Proven­tion Bio inks Chi­na deal for au­toim­mune pro­gram; Ky­owa Kirin re­leas­es pos­i­tive topline da­ta in atopic der­mati­tis

Proven­tion Bio is mak­ing its way in­to Chi­na with a new deal an­nounced Wednes­day.

The Red Bank, NJ-based biotech has agreed to a deal with a sub­sidiary of Huadong Med­i­cine to work on PRV-3279, a bis­pe­cif­ic an­ti­body-based mol­e­cule tar­get­ing CD32B and CD79B, in Chi­na, Hong Kong, Macau and Tai­wan. Proven­tion will get $6 mil­lion up­front and up to $11.5 mil­lion in fund­ing over the next three years to cov­er ex­pect­ed re­search costs.

The deal al­so in­cludes reg­u­la­to­ry and com­mer­cial mile­stones of up to $172 mil­lion. Proven­tion will re­tain all rights to PRV-3279 in the rest of the world.

Proven­tion’s the­o­ry be­hind the ex­per­i­men­tal drug is to en­gage both the CD32B and CD79B re­cep­tors to trig­ger in­hi­bi­tion of B cell func­tion and sup­press the im­mune sys­tem from at­tack­ing its own body. It’s cur­rent­ly in a Phase I tri­al for sys­temic lu­pus ery­the­mato­sus, a chron­ic au­toim­mune dis­or­der char­ac­ter­ized by an over­ac­ti­va­tion of B cells.

Wednes­day’s news comes a few months be­fore Proven­tion’s lead pro­gram teplizum­ab is due for a PDU­FA de­ci­sion in Type 1 di­a­betes at the FDA. The biotech picked up the drug in 2018, eight years af­ter it was dumped by Eli Lil­ly. — Max Gel­man

Ky­owa Kirin pro­gram meets pri­ma­ry in AD study

Japan­ese phar­ma Ky­owa Kirin has new pos­i­tive da­ta out Thurs­day for mod­er­ate to se­vere atopic der­mati­tis.

The com­pa­ny’s KHK4083 pro­gram met the pri­ma­ry end­point, with all co­horts achiev­ing sta­tis­ti­cal sig­nif­i­cance in per­cent change from base­line in Eczema Area and Sever­i­ty In­dex (EASI) af­ter 16 weeks. Ky­owa al­so not­ed the pro­gram passed in two key sec­ondary end­points, and saw fur­ther im­prove­ment in ef­fi­ca­cy af­ter week 16.

KHK4083 is a mon­o­clon­al an­ti­body tar­get­ing OX40 hop­ing to sup­press in­flam­ma­to­ry re­spons­es in a range of au­toim­mune dis­eases. Ky­owa says OX40 plays an im­por­tant role in main­tain­ing T cell pro­lif­er­a­tion and sur­vival, and this study helps val­i­date it as an ap­pro­pri­ate tar­get for AD.

Full re­sults will be shared “in the near fu­ture,” Ky­owa R&D chief Yoshi­fu­mi Torii said in a state­ment. — Max Gel­man

Chi­nese AI play­er gets $30M Se­ries A

NeoX Biotech an­nounced last week it had raised $30 mil­lion in a Se­ries A fund­ing round.

The Chi­nese com­pa­ny plans to use funds main­ly to en­hance its AI drug R&D plat­form, ac­cel­er­ate pre­clin­i­cal de­vel­op­ment and ex­pand in­ter­na­tion­al busi­ness co­op­er­a­tion. NeoX says its tech can help op­ti­mize the drug dis­cov­ery process and make it more ef­fi­cient.

“We are fo­cus­ing on cut­ting-edge drug modal­i­ties, such as mul­ti­spe­cif­ic mol­e­cules and bi­o­log­ics,” CEO Michael Chen said in a state­ment. “We use our next-gen­er­a­tion neo­Plat­form to de­sign new drug modal­i­ties and to tru­ly ‘think out of the box’, in an ef­fort to ad­dress un­drug­gable tar­gets.”

The fi­nanc­ing was co-led by Sky9 Cap­i­tal and 5Y Cap­i­tal (for­mer­ly known as Morn­ing­side Ven­ture Cap­i­tal), with par­tic­i­pa­tion from BAI Cap­i­tal and Ver­tex Ven­tures along­side ex­ist­ing in­vestors Vi­sion Plus Cap­i­tal and Se­quoia Cap­i­tal Chi­na. — Max Gel­man

Fred Hutch spin­out lands seed round for AI tech

Fred Hutchin­son Can­cer Re­search Cen­ter spin­out Ozette has nabbed a $6 mil­lion seed round to de­vel­op its AI plat­form de­signed to au­to­mate cell analy­sis.

The biotech, in­cu­bat­ed at the Allen In­sti­tute for Ar­ti­fi­cial In­tel­li­gence (AI2), says its Im­mune Mon­i­tor­ing Plat­form can ex­tract in­fo from sin­gle-cell da­ta across in­stru­ments, ex­per­i­ments and dis­ease states, con­dens­ing a man­u­al, la­bor-in­ten­sive process from months to hours.

“We’ve spent a decade work­ing at Fred Hutch to cat­alyze high-di­men­sion­al com­pu­ta­tion­al sin­gle-cell analy­sis in acad­e­mia and in­dus­try. To­day we can see the com­po­si­tion of the im­mune sys­tem at a much high­er res­o­lu­tion,” Greg Fi­nak, CTO and co-founder, said in a state­ment. “This deep­er lev­el of in­sight is crit­i­cal to de­vel­op­ing ef­fec­tive dis­ease treat­ments with few­er side ef­fects and that is some­thing every­one can feel good about.”

The seed round was led by Madrona Ven­ture Group, with help from the Allen In­sti­tute and Vul­can Cap­i­tal. — Nicole De­Feud­is

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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