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Manufacturing contract axed for Valneva’s vaccine; Penny stock halts early infection trial


French vac­cine com­pa­ny Val­ne­va and Ger­man CD­MO IDT Bi­ologi­ka have de­cid­ed to ter­mi­nate their man­u­fac­tur­ing col­lab­o­ra­tion for Val­ne­va’s Covid-19 vac­cine.

IDT Bi­ologi­ka was orig­i­nal­ly tasked with mak­ing Val­ne­va’s VLA2001 vac­cine, but the deal has been halt­ed due to “the de­liv­ery of in­ac­ti­vat­ed Covid-19 bulk vac­cine to Val­ne­va.” A state­ment from Val­ne­va al­so lists a lack of or­ders and suf­fi­cient in­ven­to­ry as the oth­er rea­sons.

With the man­u­fac­tur­ing of the vac­cine sus­pend­ed, Val­ne­va will pay €36.2 mil­lion ($35.8 mil­lion) to IDT in com­pen­sa­tion along with €4.5 mil­lion ($4.4 mil­lion) for pur­chas­ing spe­cial­ized equip­ment.

Val­ne­va will con­tin­ue to de­liv­er dos­es of the vac­cine to EU mem­ber states that had al­ready or­dered it and will keep in­ven­to­ry on hand in case of any uptick in de­mand. Val­ne­va al­so said that it is reach­ing out to dif­fer­ent na­tions across the world to ship its re­main­ing eight to 10 mil­lion dos­es over the next year.

The com­pa­ny had ini­tial­ly signed a pur­chas­ing agree­ment with the EU last year to sup­ply 60 mil­lion dos­es. In the sum­mer, how­ev­er, the EU changed its pur­chase to around 1.25 mil­lion dos­es.

Pen­ny stock biotech’s Phase II/III tri­al for ear­ly Covid-19 in­fec­tion fails to reach pri­ma­ry end­point

Well in­to the pen­ny stock zone, Adamis Phar­ma­ceu­ti­cals has hit a ma­jor road­block for its Covid-19 treat­ment.

The San Diego biotech an­nounced Wednes­day its Phase II/III clin­i­cal tri­al eval­u­at­ing the risk of us­ing Tem­pol in high-risk pa­tients with an ear­ly Covid-19 in­fec­tion had failed to hit the pri­ma­ry end­point of “sus­tained clin­i­cal res­o­lu­tion” by day 14.

The Da­ta Safe­ty Mon­i­tor­ing Board (DSMB) al­so rec­om­mend­ed that the tri­al be shut down due to a lack of ef­fi­ca­cy. While Adamis em­pha­sized that no safe­ty con­cerns were raised, it will put a hold on the tri­al and fig­ure out Tem­pol’s next move. Ac­cord­ing to Clin­i­cal­Tri­als.gov, 248 pa­tients par­tic­i­pat­ed in the tri­al.

“We are ob­vi­ous­ly dis­ap­point­ed that the study did not meet its end­points. Much of the pre­clin­i­cal work on Tem­pol for COVID-19 ex­am­ined the ef­fects of the drug on se­vere ill­ness. This tri­al did not meet its pri­ma­ry end­point, but we are ex­plor­ing the pos­si­bil­i­ty that vac­ci­na­tions and the less vir­u­lent vari­ants (Omi­cron) dur­ing the tri­al pe­ri­od may have ob­scured an ef­fect of Tem­pol,” said Adamis CMO Ron Moss in a state­ment.

In­vestors will not be hap­py as the com­pa­ny’s stock price has al­ready dropped even fur­ther in­to the pen­ny stock neb­u­la, where it has been since 2019. The price $ADMP has dropped 44% since Wednes­day’s mar­ket open­ing to $.20, mark­ing an 80% drop since Sep­tem­ber last year.



Read More: Manufacturing contract axed for Valneva’s vaccine; Penny stock halts early infection trial

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