GSK poised to leap back in­to the on­col­o­gy mar­ket with more pos­i­tive be­lan­tam­ab mafodotin re­sults — but BC­MA ri­vals are swarm­ing in be­hind

Glax­o­SmithK­line took an im­por­tant step to­ward a key new ap­proval Mon­day night, post­ing their sec­ond pos­i­tive round of piv­otal da­ta for the BC­MA-tar­get­ing mul­ti­ple myelo­ma con­ju­gate be­lan­tam­ab mafodotin (GSK2857916). And with up­beat DREAMM-2 da­ta, they’ve filed for an ap­proval with hopes of get­ting a pri­or­i­ty re­view for their “break­through” drug can­di­date.

But af­ter the stel­lar rounds of new da­ta in the BC­MA field at ASH a few days ago, don’t ex­pect a tremen­dous lev­el of ex­cite­ment to greet them over the out­come.

To be sure, a 31% over­all re­sponse rate among 97 very sick pa­tients with 3 com­plete re­spons­es in the bunch is like­ly enough to war­rant an FDA OK — giv­en reg­u­la­tors’ track record when it comes to pa­tients and op­tions. But the re­sults leave open the ques­tion of what the long-term com­mer­cial prospects can be as GSK makes its way back in­to the on­col­o­gy mar­ket af­ter a long and painful ab­sence.

Me­di­an du­ra­tion has not been es­tab­lished yet.

For ‘7916, the new da­ta batch marks a sig­nif­i­cant drop from the 60% ORR in DREAMM-1, though in­ves­ti­ga­tors note that this new tri­al in­clud­ed a much sick­er set of pa­tients with dwin­dling op­tions. At ASH we al­so saw a CAR-T from J&J that de­liv­ered a 100% re­sponse rate in the BC­MA field for mul­ti­ple myelo­ma. That came with a jaw drop­ping 69% com­plete re­sponse rate. Re­gen­eron im­pressed with its bis­pe­cif­ic REGN5458, while blue­bird and Bris­tol-My­ers Squibb lead the boom­ing BC­MA field, and now add their bis­pe­cif­ic CC-92369 to the list of am­bi­tious can­di­dates. The list goes on.

And out in front, Darza­lex con­tin­ues to make new progress in com­bi­na­tion with oth­er drugs for mul­ti­ple myelo­ma. At ASH Am­gen post­ed a 37% re­duc­tion in the risk of pro­gres­sion of mul­ti­ple myelo­ma for pa­tients treat­ed with a com­bi­na­tion of Kypro­lis and the block­buster Darza­lex from J&J and Gen­mab, com­pared to ei­ther alone.

Game over for GSK?

Not quite.

Ax­el Hoos

Ax­el Hoos, the GSK on­col­o­gy R&D chief who kept the flame of ear­ly-stage can­cer R&D burn­ing af­ter a big pipeline/com­mer­cial swap with No­var­tis, read­i­ly agrees that both the CAR-Ts as well as the bis­pecifics have a lot of ex­cit­ing da­ta be­hind them. They al­so have fur­ther to go in the clin­ic, he adds, and in CAR-T’s case, se­ri­ous cy­tokine re­lease syn­drome safe­ty is­sues as well as a con­tin­u­ing set of man­u­fac­tur­ing ob­sta­cles that con­tin­ues to drag back the pi­o­neers.

Move back to a con­ju­gate like theirs, Hoos says, and there are re­al ad­van­tages in scal­a­bil­i­ty and ac­cess that gives GSK a re­al shot at mak­ing a mark in the field — soon.

“We think we have a more po­tent agent and that should play out as you start com­bin­ing,” he adds, im­por­tant in a field where com­bi­na­tions are king. In the mean­time, every­thing from DREAMM-3 to DREAMM-10 are in the works, un­der­scor­ing a com­mit­ment to amp up their com­mit­ment to drugs that have po­ten­tial.

Armed with a break­through ther­a­peu­tic des­ig­na­tion at the FDA, and PRIME from the EMA, it’s like­ly that GSK won’t have to wait much longer be­fore it starts to put its toe back in the can­cer drug mar­ket. And with Luke Miels lead­ing the com­mer­cial charge fol­low­ing the Tesaro PARP buy­out, every­one at GSK knows they have a lot to prove as R&D chief Hal Bar­ron and CEO Em­ma Walm­s­ley take new steps to prove they’ve re­vived a stag­nant phar­ma R&D group.

Here we go.

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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