MiMedx shares swoon as purge claims CEO; Those big cuts in drug prices you heard about? Pfiz­er has oth­er ideas

→ Be­sieged by shorts with a Jus­tice De­part­ment probe re­port­ed­ly un­der way, the purge at MiMedx $MDXG has now led to the ex­it of CEO Park­er “Pe­te” Pe­tit and COO William “Bill” Tay­lor. The au­dit com­mit­tee at the biotech has been do­ing its own in­ter­nal in­ves­ti­ga­tion, which has al­ready led to the de­par­ture of the CFO and trea­sur­er. David Coles was named in­ter­im CEO. “The Board is con­fi­dent that now is the right time for MiMedx to tran­si­tion its lead­er­ship team as we look to the fu­ture and pre­pare our Com­pa­ny for its next chap­ter,” said chair­man Charles Evans. The biotechs shares swooned on the lat­est news, plung­ing 26%.

→ Pres­i­dent Don­ald Trump and his health­care team in Wash­ing­ton DC have some ex­plain­ing to do. Af­ter Trump re­cent­ly boast­ed that phar­ma com­pa­nies were prep­ping a huge cut in drug prices, Pfiz­er is coun­ter­ing with high­er prices on a slate of 100 of its port­fo­lio ther­a­pies. The scoop comes from the Fi­nan­cial Times, which has re­port­ed­ly seen the new price list. To be fair, HHS Sec­re­tary Alex Azar has con­ced­ed that the re­al­i­ty may be some­what dif­fer­ent from the pres­i­dent’s pub­lic com­ments. The move, though, will al­most cer­tain­ly stoke some kind of po­lit­i­cal back­lash. Phar­ma com­pa­nies have re­lied on a steady drum­beat of an­nu­al price hikes to cre­ate the kind of bal­ance sheet in­vestors love. It’s ab­solute­ly cer­tain to pro­duce re­sults, with­out any of the risk of R&D. It’s al­so be­come a po­lit­i­cal hot pota­to. Will Pfiz­er — which has con­sis­tent­ly thumbed its nose at pric­ing crit­ics — now prompt the ad­min­is­tra­tion to try a name-and-shame re­sponse? Will it make any dif­fer­ence?

→ Af­ter a two-month block­ade, the FDA has cleared the clin­i­cal hold it slapped on Com­pu­gen’s first-in-hu­man tri­al for its I/O drug, clear­ing the Is­raeli biotech to fi­nal­ly be­gin its first ever Phase I study. The tri­al, to be con­duct­ed in the US, will eval­u­ate the safe­ty and pre­lim­i­nary ef­fi­ca­cy of its in-house an­ti­body COM701 — both as monother­a­py and in com­bi­na­tion with a PD-1 in­hibitor — in pa­tients with sol­id tu­mors who have failed stan­dard of care treat­ments. The drug tar­gets PVRIG, a B7/CD28-like im­mune check­point tar­get can­di­date iden­ti­fied by Com­pu­gen, which has a part­ner­ship with Bay­er with an­oth­er nov­el tar­get. That was much wel­come news for in­vestors, and the com­pa­ny’s shares $CGEN surged 16.67% in pre-mar­ket trad­ing, though not still ful­ly re­cov­er­ing from the drop in late April, when the FDA hit the brakes with a a re­quest for slight mod­i­fi­ca­tion and more in­for­ma­tion.

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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.

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.

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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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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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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