Eliot Charles, MiroBio executive chairman

Ox­ford spin­out nabs al­most $100M in new cash to test PD-1 in au­toim­mune dis­eases and hunt for a CEO

Af­ter about 15 years in an Ox­ford lab and three more years in the up­start world fol­low­ing a 2019 spin­out, Miro­Bio is ready to en­ter UK clin­i­cal tri­als and, en route to the clin­ic, the biotech has picked up $97 mil­lion in Se­ries B funds.

The £80 mil­lion fi­nanc­ing round kicked off in earnest last Sep­tem­ber and in­cludes a transat­lantic con­sor­tium — led by Medicxi — ready to bankroll that first clin­i­cal tri­al, be­gin­ning “im­mi­nent­ly,” as well as the de­but study of a sec­ond pro­gram there­after, ex­ec­u­tive chair Eliot Charles, an SR One ven­ture part­ner, told End­points News.

Richard Cor­nall

The 37-em­ploy­ee biotech is based off the sci­en­tif­ic chops of Ox­ford’s Richard Cor­nall and Si­mon Davis. They’ve been study­ing check­point re­cep­tors for well over a dozen years, and Miro­Bio has tasked it­self with ad­vanc­ing their re­search in­to cre­at­ing mon­o­clon­al an­ti­bod­ies to treat au­toim­mune dis­eases.

With more than 70 in­hibito­ry check­point re­cep­tors found in the hu­man im­mune sys­tem, Miro­Bio is scan­ning through the li­brary and com­ing up with pro­grams that can take ad­van­tage of some of those, Charles said.

So far, the com­pa­ny is re­veal­ing MB272 and MB151, which are ag­o­nists for BT­LA and PD-1, re­spec­tive­ly. PD-1 is well-known in the on­col­o­gy space, but Miro­Bio wants to go af­ter undis­closed au­toim­mune dis­eases to start. Be­hind those pro­grams is ear­li­er-stage dis­cov­ery work study­ing “re­cep­tors that are much less well-known or, at least, there’s not as much out there in the lit­er­a­ture,” the chair­man said.

“There was an ap­pre­ci­a­tion that we could use mon­o­clon­al an­ti­bod­ies to ar­ti­fi­cial­ly ag­o­nize, stim­u­late these re­cep­tors and then dri­ve ac­tiv­i­ty through their path­ways,” Charles said.

The start­up will bring MB272 in­to the clin­ic “very soon” af­ter re­ceiv­ing the go-ahead from the UK’s health reg­u­la­tor re­cent­ly, he said, not­ing the pro­gram will be­gin with the typ­i­cal sin­gle- and mul­ti­ple-as­cend­ing dose stud­ies in the UK and then move in­to a Phase II pro­gram in the US, UK, Cana­da and Eu­rope. MB151 will fol­low suit.

“We’re work­ing on plans for the Phase II tri­als. We haven’t dis­closed the in­di­ca­tions yet,” Charles said.

Lynne Mur­ray

The com­pa­ny re­cent­ly hired CMO San­jay Keswani, the for­mer An­nex­on Bio­sciences CMO and Rheos Med­i­cines CEO, and pro­mot­ed SVP of R&D Lynne Mur­ray to CSO. She was pre­vi­ous­ly head of re­gen­er­a­tion for As­traZeneca’s ear­ly res­pi­ra­to­ry and im­munol­o­gy work.

The com­pa­ny will al­so look for a new CEO in the near-term, the chair­man not­ed.

While still ear­ly stage, Miro­Bio has heard from a num­ber of po­ten­tial part­ners who have ex­pressed “re­al­ly strong in­ter­est,” Charles said, so the biotech is “hav­ing con­ver­sa­tions right now.” Ide­al strate­gic part­ners, he said, would be those with “great tis­sue banks, datasets, oth­er forms of ex­per­tise that, quite frankly, as a small com­pa­ny, is just hard to ac­cess.” Those with man­u­fac­tur­ing prowess would be good, too.

Ex­ist­ing back­ers SR One, Ad­vent Life Sci­ences and Ox­ford Sci­ence En­ter­pris­es were joined by new Miro­Bio in­vestors Or­biMed and Mono­graph Cap­i­tal. Tim Fun­nell, a for­mer Miro­Bio VP of op­er­a­tions, is a part­ner at Mono­graph.

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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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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.

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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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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