VBL an­nounces pos­i­tive PhI­II da­ta for ovar­i­an can­cer drug; Gene­Cen­tric part­ners with Janssen on blad­der can­cer

VBL Ther­a­peu­tics an­nounced that it is on track in a Phase III tri­al of its drug VB-111 (ofran­er­gene obade­n­ovec) to treat plat­inum-re­sis­tant ovar­i­an can­cer in com­bi­na­tion with pa­cli­tax­el.

Af­ter con­duct­ing its sec­ond in­ter­im analy­sis, the in­de­pen­dent Da­ta Safe­ty Mon­i­tor­ing Com­mit­tee (DSMC) rec­om­mend­ed that Is­rael-based VBL con­tin­ue full steam ahead. The com­mit­tee looked at un­blind­ed over­all sur­vival rate, which is the pri­ma­ry end­point of the study, dubbed OVAL. The first analy­sis eval­u­at­ed CA-125 re­sponse.

About 400 pa­tients are ex­pect­ed to par­tic­i­pate in the tri­al, which com­pares the an­ti-can­cer gene ther­a­py agent VB-111 and pa­cli­tax­el with a place­bo and pa­cli­tax­el com­bi­na­tion.

VB-111 re­ceived or­phan drug des­ig­na­tion in the US and Eu­rope to pro­long the sur­vival of pa­tients with rGBM, and the Eu­ro­pean Com­mis­sion al­so gave it or­phan des­ig­na­tion for the treat­ment of ovar­i­an can­cer. It’s cur­rent­ly in tri­al for use in pa­tients with ra­dioio­dine-re­frac­to­ry thy­roid can­cer and re­cur­rent plat­inum-re­sis­tant ovar­i­an can­cer.

“The OVAL study con­tin­ues to show strong re­cruit­ment de­spite the COVID-19 pan­dem­ic, and we are very en­cour­aged by the high re­sponse rate of over 50% of the tri­al par­tic­i­pants, which has been main­tained,” VBL CEO Dror Harats said in a pre­pared state­ment. — Nicole De­Feud­is 

Gene­Cen­tric part­ners with Janssen to study blad­der can­cer bio­mark­ers

Gene­Cen­tric, a biotech based out of Durham, NC, an­nounced it is en­ter­ing in­to a re­search col­lab­o­ra­tion with Janssen to study RNA-based drug re­sponse bio­mark­ers for non-mus­cle in­va­sive blad­der can­cer.

The re­search will in­volve the ap­pli­ca­tion of Gene­Cen­tric’s pro­pri­etary mol­e­c­u­lar pro­fil­ing plat­form to de­ter­mine po­ten­tial sig­na­tures of dis­ease pro­gres­sion and drug re­sponse to stan­dard of care ther­a­py. Specif­i­cal­ly, the pair aim to re­search tu­mor mi­croen­vi­ron­ments in ge­nom­ic and im­mune set­tings for those with NMIBC.

Fi­nan­cial terms of the deal were not dis­closed.

The two com­pa­nies say they set­tled on NMIBC as an area of re­search be­cause, com­pared with metasta­t­ic urothe­lial car­ci­no­ma, there is much less known re­gard­ing can­cer sub­types as­so­ci­at­ed with dis­ease risk and po­ten­tial ther­a­peu­tic re­sponse. — Max Gel­man

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.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

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.

#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.

News brief­ing: Bausch Health clos­ing in on deal to ac­quire Al­le­gro as­sets; PharmAbcine strikes deal with Sam­sung Bi­o­log­ics to de­vel­op an­ti­body pro­gram

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.