DBV es­ti­mates peanut al­ler­gy drug sub­mis­sion in Q3, but it may be too lit­tle too late in race with Aim­mune

DBV Tech­nolo­gies has all but so­lid­i­fied its run­ner up sta­tus in the race to bring a peanut al­ler­gy treat­ment on to the Unit­ed States mar­ket. The French drug de­vel­op­er on Wednes­day said it would re­sub­mit an ap­pli­ca­tion to mar­ket its prod­uct — Vi­askin Peanut — in the third quar­ter, af­ter with­draw­ing its ap­pli­ca­tion late last year in re­sponse to FDA con­cerns about the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted. Mean­while, arch ri­val Aim­mune’s treat­ment AR101 is cur­rent­ly un­der FDA re­view.

DBV $DB­VT re­scind­ed an ap­pli­ca­tion to mar­ket its peanut al­ler­gy patch on De­cem­ber 20, and the fol­low­ing day, Aim­mune $AIMT sub­mit­ted its ap­pli­ca­tion for peanut al­ler­gy im­munother­a­py AR101, in ef­fect leapfrog­ging its com­pe­ti­tion for a first-mover shot at cap­tur­ing the so far un­tapped mar­ket, which is ex­pect­ed to grow to $4.5 bil­lion in 2027 glob­al­ly, ac­cord­ing to Glob­al­Da­ta. The US shut­down be­gan on De­cem­ber 22 af­ter Pres­i­dent Trump in­sist­ed on $5.7 bil­lion from Con­gress to build a wall on the south­west US bor­der.

Bri­an Sko­r­ney

By mid-Jan­u­ary, Aim­mune said the health reg­u­la­tor had no­ti­fied them that it would not be able to re­view the ap­pli­ca­tion un­til the lapse in ap­pro­pri­a­tions end­ed. Ten days lat­er, on Jan­u­ary 25th, the gov­ern­ment re­opened, and the AR101 ap­pli­ca­tion was back in con­tention.

Baird’s Bri­an Sko­r­ney said DBV’s up­date made no dif­fer­ence to his ex­pec­ta­tions.

We con­tin­ue to ex­pect that, should Vi­askin Peanut reach an Ad­Com, the an­tic­i­pat­ed pri­or ap­proval of AR101 will elim­i­nate the “there is noth­ing else avail­able” ar­gu­ment for DBV Tech­nolo­gies and pa­tient ad­vo­cates, mak­ing it more dif­fi­cult for these par­ties to make a strong case for ap­proval of Vi­askin Peanut, giv­en the med­ica­tion’s weak ef­fi­ca­cy pro­file. We be­lieve that this dy­nam­ic may ul­ti­mate­ly pre­vent Vi­askin Peanut from gain­ing reg­u­la­to­ry ap­proval, clear­ing the field for Aim­mune’s AR101.

Mean­while, when Aim­mune an­nounced that the gov­ern­ment shut­down had stymied its ap­pli­ca­tion, FDA com­mis­sion­er Scott Got­tlieb threw an­oth­er span­ner in the works, sug­gest­ing in a se­ries of tweets that al­ler­genic prod­ucts are not cov­ered by user-fees, and con­se­quent­ly do not qual­i­fy for the PDU­FA process.

For Aim­mune’s im­munother­a­py, there is no clar­i­ty on its PDU­FA sta­tus, al­though the com­pa­ny is work­ing with the agency to fig­ure what the time­line for its re­view is, Sko­r­ney not­ed.

DBV’s Vi­askin Peanut — which is de­rived from freeze-dried de­fat­ted peanut flour ex­tract­ed from raw peanuts — is an al­ler­genic ex­tract and has se­cured the FDA’s break­through ther­a­py des­ig­na­tion (BTD) sta­tus. Jef­feries an­a­lyst Eun Yang sug­gest­ed that the treat­ment’s BTD sta­tus would prompt the FDA to com­plete its re­view un­der the pri­or­i­ty re­view time­line, cit­ing a reg­u­la­to­ry ex­pert. Vi­askin Peanut is clas­si­fied as a com­bi­na­tion prod­uct, thus, it will be re­viewed by the CBER (Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search) with con­sul­ta­tion from the CDRH (Cen­ter for De­vices and Ra­di­o­log­i­cal Health), al­though CDRH tends to be slow, Yang said, re­fer­ring to the ex­pert’s com­ments.

Leerink fore­cast a US mar­ket en­try in 2021 for Vi­askin Peanut “giv­en the lack of (reg­u­la­to­ry) vis­i­bil­i­ty.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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