Pfiz­er dumps a failed PhII Hunt­ing­ton’s drug in lat­est pipeline prun­ing

Marielle Del­nomdedieu

Pfiz­er used one of its foot­notes in the Q1 re­port to sweep out an ex­per­i­men­tal Hunt­ing­ton’s drug that failed re­cent­ly in a Phase II tri­al, the lat­est in a long se­ries of im­plo­sions in the neu­ro­science field.

Pfiz­er didn’t ex­plain what went wrong for PF-02545920, but in a blog post at HD­Buzz in De­cem­ber, which was edit­ed by one of the in­ves­ti­ga­tors in the study, the drug was writ­ten off as a com­plete flop in im­prov­ing the abil­i­ty of pa­tients to func­tion bet­ter — or boost scores on any oth­er symp­toms eval­u­at­ed in the 271-pa­tient tri­al.

“We’re all very dis­ap­point­ed that the study drug didn’t meet its pri­ma­ry end­point of im­prov­ing move­ments in HD, or any of the sec­ondary end­points look­ing at oth­er fea­tures of the dis­ease,” study leader Marielle Del­nomdedieu told Ed Wild, who wrote the piece. “But de­spite the neg­a­tive out­come, we’ve learned a great deal about Hunt­ing­ton’s dis­ease and PDE10. The tri­al da­ta will be a rich re­source for HD re­search. We’re pleased with the way the tri­al was planned and run, and im­mense­ly grate­ful to the pa­tients and their rel­a­tives in­volved in the tri­al.”

PDE10 is be­lieved to be in­volved on cell sig­nal­ing, and some in­ves­ti­ga­tors be­lieve a drug could help safe­guard pateints’ brain cells and im­prove pa­tients abil­i­ty to coun­ter­act the dis­ease.

The tri­al ter­mi­na­tion and cause was al­so record­ed on clin­i­cal­tri­als.gov.

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

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

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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Covid-19 roundup: As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Forget 1 billion. AstraZeneca is now promising to supply 2 billion doses of Oxford University’s Covid-19 vaccine around the world per year.

Three new partners are coming on board to help reach that goal, as well as a broader vision to ensure access for nations that have been largely left out of the bargaining table.

CEPI — the coalition that’s been doling out grants to support other vaccine projects — is providing $383 million to support manufacturing of 300 million doses, while Gavi the Vaccine Alliance will chip in $367 million and be in charge of the procurement and distribution, a spokesperson told Wall Street Journal. A separate licensing agreement directs the Serum Institute of India to produce 1 billion doses for low- and middle-income countries, with the first 400 million due before the end of the year.

Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

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.

Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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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.

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.