E-tail­er bil­lion­aire Mick­ey Mik­i­tani has backed As­pyr­i­an Ther­a­peu­tics’ pho­toim­munother­a­py tech from the be­gin­ning, start­ing as a par­tic­i­pant in the com­pa­ny’s $40 mil­lion Se­ries A round and lat­er tak­ing the helm as CEO and wrap­ping the brand en­tire­ly in­to his Rakuten em­pire.

He’s now reeled in an­oth­er $166 mil­lion to push the com­pa­ny’s lead head and neck can­cer drug through a glob­al Phase III tri­al.

Rakuten Med­ical — for­mer­ly known as As­pyr­i­an Ther­a­peu­tics, then Rakuten As­pyr­i­an — un­veiled a Se­ries D round on Wednes­day, con­sist­ing of $75 mil­lion in new cap­i­tal and $91 mil­lion in con­vert­ible promis­so­ry notes. Gen­er­al Cat­a­lyst led the round, with some help from ex­ist­ing in­vestors like Rakuten Group and SBI Group.

“We be­lieve the ex­ten­si­bil­i­ty of the Il­lu­mi­nox plat­form has the po­ten­tial to re­de­fine the way clin­i­cians care for their pa­tients,” Paul Kwan, man­ag­ing di­rec­tor at Gen­er­al Cat­a­lyst, said in a state­ment.

The Cal­i­for­nia-based biotech’s Il­lu­mi­nox plat­form is based on pho­toim­munother­a­py work from the lab of Hisa­ta­ka Kobayashi at the Na­tion­al Can­cer In­sti­tute. Kobayashi, an imag­ing ex­pert, made the some­what serendip­i­tous dis­cov­ery that con­ju­gat­ing an an­ti­body with a light-ac­ti­vat­ed dye called IRDye 700DX, then hit­ting it with a near-in­frared light, could kill can­cer cells with­out off-tar­get tox­i­c­i­ty.

Mik­i­tani stum­bled up­on the dis­cov­ery while search­ing for a bet­ter ther­a­py for his fa­ther, who was dy­ing of pan­cre­at­ic can­cer. While it was too late to save his fa­ther, he ran with the idea, back­ing As­pyr­i­an and then tak­ing the CEO spot in 2018.

Rakuten’s lead can­di­date, ASP-1929, was grant­ed con­di­tion­al ear­ly ap­proval in Japan for ad­vanced or lo­cal­ly re­cur­rent head and neck can­cer in Sep­tem­ber, and is cur­rent­ly in a glob­al Phase III tri­al for the same in­di­ca­tion. The can­di­date em­ploys the an­ti­body ce­tux­imab con­ju­gat­ed to IRDye 700DX, and is de­signed to bind to epi­der­mal growth fac­tor re­cep­tors (EGF), which are ex­pressed in sev­er­al types of sol­id tu­mors, in­clud­ing head and neck, cu­ta­neous esophageal, lung, colon and pan­cre­at­ic can­cers. Then it’s lo­cal­ly ac­ti­vat­ed by a laser de­vice sys­tem.

Rakuten says it’s work­ing on ad­di­tion­al ther­a­pies un­der the same plat­form to treat “a range of on­co­log­i­cal in­di­ca­tions.” The com­pa­ny is al­so in­ves­ti­gat­ing ASP-1929’s ef­fi­ca­cy in com­bi­na­tion with an­ti-PD1 in mul­ti­ple tu­mor types, in­clud­ing head and neck can­cer.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.