point Danforth managing partner Stephen DiPalma was named interim CFO. DiPalma has been a CFO before at Forum Pharmaceuticals and Aquila Biopharmaceuticals, and he founded Catalyst Oncology and Athena Diagnostics.

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