Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astel­las and Sutro Bio­phar­ma are link­ing arms on a new field of an­ti­body-drug con­ju­gates that they hope will im­prove up­on ex­ist­ing can­cer im­munother­a­pies.

The Tokyo phar­ma will dole out $90 mil­lion in cash for the col­lab­o­ra­tion, the com­pa­nies said Mon­day af­ter­noon. That up­front pay­ment will ex­tend the South San Fran­cis­co biotech’s run­way from late 2023 in­to the first half of 2024, Cowen an­a­lysts not­ed.

In­vestors ap­peared to wel­come the deal, send­ing Sutro shares $STRO up 12% be­fore the open­ing bell Tues­day.

Sutro will pro­vide its know-how in im­munos­tim­u­la­to­ry an­ti­body-drug con­ju­gates and Astel­las will bring its glob­al on­col­o­gy R&D ex­per­tise to the ta­ble. The goal is to di­rect­ly kill tu­mor cells with a po­tent cy­to­tox­in paired with a com­po­nent that ex­cites an im­mune re­sponse par­tic­u­lar to the pa­tient’s tu­mor cells. The pair be­lieves the ap­proach can beat out ex­ist­ing im­munother­a­pies and help pa­tients who don’t re­spond to im­mune check­point in­hibitors.

Three bi­o­log­i­cal tar­gets are on the hori­zon for the duo. Sutro will han­dle re­search and pre­clin­i­cal stud­ies to iden­ti­fy can­di­dates and Astel­las will take over from there, over­see­ing clin­i­cal tri­als.

Nao­ki Oka­mu­ra

“Sutro is a lead­ing com­pa­ny in the area of iAD­Cs, a new modal­i­ty, and has its own orig­i­nal iADC tech­nolo­gies. The strate­gic part­ner­ship with Sutro will help us ex­pand our pipeline and widen the choice of can­cer im­munother­a­pies,” Astel­las strat­e­gy chief Nao­ki Oka­mu­ra said in a state­ment.

Each of those three po­ten­tial prod­ucts could turn in­to an ad­di­tion­al $422.5 mil­lion in biobucks, which equates to about $1.26 bil­lion in mile­stone pay­ments, should all three make it to fruition. Tack on low dou­ble-dig­it to mid-teens tiered roy­al­ties, if the drugs get on the mar­ket. Sutro can al­so sign up to share in the costs and prof­its to de­vel­op and com­mer­cial­ize the drugs in the US.

“We think this new re­search col­lab­o­ra­tion with Astel­las fur­ther val­i­dates Sutro’s unique con­ju­ga­tion tech­nol­o­gy,” Cowen an­a­lysts wrote in a note.

Sutro has crossed its Ts and dot­ted its Is on Big Phar­ma col­lab­o­ra­tions in re­cent years, with Bris­tol My­ers Squibb via Cel­gene, Mer­ck KGaA and Mer­ck.

The near­ly two-decade-old Stan­ford spin­out al­so lined up a $40 mil­lion up­front pay­ment last De­cem­ber in ex­change for li­cens­ing its lead drug in parts of Asia to Chi­na phar­ma Tasly Bio­phar­ma­ceu­ti­cals. But that deal took a turn — af­ter a batch of da­ta from a Phase I tri­al, in which a pa­tient died fol­low­ing a case of low lev­els of a cer­tain white blood cell, Tasly in­di­cat­ed it want­ed to rene­go­ti­ate terms, Sutro dis­closed in Feb­ru­ary. The up­front pay­ment switched to $25 mil­lion, the com­pa­nies lat­er said.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.