Ma­gen­ta Ther­a­peu­tics is paus­ing an ear­ly-stage clin­i­cal tri­al af­ter a pa­tient died. The death was deemed to be pos­si­bly re­lat­ed to its drug, MG­TA-117.

The biotech said the pause of the Phase I/II tri­al is vol­un­tary and gives it time to re­view all avail­able da­ta be­fore de­cid­ing what to do next. It’s al­so re­port­ed the known in­for­ma­tion to the FDA.

The dose-es­ca­la­tion tri­al was de­signed to test whether MG­TA-117, an an­ti­body-drug con­ju­gate, could serve as a more tar­get­ed al­ter­na­tive to high-in­ten­si­ty chemother­a­py as a con­di­tion­ing agent for can­cer pa­tients who are set to re­ceive a stem cell trans­plant. It re­cruit­ed pa­tients with re­lapsed/re­frac­to­ry acute myeloid leukemia and myelodys­plas­tic syn­drome.

Just a month ago, Ma­gen­ta flagged two cas­es of dose-lim­it­ing tox­i­c­i­ties — both Grade 4 res­pi­ra­to­ry se­ri­ous ad­verse events — in the co­hort re­ceiv­ing the high­est dose. The com­pa­ny stopped dos­ing in that co­hort, known as co­hort 4, but said it would con­tin­ue to dose new pa­tients in co­hort 3 based on tri­al pro­to­col.

But af­ter the lat­est tri­al par­tic­i­pant was dosed at the co­hort 3 lev­el, Ma­gen­ta said the pa­tient ex­pe­ri­enced “res­pi­ra­to­ry fail­ure and car­diac ar­rest re­sult­ing in death” — or what in­ves­ti­ga­tors would clas­si­fy as a Grade 5 se­ri­ous ad­verse event. The com­pa­ny said it’s deemed to be pos­si­bly drug-re­lat­ed, but didn’t elab­o­rate.

MG­TA-117 tar­gets the CD117 re­cep­tor, which is high­ly ex­pressed on the cell sur­face of hematopoi­et­ic stem cells and leukemia cells. Ma­gen­ta, whose mis­sion is to im­prove all as­pects of stem cell trans­plants and stem cell-based gene ther­a­pies, had hoped it could more se­lec­tive­ly de­plete stem cells than tra­di­tion­al ap­proach­es.

Co­hort 4 pa­tients were giv­en a dose of 0.13 mg/kg, while the dosage for co­hort 3 was 0.08 mg/kg.

Ma­gen­ta’s shares, which have gone through sev­er­al up­swings and down­swings, have crashed more than 85% over the past year and have been lan­guish­ing deep in pen­ny stock ter­ri­to­ry since the De­cem­ber up­date. The stock fell an­oth­er 23% to $0.38 Thurs­day morn­ing in pre-mar­ket trad­ing.

So­cial: acute myeloid leukemia cells (Shut­ter­stock)

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.

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.

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.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.