NeuEx­cell strikes deal with Fu­ji­film for stroke gene ther­a­py; J&J ex­pands in Ire­land

In an ef­fort to ad­vance a gene ther­a­py to treat is­chemic cor­ti­cal stroke, Fu­ji­film Diosynth Biotech­nolo­gies and NeuEx­cell Ther­a­peu­tics have reached an agree­ment to pro­duce drug sub­stance in Col­lege Sta­tion, TX.

Ger­ry Far­rell

Fu­ji­film will do so un­der an ac­cel­er­at­ed time­line for NeuEx­cell’s first-in-hu­man clin­i­cal stud­ies of NXL-001.

Ger­ry Far­rell, the COO of Fu­ji­film, says that the deal shows the com­pa­ny is able to work with com­pa­nies of all sizes.

“We are proud and de­light­ed to have been se­lect­ed by NeuEx­cell as the man­u­fac­tur­ing part­ner for their NXL-001 can­di­date. It is an hon­or for FDB to play a role help­ing to bring a treat­ment to pa­tients around the world who suf­fer from is­chemic cor­ti­cal stroke,” he said in a state­ment.”

NeuEx­cell is based out of Penn­syl­va­nia and is fo­cused on neu­rode­gen­er­a­tive dis­eases and the cen­tral ner­vous sys­tem. Its pipeline has in­ves­ti­ga­tion­al ther­a­pies for stroke, Hunt­ing­ton’s dis­ease, ALS, Alzheimer’s and Parkin­son’s dis­ease.

Fu­ji­film has es­tab­lished it­self as a key play­er in the gene ther­a­py pro­duc­tion plan, as it doled out $850 mil­lion in Ju­ly in­to US and UK lo­ca­tions to in­crease ca­pac­i­ty. Those ex­pan­sions will start in 2023, and brought the to­tal amount of mon­ey in­vest­ed in its CD­MO wing to $5.5 bil­lion in the past 10 years, in­clud­ing a $76 mil­lion in­crease in­to its Wa­ter­town, MA site that in­cludes eight clean­rooms and 40,000 square feet to be opened in 2022. It al­so opened a $2 bil­lion plant in Hol­ly Springs, NC, set to be op­er­a­tional by 2025.

J&J ex­pands in Ire­land

About 180 new jobs are com­ing to Cork, Ire­land, as J&J has an­nounced the ex­pan­sion of its man­u­fac­tur­ing site that’s been in op­er­a­tion since 2005.

The com­pa­ny has sub­mit­ted an ap­pli­ca­tion for a €150 mil­lion ex­pan­sion in Ringask­id­dy that will up the size by 8,202 square feet. The site is ded­i­cat­ed to man­u­fac­tur­ing prod­ucts that treat rheuma­toid arthri­tis, pso­ri­a­sis and can­cer, though it isn’t clear ex­act­ly which drugs are man­u­fac­tured there.

J&J fin­ished an ex­pan­sion at the site in 2019, adding more than 205,000 square feet of ca­pac­i­ty and an­oth­er 200 jobs.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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