Alexis Borisy, EQRx CEO

No price com­pe­ti­tion in PD-(L)1? That might not last long as EQRx, CStone read out late-stage win for chal­lenger

Drug pric­ing dis­rup­tor EQRx has made a show about its mis­sion to ag­gres­sive­ly dis­count drug mar­kets dom­i­nat­ed by ex­pen­sive med­i­cines with no mean­ing­ful price com­pe­ti­tion. One of the most ob­vi­ous tar­gets is PD-(L)1, and now one of EQRx’s part­nered drugs is get­ting its af­fairs in or­der for a late mar­ket en­try.

EQRx and CStone’s sug­e­mal­imab hit its pri­ma­ry end­point of pro­gres­sion-free sur­vival as a con­sol­i­da­tion ther­a­py for pa­tients with stage III non-small cell lung can­cer whose dis­ease hasn’t pro­gressed af­ter con­cur­rent or se­quen­tial chemora­dio­ther­a­py, the com­pa­ny said Fri­day.

The GEM­STONE-301 study fol­lowed up re­sults from GEM­STONE-302, which test­ed sug­e­mal­imab against place­bo in Stage IV NSCLC. That Phase III study, with re­sults pre­sent­ed last year, was al­so a win, and tak­en to­geth­er the da­ta “set the stage” for reg­u­la­to­ry fil­ings, the com­pa­nies said.

The Stage III test looked at PFS as de­ter­mined by a blind­ed in­de­pen­dent re­view against place­bo as its pri­ma­ry end­point, with OS, in­ves­ti­ga­tor-de­ter­mined PFS and safe­ty as the sec­ondary end­points. Sub­group analy­ses showed the drug was as­so­ci­at­ed with clin­i­cal ben­e­fit re­gard­less of whether pa­tients re­ceived con­cur­rent or se­quen­tial chemora­dio­ther­a­py pri­or to dos­ing, the com­pa­nies said.

If sug­e­mal­imab does make it across the fin­ish line, it would join a grow­ing cho­rus of an­ti-PD-(L)1s, with many of the late-stage en­trants com­ing out of Chi­nese R&D out­fits. The mar­ket is led by Mer­ck’s Keytru­da and its ex­pan­sive clin­i­cal pro­gram with Bris­tol My­ers Squibb’s Op­di­vo pret­ty far be­hind in terms of sales.

But even with a re­cent late en­try — Glax­o­SmithK­line’s Jem­per­li was the lat­est with an ap­proval in April — price com­pe­ti­tion has so far not been a fac­tor in the PD-(L)1 mar­ket. That’s where EQRx and CStone think they might have a dif­fer­en­ti­at­ing an­gle, and they haven’t been shy about it.

“EQRx was cre­at­ed to ad­dress this chal­lenge head-on by bring­ing high-qual­i­ty med­i­cines to pa­tients at much low­er prices,” EQRx CEO Alex­is Borisy said in a state­ment. “PD(L)1 ther­a­pies are the back­bone of can­cer treat­ment, and we see tremen­dous op­por­tu­ni­ty for sug­e­mal­imab as a monother­a­py or in com­bi­na­tion reg­i­mens, low­er­ing the over­all costs of im­munother­a­py op­tions.”

Of course, EQRx will be run­ning with big dogs on the mar­ket with big com­mer­cial teams. In fact, Bern­stein an­a­lyst Ron­ny Gal in a March open let­ter to Re­gen­eron CEO Len Schleifer plead­ed with the drug­mak­er to lever­age its im­mense mar­ket­ing team to a dis­count­ing strat­e­gy it­self.

Gal ar­gued that price com­pe­ti­tion has not fa­vored in­no­va­tion in on­col­o­gy, and on­col­o­gists have usu­al­ly leaned to­ward more ex­pen­sive drugs giv­en their own fi­nan­cial in­cen­tives. But with at­ti­tudes around pric­ing chang­ing, Re­gen­eron could have an op­por­tu­ni­ty to un­der­cut its com­peti­tors and snag a big share of the mar­ket be­fore more com­peti­tors like EQRx en­ter the field and in­evitably take the dis­count route.

If Re­gen­eron fol­lows that ad­vice, Gal cal­cu­lat­ed, it could se­cure an ad­di­tion­al 10% mar­ket share across some of the big­ger in­di­ca­tions, in­clud­ing non-small cell lung can­cer, re­nal cell car­ci­no­ma and melanoma. Add that up and it could spell $2 bil­lion in sales per year for Lib­tayo. Mean­while, Re­gen­eron could still ask top-dol­lar for drugs used in com­bi­na­tion with the an­ti-PD-1.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Bolt Bio CEO Randy Schatzman

Bolt Bio goes bust as in­vestors boo sin­gle re­sponse in ear­ly test against HER2-ex­press­ing tu­mors

Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech said Monday.

BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.

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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)

Bio­haven shakes up lead­er­ship team as it feels the heat from mi­graine com­peti­tors

As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.

Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.

Chen Schor, Adicet CEO

Adicet un­veils ear­ly re­spons­es for off-the-shelf drug lever­ag­ing rare T cells. Will dura­bil­i­ty hold up?

On the hunt for the next generation of “off-the-shelf” cell therapies, biotech players like Adicet Bio have looked to leverage some of the less-obvious members of the immune system as potent cancer fighters. In Adicet’s case, scarce gamma delta T cells are on the menu, and an early cut of data is showing some promise.

Adicet’s AD-001, an off-the-shelf cell therapy developed by engineering a CD20-targeting chimeric antigen receptor (CAR) onto a donor’s gamma delta T cells, posted two complete responses across four patients in an early Phase I study testing the drug in patients with heavily pretreated B cell non-Hodgkin’s lymphoma, the biotech said Monday.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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