Af­ter weath­er­ing fail­ure, re­jec­tion and lay­offs, Im­muno­Gen touts a new 'break­through' drug in its come­back plan

While the come­back plan for its lead drug is still up in the air, Im­muno­Gen says it has a sec­ond shot at an an­ti­body-drug con­ju­gate break­through.

Mark Enyedy

The FDA has grant­ed break­through ther­a­py des­ig­na­tion to IMGN632, which tar­gets CD123, in re­lapsed or re­frac­to­ry blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm. The ag­gres­sive can­cer pri­mar­i­ly af­fects the skin, bone mar­row and lymph nodes.

Hav­ing pre­sent­ed ini­tial da­ta on the first-in-hu­man study at ASH 2019, the biotech said it will re­port up­dates from the dose ex­pan­sion co­hort in De­cem­ber.

“We look for­ward to con­tin­u­ing to work with FDA to fur­ther de­fine the de­vel­op­ment path for IMGN632 in BPD­CN, in ad­di­tion to pur­su­ing our on­go­ing eval­u­a­tion of IMGN632 in AML and oth­er hema­to­log­i­cal ma­lig­nan­cies,” CEO Mark Enyedy said in a state­ment.

IMGN632 was one of three pro­grams that Jazz Phar­ma paid $175 mil­lion in cash to col­lab­o­rate on, in an R&D pact stretch­ing out to 2024.

A long­time play­er in the ADC game, Im­muno­Gen’s tech plat­form had a sig­nif­i­cant role in de­vel­op­ing Roche’s Kad­cy­la. But it’s had less luck with its own pro­grams, get­ting slapped down by the FDA af­ter the lead drug, mirve­tux­imab so­rav­tan­sine, failed a Phase III study for ovar­i­an can­cer.

Hav­ing ini­tial­ly sought ac­cel­er­at­ed ap­proval based on a sec­ondary end­point, the com­pa­ny is now count­ing on a new, sin­gle-arm tri­al to sup­port the OK. The SO­RAYA study ze­roes in on women with fo­late re­cep­tor al­pha (FRα)-high plat­inum-re­sis­tant ovar­i­an can­cer who have been pre­vi­ous­ly treat­ed with Avastin.

Amid the twists and turns Enyedy — who slashed the head­count by a few months af­ter he took the job in 2016 — reached again for the axe to con­serve cash. In ad­di­tion to lay­ing off 220 staffers, he al­so shelved IMGN779, the pro­gram for adults with re­lapsed/re­frac­to­ry CD33-pos­i­tive AML, and sub­leased the ex­tra emp­ty space.

Im­muno­Gen re­port­ed $219.5 mil­lion in cash and cash equiv­a­lents as of June 30, 2020, com­pared with $176.2 mil­lion at the end of 2019.

The big idea around AD­Cs is that by at­tach­ing a can­cer-killing tox­in to a spe­cif­ic an­ti­body, drug­mak­ers can di­rect the pay­loads pre­cise­ly to where they want them. While Im­muno­Gen boasts of ex­per­tise in all as­pects — tar­gets, an­ti­bod­ies, pay­loads and link­ers — the key com­po­nent of IMGN632 is the in-house nov­el in­dolino-ben­zo­di­azepine pay­loads, which they promise to be more po­tent than tra­di­tion­al chemother­a­py to can­cer cells but less tox­ic to nor­mal mar­row prog­en­i­tors.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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