Boehringer In­gel­heim is think­ing in block­buster terms as it throws its hat in­to the ever-widen­ing CD47 ring

Boehringer In­gel­heim is jump­ing on­to the CD47 “don’t-eat-me” path­way.

Jonathon Sedg­wick

The Ger­man com­pa­ny is pay­ing $37 mil­lion in cash and near-term mile­stones to grab rights to one of the prime tar­gets in the in­ter­play be­tween CD47 and SIRP-al­pha. By tar­get­ing SIRP-al­pha and pre­vent­ing CD47 from bind­ing to it, in­ves­ti­ga­tors at Boehringer be­lieve that they can defuse a key im­muno­sup­pres­sant and al­low macrophages to go on a can­cer cell ram­page.

They’re al­so not at all alone. CD47 it­self has be­come a tar­get for a wide va­ri­ety of biotechs, in­clud­ing Forty Sev­en, which was spun out of the lab of Stan­ford’s Irv Weiss­man. When Sur­face On­col­o­gy re­cent­ly filed their S-1, they high­light­ed their own CD47 ef­forts and a slate of ri­vals that in­cludes:

Alexo Ther­a­peu­tics, Arch On­col­o­gy, Au­ri­gene, Blink Bio­med­ical, Cel­gene, Novim­mune, OSE Im­munother­a­peu­tics, Sor­ren­to, Syn­thon Hold­ing and Tril­li­um Ther­a­peu­tics.

Now they can add Boehringer.

Boehringer be­lieves it has a strong con­tender for the crown here with the late pre­clin­i­cal OSE-172, which they in-li­censed from France’s OSE Im­munother­a­peu­tics. In ad­di­tion to the up­front and first mile­stone of $18.5 mil­lion at the launch of a loom­ing Phase I tri­al, there’s a trea­sure trove of $1.35 bil­lion in de­vel­op­ment, reg­u­la­to­ry and com­mer­cial mile­stones.

“A key area of fo­cus is the iden­ti­fi­ca­tion of drugs that tar­get myeloid cell im­mune reg­u­la­to­ry re­cep­tors of which SIRP-al­pha is a lead­ing ex­am­ple,” says Jonathon Sedg­wick, the glob­al head of can­cer im­munol­o­gy at Boehringer. And he be­lieves that Boehringer can eas­i­ly dis­tin­guish it­self from the CD47 pack.

“We feel this is the bet­ter way to go,” Sedg­wick tells me. As of now, he be­lieves that Boehringer has the on­ly SIRP-al­pha pro­gram head­ed to the clin­ic, with a chance of hit­ting an im­por­tant tar­get with much greater speci­fici­ty than the CD47 ap­proach.

“If you block CD47 then you’re al­so block­ing many oth­er path­ways,” he adds, which could com­pli­cate mat­ters. 

Boehringer has been build­ing its I/O pro­gram for sev­er­al years now, work­ing with an in-house PD-1 check­point that it plans to use for its com­bi­na­tion drug work in the field, cen­ter­ing on build­ing an im­mune re­sponse to cold tu­mors. The plan with this new drug is to start a slate of Phase I stud­ies in a range of tu­mor types and look for sig­nals on what should ad­vance to­ward piv­otal pro­grams.

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.