Penn team spot­lights a pi­lot ovar­i­an can­cer tri­al and sur­vival rates for a per­son­al­ized can­cer vac­cine

A group of in­ves­ti­ga­tors at Penn are hold­ing out hope that a new type of per­son­al­ized tu­mor vac­cine may break the crip­pling run of fail­ures that blight­ed the first wave of can­cer vac­cines.

In a tri­al among 25 ad­vanced ovar­i­an can­cer pa­tients, re­searchers took au­tol­o­gous den­drit­ic cells — a type of mes­sen­ger cells that present anti­gen ma­te­r­i­al to T cells — and pulsed them to whole-tu­mor cell lysate al­so from the pa­tients. The pa­tients then re­ceived a dose of these tu­mor-ex­posed den­drit­ic cells every three weeks, up to six months. Al­most half of the pa­tients who could be eval­u­at­ed showed a good re­sponse to the vac­cine, as in­di­cat­ed by a big in­crease in the num­ber of T cells specif­i­cal­ly re­ac­tive to tu­mor ma­te­r­i­al. The dif­fer­ence in 2-year over­all sur­vival rates be­tween the “re­spon­der” pa­tients and “non-re­spon­ders”: 100% ver­sus 25%.

With this ap­proach, the team from Uni­ver­si­ty of Penn­syl­va­nia and the Lau­sanne branch of the Lud­wig In­sti­tute for Can­cer Re­search says the vac­cine is primed with the unique set of mu­ta­tions in an in­di­vid­ual tu­mor. Giv­en its ex­po­sure to the whole tu­mor, it can stim­u­late im­mune re­sponse against not just one but “hun­dreds or thou­sands” of tu­mor-as­so­ci­at­ed tar­gets. It is al­so tu­mor-spe­cif­ic, mean­ing the vac­cine-in­duced T cells would be less like­ly to at­tack healthy cells.

To be sure, the study was de­signed pri­mar­i­ly to as­sess safe­ty and fea­si­bil­i­ty. But see­ing that a pa­tient who start­ed with stage 4 ovar­i­an can­cer (and five pri­or cours­es of chemother­a­py) re­mained dis­ease-free for five years af­ter two years of dos­ing, the in­ves­ti­ga­tors think it can prove an ef­fec­tive ap­proach to fight­ing can­cer, es­pe­cial­ly when paired up with oth­er im­munother­a­pies.

“This vac­cine ap­pears to be safe for pa­tients, and elic­its a broad an­ti-tu­mor im­mu­ni­ty — we think it war­rants fur­ther test­ing in larg­er clin­i­cal tri­als,” said lead au­thor Janos Tanyi in a state­ment about the study, pub­lished in Sci­ence Trans­la­tion­al Med­i­cine.

Biotech af­ter biotech has bit­ten the dust in pur­suit of can­cer vac­cines us­ing shared anti­gens, from Bavar­i­an Nordic and Aduro to Sel­l­as and Ar­gos, which flopped bad­ly de­spite de­ploy­ing a per­son­al­ized ap­proach.

Yet that hasn’t stopped de­vel­op­ers from try­ing.

Mod­er­na and BioN­Tech are the bet­ter known play­ers in the sec­ond wave of can­cer vac­cines, with enor­mous piles of cash for their mR­NA pro­grams. As of De­cem­ber 2017, the Can­cer Re­search In­sti­tute count­ed 344 hu­man stud­ies in progress for can­cer vac­cines.

Pa­tient seg­men­ta­tion, man­u­fac­tur­ing and cost will like­ly re­main key hur­dles for suc­cess in this field. But this kind of ear­ly re­sults is ex­act­ly what keeps com­pa­nies hope­ful.

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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