Glenn Mattes, TFF Pharmaceuticals CEO

Texas biotech ex­pands R&D and man­u­fac­tur­ing ca­pa­bil­i­ties fol­low­ing Catal­ent part­ner­ship

On­ly months af­ter Texas-based TFF Phar­ma­ceu­ti­cals net­ted a part­ner­ship with Catal­ent, the com­pa­ny is ex­pand­ing its R&D and man­u­fac­tur­ing op­er­a­tions in the cap­i­tal of the Lone Star State, through the lease of a new 3,500-square-foot fa­cil­i­ty.

The new space will be cen­tered on in­creas­ing TFF’s to­tal lab space. The ex­pan­sion adds a ded­i­cat­ed lab for the down­stream pro­cess­ing of prod­ucts cre­at­ed via its thin film freez­ing as the com­pa­ny is look­ing to in­crease its in-house re­search. The ad­di­tion­al lab space will al­low the com­pa­ny to house larg­er equip­ment to scale up its man­u­fac­tur­ing abil­i­ties and pro­duce sup­plies for pre­clin­i­cal stud­ies. TFF plans to take its new space on­line by Au­gust.

TFF al­so plans to ex­pand its prod­uct de­vel­op­ment team in Austin, which will be based at the new fa­cil­i­ty but did not dis­close the num­ber of hands it wants to bring on. The lease arrange­ment was al­so used to fi­nance the fa­cil­i­ty. TFF dis­closed in an email to End­points News that the ex­pan­sion was self-fund­ed, but no hard fig­ure was giv­en.

Ac­cord­ing to the com­pa­ny, the fa­cil­i­ty was pre­vi­ous­ly used as a health­care test­ing lab­o­ra­to­ry and the com­pa­ny has, over the past two to three months, made mod­i­fi­ca­tions to en­able prod­uct de­vel­op­ment and test­ing of their tech­nol­o­gy.

John Koleng

“The Austin fa­cil­i­ty will en­able us to in­crease test­ing ca­pac­i­ty so that we can run a larg­er num­ber of fea­si­bil­i­ty stud­ies, in­clud­ing a fo­cus on bi­o­log­ics where de­mand has con­tin­ued to grow. Ad­di­tion­al­ly, as many of our part­nered pro­grams move to clin­i­cal eval­u­a­tion, the abil­i­ty to scale-up man­u­fac­tur­ing in par­al­lel be­comes mis­sion crit­i­cal,” said John Koleng, TFF’s VP of prod­uct de­vel­op­ment and man­u­fac­tur­ing.

Koleng said in an email that TFF’s part­ner base has grown sig­nif­i­cant­ly in re­cent years and has seen an in­creased de­mand for the use of their tech­nol­o­gy, es­pe­cial­ly giv­en its ap­pli­ca­tions for hard-to-de­liv­er modal­i­ties such as bi­o­log­ics.

TFF has been on the move this year, as in March, it inked a col­lab­o­ra­tion with Catal­ent fo­cused on the gen­er­a­tion, test­ing and man­u­fac­ture of dry pow­der for­mu­la­tions. The com­pa­ny’s thin film freez­ing tech­nol­o­gy works on both small and large mol­e­cules. The process con­verts mol­e­cules in­to an in­haled dry pow­der, which de­liv­ers the drug di­rect­ly to the lungs.

The com­pa­ny cur­rent­ly has four as­sets in its pipeline, two of which are in Phase II tri­als. They al­so have a part­ner­ship to de­vel­op an in­tranasal vac­cine for in­fluen­za, Ebo­la, Mar­burg and al­phavirus­es.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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