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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Emer Cooke, EMA director (AP Photo/Geert Vanden Wijngaert)

Ahead of FDA, EMA rec­om­mends au­tho­riz­ing new gene ther­a­py treat­ment for ul­tra-rare dis­ease

Aromatic amino acid decarboxylase (AADC) deficiency is an ultra-rare genetic disease that leaves patients unable to produce certain hormones in the brain, such as dopamine and serotonin, usually leading to developmental delays, weak muscle tone and inability to control the movement of the limbs. It can also lead to multiple organ failure.

To date, there have been no treatments approved for AADC deficiency, which has been identified in less than 150 patients.

Ather­sys tries to post-hoc-an­a­lyze its way out of an­oth­er tri­al fail for stroke stem cell ther­a­py

Athersys’ stem cell therapy has failed yet again.

In a 206-person trial conducted in Japan, Athersys’ stem cell therapy for stroke failed its primary endpoint of “excellent outcome,” a combined measure of three stroke recovery scores.

While a greater percentage of patients in the treatment group reached the primary endpoint compared to placebo, that difference was not statistically significant.

Castle Creek Biosciences chair Jeff Aronin

Scoop: Af­ter pulling IPO am­bi­tions last De­cem­ber, Jeff Aron­in's Cas­tle Creek turns to pri­vate back­ers

Jeff Aronin’s cell and gene therapy biotech Castle Creek Biosciences has raised $112 million in equity, Endpoints News has learned.

The Exton, PA, biotech secured the financing from 54 investors, according to an SEC filing dated May 2. The late-stage startup had last year considered a $100 million Nasdaq debut, but in a sign of the bear market that has plagued hundreds of newly minted public biotechs, Castle Creek pulled those ambitions in the last few weeks of 2021.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.