The FDA has paused Mer­sana Ther­a­peu­tics’ Phase I clin­i­cal tri­al for a can­cer treat­ment af­ter a pa­tient died, the biotech said Mon­day morn­ing.

The death was deemed to be re­lat­ed to its drug, the Cam­bridge, MA-based biotech said.

The pa­tient who died was the sec­ond to be dosed in Mer­sana’s clin­i­cal tri­al for a STING ag­o­nist — a drug tar­get that sci­en­tists be­lieve can boost im­mune re­sponse against tu­mors but has seen a num­ber of chal­lenges over the years, from low ef­fi­ca­cy to nixed pro­grams.

Mer­sana’s drug, XMT-2056, is an an­ti­body-drug con­ju­gate meant to tar­get cells that ex­press HER2 and ac­ti­vate STING sig­nal­ing in those cells. Mer­sana start­ed the tri­al in late Jan­u­ary, look­ing to en­roll pa­tients with sol­id tu­mor can­cers that were HER2 pos­i­tive.

In Au­gust, GSK paid Mer­sana $100 mil­lion up­front for an op­tion to co-de­vel­op and com­mer­cial­ize XMT-2056, which Mer­sana tout­ed as the “biggest pre­clin­i­cal ADC deal ever.” GSK said in an emailed state­ment that it was “aware of the clin­i­cal hold.”

An­na Pro­topa­pas

Since the Phase I study was a dose es­ca­la­tion tri­al, the pa­tient was dosed at the low­est dose that Mer­sana set out to test. As a re­sult of the FDA’s clin­i­cal hold, no more pa­tients will be dosed or en­rolled in the tri­al. Mer­sana CEO An­na Pro­topa­pas said in a state­ment the com­pa­ny will be “un­der­tak­ing the work re­quired to ful­ly an­a­lyze this SAE and con­sid­er po­ten­tial next steps for de­vel­op­ment.”

Mer­sana de­clined to com­ment be­yond the press re­lease.

The biotech spe­cial­izes in an­ti­body-drug con­ju­gates, a type of treat­ment where an an­ti­body acts as the hom­ing bea­con for a can­cer drug. Mer­sana’s lead can­di­date, up­i­fi­ta­m­ab ril­sodotin, is an ADC for ovar­i­an can­cer that is cur­rent­ly in Phase III.

Mer­sana’s stock $MRSN was paused briefly Mon­day morn­ing but even­tu­al­ly slid about 5% af­ter the open­ing bell.

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.

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.

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.