Joe McCann, Point Biopharma CEO (via Point)

Point un­veils new In­dy site to shore up sup­ply chain in fight against prostate can­cer

With a new man­u­fac­tur­ing fa­cil­i­ty and a can­di­date for prostate can­cer in clin­i­cal tri­als, Point Bio­phar­ma is mov­ing fast to bring its ra­di­oli­gand op­er­a­tions on­line. Now, it will get some help from the US De­part­ment of En­er­gy.

Point will re­ceive ac­tini­um-225 from the DOE’s Iso­tope Pro­gram to sup­port its ear­ly-stage pipeline and in-house man­u­fac­tur­ing of lutetium-177, a ra­dioac­tive med­i­cine that binds it­self to tu­mor cells. The help will al­low Point to stay on track to launch in 2023 and will sup­ple­ment the com­pa­ny’s sup­ply chain from Ter­raPow­er, North­Star Med­ical and Ionetix. All of these part­ner­ships will help bol­ster the com­pa­ny’s in­ter­nal pro­duc­tion, the com­pa­ny said.

Last June, Point be­gan fin­ish­ing touch­es on an 80,000-square foot cen­ter that it in­tends to be­come one of the largest ra­di­oli­gand fa­cil­i­ties in the world. Tues­day, the com­pa­ny an­nounced that the In­di­anapo­lis pro­duc­tion fa­cil­i­ty has been com­plet­ed, and it has be­gun pro­duc­tion of PNT-2002. The can­di­date is a PS­MA-tar­get­ed ther­a­py for metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer, which ac­counts for more than 85% of prostate can­cers. About 52,000 men are di­ag­nosed with this form of can­cer.

“With our fa­cil­i­ty now op­er­a­tional, Point is one of the on­ly phar­ma­ceu­ti­cal com­pa­nies glob­al­ly po­si­tioned to man­u­fac­ture ra­dio­phar­ma­ceu­ti­cals on a com­mer­cial scale,” CEO Joe Mc­Cann said in a state­ment. “Our team’s sig­nif­i­cant ex­pe­ri­ence and ex­per­tise in the de­vel­op­ment of ra­dio­phar­ma­ceu­ti­cals is high­light­ed by the con­sis­ten­cy and speed of our ex­e­cu­tion of the SPLASH tri­al. These unique core strengths po­si­tion POINT to be a leader in this bur­geon­ing modal­i­ty.”

The SPLASH tri­al — which be­gan in De­cem­ber — added the In­di­anapo­lis site to its sup­ply chain along­side its In­ves­ti­ga­tion­al New Drug amend­ment. The site is pro­duc­ing no-car­ri­er-added lutetium-177 as of last month, and en­roll­ment of 400 pa­tients in the US and Cana­da has al­ready be­gun. En­roll­ment of par­tic­i­pants from the UK and Eu­rope will start lat­er this quar­ter.

Right now, there are 21 sites in North Amer­i­ca en­rolled in the tri­al. Da­ta are ex­pect­ed by the mid­dle of 2023.

Point is ex­pect­ed to learn the reg­u­la­to­ry de­ci­sions sur­round­ing can­di­date PNT-2003 — which tar­gets so­mato­statin re­cep­tor-pos­i­tive neu­roen­docrine tu­mors — by the end of Q1 this year. The com­pa­ny is ex­plor­ing an AN­DA for GEP NETs and an NDA for non-GEP NETs.

In March, the com­pa­ny en­tered a re­verse-merg­er agree­ment with Boston-based Re­search Al­liance Corp. I, the first SPAC backed by biotech in­vestor Pe­ter Kolchin­sky. Point re­ceived a pro­ject­ed $300 mil­lion in pro­ceeds through the ac­qui­si­tion, which in­cludes $165 mil­lion from RA Cap­i­tal and oth­er in­vestors. The move helped fi­nance the com­pa­ny to a point where they could com­plete Phase III tri­als for ra­di­oli­gands to treat prostate and neu­roen­docrine can­cers. They al­so went to­ward strength­en­ing in­ter­nal man­u­fac­tur­ing and lo­gis­tics ca­pa­bil­i­ties.

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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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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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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