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.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Clockwise from left: Canaccord Genuity principal Michelle Gilson, Canaccord Genuity CSO Brian Mueller and BioMarin CSO Hank Fuchs (Canaccord Genuity webcast)

Bio­Marin CSO diss­es ri­vals for the he­mo­phil­ia A gene ther­a­py crown: Way be­hind, fac­ing big re­cruit­ment chal­lenges and at best a .6 on the gen-one scale

The leader in the race to a hemophilia A gene therapy does not like to be compared unfavorably to the competition. And when their top execs do the comparing, don’t look for any modesty — BioMarin, they say, owns the lead.

As Factor VIII expression wanes over time, quite a few analysts have raised questions about the kind of future BioMarin’s gene therapy — a supposed once-and-done treatment — faces if it stops working. But just 7 days away from their PDUFA date, with high odds of success, the top execs clearly feel that they are way out front, while promising their rivals will discover there’s a tough slog ahead trying to pursue trials where large numbers of patients are ineligible for new therapies.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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