An­oth­er $25 mil­lion is flow­ing the way of a Cal­i­for­nia biotech at­tempt­ing to fix the “tri­al and er­ror” sys­tem in neu­ro­science drug R&D.

Al­to Neu­ro­science picked up the cap­i­tal from Al­pha Wave Ven­tures via an ex­ten­sion to its Se­ries B, bring­ing to­tal eq­ui­ty raised to $100 mil­lion since the start­up’s 2019 found­ing. The biotech al­so re­cent­ly signed up for a $35 mil­lion cred­it fa­cil­i­ty.

All that cap­i­tal will help the biotech in­ves­ti­gate four drugs through four Phase II read­outs, Al­to said Mon­day morn­ing. That means enough mon­ey to keep the lights on in­to 2025, a year longer than pro­ject­ed un­der the orig­i­nal Se­ries B close.

Co-found­ing CEO Amit Etkin told End­points News the fund­ing will al­so sup­port Phase I stud­ies this year to get a bet­ter un­der­stand­ing of how the biotech’s drug can­di­dates work, what dos­es to bring for­ward and which in­di­ca­tions to test them in across more Phase II stud­ies in the next two years.

The ap­prox­i­mate­ly 50-em­ploy­ee start­up hopes to move past the “tri­al and er­ror” ap­proach of neu­ro­science drug de­vel­op­ment, per­haps most rec­og­niz­able by the lengths pa­tients have to go through to find the de­pres­sion meds that ac­tu­al­ly work for them.

To do so, Al­to is pair­ing a trove of da­ta on EEG ac­tiv­i­ty, ge­net­ics, be­hav­ioral task mea­sure­ments and oth­er fac­tors to see which of its drugs fits best with pa­tients who have de­pres­sion, post-trau­mat­ic stress dis­or­der and oth­er men­tal health con­di­tions. The com­pa­ny’s ar­ti­fi­cial in­tel­li­gence plat­form homes in on three buck­ets: cog­ni­tion, emo­tion and sleep.

Ear­li­er this month, the biotech tout­ed open-la­bel Phase IIa re­sults for its lead de­pres­sion as­set, AL­TO-100, which were sta­tis­ti­cal­ly sig­nif­i­cant as both a sin­gle ther­a­py and ad­junc­tive.

The goal is to get at least one of its drugs in­to Phase III, which would like­ly re­quire an­oth­er cap­i­tal in­fu­sion, the CEO said.

“We are en­cour­aged by their unique ap­proach backed by over a decade of hu­man da­ta ex­plor­ing brain mech­a­nisms and pa­tient het­ero­gene­ity,” Al­pha Wave man­ag­ing di­rec­tor Chris Dim­itropou­los, who’s join­ing the Al­to board, said in a state­ment. “The re­cent pos­i­tive clin­i­cal re­sults in de­pres­sion pro­vide con­fi­dence that a pre­ci­sion ap­proach in this field is achiev­able and like­ly to dri­ve bet­ter out­comes for pa­tients.”

The lead­er­ship team in­cludes Etkin, the CEO and a Stan­ford pro­fes­sor; co-founder and chief strat­e­gy of­fi­cer Dan Se­gal (for­mer ex­ec­u­tive of neu­ro­science com­pa­ny To­tal Brain); CMO Adam Savitz (af­ter 10 years at Janssen); co-founder and da­ta sci­ence chief Wei Wu; CFO Nick Smith and COO Mikael Elias­son.

Etkin said the biotech works di­rect­ly with clin­i­cal tri­al sites and doesn’t use con­tract re­search or­ga­ni­za­tions so it can keep costs down. The com­pa­ny will an­nounce an­oth­er per­son to its lead­er­ship team soon, he said.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.

In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.