Stan­ford spin­out Forty Sev­en ar­rives at AS­CO with a snap­shot of promis­ing CD47 da­ta — and a $115M IPO in hand

CHICA­GO — Here’s a neat trick for up-and-com­ing on­col­o­gy biotechs to con­sid­er.

Irv Weiss­man

Ex­ecs for Forty Sev­en, the CD47 star found­ed by Stan­ford’s leg­endary Irv Weiss­man, filed for a $115 mil­lion IPO on Fri­day and then — in­stead of hun­ker­ing down for the qui­et pe­ri­od — prompt­ly flew out to Chica­go to tout a promis­ing set of proof-of-con­cept da­ta for their lead drug at AS­CO.

Forty Sev­en has pre­lim­i­nary da­ta on 22 pa­tients tak­ing 5F9, with an im­pres­sive ini­tial snap­shot of ear­ly da­ta for the small group. Fif­teen of the pa­tients suf­fer from treat­ment re­sis­tant dif­fuse large B-cell lym­phoma (DL­B­CL) and the oth­er 7 have fol­lic­u­lar lym­phoma. In DL­B­CL in­ves­ti­ga­tors tracked an ob­jec­tive re­sponse rate of 40% with a third achiev­ing a com­plete re­sponse; in fol­lic­u­lar lym­phoma the ORR was 71% with 43% achiev­ing a CR.

It’s still too ear­ly to set a me­di­an rate on the du­ra­tion of re­sponse, but the re­searchers say that just 1 of the 22 saw their can­cer progress af­ter 6 months.

Mark Mc­Camish

5F9 is an an­ti­body that tar­gets the pop­u­lar CD47 re­cep­tor tar­gets, which has in­spired a slate of de­vel­op­ment ef­forts. Hit­ting that tar­get is in­tend­ed to scram­ble the “don’t-eat-me” sig­nal that can­cer cells re­ly on to avoid be­ing chewed up by macrophages. And the Men­lo Park, CA-based biotech has 6 stud­ies un­der­way in sol­id tu­mors, acute myeloid leukemia, non-Hodgkin’s lym­phoma and col­orec­tal car­ci­no­ma.

The biotech plans to push its stud­ies ahead as a mono ther­a­py as well as in com­bi­na­tions with PD-1/PD-L1 and CT­LA-4 check­point in­hibitors, start­ing with Genen­tech’s Tecen­triq.

Alan Troun­son

Forty Sev­en has an in­ter­est­ing past. The 78-year-old Weiss­man was able to wran­gle sub­stan­tial sup­port for his ear­ly re­search work on CD47 from the Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Med­i­cine, even launch­ing ear­ly hu­man stud­ies — a rare feat in aca­d­e­m­ic cir­cles. Weiss­man and for­mer CIRM chief Alan Troun­son en­joyed a tight re­la­tion­ship, which ex­tend­ed to Troun­son’s ap­point­ment to the board of an­oth­er start­up that Weiss­man had helped found — Stem­Cells —short­ly af­ter his de­par­ture from the agency. And Forty Sev­en is still get­ting mon­ey from CIRM un­der its lat­est $19 mil­lion grant.

So far the com­pa­ny has raised $149 mil­lion and spent $84 mil­lion of that, ac­cord­ing to the S-1.

Mark Mc­Camish, a No­var­tis vet who en­joyed a $3.7 mil­lion pay pack­age last year, is the CEO. He al­so has 3.6% of the stock. Light­speed Ven­tures Part­ners and Sut­ter Hill Part­ners each con­trol 16.8% of the stock, fol­lowed by Clarus at 15.8%. And Weiss­man has re­tained a hefty 9.5% of the eq­ui­ty, which could soon be worth a small for­tune.

Forty Sev­en in­cludes the fol­low­ing com­pa­nies on its list of ri­vals in the field: Cel­gene Cor­po­ra­tion, Tril­li­um Ther­a­peu­tics, Alexo Ther­a­peu­tics, Arch Ther­a­peu­tics, Sur­face On­col­o­gy, Novim­mune, OSE Im­munother­a­peu­tics and Au­ri­gene Dis­cov­ery Tech­nolo­gies.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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