Beat­ing out mar­ket lead­ers in PhII, an­tibi­ot­ic-mak­er Al­le­cra read­ies for Phase III tri­als

Eu­ro­pean biotech Al­le­cra an­nounced good news from the front­lines of its fight against mul­tidrug-re­sis­tant gram-neg­a­tive bac­te­ria – some of the most dan­ger­ous su­per­bugs around – af­ter wrap­ping up a Phase II study of its in­ves­ti­ga­tion­al an­tibi­ot­ic.

The com­pa­ny’s lead an­tibi­ot­ic can­di­date, an ex­tend­ed spec­trum β-lac­ta­mase in­hibitor known as AAI101, met all of the study’s ob­jec­tives, prep­ping Al­le­cra to take the drug in­to Phase III.

Nicholas Bene­dict

In the Phase II tri­al, AAI101 was giv­en in­tra­venous­ly to pa­tients in com­bi­na­tion with a well-known an­tibi­ot­ic called ce­fepime for the treat­ment of hos­pi­tal­ized pa­tients with com­pli­cat­ed UTIs. The com­bo was found safe and well-tol­er­at­ed and achieved high rates of mi­cro­bi­o­log­i­cal erad­i­ca­tion and clin­i­cal cure. Al­le­cra said all test­ed pathogens were sus­cep­ti­ble to their com­bo of ce­fepime and AAI101, in­clud­ing those not sus­cep­ti­ble ei­ther to ce­fepime alone or to the mar­ket leader, piperacillin/tazobac­tam (mar­ket­ed un­der the brand name Tazocin, among oth­ers).

Al­le­cra, found­ed in 2013, has al­ready raised a few rounds of cash to fu­el its op­er­a­tions so far, in­clud­ing a re­cent tranched deal (the first stage of which was rough­ly $11 mil­lion) led by Xer­aya Cap­i­tal with some back­ing from Bio­Med­Part­ners. That fol­lowed a $24.7 mil­lion Se­ries B in 2016, and a $19.6 mil­lion launch round back in 2013.

“The re­sults from Al­le­cra’s Phase II Cac­tus study so­lid­i­fy Al­le­cra’s plans to ad­vance ce­fepime/AAI101 in­to Phase III lat­er this year,” said Nicholas Bene­dict, co-founder and chief ex­ec­u­tive of­fi­cer of Al­le­cra in a state­ment.

Last No­vem­ber, ce­fepime/AAI101 was grant­ed fast track des­ig­na­tion by the FDA for the treat­ment of cU­TI, com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions and hos­pi­tal-ac­quired bac­te­r­i­al pneu­mo­nia/ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia. FDA has al­so grant­ed ce­fepime/AAI101 qual­i­fied in­fec­tious dis­ease prod­uct sta­tus.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down a €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Scripps reach­es $10M set­tle­ment with gov­ern­ment over al­le­ga­tions NIH grants weren't prop­er­ly ac­count­ed for

Scripps Research Institute has settled a case with the Justice Department alleging claims of misappropriated funds, the US attorney for the district of Maryland announced late last week.

Prosecutors said the institute improperly used NIH-funded research grants for non-grant related activities, including working on new grant applications, teaching activities and other administrative tasks. As part of the settlement, Scripps has agreed to pay $10 million.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.