Anat Cohen-Dayag, Compugen CEO

Com­pu­gen touts ovar­i­an can­cer da­ta in com­bo with Op­di­vo, an­ti-TIG­IT from ex-part­ner Bris­tol My­ers

Com­pu­gen pre­sent­ed a batch of da­ta from ear­ly-stage tri­als of its an­ti-PVRIG can­di­date in dual and triple com­bi­na­tion stud­ies, in­clud­ing one with an an­ti-TIG­IT ther­a­py, but the pair­ings are no longer part of the biotech’s strat­e­gy af­ter it re­cent­ly axed a years­long Bris­tol My­ers Squibb col­lab­o­ra­tion.

And, for a brief pe­ri­od this fall, the in­di­ca­tion was not a fo­cus of the biotech’s fu­ture de­vel­op­ment plans, but Tues­day’s da­ta are enough to shore up con­fi­dence for an­oth­er study in plat­inum re­sis­tant ovar­i­an can­cer, the Holon, Is­rael-based drug de­vel­op­er said Tues­day.

In one of the stud­ies par­tial­ly pre­sent­ed Tues­day, Com­pu­gen paired its as­set, COM701, with Bris­tol My­ers’ Op­di­vo and an­ti-TIG­IT BMS-986207 in pa­tients with plat­inum re­sis­tant ovar­i­an can­cer.

As of Nov. 23, the biotech ob­served four con­firmed par­tial re­spons­es out of 20 pa­tients who had a me­di­an num­ber of four pri­or ther­a­pies. Three of those four pa­tients were re­spond­ing “for at least 9 months,” Com­pu­gen said. The re­spon­ders are still tak­ing the drug, “there­fore me­di­an du­ra­tion of re­sponse has not been reached.”

An­oth­er five of the 20 pa­tients have sta­ble dis­ease, Com­pu­gen re­port­ed.

In the oth­er study, COM701 was on­ly paired with Op­di­vo in pa­tients with plat­inum re­sis­tant ep­ithe­lial ovar­i­an can­cer who had re­ceived a me­di­an num­ber of six pre­vi­ous ther­a­pies. Al­so as of Nov. 23, two of 20 pa­tients had a par­tial re­sponse, with one on­go­ing at the cut­off date. One of those pa­tients had pre­vi­ous­ly re­ceived sev­en lines of treat­ments. An­oth­er sev­en pa­tients had sta­ble dis­ease.

Ovar­i­an can­cer has long been a dif­fi­cult cor­ner of on­col­o­gy for check­point in­hibitors, with ear­ly phase tri­als of PD-L1/PD1 in­hibitors show­ing re­sponse rates in the range of 10% to 15%.

Go­ing for­ward, COM701 will not be test­ed in com­bi­na­tion with BMS as­sets. In Au­gust, the biotech said it was end­ing its pact with Bris­tol My­ers, inked in 2018 and planned to con­clude to­ward the end of 2023, which came as a “sur­prise” to Jef­feries an­a­lysts. CEO Anat Co­hen-Dayag said the com­pa­ny has a “very good re­la­tion­ship with Bris­tol.”

At the time, Com­pu­gen al­so said it was fo­cus­ing in on MSS-col­orec­tal can­cer and non-small cell lung can­cer. The NSCLC pa­tient pop­u­la­tion has a lot of da­ta, and some of the key TIG­IT play­ers, like Gilead/Ar­cus, are test­ing their ther­a­pies in that pa­tient pop­u­la­tion. There would be a high bar to meet, and com­pet­ing for pa­tients would sure­ly be part of the equa­tion, but Com­pu­gen thought it would lead to a high prob­a­bil­i­ty of suc­cess, Co­hen-Dayag said.

But months lat­er, the biotech re­vised the fo­cus once again, swap­ping NSCLC for ovar­i­an can­cer af­ter be­ing en­cour­aged by da­ta.

Co­hen-Dayag told End­points News the biotech “couldn’t ig­nore” the da­ta they were see­ing out of the stud­ies in pa­tients with ovar­i­an can­cer, who typ­i­cal­ly are “not re­al­ly re­spond­ing to any­thing.”

The near­ly 30-year-old biotech, close to pen­ny stock ter­ri­to­ry, will move COM701 for­ward in two stud­ies. One of the tri­als will start ear­ly next year as a triplet in­ves­ti­ga­tion: COM701 plus Com­pu­gen’s own an­ti-TIG­IT (COM902) and Mer­ck’s Keytru­da. En­roll­ment will wrap next year in that study, which will en­roll up to 20 pa­tients with metasta­t­ic MSS-CRC.

The sec­ond study is still un­der de­sign and will in­clude plat­inum re­sis­tant ovar­i­an can­cer pa­tients who are im­mune check­point in­hibitor naïve. Co­hen-Dayag de­clined to say whether the tri­al will be monother­a­py, dual or oth­er sorts of com­bi­na­tions.

Com­pu­gen was orig­i­nal­ly a com­pu­ta­tion­al soft­ware part­ner to the phar­ma in­dus­try but has since ex­pand­ed to in­clude its own pipeline, like Schrödinger and oth­ers. The com­pa­ny is al­so part­nered with As­traZeneca and re­cent­ly re­ceived a mile­stone pay­ment as part of the pact’s pro­gres­sion in­to Phase II with a bis­pe­cif­ic an­ti­body.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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Vu Truong, Aridis Pharmaceuticals CEO (Aridis/Nasdaq)

Aridis' mon­o­clon­al an­ti­body fails PhI­II, but plans for sec­ond tri­al any­way

Aridis Pharmaceuticals’ monoclonal antibody missed the bar in a Phase III test in ventilator-associated pneumonia caused by the gram-positive bacteria S. aureus, the company announced Wednesday. 

But Aridis is planning for a second Phase III study anyway once it discusses the findings with the FDA and the European Medicines Agency. Execs blamed recruitment challenges stemming from Covid-19 and Russia’s invasion of Ukraine for the miss, cutting their enrollment target in half.

Al Gianchetti, XyloCor CEO

Xy­lo­Cor wraps up PhII for heart dis­ease gene ther­a­py, plans for piv­otal tri­al

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.