Mereo re­verse merges with a flail­ing On­coMed and preps for a back flip on­to Nas­daq

Long af­ter the bright lights had dimmed and the mar­quee part­ners had large­ly slipped away from On­coMed $OMED, the Cal­i­for­nia biotech has one last role to play.

Denise Scots-Knight

The com­pa­ny, with a mar­ket cap that had dwin­dled to less than cash, has be­come a re­verse merg­er ve­hi­cle for the UK’s Mereo, which will now do a back flip on­to Nas­daq as the mar­ket re­mains tur­bu­lent. Mereo — which is list­ed on the Lon­don ex­change, some­thing of a back­wa­ter these days — had tak­en a shot at a US IPO in bet­ter days, though, drop­ping out of the queue last spring.

In prepa­ra­tion for the re­verse merg­er, On­coMed is shed­ding every­thing but a core group of staffers to main­tain op­er­a­tions un­til Mereo can com­plete the deal, with a “sig­nif­i­cant re­duc­tion in its work­force.”

This is the lat­est in a se­ries of re­verse merg­ers us­ing the shell of near-dead com­pa­nies. Ar­sa­nis opened its doors to X4 re­cent­ly, with Edge Ther­a­peu­tics and Bioblast play­ing sim­i­lar roles.

Mereo — helmed by Denise Scots-Knight — will be left in to­tal con­trol, with a plan to try and coax sup­port from the in­vest­ment com­mu­ni­ty as it jet­ti­sons On­coMed’s re­main­ing lead drug.

Their state­ment:

Dur­ing 2019 we con­tin­ue to ex­pect sev­er­al val­ue in­flec­tion points, in­clud­ing da­ta from our Phase 2b dose rang­ing study for BPS-804 for os­teo­ge­n­e­sis im­per­fec­ta and da­ta from our Phase 2 dose rang­ing study for MPH-966 for al­pha-1 an­tit­rypsin de­fi­cien­cy both be­ing run in the US and Eu­rope. Along­side these mile­stones, we are al­so pro­gress­ing part­ner­ing dis­cus­sions for our oth­er two prod­ucts, BCT-197 for acute ex­ac­er­ba­tions of COPD and BGS-649 for hy­pog­o­nadotrop­ic hy­pog­o­nadism. We al­so in­tend to be­gin part­ner­ing dis­cus­sions for On­coMed’s navi­cix­izum­ab pro­gramme, which has gen­er­at­ed en­cour­ag­ing clin­i­cal da­ta in ovar­i­an can­cer that should guide fur­ther clin­i­cal de­vel­op­ment.

Cel­gene ev­i­dent­ly re­tains one last op­tion on an On­coMed drug. Two months ago Cel­gene cut loose from navi­cix­izum­ab as On­coMed strug­gled to sur­vive.

 

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.