Affimed and NKMax America to Study the Combination of AFM24, an EGFR-Targeted Innate Cell Engager, with SNK01 Natural Killer Cell Therapy

  • Proof of Concept study to establish safety and recommended dose of Affimed’s innate cell engager (ICE®) AFM24 in combination with NKMax America’s Natural Killer (NK) cells in solid tumors

  • Pre-clinical data substantiates synergy between Affimed’s ICE® molecules and both NKMax America’s autologous and cryopreserved allogeneic NK cell therapy products

Heidelberg, Germany, and Santa Ana, California, October 20, 2020 – Affimed N.V. (NASDAQ: AFMD) and NKMax America Inc., both clinical stage biotech companies focused on harnessing the power of the body’s innate immune system, announced today that they entered into a clinical collaboration agreement to investigate the combination of AFM24, a CD16A/EGFR-targeted ICE®, with the autologous NK cell product SNK01. Pursuant to the collaboration, the companies plan to explore the combination in a first-in-human proof-of-concept (POC) trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms. The results of the preclinical collaboration have shown substantive synergy between Affimed’s ICE® molecules and NKMax America’s autologous and cryopreserved allogeneic natural killer cell products.

Under the agreement, the companies will contribute their respective product candidates and resources towards submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and a subsequent clinical trial. The clinical trial will combine NKMax America’s SNK01 (enhanced natural killer cells) with AFM24 in the autologous setting with the option to expand the clinical trial to the allogeneic setting. The cost of the clinical study will be shared by Affimed and NKMax America. The agreement also provides for the opportunity to pursue further clinical study combinations with additional product candidates from both parties.

NKMax America has developed a proprietary NK cell expansion and activation technology platform which allows it to produce unprecedented commercial amounts of autologous and allogeneic NK cells from numerous donors that have near total expression of activating receptors like CD16A, NKG2D, NKp30 and NKp46. In addition, its unique technology increases the cytotoxicity of the expanded NK cells by nearly 8000 percent. In addition, the SNK01 product does not require lymphodepletion or cytokine support.

Using its ROCK® (Redirected Optimized Cell Killing) platform, Affimed has developed a novel pipeline of ICE® products. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE®, is unique due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), whereas other EGFR-directed therapies rely heavily on signal transduction inhibition. A first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study is underway evaluating AFM24 as monotherapy in patients with advanced solid EGFR-expressing malignancies whose disease has progressed after treatment with previous anticancer therapies.

“We believe combining ICE® molecules generated from our ROCK® platform with adoptive NK cell transfer can improve patient outcomes by ensuring patients have active and viable innate cells to be directed to the tumor and induce cytotoxic killing. In addition,

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The place in North America with no Covid-19 cases

Covid-19 cases are rising in many parts of Canada, but one region – Nunavut, a northern territory – is a lone place in North American that can say it’s free of coronavirus in its communities.

Last March, as borders around the world were slamming shut as coronavirus infections rose, officials in Nunavut decided they too would take no risks.

They brought in some of the strictest travel regulations in Canada, barring entry to the territory almost all non-residents.

Residents returning home from the south would first have to spend two weeks, at the Nunavut government’s expense, in “isolation hubs” – hotels in the cities of Winnipeg, Yellowknife, Ottawa or Edmonton.

Security guards are stationed throughout the hotels, and nurses check in on the health of those isolating. To date, just over 7,000 Nunavummiut have spent time in these hubs as a stopover on their return home.

It’s not been without challenges: People have been caught breaking isolation and have had stays extended, which has in part contributed to occasional wait times to enter the some of the hubs. There have been complaints about the food available to those confined to the hubs.

But, as coronavirus infections spread throughout Canada, and with the number of cases on the rise again, the official case count in Nunavut remains zero.

Graph of daily cases and deaths in Canada, showing recent uptick
Graph of daily cases and deaths in Canada, showing recent uptick

The “fairly drastic” decision to bring in these measures was made both due to the population’s potential vulnerability to Covid-19 and the unique challenges of the Arctic region, says Nunavut’s chief public health officer, Dr Michael Patterson.

About 36,000 people live in Nunavut, bounded by the Arctic Ocean to the north and the Northwest Territories to the west, in 25 communities scattered across its two million square kilometres (809,000 square miles). That’s about three times the size of the largest US state – Texas.

The distances are “mind-boggling at times”, admits Dr Patterson.

Natural isolation is likely part of the reason for the lack of cases – those communities can only be reached year-round by plane.

A general view of Sylvia Grinnel Territorial Park during a 3 day official visit to Canada on June 29, 2017 in Iqaluit, Canada.
Over 80% of the residents of Nunavut are Inuit

In late September, there was an outbreak linked to workers who flew in from the south to a remote gold mine 160km (100 miles) from the Arctic Circle.

(Those cases are currently being counted as infections in the miners’ home jurisdictions, keeping the territory’s official positive count nil).

That outbreak has “almost no chance” of spreading in the community because there hasn’t been any travel between the mine and any of the communities for months, says Dr Patterson.

But where isolation can help, it can also create hurdles.

Most communities don’t have the capacity to do Covid-19 testing locally, so tests have to be flown in and out.

Early on, tests results could take a week meaning “you’re really, really far behind by the time you can identify and respond”, Dr Patterson says. There are efforts underway to boost testing capacity and turnaround times

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America Sees Daily COVID Cases Pass 60,000 Once Again | Health News

By Robin Foster and E.J. Mundell
HealthDay Reporters

(HealthDay)

FRIDAY, Oct. 16, 2020 (HealthDay News) — The number of new U.S. coronavirus cases topped 60,000 on Thursday, a tally not reported since early August, as health experts worried the coming winter might push the toll even higher.

The latest numbers have also sent the country’s total COVID-19 case count past 8 million, the The New York Times reported.

The surge is nationwide, with cases multiplying across the country: Forty-four states and the District of Columbia have higher caseloads now than in mid-September, and the new coronavirus is spreading across rural communities in the Midwest, the Upper Midwest and the Great Plains, the Washington Post reported.

On Thursday, Wisconsin set a record with more than 4,000 new cases reported, the newspaper said. Illinois also reported more than 4,000 cases on Thursday, breaking records that were set in April and May. Ohio set a new high, as did Indiana, New Mexico, North Dakota, Montana and Colorado, the Post reported.

“We know that this is going to get worse before it gets better,” Wisconsin Department of Health Services secretary-designee Andrea Palm said during a briefing Thursday, the Post reported. “Stay home. Wear a mask. Stay six feet apart. Wash your hands frequently.”

Some hospitals in the Upper Midwest and Great Plains have become jammed with patients and are running low on ICU beds, the Post reported. Montana reported a record 301 hospitalized COVID-19 patients Thursday, with 98 percent of the inpatient beds occupied the day before in Yellowstone County.

In just the past week, at least 20 states have set record seven-day averages for infections, and a dozen have hit record hospitalization rates, according to health department data analyzed by the Post.

The reopening of many schools and colleges did not fuel a major spike in cases right away, as some experts had feared, but the numbers have steadily gone upward since, the newspaper reported.

The jump in cases and hospitalizations has been followed by a more modest rise in COVID-19 deaths, most likely due to better patient care from now-seasoned medical workers. The widespread use of powerful steroids and other treatments has lowered mortality rates among people who are severely ill, the Post reported.

Still, experts caution that most Americans remain vulnerable to COVID infection and the virus will likely spread more easily as colder weather sends more people indoors, where they might be exposed to larger amounts of the virus in poorly ventilated spaces.

“Inevitably, we’re moving into a phase where there’s going to need to be restrictions again,” David Rubin, director of PolicyLab at Children’s Hospital of Philadelphia, told the Post.

Second COVID vaccine trial paused

A second coronavirus vaccine trial has been paused after an unexplained illness surfaced in one of the trial’s volunteers.

Johnson & Johnson, which only began a phase 3 trial of its vaccine last month, did not offer any more details on the illness and did not say whether the sick participant had

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