Park­er In­sti­tute, MD An­der­son and Seres de­vel­op­ing a mi­cro­bio­me/PD-1/L1 com­bo; CRISPR-Cas an­timi­cro­bial biotech Lo­cus rais­es $17M

→ Just days ago, MD An­der­son re­searcher Jen­nifer War­go and col­leagues pub­lished new re­search that showed how the gut mi­cro­bio­me played a big role in de­ter­min­ing whether or not a check­point ther­a­py could help save your life. This morn­ing, MD An­der­son and the sci­en­tif­ic net­work afi­ciona­dos at the Park­er In­sti­tute have put a deal to­geth­er to col­lab­o­rate with lead­ing mi­crio­bio­me biotech Seres on a pill. Seres’ $MCRB bac­te­ria pill is the pre­clin­i­cal SER-401. And the biotech land­ed a deal for MD An­der­son’s IP. The Park­er In­sti­tute will spon­sor a clin­i­cal tri­al to see if it works.

→ Re­search Tri­an­gle Park, NC-based Lo­cus Bio­sciences has round­ed up a $17 mil­lion A round to start mov­ing its an­timi­cro­bials in­to the clin­ic. The biotech is us­ing CRISPR-Cas tech to cre­ate a new ap­proach to coun­ter­at­tack­ing against drug-re­sis­tant su­per­bugs. AR­TIS Ven­tures led the round, with ad­di­tion­al fi­nanc­ing from Ten­cent Hold­ings Lim­it­ed, Ab­stract Ven­tures, and the North Car­oli­na Biotech­nol­o­gy Cen­ter.

→ The FDA has ap­proved a pill for schiz­o­phre­nia that in­cludes a dig­i­tal sen­sor that records that the pa­tient has tak­en the med­ica­tion, dis­patch­ing the in­for­ma­tion via a patch worn on the skin. The prod­uct is Ot­su­ka Phar­ma­ceu­ti­cal’s Abil­i­fy MyCite. The tech is there for an ob­vi­ous rea­son, with ap­pli­ca­tions in men­tal health for en­sur­ing com­pli­ance with dos­ing. By all ac­counts, these new dig­i­tal prod­ucts will be­come a rou­tine fea­ture in med­i­cine.

→ In an agree­ment that in­volved form­ing a new sub­sidiary, Itus Cor­po­ra­tion has se­cured an ex­clu­sive world­wide li­cense to The Wis­tar In­sti­tute’s CAR-T tech­nol­o­gy aimed at treat­ing sol­id tu­mors — ovar­i­an can­cer be­ing its first tar­get. Cer­tain­ty Ther­a­peu­tics is the name of the new com­pa­ny ma­jor­i­ty owned by the biotech $ITUS, a sis­ter to Itus’ can­cer de­tec­tion sub­sidiary Anixa Di­ag­nos­tics. While CAR-T has seen ex­cit­ing re­sults in B-cell can­cers, lit­tle progress on sol­id tu­mors has been made, CEO Amit Ku­mar said in a state­ment, and Itus is “ex­cit­ed to be at the fore­front of us­ing CAR-T tech­nol­o­gy against sol­id tu­mors,” in­clud­ing prostate, pan­cre­at­ic and oth­er can­cers.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

Man­u­fac­tur­ing Roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.

9 Me­ters Bio­phar­ma and Cara Ther­a­peu­tics tout mid-stage da­ta for gas­troin­testi­nal, pru­ri­tus stud­ies

While 9 Meters Biopharma is still floundering in the penny stock market, the company is hoping the latest results for its candidate to treat short bowel syndrome, or SBS, can put together some positive momentum.

The company today announced preliminary topline results from its Phase II VIBRANT study. Its candidate, vurolenatide, is a long-acting GLP-1 receptor agonist in development for the treatment of adult patients with SBS.

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of pharma environmental, social and governance (ESG) efforts in the past two years has been meteoric as investors turn their attention to sustainable funding. However, investors aren’t the only ones watching. Patients are beginning to tune into pharmas’ ESG promises too.

Patient advocacy groups familiar with ESG regard it as an important issue and want to be included in helping pharma companies set ESG policies and targets, according to a new report from PatientView. That’s quite different from what the investment community wants across a variety of Gartner’s defined financial, competitive, strategic and perception goals.

Bo Cumbo, AavantiBio CEO

Scoop: A small gene ther­a­py biotech, flush with ex-Sarep­ta and blue­bird lead­ers, guts CMC

En route to entering the clinic with its first AAV-based gene therapy for a rare neuromuscular disease, AavantiBio has let go of 30 employees, Endpoints News has learned.

The move comes after a year stacking its executive bench with ex-Sarepta and bluebird bio leaders and inking multiple partnerships with the likes of Aldevron, Catalent and Resilience. The biotech also formed a scientific advisory board in February.

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Kate Haviland, Blueprint Medicines CEO

What bear mar­ket? Blue­print lines up $1.25B to ex­pand la­bels, maybe tack on more drugs

As it works to pad the case for expanding its Ayvakit and Gavreto labels, Blueprint Medicines has lined up $1.25 billion in funding, with some of that money seemingly earmarked for acquisitions or pipeline expansion projects.

Following the likes of BioCryst, Cytokinetics and MorphoSys, Blueprint is aiming to monetize the royalties of its RET+ non-small cell lung cancer and thyroid cancer drug Gavreto with Royalty Pharma. The investment group will dole out $175 million upfront and might tack on another $165 million in biobucks as part of Blueprint’s royalties receivable from net sales of the drug by Roche outside the US, sans China.

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FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”