World Trade Or­ga­ni­za­tion di­rec­tor-gen­er­al Ngozi Okon­jo-Iweala called on mem­bers late last week to move swift­ly and forge at least a draft agree­ment on the di­vi­sive IP waiv­er for Covid-19 vac­cines by the end of Feb­ru­ary.

Those ad­vo­cat­ing for such a waiv­er, in­clud­ing coun­tries like the US, In­dia and South Africa and oth­er aid groups like Doc­tors With­out Bor­ders, have called to help more coun­tries man­u­fac­ture their own vac­cines more quick­ly, a task that has lost sig­nif­i­cant time due to these long ne­go­ti­a­tions. Some like MSF ar­gue that the waiv­er shouldn’t just in­clude vac­cines but should pro­vide a “crit­i­cal le­gal path­way for coun­tries to fa­cil­i­tate more di­ver­si­fied and sus­tain­able pro­duc­tion and sup­ply” of all Covid-re­lat­ed tools, in­clud­ing tests and ther­a­peu­tics too.

Even Eu­ro­pean lead­ers, who at first balked at the idea, seemed to have come around in re­cent months.

On the oth­er side of the de­bate, the vac­cine de­vel­op­ers that de­vel­oped the cur­rent suite of prod­ucts (of­ten with sig­nif­i­cant gov­ern­ment sup­port) ar­gue that the IP waiv­er is not what’s con­strain­ing pro­duc­tion. Pfiz­er and BioN­Tech say they ex­pect to pro­duce 4 bil­lion dos­es of their vac­cine in 2022, and the IF­P­MA has said that man­u­fac­tur­ers in the US, EU, In­dia and Chi­na will like­ly make more than 12 bil­lion dos­es by mid-2022.

“We don’t want to cre­ate a sit­u­a­tion where peo­ple com­pete for re­sources, where there are dif­fer­ent ver­sions of the prod­uct,” BioN­Tech CEO Uğur Şahin told End­points News in an in­ter­view in No­vem­ber. “We re­al­ly be­lieve the way to deal with that is to ask the ques­tion of how — how this can be pro­duced, and to be re­al­ly pa­tient. It took us 10 years to de­vel­op this; there are 50,000 steps, it’s not just the man­u­fac­tur­ing, but the an­a­lyt­i­cal as­says, dozens of which need to be val­i­dat­ed.”

Re­gard­less, WTO’s Okon­jo-Iweala is push­ing ahead with her plan, de­spite an al­ready-missed De­cem­ber dead­line on the waiv­er.

“We should strive to get this re­sult out by the end of Feb­ru­ary. It will be re­al­ly sad if this or­ga­ni­za­tion keeps talk­ing and de­bat­ing on this pan­dem­ic, and that by the time we come up with a re­sponse peo­ple will not think it rel­e­vant. I think we should re­al­ly move with all speed to try and con­clude this by the end of Feb­ru­ary,” she said in a state­ment.

On Feb. 11, the WTO will hold a tech­ni­cal work­shop to sup­port these on­go­ing dis­cus­sions around Covid-19 vac­cine R&D, man­u­fac­tur­ing and dis­tri­b­u­tion, with rep­re­sen­ta­tives from As­traZeneca and No­vavax speak­ing.

“I have heard that there could be some sort of deal by then. No de­tails yet But I know that the EU, In­dia, South Africa, and the Unit­ed States have been meet­ing at the min­is­te­r­i­al lev­el on this,” Thiru Bal­a­sub­ra­ma­ni­am, the Gene­va rep­re­sen­ta­tive of the NGO Knowl­edge Ecol­o­gy In­ter­na­tion­al, told End­points.

Re­gard­ing these small-group dis­cus­sions on the IP-re­lat­ed as­pects of the pan­dem­ic re­sponse, Okon­jo-Iweala asked for WTO mem­bers’ pa­tience.

“This is a very dif­fi­cult is­sue. If it were easy, it would have been re­solved in the al­most two years that this dis­cus­sion has been go­ing on (in the TRIPS Coun­cil). This small group process … is go­ing on but it is very tough. I have to say there is no easy road,” she added.

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.