Manos Perros, Entasis CEO

As­traZeneca's for­mer an­tibi­otics unit claims a PhI­II win in drug-re­sis­tant bac­te­ria af­fect­ing sick­ly pa­tients

The man­age­ment team at En­ta­sis, As­traZeneca’s old an­tibi­otics unit spun out six years ago, has a new dataset it’s sim­ply de­light­ed to share.

En­ta­sis re­vealed Phase III da­ta out­lin­ing how an an­tibi­ot­ic for in­fec­tions caused by Acine­to­bac­ter bau­man­nii reached its pri­ma­ry end­point of non-in­fe­ri­or­i­ty. Re­searchers com­pared the pro­gram — known as sul­bac­tam-dur­lobac­tam or SUL-DUR — to the an­tibi­ot­ic col­istin, say­ing their drug saw low­er lev­els of all-cause mor­tal­i­ty af­ter four weeks in treat­ment-re­sis­tant pa­tients.

In­vestors gave the news a mut­ed golf clap, send­ing En­ta­sis shares $ET­TX about 3% high­er in ear­ly Tues­day trad­ing.

Acine­to­bac­ter in­fec­tions gen­er­al­ly at­tack crit­i­cal­ly ill pa­tients, En­ta­sis says, en­ter­ing the blood­stream and some­times caus­ing pneu­mo­nia. It’s a class of bac­te­ria that can be­come re­sis­tant to oth­er types of an­tibi­otics such as car­bapen­ems, a com­mon­ly used med­ica­tion for bac­te­r­i­al in­fec­tions world­wide.

There are lim­it­ed treat­ment op­tions should pa­tients find them­selves suf­fer­ing from a drug-re­sis­tant bac­te­ria, the void En­ta­sis hopes to fill. Its sci­en­tists are work­ing not just on Acine­to­bac­ter in­fec­tions but a whole host of oth­er an­tibi­ot­ic meds, and just last month an­nounced they would start hu­man tri­als for a pro­gram that could kill a heav­i­ly scru­ti­nized bug in Pseudomonas.

Tues­day’s da­ta come from a study that en­rolled 207 pa­tients. En­ta­sis set up two parts for the tri­al — Part A ran­dom­ized the in­fect­ed in­di­vid­u­als in­to SUL-DUR and col­istin arms, while Part B was open-la­bel, ex­am­in­ing SUL-DUR in pre­vi­ous­ly failed treat­ments. Of the 125 evalu­able pa­tients in Part A, 19% of pa­tients died on SUL-DUR af­ter 28 days com­pared to 32.3% on col­istin.

Be­cause the pri­ma­ry end­point was non-in­fe­ri­or­i­ty, En­ta­sis did not pow­er the study for p-val­ues here, CEO Manos Per­ros said in a Tues­day morn­ing in­vestor call. In Part B, En­ta­sis said it saw a sim­i­lar all-cause mor­tal­i­ty rate for SUL-DUR at 17.9% of pa­tients.

But where En­ta­sis sees its drug set­ting it­self apart from com­peti­tors is in safe­ty, par­tic­u­lar­ly in the end­point look­ing at nephro­tox­i­c­i­ty. Re­searchers saw a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in nephro­tox­i­c­i­ty be­tween the SUL-DUR and col­istin groups in Part A: nephro­tox­i­c­i­ty was 13.2% in the treat­ment arm ver­sus 37.6% in the con­trol, good for a p-val­ue of p=0.0002.

“This is the key dif­fer­en­tia­tor,” En­ta­sis CMO David Al­tarac said on the call.

Over­all ad­verse events were com­pa­ra­ble be­tween the groups, but drug-re­lat­ed side ef­fects were nu­mer­i­cal­ly low­er among those tak­ing SUL-DUR. On­ly 11 of 91 pa­tients in the ac­tive arm ex­pe­ri­enced a drug-re­lat­ed ad­verse event, com­pared to 26 of 86 tak­ing col­istin.

Big Phar­ma large­ly left the an­tibi­otics space around the time As­traZeneca spun out En­ta­sis in 2015, as dis­mal re­sults con­tin­ued to hound clin­i­cal tri­als. The field al­so con­tin­ues to see a large­ly bro­ken re­im­burse­ment sys­tem, and the WHO has warned the pipeline for new an­tibi­otics is grow­ing ever spars­er.

But if every­thing goes right for En­ta­sis, the com­pa­ny will be ready to sub­mit its NDA in mid-2022.

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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