Rid­ing the coat­tails of a mas­sive $600 mil­lion cash raise in June, In­tel­lia an­nounced that the FDA ac­cept­ed their IND ap­pli­ca­tion for their gene edit­ing treat­ment NT­LA-5001, built as a treat­ment for acute myeloid leukemia.

The Cam­bridge, MA biotech said that they have plans to start pa­tient screen­ing in a Phase I/IIa study by the end of 2021. The study will eval­u­ate the ef­fects of a sin­gle dose of the treat­ment in adults who have de­tectable AML af­ter hav­ing re­ceived stan­dard first-line ther­a­py. The study will con­tain a dose es­ca­la­tion and ex­pan­sion phase, with up to 54 par­tic­i­pants.

“The FDA’s ac­cep­tance of our IND for NT­LA-5001 is an im­por­tant mile­stone in our pur­suit of de­vel­op­ing ad­vanced cell ther­a­pies uti­liz­ing In­tel­lia’s pro­pri­etary en­gi­neer­ing plat­form to treat pa­tients with can­cer,” said In­tel­lia pres­i­dent and CEO John Leonard.

Out­side of the US, In­tel­lia al­so sub­mit­ted a reg­u­la­to­ry ap­pli­ca­tion to the UK for NT­LA-5001.

San­té clos­es over­sub­scribed Fund IV af­ter rais­ing $260 mil­lion

Texas health­care in­vest­ment firm San­té fi­nal­ly closed its over­sub­scribed Fund IV. The $260 mil­lion fund will make in­vest­ments across ear­ly-stage biotech, healthtech and medtech com­pa­nies, ac­cord­ing to a com­pa­ny state­ment.

Fund IV se­cured com­mit­ments from more than two-dozen part­ners, in­clud­ing new in­sti­tu­tion­al in­vestors in Asia and Latin Amer­i­ca. Re­turn­ing part­ners ac­count­ed for near­ly 90% of the raised funds.

San­té co-founder and man­ag­ing di­rec­tor Kevin La­lande said in a state­ment: “The con­fi­dence and com­mit­ment of our in­vestors led to the quick­est fundraise since in­cep­tion. We are grate­ful for their part­ner­ship as we de­ploy this next fund to cap­i­tal­ize on sig­nif­i­cant health­care op­por­tu­ni­ties and nur­ture cut­ting-edge tech­nolo­gies.”

Zai Lab ex­pands US op­er­a­tions with of­fice in Cam­bridge

Zai Lab is ex­pand­ing its pres­ence in the Unit­ed States — by open­ing an of­fice in biotech hub Cam­bridge. The new of­fice will be the head­quar­ters of dif­fer­ent busi­ness op­er­a­tions such as al­liance man­age­ment, along with le­gal and gov­er­nance func­tions.

“We are ex­cit­ed to ex­pand our pres­ence in the U.S. by open­ing a new Zai Lab of­fice in Cam­bridge,” Zai Lab CEO and chair Saman­tha Du said in a state­ment. “This is an im­por­tant step in Zai Lab’s jour­ney to be­come a glob­al bio­phar­ma­ceu­ti­cal com­pa­ny, a part­ner of choice and a place where our em­ploy­ees can do their best work.”

This an­nounce­ment comes al­most im­me­di­ate­ly af­ter Zai Lab an­nounced on Tues­day that they re­ceived BTD for be­mar­ituzum­ab from the NM­PA. They are now look­ing to ad­vance the drug in­to reg­is­tra­tional tri­als.

Bio­gen re­leas­es re­sults from Phase II study on neu­ropa­thy pain drug

Cam­bridge, MA biotech Bio­gen an­nounced pos­i­tive topline re­sults from its Phase II study of vixot­rig­ine, a non-opi­oid oral pain drug be­ing eval­u­at­ed for the treat­ment of small fiber neu­ropa­thy (SFN).

The CON­VEY study had a dou­ble-blind pe­ri­od, where pa­tients were ad­min­is­tered 200 mg of vixot­rig­ine twice dai­ly. That arm met its pri­ma­ry end­point of change from base­line to week 12 of the dou­ble-blind pe­ri­od in mean av­er­age dai­ly pain (ADP) score.

In the same study, there was an open-la­bel pe­ri­od where all par­tic­i­pants who en­rolled re­ceived a high­er dose of the drug — 350 mg twice dai­ly. This pre­ced­ed the dou­ble-blind por­tion of the study.

While the 350 mg twice dai­ly arm did not meet the pri­ma­ry end­point, it met sta­tis­ti­cal sig­nif­i­cance in the Pa­tient Glob­al Im­pres­sion of Change (PG­IC) at week 12. Da­ta from the study will in­form po­ten­tial dos­es for study in fu­ture Phase III clin­i­cal tri­als.

“We are en­cour­aged by the over­all re­sults of the CON­VEY study,” said Bio­gen SVP and head of the ther­a­peu­tics de­vel­op­ment unit Kather­ine Daw­son. “We are grate­ful to all the par­tic­i­pants, in­ves­ti­ga­tors and study staff who con­tributed to this study and al­lowed us to eval­u­ate vixot­rig­ine as a non-opi­oid treat­ment op­tion.”

Niger­ian start­up 54gene rais­es $25 mil­lion in Se­ries B — Re­port

Ge­nomics start­up 54gene re­cent­ly raised $25 mil­lion in a Se­ries B round to ad­vance its pre­ci­sion med­i­cine ca­pa­bil­i­ties.

Ac­cord­ing to TechCrunch, the round comes a year af­ter the com­pa­ny, found­ed by Abasi Ene-Obong in 2019, raised $15 mil­lion in a Se­ries A and two years af­ter it closed a $4.5 mil­lion seed round.

The com­pa­ny launched a ge­net­ic se­quenc­ing and mi­croar­ray lab in La­gos, Nige­ria last Sep­tem­ber through a part­ner­ship with Il­lu­mi­na.

Ac­cord­ing to a press re­lease is­sued by Il­lu­mi­na last year, the fa­cil­i­ty will look at ge­net­ic in­for­ma­tion for health re­search and drug de­vel­op­ment — and Ene-Obong fur­ther said that the lab will do whole-genome se­quenc­ing and whole-ex­ome se­quenc­ing as part of the lab’s work.

New York biotech Ban­tam com­pletes $25 mil­lion in seed fund­ing

Ban­tam Phar­ma­ceu­ti­cal com­plet­ed a $25 mil­lion seed fund­ing round to fi­nal­ize ac­tiv­i­ties for its lead pro­gram BTM-3566. The funds are in­tend­ed to fin­ish prepa­ra­tions so the com­pa­ny can file its IND, which it plans to do in Feb­ru­ary — along with mak­ing prepa­ra­tions for first-in-hu­man clin­i­cal tri­als.

The fund­ing was co-led by Ban­tam’s cur­rent in­vestors.

Ban­tam is look­ing to start Phase I clin­i­cal stud­ies in pa­tients with B-cell hema­to­log­i­cal ma­lig­nan­cies in Q2 of 2022. Ban­tam has es­tab­lished its op­er­a­tions in the North Car­oli­na Re­search Tri­an­gle.

“This fund­ing en­ables Ban­tam Phar­ma­ceu­ti­cal to be ful­ly pre­pared to en­ter the clin­ic for first in hu­man stud­ies in ear­ly 2022, rep­re­sent­ing a ma­jor mile­stone. We are ex­cit­ed about mov­ing to the next stage of de­vel­op­ment,” said co-found­ing in­vestor and board mem­ber Li­onel Gold­frank in a state­ment.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.