Jasper Ther­a­peu­tics, broad­ly aimed at mak­ing cell ther­a­py safer, re­leased pre­lim­i­nary da­ta for its com­ple­ment to stem cell trans­plants on Mon­day.

The biotech is run­ning an open-la­bel Phase I tri­al of its lead pro­gram JSP191, an an­ti-CD117 mon­o­clon­al an­ti­body that tar­gets the stem cell fac­tor re­cep­tor, as a con­di­tion­ing agent in pa­tients aged 65 to 74 with myelodys­plas­tic syn­dromes or acute myeloid leukemia that are un­der­go­ing blood cell trans­plan­ta­tion. Six pa­tients have re­ceived the treat­ment thus far, and all six showed suc­cess­ful en­graft­ment.

Re­searchers al­so saw donor myeloid chimerism of at least 95% in five of six evalu­able pa­tients at 28 days. Three of the five al­so showed that resid­ual dis­ease could not be found, in­di­cat­ing a “com­plete erad­i­ca­tion,” Jasper said.

Jasper’s the­o­ry be­hind JSP191 is that it blocks the stem cell fac­tor from bind­ing to CD117 and dis­rupts sur­vival sig­nals, caus­ing the stem cells to die off. That cre­ates an “emp­ty space” of sorts in the bone mar­row, al­low­ing for donor or gene-cor­rect­ed trans­plant­ed stem cells to en­graft.

The com­pa­ny launched out of Stan­ford, emerg­ing from stealth in late 2019 with a $35 mil­lion Se­ries A round.

Eu­rope ap­proves Ruko­bia for drug-re­sis­tant HIV

GSK’s Vi­iV saw the FDA ap­prove its twice-dai­ly pill for HIV back in Ju­ly, but now they’ve re­ceived the green light on an­oth­er con­ti­nent.

The Eu­ro­pean Union on Mon­day grant­ed Ruko­bia the thumbs up for use in com­bi­na­tion with oth­er an­ti­retro­vi­ral ther­a­pies in adults with drug-re­sis­tant HIV, about two months af­ter the CHMP not­ed its pos­i­tive opin­ion. In the ran­dom­ized co­hort of the drug’s piv­otal tri­al, 60% of the 272 pa­tients who re­ceived Ruko­bia in ad­di­tion to op­ti­mized back­ground ther­a­py saw un­de­tectable HIV vi­ral load af­ter 96 weeks.

“There still re­mains a small sub­set of peo­ple liv­ing with mul­ti-drug re­sis­tant HIV who are at risk of hav­ing their dis­ease progress,” Vi­iV CEO Deb­o­rah Wa­ter­house said in a state­ment. “We aim to meet the di­verse needs of the HIV com­mu­ni­ty.”

Ruko­bia func­tions by tar­get­ing the first step of the HIV life cy­cle and shows no cross-re­sis­tance to oth­er cur­rent­ly li­censed an­ti­retro­vi­ral class­es, Vi­iV says. That can help HIV pa­tients who have strug­gled to sup­press their vi­ral lev­els us­ing oth­er treat­ments.

Vi­iV al­so notched an ap­proval in the US for Cabe­nu­va last month, be­com­ing the first FDA-ap­proved in­jectable for HIV. The ther­a­py will look to re­place the dai­ly oral pills that are cur­rent­ly stan­dard of care in treat­ing HIV-pos­i­tive adults.

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Shanghai biotech Yingli Pharma wants to bring its small molecule drug research global — and a new pact with MD Anderson will help it get there.

Yingli and MD Anderson have inked a 5-year collaboration deal that will put its cancer candidates — some of which have already generated data in China — into trials in the US. The lead program is linperlisib, a PI3Kδ inhibitor that’s in a Phase III trial in follicular lymphoma, according to Yingli’s website. In the US, MD Anderson will work with Yingli to put the candidate in a Phase II trial for peripheral T cell lymphoma (PTCL), an uncommon and aggressive type of non-Hodgkin’s lymphoma.