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2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs
top stories
1. Vertex-partnered gene therapy biotech Affinia scraps IPO plans
2. Amgen, years behind rivals, says PhI obesity drug shows durability signs
3. Verve reveals letter from FDA that lays out conditions to lift base editing trial hold
4. Gene therapy goes acoustic as ARCH-backed biotech launches with ultrasound gene delivery platform
5. Nkarta underscores safety of CAR-NK, boasts early responses
6. Pfizer-backed Mediar Therapeutics ropes in another Big Pharma investor
7. Updated: Arbitrator awards $157M to Soon-Shiong's ImmunityBio in dispute with Sorrento
8. After M&A fell through, TherapeuticsMD sells hormone therapy, contraceptive ring for $140M cash plus royalties
9. Valneva's chikungunya vaccine on track for FDA nod after long-term antibody data
more stories
 
Max Gelman
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Welcome back to another week with Endpoints, thanks as always for reading. On Wednesday, we’ll be revealing the picks for our annual Women in Biopharma R&D feature, as well as hosting a webinar moderated by Amber Tong and Nicole DeFeudis. Sign up here to save your spot.

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Max Gelman
Senior Editor, Endpoints News
@MaxGelman
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2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs
by Allucent

In the con­text of to­day’s glob­al eco­nom­ic en­vi­ron­ment, there is an in­creas­ing need to work smarter, faster and lean­er across all facets of the life sci­ences in­dus­try.  This is par­tic­u­lar­ly true for small and mid-sized biotech com­pa­nies, many of which are fac­ing de­clin­ing val­u­a­tions and com­pet­ing for in­creas­ing­ly lim­it­ed fund­ing to pro­pel their sci­ence for­ward.  It is im­por­tant to rec­og­nize that with­in this frame­work, many of these small­er com­pa­nies al­ready find them­selves re­source-chal­lenged to de­sign and man­age clin­i­cal stud­ies them­selves be­cause they don’t have large teams or in-house ex­perts in nav­i­gat­ing the var­i­ous as­pects of the drug de­vel­op­ment jour­ney. This can be par­tic­u­lar­ly chal­leng­ing for the most com­plex and dif­fi­cult to treat dis­eases where no pre­vi­ous path­way ex­ists and pa­tients are ur­gent­ly await­ing break­throughs.

No­tably, this en­vi­ron­ment comes at a time when there’s an un­prece­dent­ed amount of ground­break­ing sci­ence com­ing out of small­er biotechs.  In fact, of the near­ly 7,000 drugs in ac­tive de­vel­op­ment by biotech to­day, a record 77% are from small­er com­pa­nies.i

While to­day’s land­scape presents some sig­nif­i­cant chal­lenges, there is al­so much op­por­tu­ni­ty re­lat­ed to clin­i­cal de­vel­op­ment of these in­no­v­a­tive med­i­cines head­ing in­to 2023, that if re­al­ized, will bring im­mense val­ue to the biotech in­dus­try – and so­ci­ety over­all.  For ex­am­ple, de­spite decades of ef­fort and progress, there is still un­tapped op­por­tu­ni­ty to re­al­ize the im­pact that tech­nol­o­gy can have on the ef­fi­cien­cy and qual­i­ty of clin­i­cal re­search.  For in­stance, mod­el­ing and sim­u­la­tion is just one av­enue that of­fers sig­nif­i­cant po­ten­tial to im­prove drug de­vel­op­ment.  Fur­ther­more, the cur­rent so­cio-po­lit­i­cal en­vi­ron­ment com­bined with the dig­i­tal tools at our dis­pos­al to­day pro­vides fer­tile ground to re­al­ize the po­ten­tial of de­cen­tral­ized clin­i­cal tri­als – which can in­crease pa­tient ac­cess and di­ver­si­ty, ac­cel­er­ate de­vel­op­ment, and gen­er­ate stronger, more in­clu­sive, and bet­ter rep­re­sen­ta­tive da­ta.

As Mark A. Gold­berg, chair­man and chief ex­ec­u­tive of­fi­cer of Al­lu­cent ex­plains, “In the face of the glob­al, macro-eco­nom­ic chal­lenges en­dured through­out 2022, it is im­por­tant to fo­cus on the per­sis­tent need for in­no­va­tion and how we can help bring need­ed med­i­cines to pa­tients.  There’s much rea­son to be hope­ful based on the ground­break­ing sci­ence com­ing from small­er biotech com­pa­nies to­day and the for­ward-think­ing drug de­vel­op­ment ap­proach­es we can lever­age. That’s why we’re laser-fo­cused on think­ing big for small and mid-sized biotechs, and pro­vid­ing them with nim­ble, strate­gic so­lu­tions to help them suc­ceed – and it’s why I’m ex­treme­ly op­ti­mistic about what lies ahead for 2023 and be­yond.”

Small­er Biotechs Have Ex­pe­ri­enced a Tu­mul­tuous Year, and Weath­ered it Well

De­spite many up­heavals af­fect­ing glob­al busi­ness through­out 2022 – such the Covid-     19 pan­dem­ic and its af­ter­math, the war in Ukraine, and in­fla­tion – the out­look for small and mid-sized biotech com­pa­nies re­mains strong.  In fact, from a drug de­vel­op­ment stand­point, 6,918 clin­i­cal pro­grams were re­port­ed in 2022 – up 6.3% ver­sus 2021 – with 77% of them orig­i­nat­ing from small com­pa­nies.i

More­over, in 2022 an es­ti­mat­ed 70% of US FDA ap­provals for new treat­ments orig­i­nat­ed in small com­pa­nies, com­pared to 66% in 2021.i

The sci­en­tif­ic in­no­va­tion com­ing from small­er biotechs and the num­ber of clin­i­cal pro­grams be­ing put forth by these com­pa­nies po­si­tion the sec­tor well head­ing in­to the new year.  To re­al­ize the po­ten­tial; how­ev­er, a num­ber of chal­lenges will need to be ad­dressed.

Im­prov­ing Ef­fi­cien­cy and Qual­i­ty of Clin­i­cal Re­search Through Mod­el­ing & Sim­u­la­tion

The down-shift in in­vestor sen­ti­ment that biotech is now ex­pe­ri­enc­ing be­gan in late 2021, and is ex­pect­ed to con­tin­ue for some time.  As Bar­bara Ryan of Ernst & Young LLP ex­plains in the EY 2022 Biotech­nol­o­gy Re­port, “We are clear­ly liv­ing through an in­no­va­tion re­nais­sance, and the fun­da­men­tals of the in­dus­try are quite strong.  But from a stock mar­ket per­spec­tive, we are liv­ing through the deep­est and longest cor­rec­tion that we’ve seen in the biotech in­dex­es since their in­cep­tion.”ii

Giv­en this land­scape, small and mid-sized biotech com­pa­nies need to be par­tic­u­lar­ly in­ten­tion­al about their de­ci­sion-mak­ing process from the out­set to help pro­pel their sci­ence for­ward to­ward suc­cess.  The in­her­ent val­ue in these com­pa­nies is in the po­ten­tial of their pipelines, which may con­sist of just one or two com­pounds for small­er-sized com­pa­nies – mak­ing it im­per­a­tive to make the right de­ci­sions and get their drug de­vel­op­ment pro­grams off the ground on a strong foot­ing and keep those pro­grams mov­ing for­ward ef­fi­cient­ly and ef­fec­tive­ly.

One key les­son learned in the wake of the Covid-19 Pan­dem­ic is the need for the life sci­ences in­dus­try to em­ploy more ef­fec­tive use of tech­nol­o­gy and da­ta. From a drug de­vel­op­ment per­spec­tive, there are still many un­tapped op­por­tu­ni­ties to do just this.  To­day, tech­niques such as MIDD (Mod­el In­formed Drug De­vel­op­ment) can be used to im­pact crit­i­cal de­ci­sion-mak­ing and, in some cas­es, re­duce the need for cer­tain tri­als.

MIDD in­te­grates da­ta and mod­els from non-clin­i­cal and clin­i­cal pro­grams, as well as da­ta from oth­er rel­e­vant ex­ter­nal re­search, to in­crease the prob­a­bil­i­ty of suc­cess in de­vel­op­ing med­i­cines.  It lever­ages a range of quan­ti­ta­tive ap­proach­es to in­form de­ci­sion mak­ing, ex­trap­o­lat­ing da­ta from large pop­u­la­tions with sim­i­lar char­ac­ter­is­tics to pro­vide sup­port­ing ev­i­dence for safe­ty, ef­fec­tive­ness, and dos­ing.  These in­sights can be used to in­form clin­i­cal tri­al de­sign and pre­dict tri­al out­comes – lead­ing to more ef­fi­cient, less cost­ly, and more pre­cise re­search.  They can al­so help drug de­vel­op­ers se­lect ap­pro­pri­ate dos­es for first-in-hu­man (FIH) clin­i­cal tri­als and in spe­cial pop­u­la­tions, such as re­nal and he­pat­ic im­pair­ment or pe­di­atric pa­tients – a fun­da­men­tal step in min­i­miz­ing pa­tient risk and in­creas­ing suc­cess rates.

A Ripe En­vi­ron­ment to Im­prove Pa­tient Ac­cess and In­crease Di­ver­si­ty

An­oth­er key im­per­a­tive head­ing in­to 2023 is the press­ing need to im­prove pa­tient ac­cess and en­sure racial and eth­nic di­ver­si­ty in clin­i­cal re­search. The great­est chal­lenge in con­duct­ing clin­i­cal tri­als to­day re­mains re­cruit­ing and re­tain­ing pa­tients – and the vast ma­jor­i­ty of pa­tients who are re­cruit­ed and re­tained are Cau­casian.

Il­lus­trat­ing the dis­par­i­ties that ex­ist cur­rent­ly, the US Food and Drug Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion and Re­search re­leased a re­port in 2020 in­di­cat­ing 75% of en­rollees in clin­i­cal tri­als for nov­el ther­a­pies are white, with dis­pro­por­tion­ate­ly low re­cruit­ment among non-white eth­nic groups.iii

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Rick Modi, Affinia Therapeutics CEO
1
by Kyle LaHucik

Affinia Ther­a­peu­tics has ditched its plans to go pub­lic in a rel­a­tive­ly closed-door mar­ket that has not fa­vored Nas­daq de­buts for the drug de­vel­op­ment in­dus­try most of this year. A pan­dem­ic surge in 2020 and 2021 opened the doors for many pre­clin­i­cal star­tups, which caught Affini­a's at­ten­tion and gave the gene ther­a­py biotech con­fi­dence in the be­gin­ning days of 2022 to send in its S-1.

But on Fri­day, Affinia threw in the S-1 tow­el and con­clud­ed now is not the time to step on­to Wall Street. The biotech has put out few pub­lic an­nounce­ments since the spring of this year. End­points News picked the start­up as one of its 11 biotechs to watch last year.

The Waltham, MA biotech had raised $178 mil­lion in pro­ceeds pri­or to the S-1 fil­ing in the first week of 2022. Bankrollers in­clude New En­ter­prise As­so­ci­ates, F-Prime, At­las, Cas­din Cap­i­tal, Avid­i­ty Part­ners, EcoR1, Far­al­lon, Google's ven­ture arm, Lon­za and oth­ers. Pro­ceeds from the IPO and the $149 mil­lion in the bank, as of Sep­tem­ber 2021, would have been enough to keep the lights on "in­to 2024," Affinia said in its S-1.

Rel­a­tive­ly few biotechs have braved the chop­py IPO wa­ters this year, save for the likes of David Li­u's Prime Med­i­cine. A few drug de­vel­op­ers have cho­sen to go pub­lic via the blank check ve­hi­cle, but not all of those have panned out ei­ther.

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Prepare for Successful Commercialization of Allogeneic Cell Therapies
2
by Kyle LaHucik

While NBC ran "The Biggest Los­er" for 17 sea­sons, deemed tox­ic by crit­ics for the re­al­i­ty show's pun­ish­ing ex­er­cise and di­et up­heavals, re­searchers in phar­ma­ceu­ti­cal labs have been at­tempt­ing to cre­ate pre­scrip­tion drugs that in­duce weight loss — and one phar­ma bet­ting it can re­quire less fre­quent dos­ing is out with a new crop of da­ta.

Am­gen was rel­a­tive­ly late to the game com­pared to its ap­proved com­peti­tor No­vo Nordisk and green light-ap­proach­ing ri­val Eli Lil­ly. But ear­ly da­ta sug­gest­ed Am­gen's AMG 133 led to a 14.5% weight re­duc­tion in the first few months of dos­ing, buoy­ing shares ear­li­er this fall, and now the Cal­i­for­nia phar­ma is out with its first batch of dura­bil­i­ty da­ta show­ing that fig­ure fell slight­ly to 11.2% about 150 days af­ter the last dose. Am­gen pre­sent­ed at the 20th World Con­gress on In­sulin Re­sis­tance, Di­a­betes & Car­dio­vas­cu­lar Dis­ease on Sat­ur­day af­ter­noon.

Novo's We­govy is al­ready a Hol­ly­wood dar­ling and up­tak­en by the likes of Elon Musk since get­ting a 2021 la­bel ex­pan­sion af­ter a 2017 di­a­betes nod (Ozem­pic), and Lil­ly is with­in quar­ters of com­plet­ing its sub­mis­sion for tirzepatide, which is on the path to a fast-tracked ap­proval af­ter se­cur­ing mar­ket­ing au­thor­i­ty ear­li­er this year as Moun­jaro for Type I di­a­betes.

Known for drugs like Ote­zla and more re­cent­ly notch­ing first in the KRAS race with Lumakras, Am­gen is wad­ing in­to the obe­si­ty treat­ment mar­ket with a drug that at­tacks two path­ways, like Eli Lil­ly. In­stead of hit­ting the gas ped­al on both path­ways like Lil­ly, Am­gen is ramp­ing up one (GLP1) and tam­ing the oth­er (GIP) based on a ge­net­ic study that its sub­sidiary helped con­duct — in which "Moth­er Na­ture’s ex­per­i­ment" showed in­hi­bi­tion, rather than stim­u­la­tion, did the trick, Am­gen VP Na­ri­mon Honar­pour told End­points News.

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Sekar Kathiresan, Verve Therapeutics CEO
3
by Paul Schloesser

We now know why Verve's lead can­di­date was placed on hold last month by US reg­u­la­tors.

In an SEC fil­ing, Verve laid out the FDA's con­di­tions for lift­ing the hold on its lead ther­a­py, VERVE-101. That in­cludes sub­mit­ting pre­clin­i­cal da­ta about po­ten­cy dif­fer­ences in hu­man ver­sus non-hu­man cells, risks of gene edit­ing germline cells, and off-tar­get analy­ses in non-he­pa­to­cyte cell types.

The FDA al­so wants clin­i­cal da­ta from the on­go­ing Heart-1 tri­al, and to mod­i­fy the tri­al pro­to­col in the US to add ad­di­tion­al con­tra­cep­tive mea­sures and in­crease the length of a stag­ger­ing in­ter­val be­tween the dos­ing of par­tic­i­pants.

The goal of the ther­a­py is to per­ma­nent­ly turn off the PC­SK9 gene in pa­tients with an in­her­it­ed dis­ease that caus­es ex­treme­ly high cho­les­terol lev­els.

Verve said in the fil­ing that it plans to "sub­mit a re­sponse as ex­pe­di­tious­ly as pos­si­ble" the FDA. The biotech al­so said that it is con­tin­u­ing to en­roll pa­tients for the tri­al in the UK and in New Zealand — and plans to re­port ini­tial da­ta from the dose-es­ca­la­tion part of the tri­al lat­er this year.

Verve de­clined to com­ment to End­points News out­side of the fil­ing.

The rev­e­la­tions of the FDA's asks are the newest de­vel­op­ment that Verve an­nounced since its base edit­ing tri­al got put on hold just last month. A Phase Ib tri­al in­ves­ti­gat­ing VERVE-101 kicked off in Ju­ly as the biotech start­ed dos­ing pa­tients in New Zealand and the UK.

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Precision BioSciences
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PANTHERx Rare Pharmacy
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Ken Greenberg, SonoThera CEO
4
by Lei Lei Wu

Af­ter co-found­ing two biotechs off virus-based ther­a­pies, one for pain and one for can­cer, Ken Green­berg de­cid­ed to go in a dif­fer­ent di­rec­tion for his newest biotech, SonoThera.

Based out of San Fran­cis­co, SonoThera an­nounced Mon­day morn­ing that it raised $60.75 mil­lion to de­vel­op new gene ther­a­pies — but de­liv­ered by ul­tra­sound, which Green­berg says can ad­dress the ma­jor chal­lenges fac­ing more con­ven­tion­al vi­ral gene ther­a­pies.

Green­berg pre­vi­ous­ly co-found­ed Co­da Bio­ther­a­peu­tics, which is de­vel­op­ing an ade­no-as­so­ci­at­ed virus-based ther­a­py for pain and On­corus, which wants to use an on­colyt­ic virus against can­cer but laid off just un­der 20 em­ploy­ees last week.

“I've been work­ing in the gene ther­a­py space for about 20 years now. And dur­ing that time, the ma­jor­i­ty of the work was with vi­ral vec­tors, whether it's AAV or , or her­pes, or ade­n­ovirus, and as well as some non-vi­ral sys­tems ... I got a good feel­ing for where things are work­ing and where they don't, and where the short­com­ings are of the cur­rent modal­i­ties that are used,” he told End­points News.

SonoThera’s Se­ries A was led by ARCH Ven­ture Part­ners, fol­lowed by the ven­ture arms of a num­ber of big com­pa­nies — Il­lu­mi­na, John­son & John­son, Ver­tex and Eli Lil­ly — and Med­ical Ex­cel­lence Cap­i­tal, Alexan­dria Ven­ture In­vest­ments, Lifes­pan In­vest­ments, Formic Ven­tures, Foothill Ven­tures and Wil­son Son­si­ni.

The biotech was found­ed by Green­berg; Michael David­son, the CEO of NewAms­ter­dam Phar­ma and co-founder of Cor­vidia Ther­a­peu­tics, which No­vo Nordisk bought in 2020 for $725 mil­lion; and Steve Fe­in­stein of Rush Uni­ver­si­ty, who pre­vi­ous­ly in­vent­ed di­ag­nos­tic imag­ing agents and will serve as SonoThera’s CSO. David­son is the chair­man of SonoThera’s board, where ARCH’s Steven Gillis is now al­so a mem­ber.

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Is Alzheimer’s R&D finally moving past the crossroads?
Is Alzheimer’s R&D finally moving past the crossroads?
sponsored by Prothena
5
by Amber Tong

The first gen­er­a­tion of per­son­al­ized CAR-T ther­a­pies made big waves in the treat­ment of lym­phoma for their stun­ning ef­fi­ca­cy. Nkar­ta is hop­ing its off-the-shelf nat­ur­al killer cell ap­proach will stand out on safe­ty — while keep­ing some of those im­pres­sive num­bers on re­spons­es.

In a new up­date from its Phase I dose es­ca­la­tion study, the South San Fran­cis­co-based biotech re­port­ed that sev­en out of 10 pa­tients treat­ed with the high­est dos­es of its NK cell ther­a­py, NKX019, achieved a com­plete re­sponse, trans­lat­ing to a com­plete re­sponse rate of 70%.

“The emerg­ing safe­ty pro­file of NKX019 is po­ten­tial­ly game-chang­ing,” said CEO Paul Hast­ings on an in­vestor call.

NKX019 hits the same tar­get as Yescar­ta and Kym­ri­ah, the first ap­proved CAR-Ts. But there are some key dif­fer­ences: It con­sists of NK cells that are al­lo­gene­ic, mean­ing doc­tors don’t need to go through the long process of har­vest­ing cells from pa­tients them­selves and en­gi­neer­ing them. And while most CAR-Ts are on­ly in­fused once, some pa­tients in the Nkar­ta tri­al were giv­en mul­ti­ple cy­cles of NKX019.

The new da­ta build on an ini­tial read­out in April, when the com­pa­ny re­port­ed ear­ly re­spons­es. This time around, they have six more pa­tients in the pool and a longer fol­low-up.

Specif­i­cal­ly, Nkar­ta sin­gled out the ab­sence of cy­tokine re­lease syn­drome or neu­ro­tox­i­c­i­ties, which have been the hall­mark of ear­ly CAR-T drugs.

“While oc­ca­sion­al tran­sit and man­age­able in­fu­sion-re­lat­ed re­ac­tions were ob­served and some were even la­beled as CRS by our in­ves­ti­ga­tors, the ear­ly on­set and prompt res­o­lu­tion of symp­toms, some­times with­out any in­ter­ven­tion at all, is clear­ly not the clas­sic CRS that is seen with CAR-T cell ther­a­pies,” Hast­ings added.

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6
by Tyler Patchen

A biotech cen­tered on treat­ing fi­bro­sis — born out of Mass Gen­er­al and Brigham and Wom­en's Hos­pi­tal — has re­ceived a fi­nan­cial boost.

Ac­cord­ing to an SEC fil­ing, the com­pa­ny has raised $31,761,186 in its lat­est fund­ing round, which in­cludes 17 in­vestors. The fil­ing lists six names at­tached to the com­pa­ny, in­clud­ing Mered­ith Fish­er, a part­ner at Mass Gen­er­al Brigham Ven­tures and Me­di­ar’s act­ing CEO.

Oth­er names in the fil­ing in­clude Pe­ter Park­er, the man­ag­ing gen­er­al part­ner at Mis­sion Bio­Cap­i­tal, and Michael Baran, a part­ner at Pfiz­er Ven­tures, who are mem­bers of Me­di­ar’s board. Nan­di­ta Shangari, man­ag­ing di­rec­tor of the No­var­tis Ven­ture Fund; Maina Bhaman, a part­ner at Sofinno­va Ven­tures; and An­dreas Ju­rgeit, a part­ner at Gimv, were al­so list­ed on the doc­u­ment.

End­points News has reached out for more in­for­ma­tion on the fund­ing. In an email, Fish­er said that Me­di­ar is not com­ment­ing at this time.

Me­di­ar, which was found­ed by Mass Gen­er­al Brigham Ven­tures and re­searchers from the in­sti­tu­tion in 2019, is still in the pre­clin­i­cal stage. The biotech is de­vel­op­ing can­di­dates to try and halt or re­verse fi­bro­sis by us­ing the cell known as the my­ofi­brob­last.

The biotech raised a seed ex­ten­sion in 2021, which brought on Pfiz­er Ven­tures and Ono Ven­ture In­vest­ment as new mem­bers to bring the to­tal back­ing to $20 mil­lion. Mass Gen­er­al Brigham Ven­tures led the ini­tial seed round in 2019, along with oth­er in­vestors, to sup­port a dis­cov­ery plat­form and the de­vel­op­ment of an­ti­body treat­ments.

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Patrick Soon-Shiong (Evan Vucci/AP Images)
7
by Kyle LaHucik

Sor­ren­to Ther­a­peu­tic­s' years­long bat­tle with Nant­Cell and NAN­Ti­body has come to an ar­bi­tra­tion award, but ad­di­tion­al le­gal pro­ceed­ings cen­tered around a “catch-and-kill” scheme re­main pend­ing.

On Fri­day, the ar­bi­tra­tor in the dis­pute be­tween Sor­ren­to and Nant­Cell and Im­munother­a­py NAN­Ti­body LLC is­sued an award that grants con­trac­tu­al dam­ages and pre-award in­ter­est.

The ar­bi­tra­tor award­ed Nant­Cell (part of bil­lion­aire Patrick Soon-Sh­iong’s Im­mu­ni­ty­Bio) near­ly $157 mil­lion and NAN­Ti­body close to $17 mil­lion. Post-award, pre­judg­ment in­ter­est will ac­crue at 9% per an­num, ac­cord­ing to an SEC fil­ing sent in by Sor­ren­to.

Sor­ren­to doesn’t agree with the rul­ing.

“The Com­pa­ny be­lieves the Award was wrong­ly de­cid­ed and is eval­u­at­ing next steps, in­clud­ing, among oth­er things, po­ten­tial grounds to va­cate, mod­i­fy, or cor­rect the Award un­der ap­plic­a­ble law,” Sor­ren­to wrote in the SEC fil­ing, signed by Hen­ry Ji, the biotech’s chair­man, pres­i­dent and CEO.

Mean­while, in an SEC fil­ing lat­er Mon­day morn­ing, Im­mu­ni­ty­Bio said it will seek the award in a time­ly man­ner.

"This de­ci­sion by the ar­bi­tra­tor is fi­nal and bind­ing on the par­ties, and we in­tend to pur­sue con­fir­ma­tion of the award prompt­ly. Af­ter ob­tain­ing a judg­ment, we in­tend to pur­sue vig­or­ous­ly the col­lec­tion of the award and ap­plic­a­ble in­ter­est from Sor­ren­to, but we make no as­sur­ances that we will re­ceive the full amount or with re­spect to the tim­ing of our re­ceipt of funds," Im­mu­ni­ty­Bio wrote in part in its fil­ing with the SEC.

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Cell & gene therapies are headed to critical milestones
Cell & gene therapies are headed to critical milestones
sponsored by Endpoints News
8
by Amber Tong

Ther­a­peu­tic­sMD, a women’s health com­pa­ny whose one-time bil­lion-dol­lar val­u­a­tion seems a dis­tant mem­o­ry as its block­buster as­pi­ra­tions pe­tered out, is fi­nal­ly cash­ing out.

Aus­tralia’s Mayne Phar­ma is pay­ing $140 mil­lion up­front to li­cense es­sen­tial­ly Ther­a­peu­tic­sMD’s whole port­fo­lio, in­clud­ing two pre­scrip­tion drugs that treat con­di­tions re­lat­ing to menopause, a con­tra­cep­tive vagi­nal ring as well as its pre­scrip­tion pre­na­tal vi­t­a­min brands.

The deal caps Ther­a­peu­tic­sMD’s long search for a way out af­ter a re­cent M&A pro­pos­al fell through. While EW Health­care Part­ners had of­fered to pay $10 a share to buy out the biotech in a deal val­ued at $177 mil­lion, the pri­vate eq­ui­ty firm ul­ti­mate­ly failed to snap up enough shares. And time was run­ning out, giv­en that Ther­a­peu­tic­sMD was in debt and on­ly had $27 mil­lion in cash as of Sept. 30.

“This trans­ac­tion will al­low us to re­pay in full our debt to Sixth Street Part­ners and re­deem our pre­ferred stock from Rubric Cap­i­tal Man­age­ment, while al­so es­tab­lish­ing a fu­ture roy­al­ty rev­enue stream for our com­mon share­hold­ers,” said Ther­a­peu­tic­sMD chair­man Tom­my Thomp­son, who's al­so a for­mer HHS sec­re­tary and for­mer gov­er­nor of Wis­con­sin.

Shares TXMD ticked up about 4% to $4.61 in pre-mar­ket trad­ing.

Once the deal is wrapped, ex­ecs added, Ther­a­peu­tic­sMD should be con­sid­ered a “roy­al­ty com­pa­ny” with rights to a 20-year roy­al­ty stream from the prod­ucts that Mayne Phar­ma — which has op­er­a­tions around the world mar­ket­ing brand­ed and gener­ic drugs — will now take over sell­ing.

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9
by Katherine Lewin

The chikun­gun­ya virus met its match in Val­ne­va’s vac­cine can­di­date, VLA1553, ac­cord­ing to da­ta from an an­ti­body per­sis­tence tri­al re­leased to­day.

The tri­al found that 99% of 363 par­tic­i­pants re­tained neu­tral­iz­ing an­ti­bod­ies 12 months af­ter a sin­gle dose of vac­cine in the com­pa­ny's ear­li­er, larg­er Phase III tri­al, called VLA1553-301. The par­tic­i­pants from the long-term study will con­tin­ue to be mon­i­tored for at least five years.

Val­ne­va plans to fi­nal­ize its BLA sub­mis­sion with the FDA by the end of this year. The pro­gram re­ceived FDA fast track and break­through ther­a­py des­ig­na­tions in 2018 and 2021. The larg­er Phase III study, VLA1553-301, in March showed that the vac­cine gen­er­at­ed a serore­sponse rate of 96% six months af­ter vac­ci­na­tion.

If the vac­cine is ap­proved, the com­pa­ny will be first in­to a glob­al mar­ket for vac­cines against chikun­gun­ya that could ex­ceed $500 mil­lion an­nu­al­ly by 2032, ac­cord­ing to an es­ti­mate cit­ed by Val­ne­va from VacZine An­a­lyt­ics, a mar­ket re­search firm.

Val­ne­va has al­ready signed with the In­sti­tu­to Bu­tan­tan in Brazil for the de­vel­op­ment, man­u­fac­tur­ing and mar­ket­ing of VLA1553 to make it more ac­ces­si­ble for low- and mid­dle-in­come coun­tries. And in No­vem­ber, the com­pa­ny hired GSK vet­er­an Di­pal Pa­tel to be its chief com­mer­cial of­fi­cer and help with a po­ten­tial launch.

Val­ne­va is the first com­pa­ny to bring a chikun­gun­ya vac­cine in­to Phase III de­spite decades of ef­forts fo­cus­ing on the trop­i­cal dis­ease. Chikun­gun­ya, car­ried by mos­qui­toes, is a vi­ral dis­ease caused by the virus of the same name. It can cause fever, joint and mus­cle pain, headache, nau­sea, rash and chron­ic arthral­gia. It of­ten caus­es sud­den large out­breaks, es­pe­cial­ly in the Amer­i­c­as. As of Sep­tem­ber 2020, there were more than three mil­lion re­port­ed cas­es in the Amer­i­c­as and it has spread to over 100 coun­tries.

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