Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

In­ovio's Covid-19 vac­cine stud­ies just hit a brick wall at the Pen­ta­gon. Are oth­er hope­fuls in trou­ble?

In­ovio re­ceived some harsh news from the Pen­ta­gon on Fri­day re­gard­ing its Covid-19 vac­cine pro­gram, and it could prove fore­bod­ing to oth­er mid-stage play­ers in the space.

The US De­part­ment of De­fense has scut­tled fund­ing for In­ovio’s Phase III Covid-19 vac­cine tri­al, In­ovio said in a press re­lease, but will con­tin­ue to fund the study’s Phase II seg­ment. Fri­day’s move comes as a re­sult of a grow­ing avail­abil­i­ty of au­tho­rized vac­cines in the US, In­ovio said the de­part­ment com­mu­ni­cat­ed to them. End­points News has reached out to DoD for com­ment.

“The de­ci­sion re­sults from the chang­ing en­vi­ron­ment of COVID-19 with the rapid de­ploy­ment of vac­cines,” DoD said, per In­ovio. “This de­ci­sion is not a re­flec­tion of the awardee or prod­uct, rather a fast-mov­ing en­vi­ron­ment as­so­ci­at­ed with the for­mer Op­er­a­tion Warp Speed on de­ci­sions re­lat­ed to fu­ture prod­ucts.”

In­ovio hus­tled to re­as­sure in­vestors that the fund­ing with­draw­al did not stem from their vac­cine can­di­date it­self, dubbed INO-4800, say­ing in its state­ment that the de­ci­sion was un­re­lat­ed to the pro­gram’s da­ta or par­tial clin­i­cal hold that’s been in place since last Sep­tem­ber. Fur­ther­more, the com­pa­ny’s re­lease led with the seem­ing­ly in­nocu­ous note on how they’re plan­ning for a Phase III tri­al to take place pre­dom­i­nant­ly out­side the US.

But most didn’t seem to be as­suaged, as In­ovio $INO shares were crushed ear­ly Fri­day. The stock was down more than 30% at points in pre-mar­ket trad­ing, and opened down 25%.

In­ovio’s sup­port had come from the de­part­ment’s Joint Pro­gram Ex­ec­u­tive Of­fice for Chem­i­cal, Bi­o­log­i­cal, Ra­di­o­log­i­cal and Nu­clear De­fense. The of­fice’s point over vac­cine avail­abil­i­ty could prove as a warn­ing sign for oth­er gov­ern­ment-backed Covid-19 projects that haven’t yet hit the mar­ket. Ac­cord­ing to the lat­est CDC num­bers, more than 135 mil­lion Amer­i­cans have re­ceived at least one vac­cine dose, ac­count­ing for 52% of the pop­u­la­tion over 18.

Those fig­ures come large­ly as a re­sult of the Pfiz­er/BioN­Tech and Mod­er­na vac­cines, which were the first two to re­ceive EUAs in the US af­ter their Phase III da­ta read out last No­vem­ber. Of the near­ly 219 mil­lion dos­es ad­min­is­tered so far, about 114 mil­lion have come from Pfiz­er/BioN­Tech and 95 mil­lion from Mod­er­na.

An ad­di­tion­al 8 mil­lion dos­es of the one-shot J&J vac­cine have al­so been giv­en, and that shot’s roll­out hold is ex­pect­ed to be lift­ed as ear­ly as Fri­day. And No­vavax has pre­vi­ous­ly said it ex­pects its own EUA to come as soon as next month, fur­ther com­pli­cat­ing mat­ters for In­ovio and oth­er Covid-19 shots from small play­ers in late-stage de­vel­op­ment.

INO-4800 is a DNA-based vac­cine can­di­date com­posed of an op­ti­mized DNA plas­mid, In­ovio says. The ap­proach dif­fers from the ma­jor vac­cine play­ers’ strat­e­gy of us­ing mR­NA (Pfiz­er and Mod­er­na), ade­n­ovirus­es (J&J and As­traZeneca) and pro­tein-based de­liv­ery (No­vavax). In­ovio had re­leased some ear­ly-stage da­ta on their can­di­date just last week, say­ing T cell re­spons­es were “ful­ly main­tained” against the coro­n­avirus vari­ants that emerged in the UK, South Africa and Brazil when com­pared to re­spons­es to the orig­i­nal Wuhan, Chi­na strain. They not­ed that the sam­ples were col­lect­ed from vary­ing time­points from when their Phase I tri­al par­tic­i­pants were im­mu­nized.

It’s been a trou­bled few months for In­ovio, which has seen its Covid-19 vac­cine pro­gram stuck in neu­tral ever since the FDA slapped a par­tial hold on its Phase III tri­al in late Sep­tem­ber. Reg­u­la­tors had raised ques­tions over the pro­gram’s de­vice used to in­ject the vac­cine in­to the skin, and In­ovio said in March that it is plan­ning to re­spond to the agency next month.

In a 10-K fil­ing at the time, In­ovio ad­mit­ted its vac­cine ef­forts may end up be­ing fruit­less, writ­ing, “We do not know whether our planned Phase 3 clin­i­cal tri­al will be­gin on time or be com­plet­ed on sched­ule, if at all.”

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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(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.

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.

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.

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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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.