Ada­gio plans to sub­mit an EUA for its mon­o­clon­al an­ti­body against Covid-19 in Q2 2022, the com­pa­ny an­nounced in its Q3 up­date.

The sub­mis­sion will be based on the com­pa­ny’s STAMP tri­al of new­ly di­ag­nosed Covid-19 pa­tients. The in­ves­ti­ga­tion­al mAb is de­signed to of­fer broad neu­tral­iz­ing ac­tiv­i­ty against  SARS-CoV-2, in­clud­ing many of the dom­i­nat­ing vari­ants.

Ada­gio has al­so tout­ed ADG20 as an al­ter­na­tive treat­ment for those who will be bad can­di­dates for the pills Mer­ck and Pfiz­er have brought for­ward. But new pills brought for­ward from these com­pa­nies have the po­ten­tial to cut in­to its mar­ket. And they’ve not­ed their in­jectable for­mu­la­tions than mon­o­clon­al an­ti­bod­ies that have to be giv­en by IV, al­though ri­vals such as Vir and Re­gen­eron are work­ing on sim­i­lar for­mu­la­tions.

“Our sin­gle in­jec­tion de­liv­ery avoids the in­con­ve­niences as­so­ci­at­ed with IV ad­min­is­tra­tion or mul­ti­ple in­jec­tions,” said CMO Lynn Con­nol­ly in a press re­lease. “The world con­tin­ues to face a host of chal­lenges in ful­ly ad­dress­ing the COVID-19 cri­sis. Al­ter­na­tives or sup­ple­ments to vac­cines for the pre­ven­tion of COVID-19 are need­ed for im­muno­com­pro­mised in­di­vid­u­als and those who re­main hes­i­tant to re­ceive a vac­cine or to vac­ci­nate their chil­dren.

CEO Till­man Gern­gross said in a press re­lease that the com­pa­ny has got­ten clear feed­back from the FDA on a strat­e­gy to sub­mit an EUA, and has ex­pand­ed its clin­i­cal pro­gram to add ad­di­tion­al pa­tient sub­sets, such as in­clud­ing im­muno­com­pro­mised in­di­vid­u­als and chil­dren.

“Our com­mer­cial-readi­ness ef­forts are well un­der­way and with a strong bal­ance sheet, we are ready to move quick­ly to en­able ac­cess to in­di­vid­u­als in need of COVID-19 pre­ven­tion and treat­ment op­tions, if au­tho­riza­tion and/or ap­proval is grant­ed,” he said.

The treat­ment is en­rolling par­tic­i­pants for tri­als eval­u­at­ing the suc­cess at pre­vent­ing the virus as well. As of Sept. 30, Ada­gio is val­ued at $666.3 mil­lion, and R&D ex­pens­es were $49.4 mil­lion, the com­pa­ny re­port­ed.

In Ju­ly, Gern­gross inked a deal to make and com­mer­cial­ize a treat­ment sim­i­lar to ADG20 in south­ern Asia. Ada­gio will pro­vide Bio­con with ma­te­ri­als and know-how to make the ther­a­py, in­clud­ing da­ta from on­go­ing Phase II/III tri­als and ac­cess to its po­ten­tial EUA pack­age.

HIPRA to en­ter PhII tri­als

The Cat­alo­nia-based com­pa­ny HIPRA has got­ten the OK from Span­ish reg­u­la­tors to start a Covid-19 vac­cine tri­al, Spain Prime Min­is­ter Pe­dro Sánchez said Mon­day.

The Phase II tri­al will test the vac­cine in more than 1,000 vol­un­teers in 10 hos­pi­tals across the coun­try. Sánchez called the news of the vac­cine’s de­vel­op­ment “ex­tra­or­di­nary” at an event, and said that the gov­ern­ment has giv­en a 15 mil­lion eu­ro grant to help de­vel­op the drug. Hipra has been work­ing on two Covid-19 shots, one that us­es mR­NA and an­oth­er that us­es a re­com­bi­nant pro­tein sim­i­lar to No­vavax’s jab.

Hipra ex­pects to pro­duce 600 mil­lion dos­es in 2022, Reuters said.

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.