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

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Aptinyx eval­u­ates fu­ture of the com­pa­ny fol­low­ing two failed tri­als, 60% lay­offs

This year has been tough for Aptinyx — two failed trials, a 60% cut in its workforce, and now the company has brought on a firm to help evaluate the future of the company.

The press release noted it’s working with the firm Ladenburg Thalmann as its financial advisor to assist in exploring and evaluating “strategic alternatives” — a process that a growing group of struggling biotechs has embarked on, sometimes ending in a merger, asset sale or wind-down.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.