Har­bour Bio­Med jumps in­to the crowd­ed PD-1/L1 race, look­ing to take a Chi­nese as­set glob­al as check­point pipeline bulges

Can two Chi­nese biotechs vault a home­grown PD-L1 agent to fron­trun­ner sta­tus in the crowd­ed glob­al check­point race?

Har­bour Bio­Med thinks the an­swer is yes, and it’s will­ing to spend a to­tal of $350 mil­lion to make that a re­al­i­ty.

Pay­ing an un­spec­i­fied up­front to Cheng­du-based Kelun Biotech — with whom it al­ready has an ear­ly-stage col­lab­o­ra­tion — Har­bour grabs ex­clu­sive rights to de­vel­op, man­u­fac­tur­ing and com­mer­cial­ize A167 out­side of greater Chi­na. Har­bour is head­quar­tered in Shang­hai with a Boston out­post.

In ad­di­tion to shar­ing da­ta from the Phase I and II tri­als it’s been con­duct­ing in Chi­na among pa­tients with lym­phoma and sol­id tu­mors, Kelun will al­so work with Har­bour to ex­plore any po­ten­tial com­bi­na­tion ther­a­pies — a hot strat­e­gy with check­point in­hibitors. And all that will ide­al­ly form the ba­sis of the de­vel­op­ment, reg­u­la­to­ry and com­mer­cial mile­stones.

Jing­song Wang

“We plan to con­duct A167-based com­bi­na­tion tri­als glob­al­ly by our­selves, in­clud­ing with in­no­v­a­tive com­pounds we are de­vel­op­ing, or in col­lab­o­ra­tion with our part­ners, to find bet­ter ther­a­peu­tic op­tions against a wide range of tu­mor types,” said CEO Jing­song Wang, a Sanofi R&D vet, in a state­ment.

A167 was one of 22 PD-1/L1 check­points da­ta an­a­lyt­ics firm Pharm­Cube count­ed in its re­cent tal­ly of Chi­nese biotech ef­forts in the field. And that fits in­to a glob­al ex­plo­sion of check­point stud­ies, which the Can­cer Re­search In­sti­tute es­ti­mat­ed at 1,502 clin­i­cal tri­als (1,105 of those com­bos) in­volv­ing 164 PD-1/L1 agents last De­cem­ber.

CRI warned that the gold rush on I/O was lead­ing com­pa­nies to jump in­to com­bo stud­ies with­out much sci­en­tif­ic back­ing. And the on­rush of new PD-1/L1s in the clin­ic could have big im­pli­ca­tions for mar­ket lead­ers Mer­ck and Bris­tol-My­ers Squibb, which both en­joy block­buster in­come from their check­points.

This marks the sec­ond li­cens­ing pact for Har­bour this month, hav­ing just ob­tained Chi­na rights to a breast can­cer drug tar­get­ing HER2 and CD3 from In­dia’s Glen­mark Phar­ma­ceu­ti­cals days ago.

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.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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