Lipocine shifts fo­cus to CNS; Drug ap­proval trig­gers cap­i­tal in­fu­sion at Fen­nec

Lipocine, af­ter a years­long quest to snag FDA ap­proval for its oral testos­terone drug, has de­cid­ed to shift fo­cus to cen­tral ner­vous sys­tem dis­or­ders.

The Salt Lake City biotech of­fered up the new vi­sion Mon­day morn­ing in what CEO Ma­hesh Pa­tel says will al­low the com­pa­ny to “man­age our re­sources ef­fi­cient­ly.”

Lipocine will con­tin­ue fo­cus­ing on oral drugs, this time with en­doge­nous neu­roac­tive steroids (NAS) that it hopes can treat var­i­ous CNS con­di­tions. This comes half a year af­ter its oral testos­terone re­place­ment ther­a­py for hy­pog­o­nadism was ap­proved, fol­low­ing mul­ti­ple FDA snags, and is be­ing mar­ket­ed by li­cense-hold­er and com­mer­cial­iza­tion part­ner Antares Phar­ma. Lipocine still seeks an ex-US com­mer­cial­iza­tion leader.

On the list of po­ten­tial dis­or­ders that Lipocine can ad­dress, based on stud­ies show­ing NAS’ abil­i­ty to im­pact the CNS, are de­pres­sion, move­ment dis­or­ders, epilep­sy, anx­i­ety and neu­rode­gen­er­a­tive dis­eases. First up are post­par­tum de­pres­sion and women with epilep­sy, Lipocine said. The com­pa­ny ex­pects to have re­sults for a phar­ma­co­ki­net­ic bridge study of the PPD as­set in the first quar­ter of next year.

The com­pa­ny will fin­ish up its Phase II study of LPCN1148 in liv­er cir­rho­sis. Lipocine will look for part­ners for that as­set, as well as LPCN1144 for non-cir­rhot­ic NASH, LPCN1107 for pre­ven­tion of pre-term birth and LPCN1111 for TRT. — Kyle LaHu­cik

Third time’s the charm for Fen­nec, and mon­ey flows in

As part of its agree­ment last month, Fen­nec now has $20 mil­lion to tap in­to as it bankrolls the launch of its new drug.

Days ago, the FDA ap­proved Fen­nec’s drug for low­er­ing the risk of hear­ing loss in pe­di­atric can­cer pa­tients who are on chemother­a­py. That trig­gered the clos­ing of $20 mil­lion of se­nior se­cured promis­so­ry notes from Pet­ri­chor Health­care Cap­i­tal Man­age­ment. The in­vestor of­fered up $5 mil­lion last month at the time of the agree­ment.

An­oth­er $20 mil­lion is avail­able pri­or to the end of 2023. The com­pa­ny’s shares $FENC were down more than 6.5% af­ter the open­ing bell on Mon­day.

The Ped­mark ap­proval came af­ter two pre­vi­ous failed at­tempts for Fen­nec. — Kyle LaHu­cik

Aneb­u­lo un­veils in­ter­im da­ta on its mar­i­jua­na over­dose treat­ment

In the first two co­horts out of at least six for Part B of its Phase II clin­i­cal tri­al, Aneb­u­lo Phar­ma­ceu­ti­cals said its drug for mar­i­jua­na over­dose had an ef­fect.

Two co­horts were chal­lenged with 21 mg of THC and then were giv­en ei­ther 30 mg or 10 mg of ANEB-001 — a cannabi­noid re­cep­tor an­tag­o­nist — or place­bo. The par­tic­i­pants who got place­bo felt high, had in­creased body sway, and de­creased alert­ness. But those who got Aneb­u­lo’s drug had sig­nif­i­cant re­duc­tions in all three of those symp­toms.

Aneb­u­lo not­ed the ef­fect of its drug was sim­i­lar to what it had seen in Part A, which had chal­lenged par­tic­i­pants with half the amount of THC and treat­ed them with 50 or 100 mg of ANEB-001.

The Austin, TX-based biotech will con­tin­ue test­ing its drug for acute cannabi­noid in­tox­i­ca­tion, or ACI for short, in ad­di­tion­al co­horts of up to 15 par­tic­i­pants. The tri­al is be­ing run in the Nether­lands.

In a state­ment, Aneb­u­lo CEO Si­mon Allen said:

We are cur­rent­ly ex­plor­ing the ef­fects of de­layed dos­ing to bet­ter un­der­stand re­al-world con­di­tions. In this cir­cum­stance, we chal­lenge sub­jects with THC one hour be­fore ad­min­is­ter­ing ANEB-001. With no FDA ap­proved ther­a­peu­tic, ACI of­ten re­quires lengthy emer­gency de­part­ment stays with ex­pen­sive fol­low-on in­ter­ven­tions for neu­ropsy­chi­atric com­pli­ca­tions such as anx­i­ety and acute psy­chosis. We be­lieve ANEB-001 will play a crit­i­cal role in re­duc­ing the bur­den of ACI for the pa­tient and the health­care sys­tem.

— Lei Lei Wu

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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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:

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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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

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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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.