Tes­sa show­cas­es pre­clin­i­cal promise of 'all-in-one' add-on to its can­cer cell ther­a­py, in march to the clin­ic

At Tes­sa Ther­a­peu­tics, the big idea has been to adapt virus-spe­cif­ic T cells (VST) to tar­get vi­ral­ly-as­so­ci­at­ed tu­mors, and swarm can­cer cells. Re­searchers be­lieve these VSTs can be ver­sa­tile, mak­ing su­pe­ri­or CAR-Ts that can then be com­bined with an on­colyt­ic virus and a check­point in­hi­bi­tion strat­e­gy. In its lat­est pre­clin­i­cal tri­al, the Sin­ga­pore-based biotech has spot­light­ed one such “all-in-one” ap­proach that they are now tak­ing in­to the clin­ic.

Ivan Ho­rak

The treat­ment, which is tai­lored for HER2-pos­i­tive sol­id tu­mors, con­sists of two steps: First, in­ves­ti­ga­tors in­ject an on­colyt­ic ade­n­ovirus in­to a tu­mor site, si­mul­ta­ne­ous­ly killing tu­mor cells and se­cret­ing PD-L1 block­ing an­ti­bod­ies and IL-12p70 cy­tokines. Then comes the CAR-T, which pil­lages the re­gion sys­tem­i­cal­ly to clear out oth­er can­cer cells.

In head and neck squa­mous cell car­ci­no­ma xenograft mod­els, Tes­sa re­ports, the com­bi­na­tion im­proved sur­vival to >100 days com­pared to ap­prox­i­mate­ly 25 days with ei­ther ap­proach alone.

That’s sig­nif­i­cant as metasta­t­ic HER2-pos­i­tive sol­id tu­mors re­main in­cur­able even with ex­ist­ing an­ti-HER2 tar­get­ed ther­a­pies, said Ivan Ho­rak, Tes­sa’s pres­i­dent of R&D. He added:

What’s par­tic­u­lar­ly en­cour­ag­ing from the pre­clin­i­cal study find­ings is that, it sug­gests the ef­fec­tive­ness of on­colyt­ic ade­n­ovirus in mim­ic­k­ing the body’s an­ti-vi­ral im­mune re­sponse to en­hance the ac­tiv­i­ty of T cells against HER2-pos­i­tive can­cer cells. The re­sults sup­port the sci­en­tif­ic no­tion that lo­cal­ly-pro­duced an­ti PDL1 an­ti­body ef­fec­tive­ly pro­tects T cells from the im­muno­sup­pres­sive tu­mor en­vi­ron­ment and ac­ti­va­tion cy­tokine IL-12p70 en­hances tu­mor in­flam­ma­tion to im­prove T cells tu­mor pen­e­tra­tion.

Bay­lor Col­lege of Med­i­cine — Tes­sa’s col­lab­o­ra­tor for the pre­clin­i­cal study — will lead the Phase I, an IND for which will be sub­mit­ted by the end of the year.

It will be a bas­ket tri­al in­volv­ing pa­tients with dif­fer­ent HER2-pos­i­tive can­cers, Ho­rak said. Ac­cord­ing to a post­ing on clin­i­cal­tri­als.gov, that spans blad­der can­cer, head and neck squa­mous cell car­ci­no­ma, can­cer of the sali­vary gland, lung can­cer, breast can­cer, gas­tric can­cer, esophageal can­cer, col­orec­tal can­cer and pan­cre­at­ic ade­no­car­ci­no­ma across 39 pa­tients — though Tes­sa em­pha­sizes that their plans could evolve as they prep the IND.

In a sec­ond big set­back for Covid-19 an­ti­body treat­ment hopes, Re­gen­eron halts en­roll­ment for more se­vere pa­tients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19.

The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen or mechanical ventilation in one of the trials on their antibody cocktail, after finding “a potential safety signal” and “an unfavorable risk/benefit profile.” The news comes a week after the NIH scrapped a trial of Eli Lilly’s Covid-19 antibody after finding it was having little effect on an initial cohort of hospitalized patients.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Bel­licum slash­es 79% of staffers af­ter ear­ly da­ta quash hope around next-gen CAR-T

Bellicum Pharmaceuticals tried to make it work.

Over the past months the Houston-based CAR-T player sold its manufacturing facility to MD Anderson — transferring 35 employees in the process — in favor of an outsourced arrangement and completed a reverse stock split, while dribbling out new data and getting an IND cleared.

But new interim data from a Phase I/II trial provided the last straw. Bellicum disclosed late Thursday that it will be laying off 79% of its staff, shaving the workforce from 68 to just 14 by the end of 2020.

George Golumbeski (L) and Faheem Hasnain

George Golumbes­ki and Fa­heem Has­nain team up with Ver­tex Ven­tures HC in man­ag­ing $320M of biotech cash

Two longtime biotech veterans are joining a multibillion dollar VC firm in order to help steer its latest fund.

George Golumbeski and Faheem Hasnain have signed on to Vertex Ventures HC as executive advisors, the company announced Thursday, and will assist with their depth of experience in managing $320 million of capital. Both have had previous working relationships with managing partners Carolyn Ng and Lori Hu, which evolved “organically” to get to this point, Ng said.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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As­traZeneca sells off heart fail­ure and hy­per­ten­sion drugs to Chep­lapharm for $400M

Out with the old and in with the new: AstraZeneca is selling off two heart failure and hypertension drugs to Germany-based Cheplapharm, bagging $400 million and making way for development in other areas.

Cheplapharm paid $200 million for the European rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil and hydrochlorothiazide) back in 2018. They’re now doubling that amount for commercial control in more than 70 countries.

News brief­ing: Ax­o­vant faces months of de­lay on lead Parkin­son's gene ther­a­py; Chi­nese CAR-T biotech nabs $100M

One of Axovant’s top gene therapy prospects for its second act is hitting a roadblock that could push its clinical timelines back by almost a year.

In an update, the biotech said it was informed about delays in CMC data and third-part fill-finish issues around mid-October by its manufacturing partner, Oxford Biomedica. Axovant has been developing a suspension-based process for the Parkinson’s drug; with that taking longer than expected, it now believes “it is unlikely that its planned randomized, sham-controlled trial of AXO-Lenti-PD will enroll patients by the end of calendar year 2021.”

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Covid-19 roundup: Flush with $486M con­tract, As­traZeneca signs Lon­za up to man­u­fac­ture an­ti­bod­ies; BioN­Tech's Ugur Sahin ex­pects vac­cine da­ta 'in a fort­night'

Days after scoring a $486 million BARDA contract to develop and manufacture its long-acting antibody combo for Covid-19, AstraZeneca has tapped Lonza to produce the drug substance at its mid-scale facility in Portsmouth, NH.

The drug, dubbed AZD7442, puts together two antibodies, first discovered by scientists at Vanderbilt University Medical Center, derived from convalescent patients who recovered from a SARS-CoV-2 infection. AstraZeneca licensed them in June and has since further engineered them with half-life extension and reduced Fc receptor binding.