Fail­ure-prone Unum cuts jobs, los­es sci­en­tif­ic chief, and changes fo­cus yet again

At­las Ven­ture-backed Unum, which once har­bored am­bi­tions to ri­val the two CAR-T ther­a­pies Kym­ri­ah and Yescar­ta, is pay­ing the price for a laun­dry list of set­backs.

Seth Et­ten­berg Unum

On Mon­day, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny said it was cut­ting its work­force by 43 em­ploy­ees (rough­ly 60% of the to­tal head­count) to fo­cus its ef­forts on a pre­clin­i­cal pro­gram. It al­so dis­closed the de­par­ture of its chief sci­en­tif­ic of­fi­cer, Seth Et­ten­berg, as it ceas­es the de­vel­op­ment of tri­als har­ness­ing its maid­en tech­nol­o­gy: AC­TR.

The tri­als shelved in­clude an ear­ly-stage lym­phoma pro­gram test­ing the ex­per­i­men­tal drug, AC­TR707, in com­bi­na­tion with rit­ux­imab (Roche’s MabThera), as well as a Phase I sol­id tu­mor tri­al eval­u­at­ing the com­bi­na­tion of AC­TR707 and trastuzum­ab (Roche’s Her­ceptin).

Cell ther­a­pies un­der the plat­form were en­gi­neered to arm a pa­tient’s T cells with the ar­se­nal to launch a dou­ble at­tack on can­cer cells. First, the cells are de­signed to ex­press AC­TR — a chimeric pro­tein made out of com­po­nents from T cells and nat­ur­al killer cells — and then are com­bined with the tu­mor-tar­get­ing abil­i­ty of co-ad­min­is­tered an­ti­bod­ies.

The plat­form has seen fail­ure af­ter fail­ure. Back in 2018, in its IPO fil­ing, the com­pa­ny dis­closed that two out of nine pa­tients in the high-dose arm of a clin­i­cal tri­al for their then-lead cell ther­a­py — AC­TR087 — had died, forc­ing the FDA to im­pose a clin­i­cal hold that was lift­ed just ahead of their bid to go pub­lic. While it broke no laws, the com­pa­ny’s ap­proach to trans­paren­cy didn’t win it any plau­dits — the IPO was priced at the bot­tom of the range.

Then, last year, things got worse. Ex­ec­u­tives in Ju­ly re­vealed that the FDA had slapped an­oth­er clin­i­cal hold on AC­TR087,  af­ter a pa­tient in the safe­ty co­hort of a Phase I study ex­pe­ri­enced a raft of se­ri­ous ad­verse events. By this time, Unum — which is al­so backed by F-Prime Cap­i­tal — had repri­or­i­tized its pipeline to fo­cus on AC­TR707.

Come No­vem­ber, AC­TR087 was for­mal­ly aban­doned amid a broad­er shift from hema­tol­ogy to sol­id tu­mors. The com­pa­ny’s oth­er tech plat­form, BOXR, hit the spot­light.

The tu­mor mi­croen­vi­ron­ment in many sol­id tu­mor can­cers is deeply im­muno­sup­pres­sive, block­ing T cells from func­tion­ing nor­mal­ly. Unum’s Bolt-on Chimeric Re­cep­tor (BOXR) is de­signed to “bolt-on” trans­genes to boost in­trin­sic T cell func­tion­al­i­ty to con­quer that im­muno­sup­pres­sion.

In Unum’s lat­est up­date, it looks like AC­TR707 has al­so made the scrap heap — leav­ing pre­clin­i­cal BOXR1030 as the sole fo­cus. The com­pa­ny’s shares $UM­RX wad­ed deep­er in­to pen­ny stock ter­ri­to­ry, dip­ping slight­ly pre­mar­ket to 54 cents.

Re­gen­er­a­tive stem cell play­er Blue­Rock Ther­a­peu­tics, mean­while, has scored the ser­vices of Unum’s erst­while CSO Et­ten­berg.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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John Leonard, Intellia CEO

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.