One of Af­fimed’s new glass slip­pers cracks as a dead­ly in­ci­dent forces halt to PhI can­cer tri­als

Af­fimed’s Cin­derel­la sto­ry has tak­en a dead­ly twist.

Just a few weeks af­ter sign­ing Genen­tech on to the plat­form for a col­lab­o­ra­tion us­ing its NK cell tech for guid­ing an im­mune re­sponse against can­cer, re­searchers for the biotech $AFMD have waved back pa­tients in a Phase I pro­gram for their CD19/CD3-tar­get­ing T cell en­gager AFM11 af­ter the death of one pa­tient and a life-threat­en­ing re­ac­tion in two oth­ers.

The Phase I ef­fort cov­ers two types of can­cer: CD19 pos­i­tive B-cell non-Hodgkin lym­phoma and acute lym­phoblas­tic leukemia. Now the biotech has put the tri­als on hold and Af­fimed ex­ecs say they’ve in­formed reg­u­la­tors as they in­ves­ti­gate what went wrong.

Its shares tanked, plung­ing 30% on the news.

Adi Hoess, Af­fimed CEO

There’s no word in the com­pa­ny’s state­ment what the re­ac­tion was, just that the three pa­tients were on the high dose of a drug that tar­gets CD3. Their more ad­vanced work on an NK cell en­gage­ment strat­e­gy will pro­ceed.

Af­fimed has been on a roller coast­er ride over the last few months. Its stock was beat­en up dur­ing the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion meet­ing in June as the com­pa­ny of­fered up an ear­ly look at pos­i­tive re­spons­es in their ear­ly study of AFM13, its lead NK cell en­gager can­di­date. 

Then, when Genen­tech stepped up with $96 mil­lion up­front and bil­lions in po­ten­tial mile­stones, the biotech world took a clos­er look at the NK tech that the big Roche sub­sidiary was most in­ter­est­ed in — and the stock soared.

That deal com­bined Genen­tech’s deep ex­pe­ri­ence with tu­mor bi­ol­o­gy with the biotech’s own know-how in ac­ti­vat­ing NK cells while us­ing a plat­form tech that the CEO de­scribed as a “sim­pli­fied en­gi­neer­ing sys­tem” that can cre­ate new ther­a­peu­tics with­out the need for adding a lot of staff. The plat­form spe­cial­izes in “tetrava­lent, mul­ti-spe­cif­ic im­mune cell en­gagers,” with an an­ti­body ap­proach that ap­plies to a va­ri­ety of dis­ease set­tings, bring­ing in the tu­mor cell killers need­ed to di­rect­ly en­gage can­cer.

A num­ber of pa­tients have been killed in tri­als dur­ing the last few years, most no­tably at Juno, which had to scrap its lead CAR-T and drop out of the race for the first ap­proval in the field af­ter a se­ries of dead­ly in­ci­dents. 

The com­pa­ny, now a sub­sidiary of Cel­gene, as well as for­mer CEO Hans Bish­op, re­cent­ly signed off on a $24 mil­lion pay­ment to the stock­hold­ers who brought a class ac­tion suit against the biotech based on their claims that the com­pa­ny had mis­led in­vestors by con­ceal­ing the death of the first pa­tient. 

That amounts to a speed­ing tick­et af­ter Cel­gene paid $9 bil­lion for the group, which is now pur­su­ing a new, safer lead pro­gram.

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.

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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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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