In­ovio ax­es staff, chops R&D pro­grams in chase for elu­sive com­mer­cial win — though there's still a lot on their plate

Ral­ly­ing around its late-stage HPV projects, In­ovio Phar­ma­ceu­ti­cals $INO is slash­ing 28% of its work­force — around 80 staffers — and ax­ing sev­er­al ear­ly-stage pro­grams to bring its burn rate down by 25%.

Joseph Kim In­ovio

The Ply­mouth Meet­ing, PA-based biotech in­sists that the sole mo­tive is to con­sol­i­date its scat­tered pipeline, cre­at­ing “a more ef­fi­cient or­ga­ni­za­tion with greater fi­nan­cial flex­i­bil­i­ty and a longer run­way,” ac­cord­ing to CEO Joseph Kim. While In­ovio end­ed the first quar­ter with $128.0 mil­lion in cash and cash equiv­a­lents, though, its stock has tum­bled 28% since the be­gin­ning of the year to $3. It’s fall­en an­oth­er 13% pre-mar­ket.

And even af­ter the re­struc­tur­ing In­ovio’s re­main­ing team of 200 will still be spread among a siz­able ar­ray of projects — re­flect­ing a “John­ny-on-the-spot” op­tics that the 40-year-old com­pa­ny has been chas­tised for.

The top pri­or­i­ty is lead as­set VGX-3100, a DNA-based im­munother­a­py sup­posed to pre­vent can­cer by treat­ing cer­vi­cal dys­pla­sia caused by HPV.

In­ovio had in­tend­ed to kick­start Phase III in 2016, but a clin­i­cal hold is­sued by FDA reg­u­la­tors pushed the time­line back by at least half a year. Three years lat­er, it has fi­nal­ly com­plet­ed en­roll­ment for the first tri­al and be­gun re­cruit­ing pa­tients for the next.

Next on the list is INO-3107 for re­cur­rent res­pi­ra­to­ry pa­pil­lo­mato­sis, a rare dis­ease al­so caused by HPV in­fec­tions. Hav­ing sat on the back­burn­er for a while, the drug will get some fresh clin­i­cal ac­tion with­in 12 months.

Then there’s ME­DI0457, the on­ly as­set that As­traZeneca is still in­ter­est­ed in af­ter walk­ing away from a part­ner­ship dat­ing back to 2015. The on­go­ing study, which the phar­ma gi­ant is steer­ing, stud­ies the drug in com­bi­na­tion with Imfinzi in head and neck can­cer. Phase II da­ta are ex­pect­ed by next Au­gust.

The last two pro­grams in fo­cus have noth­ing to do with HPV. Af­ter aban­don­ing a plan to ad­vance INO-5401 for blad­der can­cer, In­ovio now wants to see if it has a fu­ture in glioblas­toma mul­ti­forme — where they see a high­er un­met med­ical need. It al­so has its hands on pre­clin­i­cal DNA-en­cod­ed bi-spe­cif­ic T cell en­gagers, a tech­nol­o­gy it’s keen to move for­ward.

Of course, In­ovio still has all the oth­er part­ner-fund­ed pro­grams: Las­sa and MERS vac­cine pro­grams fund­ed by the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions, Zi­ka project backed by the Gates Foun­da­tion; and a de­liv­ery de­vice sup­port­ed by the Med­ical CBRN De­fense Con­sor­tium.

Ear­li­er this year In­ovio had spun out its im­munother­a­py plat­form to a start­up dubbed Ge­neos Ther­a­peu­tics, bring­ing in San­té Ven­tures to lead a $10.5 mil­lion launch round.

So­cial im­age: Shut­ter­stock

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Martin Shkreli (Photo by Drew Angerer/Getty Images)

Mar­tin Shkre­li re­ceives life­time in­dus­try ban, forced to re­turn al­most $65M in prof­its af­ter an­ti­com­pet­i­tive scheme

Martin Shkreli will have to find a new nickname.

A federal judge banned the former biotech CEO and “Pharma Bro” from the drug industry on Friday, ordering him to pay nearly $65 million in illicit profits. Shkreli was convicted of securities fraud in 2017 and is currently serving a seven-year prison sentence, though he originally gained notoriety for raising the price of the antiparasitic drug Daraprim from $13.50 to $750 in 2015.