Tom Graney, Oxurion CEO

Bel­gian eye biotech gets ham­mered by in­vestors af­ter PhII tri­al fails ef­fi­ca­cy on key end­points

Bel­gian biotech and pen­ny stock play­er Ox­u­ri­on was al­ready hov­er­ing around the $1.06/share mark this past week on the Eu­ronext stock ex­change in Brus­sels — and with the com­pa­ny’s newest an­nounce­ment, its stock price has tanked.

The eye-fo­cused biotech an­nounced a Phase II fail ear­ly Mon­day in Part A of a Phase II tri­al on the com­pa­ny’s in­te­grin an­tag­o­nist can­di­date to treat di­a­bet­ic mac­u­lar ede­ma or DME. Al­though the can­di­date, al­so called THR-687, was shown to be safe and well-tol­er­at­ed (a fact the com­pa­ny em­pha­sized), ev­i­dence to prove ef­fi­ca­cy was “in­suf­fi­cient” on the main end­points for the tri­al: best-cor­rect­ed vi­su­al acu­ity (the best vi­sion cor­rec­tion pos­si­ble with ei­ther glass­es or con­tact lens­es) and thick­ness of the mac­u­la, al­so known as cen­tral sub­field thick­ness.

The com­pa­ny had first start­ed dos­ing pa­tients with THR-687 back in Oc­to­ber, ac­cord­ing to a press re­lease is­sued at the time.

The biotech said in a state­ment that it is not ad­vanc­ing THR-687 to part B of the tri­al, which leaves it in lim­bo as to what the can­di­date’s fi­nal fate will be. In the mean­time, Ox­u­ri­on is now down to one can­di­date in its pipeline, a PKal in­hibitor named THR-149 cur­rent­ly in an­oth­er Phase II tri­al al­so for DME. Re­sults from Part B of that tri­al are ex­pect­ed some­time next year.

Ox­u­ri­on did not re­spond to a re­quest for com­ment be­fore pub­li­ca­tion time. How­ev­er, CEO Tom Graney said in a state­ment that,

As we dis­con­tin­ue our de­vel­op­ment of THR-687, we will ex­plore po­ten­tial part­ner­ship op­por­tu­ni­ties for the as­set. Ad­di­tion­al­ly, we are un­der­tak­ing a thor­ough re­view of our cap­i­tal and re­source al­lo­ca­tion plans to en­sure that they are aligned with our ob­jec­tive of max­i­miz­ing val­ue cre­ation for all stake­hold­ers.

The biotech’s stock got hit hard short­ly af­ter the an­nounce­ment went out, with the biotech OX­UR open­ing up the mar­ket at a 30% loss at 0.7 eu­ros, or about 75 cents a share and drop­ping even fur­ther to around a 40% drop. Ox­u­ri­on had al­so raised more than $10.5 mil­lion back in March through a pri­vate eq­ui­ty place­ment, of which 80% was ear­marked to help fund the biotech’s clin­i­cal tri­als.

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.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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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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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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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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.

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.”