The US De­part­ment of De­fense has se­lect­ed a No­va Scot­ian bio­phar­ma for a $10 mil­lion grant to ad­vance the pro­duc­tion of its biode­fense vac­cine ATI-1701.

Ap­pili Ther­a­peu­tics is pro­duc­ing a vac­cine to pre­vent the in­fec­tion of Fran­cisel­la tu­laren­sis, a top-pri­or­i­ty bio­threat and causative agent of tu­laremia. Fran­cisel­la tu­laren­sis, a Cat­e­go­ry A pathogen, has the abil­i­ty to cause lethal pneu­mo­nia and sys­temic in­fec­tion. An aerosolized form of the agent can be more in­fec­tive than an­thrax, the com­pa­ny said in a re­lease, and is con­sid­ered to have the po­ten­tial for a bioter­ror­ism at­tack.

“Ad­vanc­ing ATI-1701 could have a trans­for­ma­tive im­pact on mit­i­gat­ing this high risk to na­tion­al se­cu­ri­ty and pub­lic health,” CEO Ar­mand Bal­boni said in a state­ment. “We look for­ward to con­tin­u­ing to ad­vance this vac­cine can­di­date and fur­ther strength­en­ing our part­ner­ships with gov­ern­ment agen­cies around the world to ad­dress this ur­gent bioter­ror­ism threat.” 

In Jan­u­ary, Ap­pili an­nounced pre­clin­i­cal tri­al re­sults show­ing a sur­vival rate of 29% in a vac­ci­nat­ed co­hort, com­pared with 0% of those who re­ceived a place­bo vac­ci­na­tion.

Boston-area biotech touts new PhII da­ta

A Phase II tri­al test­ing Goldfinch Bio’s can­di­date to treat kid­ney dis­ease showed pos­i­tive pre­lim­i­nary da­ta, with a 32% mean re­duc­tion in Urine pro­tein/cre­a­ti­nine ra­tio.

GFB-887 is a podocyte-tar­get­ing small-mol­e­cule in­hibitor for the treat­ment of fo­cal seg­men­tal glomeru­lar scle­ro­sis, FS­GS for short, and di­a­bet­ic nephropa­thy. Pre­lim­i­nary re­sults showed pa­tients saw a sig­nif­i­cant re­duc­tion in UP­CR af­ter a 12-week treat­ment and that nine of the 10 treat­ed pa­tients ex­pe­ri­enced a re­duc­tion in UP­CR, while four of the sev­en treat­ed with a place­bo saw an in­crease.

No se­ri­ous side ef­fects were found in con­nec­tion to the drug, Goldfinch said.

“These pre­lim­i­nary re­sults con­tribute to my be­lief that we are on the thresh­old of an ex­cit­ing new era in the treat­ment of FS­GS and oth­er kid­ney dis­eases, which will be de­fined by tar­get­ed, pa­tient sub­set-dri­ven ther­a­pies, with po­ten­tial­ly lim­it­ed sys­temic side ef­fects, and long-await­ed hope for pa­tients,” said Kather­ine Tut­tle, an in­ves­ti­ga­tor on the tri­al. “Da­ta sug­gest that in­cre­men­tal re­duc­tions in pro­tein­uria can lead to clin­i­cal­ly mean­ing­ful dif­fer­ences in the rate of dis­ease pro­gres­sion, which may of­fer FS­GS pa­tients years of pre­served na­tive kid­ney func­tion, de­lay­ing kid­ney fail­ure and the need for dial­y­sis or trans­plant.”

FS­GS is a dis­ease that can even­tu­al­ly cause loss of kid­ney func­tion and kid­ney fail­ure. There are no cur­rent­ly ap­proved treat­ments.

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

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.

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.