Image: Amber Tong for Endpoints News

Bel­lus hopes to fu­el up on IPO cash as it squares off with gi­ant Mer­ck on a ri­val drug

Fu­eled by a suc­cess­ful Phase I tri­al treat­ing chron­ic cough and lured by the promise of tak­ing their lead drug to oth­er ap­pli­ca­tions, Mon­tre­al-based Bel­lus Health is look­ing to make its de­but on Nas­daq with a $60 mil­lion IPO.

The pub­lic of­fer­ing could be a ma­jor boon to the small Cana­di­an com­pa­ny as it looks to out­pace phar­ma gi­ant Mer­ck in the race to bring a P2X3-block­ing drug to mar­ket. Block­ing the P2X3 re­cep­tor is a close­ly stud­ied method for re­duc­ing dis­or­ders around hy­per­sen­si­tiv­i­ty, in­clud­ing most promi­nent­ly chron­ic cough.

Mer­ck has al­ready brought their ver­sion — gefapix­ant, or MK-7264 — to Phase III tri­als for chron­ic cough treat­ment, with high hopes in cre­at­ing a ma­jor new fran­chise pro­gram. But Bel­lus points out in the S-1 fil­ing that in their Phase I tri­al for BLU-5937 they were able to pro­duce pos­i­tive re­sults with­out the taste-al­ter­ing side ef­fects that have marred Mer­ck’s tri­als. In Mer­ck’s lat­est tri­al, over 70% of pa­tients who re­ceived 50 mg ex­pe­ri­enced taste loss or al­ter­ation, com­pared to 5% of pa­tients in Bel­lus’s. In Ju­ly, Bel­lus be­gan its Phase II tri­al for chron­ic cough, which af­fects 26 mil­lion Amer­i­cans.

No ef­fec­tive treat­ment cur­rent­ly ex­ists.

Bel­lus al­so touts their P2X3 in­hibitor as po­ten­tial­ly use­ful against oth­er dis­or­ders re­lat­ed to hy­per­sen­si­tiv­i­ty. In 2020 they will be­gin a Phase II tri­al on eczema. The atopic der­mati­tis field is crowd­ed, but Bel­lus claims 40-50% of pa­tients are dis­sat­is­fied with their treat­ment.

In June Baird an­a­lyst Bri­an Sko­r­ney not­ed that he viewed BLU-5937 as a dif­fer­en­ti­at­ed as­set, say­ing it “may over time prove to be the best-in-class P2X3 an­tag­o­nist.”

Orig­i­nal­ly called Neu­rochem, the com­pa­ny was forced to re­struc­ture in 2008 af­ter their bid to launch their Alzheimer’s drug failed in a large clin­i­cal study. They changed their name and be­gan fo­cus­ing on or­phan drugs, al­though ALZ-801 was
li­censed by Alzheon in 2013.

This will be the sec­ond ma­jor fundrais­er in less than a year for Bel­lus, as it raised $35 mil­lion at $0.95 a share from an eq­ui­ty of­fer­ing in De­cem­ber.

As of June 30, the com­pa­ny had $42.4 mil­lion cash on hand. Bel­lus hopes to even­tu­al­ly sell BLU-5937 at $300-$600 per pa­tient, per month. List­ed in Cana­da, the com­pa­ny’s shares were trad­ing at $2.04.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.