Ab­b­Vie jumps on the on­colyt­ics band­wag­on, em­brac­ing Turn­stone in new col­lab­o­ra­tion

Turn­stone CEO Sam­my Farah

Ab­b­Vie has paid for a front row seat on the can­cer drug strat­e­gy be­ing in­ves­ti­gat­ed in the clin­ic at Turn­stone Bi­o­log­ics. The phar­ma out­fit snagged an op­tion to buy Turn­stone’s lead ther­a­py com­bin­ing an on­colyt­ic virus ap­proach and can­cer vac­cine. And if they dive in, Ab­b­Vie ex­pects to line up a shot at a se­ries of tu­mor types with an op­tion on two more pro­grams that Turn­stone will work on.

“This is the largest part­ner­ship ever formed in this field,” says Turn­stone CEO Sam­my Farah, who’s clear­ly pumped to be align­ing his biotech with a promi­nent play­er in can­cer R&D. “It’s a very sig­nif­i­cant, very mean­ing­ful part­ner­ship on many lev­els.”

Us­ing an en­gi­neered Mara­ba virus, re­searchers have pushed Ad-MG1-MAGEA3 in­to two Phase I/II stud­ies. The es­sen­tial ap­proach here fol­lows a clas­sic on­colyt­ics ap­proach — in­fect­ing a can­cer cell with the virus, which then ex­plodes. While there are a host of next-gen pro­grams to fol­low up on Am­gen’s Im­ly­g­ic, Turn­stone al­so in­cludes some­thing of a twist.

Sev­er­al of these sec­ond-wave on­colyt­ics are sys­tem­i­cal­ly ad­min­is­tered, which may help si­mul­ta­ne­ous­ly at­tack the ori­gin tu­mor as well as metasta­t­ic sites. While many of these next-gen pro­grams re­ly on the anti­gens re­leased in the tu­mor ex­plo­sion to re­cruit a CD4- and CD8-pos­i­tive T cell at­tack for a mop­ping up op­er­a­tion — com­bined with a longterm mem­o­ry for the can­cer that should en­hance dura­bil­i­ty — Turn­stone’s ther­a­py en­codes a spe­cif­ic shared tu­mor anti­gen to make it in­to a can­cer vac­cine.

That added el­e­ment, Farah notes, makes for a key dif­fer­en­ti­a­tion from the rest of the drugs now in the clin­ic.

The third leg of this calls for a check­point in­hibitor, an­oth­er com­mon fea­ture in the on­colyt­ics are­na, so physi­cians could add a dis­arm­ing pro­ce­dure with a tar­get­ed at­tack and im­mune sys­tem as­sault.

Im­ly­g­ic, bet­ter known in some cir­cles at T-Vec, has helped es­tab­lish the proof that on­colyt­ics can make a sig­nif­i­cant dif­fer­ence for pa­tients. And while can­cer vac­cines have been in­ef­fec­tive so far in the clin­ic, they’re role is to en­hance the ther­a­peu­tic ef­fect of the vi­ral at­tack. Check­points, mean­while, are be­ing added to just about every­thing.

Tom Hud­son, Ab­b­Vie

Turn­stone’s lead ther­a­py us­es the MAGE-A3 anti­gen for the vac­cine el­e­ment — the same tar­get that GSK tried and failed with in 2014.

A lit­tle more than a year ago Or­biMed led Turn­stone’s $41.4 mil­lion B round, with an ex­pand­ed syn­di­cate that in­clud­ed new in­vestor F-Prime Cap­i­tal Part­ners and ex­ist­ing in­vestors FAC­IT and Ver­sant Ven­tures, which led Turn­stone’s Se­ries A.

Af­ter the Phase I dose es­ca­la­tion phase is com­plete, Farah says he ex­pects that it will take a cou­ple of more years to com­plete the Phase II part of that tri­al. And along the way, he ex­pects the 25 mem­ber staff at Turn­stone to dou­ble over the next 12 to 18 months.

Ab­b­Vie added an en­dorse­ment with its col­lab­o­ra­tion.

“This unique ap­proach to can­cer treat­ment com­ple­ments our ex­pand­ing port­fo­lio of nov­el ther­a­pies in de­vel­op­ment,” said Tom Hud­son, vice pres­i­dent, on­col­o­gy dis­cov­ery and ear­ly de­vel­op­ment, Ab­b­Vie. “The com­bi­na­tion of our world-class ex­per­tise in on­col­o­gy drug de­vel­op­ment part­nered with Turn­stone’s in­no­v­a­tive ther­a­peu­tic plat­form has the po­ten­tial to gen­er­ate first-in-class im­munother­a­pies that can at­tack tu­mors di­rect­ly and im­prove pa­tients’ re­sponse to treat­ment.”

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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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.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

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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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Roche un­veils three new mon­key­pox tests as cas­es rise

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.