FDA side­swipes Ne­oleukin with clin­i­cal hold on lead im­munother­a­py can­di­date, sends shares plum­met­ing

Nat­ur­al killer and CD8 T cells for on­col­o­gy have been a hotbed of in­vest­ment in re­cent years, with some Big Phar­ma play­ers dab­bling in the ef­fort. A small­er com­peti­tor, Seat­tle’s Ne­oleukin Ther­a­peu­tics, hoped to give its IL-2 in­no­va­tor a shot at boost­ing those cells with­out the tox­i­c­i­ty con­cerns, but the FDA had oth­er ideas.

The FDA has placed a clin­i­cal hold on Ne­oleukin’s IND ap­pli­ca­tion for NL-201, a de no­vo cy­tokine re­cep­tor ag­o­nist for IL-2 and IL-15, which it hoped to test in ex­pand­ing CD8 T cells and nat­ur­al killer cells for use in on­co­log­ic ther­a­peu­tic ar­eas, the com­pa­ny said Fri­day.

The FDA re­quired Ne­oleukin to come up with a new as­say for the ther­a­py that would more ac­cu­rate­ly mea­sure the amount of pro­tein be­ing ad­min­is­tered to pa­tients in a pos­si­ble Phase I tri­al and en­sure the cor­rect dos­ing and ad­min­is­tra­tion of the drug, Ne­oleukin said. The FDA al­so posed “ad­di­tion­al ques­tions” to the biotech un­con­nect­ed to the hold that were not dis­closed in a re­lease.

Jonathan Drach­man

“We will work dili­gent­ly to ad­dress the FDA’s ques­tions as quick­ly as pos­si­ble,” CEO Jonathan Drach­man said in a state­ment. “We be­lieve that we will be able to de­vel­op the re­quest­ed as­say and re­spond with­in the next sev­er­al months. While we do not have a de­fin­i­tive time­line as to when we will be able to ob­tain clear­ance to pro­ceed, we look for­ward to work­ing with the FDA to sat­is­fy their re­quests.”

On the heels of the news, Ne­oleukin $NLTX was trad­ing down 18% be­fore the bell Fri­day at around $12.97.

Ne­oleukin, which launched with re­search out of the Uni­ver­si­ty of Wash­ing­ton in Jan­u­ary 2019, looked to shake up the IL-2 space by stim­u­lat­ing the ex­pan­sion of tu­mor fight­ing cells while side­step­ping pro­tein re­cep­tor CD25, which has been tied to tox­i­c­i­ty con­cerns.

In Au­gust 2019, the com­pa­ny went pub­lic af­ter a re­verse merg­er with Aquinox Phar­ma­ceu­ti­cals, which took a 61.42% stake in the new com­pa­ny in ex­change for $65 mil­lion in cap­i­tal for Ne­oleukin.

As part of that merg­er, Drach­man as­sumed the CEO role as David Main stepped away, mark­ing a new be­gin­ning for the team. Drach­man brought on VP ap­pointees Daniel Sil­va, Umut Ulge and Carl Walkey to con­tin­ue their work in re­search, trans­la­tion­al med­i­cine and cor­po­rate de­vel­op­ment, re­spec­tive­ly.

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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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.

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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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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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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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”