For­mer No­vo chair­man Göran An­do joins the board as Tes­sa bags $50M in ad­di­tion­al fund­ing

As Tes­sa Ther­a­peu­tics preps a piv­otal late-stage tri­al read­out and ramps up clin­i­cal ac­tiv­i­ty for ear­ly-stage as­sets, it will be joined by a high pro­file board mem­ber as well as new in­vestors who just in­fused $50 mil­lion in­to the com­pa­ny.

Göran An­do

Göran An­do, the re­cent chair­man of No­vo Nordisk, is now an in­de­pen­dent di­rec­tor at Tes­sa. He joins a team that now has a whop­ping to­tal of $130 mil­lion to steer its virus-spe­cif­ic T cell tech­nol­o­gy-based prod­ucts to the mar­ket, in­clud­ing an $80 mil­lion raise from a sig­nif­i­cant group of Asian in­vestors an­nounced four months ago. Lead­ing that well-heeled pack was Temasek, the sov­er­eign wealth fund of Sin­ga­pore, where Tes­sa is based.

An­do was the CEO of Cell­tech be­fore it was ac­quired by UCB, and pri­or to that had served in R&D roles at Bris­tol-My­ers Squibb and Phar­ma­cia. Hav­ing sat on nu­mer­ous biotech boards, An­do says he’s drawn to Tes­sa’s unique ap­proach to T cell ther­a­py, “one of the most ex­cit­ing ar­eas in the health­care sec­tor to­day.”

Han Chong Toh

Root­ed in re­search work CSO John Con­nol­ly and CMO Han Chong Toh — of Bay­lor and the Na­tion­al Can­cer Cen­tre Sin­ga­pore, re­spec­tive­ly — Tes­sa adapts T cells to go af­ter vi­ral­ly-as­so­ci­at­ed tu­mors like cer­vi­cal and head and neck can­cer. That ap­proach, which promis­es to go be­yond some of the ground­break­ing suc­cess­es that CAR-T treat­ments have had in blood can­cers in­to sol­id tu­mors, has at­tract­ed a part­ner­ship with Park­er In­sti­tute for Can­cer Im­munother­a­py.

“Ob­vi­ous­ly there’s a lot of press and clin­i­cal da­ta and ex­cite­ment around CAR-T,” Fred Rams­dell, the vice pres­i­dent for re­search at the Park­er In­sti­tute, told End­points News at the time. “That’s great and won­der­ful. What Tes­sa is do­ing is a lot dif­fer­ent.”

John Con­nol­ly

A Phase III tri­al tar­get­ing Ep­stein-Barr Virus pos­i­tive na­sopha­ryn­geal can­cer is on­go­ing in the US and four Asian coun­tries, a pro­gram that came up with ex­cel­lent PhII da­ta when com­pared to his­tor­i­cal re­sults: two- and three-year sur­vival rates at 62.9% and 37.1%.

With the new round of fund­ing (the in­vestors were not dis­closed), the biotech will have plen­ty of cash to steer an HPV pro­gram for cer­vi­cal can­cer and oropha­ryn­geal can­cer in­to Phase II in 2019. Tes­sa has al­so been lin­ing up new tech on on­colyt­ic virus­es and chimeric anti­gen re­cep­tors for its next-gen work, which would bring them in­to liv­er and lung can­cers.

“Com­bined with the ad­di­tion­al fund­ing we have raised by ex­pand­ing our re­cent fund­ing round, I feel that we are now at a key mo­ment in our jour­ney as an im­por­tant play­er in the de­vel­op­ment of cel­lu­lar im­munother­a­py, and we are de­light­ed that Dr. An­do is join­ing us at this ex­cit­ing stage,” said CEO An­drew Khoo in a state­ment.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”