On November 12, 2021 xCures reported their poster presentation at the 26th Annual Meeting of the Society for Neuro-Oncology, held from the 18th to the 21st of November (Press release, xCures, NOV 12, 2021, View Source [SID1234595513]). The Society for Neuro-Oncology (SNO) is a multidisciplinary society of healthcare professionals dedicated to promoting advances in neuro-oncology through research and education. Their annual meeting features research and educational sessions on brain tumors, including the latest on diagnosis and treatments.

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xCures poster presentation, entitled XCELSIOR: A real-time, real-world learning platform for patients with advanced cancer, will show clinical outcomes of real-world datasets from over 400 CNS cancer patients and approximately 250 glioblastoma patients. XCELSIOR is a direct-to-patient evidence-based platform leveraging a nationwide observational research protocol. The platform allows for continuous learning towards informing treatment decisions by aggregating, normalizing, and analyzing N-of-1 clinical outcomes from anywhere in the country.

At the conference, xCures will discuss their real-time learning infrastructure and present results of clinical case studies for pharma and non-profit groups, including more than 100 reported virtual tumor boards. Outcomes shown will be from real-world evidence generated from hundreds of patients with CNS cancers that xCures have helped in partnership with Cancer Commons and the Musella Foundation.

"I look forward to connecting with colleagues and presenting our first analysis of real-world clinical outcomes of CNS cancer patients from our observational registry, including a preliminary analysis of patients that received immune checkpoint inhibitors," stated Tim Stuhlmiller, VP of Scientific and Medical Affairs at xCures. "It is inspiring to see our approach to gather and analyze real-world data in real-time via patient participation in a nationwide observational research protocol yield evidence-based insights."

Al Musella, President of the Musella Foundation said, "With the launch of their provider portal xDECIDE, the xCures platform offers a major opportunity for oncologists all over the country to collaborate on observational research without the burden of data entry. The CNS dataset presented at the conference provides a foundation for ongoing clinical research to identify the most promising new combinations of therapies in glioblastoma."

"Cancer Commons’ close partnership with xCures, the Musella Foundation, and the expert physician advisers that serve on our virtual tumor boards has helped inform brain cancer patients across the U.S. about treatment options specific to their case. The data presented here demonstrates our first steps towards building a ‘learning health system’ that we hope will change the care for brain cancer patients, tightly integrate clinical care and research, and help us learn from each individual’s experience." said Matt Warner, Scientist at Cancer Commons.

For more information, visit the poster session on Friday, November 19th from 7:30-9:30 pm EST in Exhibit Hall D, or attend the live presentation of the xCures platform and preliminary RWD on CNS cancers on Saturday, November 20th at 1 pm EST in Room 309 in the Hynes convention center.

On November 12, 2021 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that new data from its best-in-class memory natural killer (NK) cell therapy platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Wugen, NOV 12, 2021, View Source [SID1234595347]). The presentation highlighted the preclinical development and proprietary manufacturing details of Wugen’s lead product candidate WU-NK-101 for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The findings presented at SITC (Free SITC Whitepaper) support development of WU-NK-101 as an off-the-shelf therapy for r/r AML and solid tumor indications.

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"These data showcase our differentiated approach to off-the-shelf cell therapies for cancer," said Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen. "Our memory NK cell platform is uniquely designed to overcome the limitations of existing cell therapy alternatives by delivering enhanced function, persistence, and ultimately efficacy without the need for feeder cells during the manufacturing process. Eliminating this step simplifies the process and allows us to deliver a safer product. We have prioritized manufacturing from the start and are proud that today’s data underscores our preparedness to deliver our product at-scale and provide powerful treatments to patients."

Today’s presentation highlighted the following:

WU-NK-101 memory NK cells demonstrated robust cytotoxic efficacy in vitro, producing high levels of immune-activating cytokines and immune-attracting chemokines.

WU-NK-101 showed strong anti-tumor activity in vivo, with long-term persistence and increased CD16 expression.

WU-NK-101 drove robust antibody-dependent cell-mediated cytotoxicity (ADCC) activity against solid tumor cell lines in combination with approved therapeutic antibodies.

Wugen’s process enables commercial-scale manufacturing of WU-NK-101 by using WU-PRIME, a single GMP-grade fusion protein complex, and WU-EXPAND, a feeder cell-free expansion system, in combination with a proprietary cryopreservation method to maintain an enhanced memory phenotype and preserve functionality.

The details of Wugen’s presentation at SITC (Free SITC Whitepaper) are as follows:

Title: Development of WU-NK-101, a feeder cell-free expanded allogeneic memory NK cell product with potent anti-tumor activity

Presenting Author: Mary E. Mathyer, Ph.D.

Abstract Number: 188

Abstracts will be available Tuesday, November 9, 2021, at 8:00 a.m. ET

Additional meeting information can be found on the SITC (Free SITC Whitepaper) website at:

View Source

The poster will be available on the "Scientific Publications" section of Wugen’s website.

On November 12, 2021 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the "Company"), a clinical-stage gene-editing company employing its core technology to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR-)T cells in the field of immuno-oncology and gene-edited hematopoietic stem cells in other indications, reported the first preclinical data on UCARTMESO, its allogeneic CAR-T cell product candidate targeting mesothelin, being developed for patients with mesothelin-expressing solid tumors (Press release, Cellectis, NOV 12, 2021, View Source [SID1234595387]).

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The data were presented today in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting titled "Mesothelin (MSLN) targeting allogeneic CAR-T cells engineered to overcome tumor immunosuppressive microenvironment". Poster # 143.

The poster presentation highlighted the following preclinical data:

Mesothelin is an interesting target for CAR-T cell therapy for solid tumors because it is highly and consistently expressed in mesothelioma and pancreatic cancers. It is also over-expressed in subsets of other solid tumors (ovarian cancer, non-small cell lung cancer, gastric cancer, triple-negative breast cancer) while modestly expressed in healthy cells, indicating that targeting mesothelin may result in a safe and effective therapy.
UCARTMESO product candidate is composed of allogeneic non-alloreactive T cells edited with TALEN-encoding mRNAs to disrupt TRAC, CD52 and TGFBR2 genes, and transduced ex vivo with a recombinant lentiviral vector (rLV) to express a second-generation CAR targeting MSLN. It is the first TALEN-induced triple knock out (KO) product candidate in the allogeneic CAR-T space.
The preclinical data demonstrated potent activity of UCARTMESO in vitro and in vivo against MSLN expressing cell lines, and in vivo activity in pancreatic and pleural mesothelioma mouse models.
Due to TGFBR2 KO, UCARTMESO was shown to restore IL2RA upregulation upon in vitro activation, even in media rich in TGFB1, which contributes to the immune suppressive microenvironment in tumors.
Laurent Poirot, PhD, Senior Vice President Immunology, noted: "Overall, the data demonstrated that the TGFBR2 gene knock out provides valuable additional properties to UCARTMESO, which may result in a very effective therapy despite an immune suppressive tumor microenvironment, and supports its clinical development for the treatment of solid tumors."

A copy of the presentation will be available on Cellectis’ website here, shortly after the event.

On November 12, 2021 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and nine months ended September 30, 2021 (Press release, ProMIS Neurosciences, NOV 12, 2021, View Source [SID1234595404]).

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"We are pleased to be ramping up our efforts to advance our lead asset, PMN 310, closer toward the clinic," said Gene Williams, ProMIS’ Chairman and CEO. "The financing we secured earlier this year is enabling us to unlock the potential of our platform, which we believe could have significant impact on the treatment of several neurological diseases, including Alzheimer’s Disease (AD), Parkinson’s Disease and ALS. The strengthening of our management team and Board this quarter has also enabled us to leverage worldwide development and patent expertise and strengthen our overall competitive position."

Corporate Highlights

On July 2, 2021, the Company announced the voting results of its annual meeting of shareholders held on June 30, 2021, in Vancouver, British Columbia, Canada. All resolutions described in the Management Proxy Circular and placed before the meeting were approved by the shareholders.
On July 8, 2021, the Company announced that it had filed and obtained a receipt for the Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec.
On August 25, 2021, we announced the closing of a public offering for gross proceeds of US$20,125,000 (CDN$25,522,525).
On October 7, 2021, we announced that we would hold a special general meeting of shareholders (the "Special Meeting") on December 1, 2021. We set October 18, 2021, as the record date for the Special Meeting. The purpose of the Special Meeting is to ask shareholders to grant the Board of Directors the authority, exercisable in the Board’s discretion, to consolidate (or reverse split) the Company’s issued and outstanding common shares in furtherance of a potential listing of the Company’s shares on a stock exchange in the United States.
People

On September 1, 2021, the Company appointed Josh Mandel-Brehm to the board of directors. Mr. Mandel-Brehm has held various key business development and operations leadership roles at leading biotechnology companies.
On September 23, 2021, the Company appointed Maggie Shafmaster, JD, PhD, to the board of directors. Dr Shafmaster has approximately 30 years of experience providing intellectual property advice to biotechnology and pharmaceutical industries.
On October 22, 2021, the Company announced the expansion of its senior management team. The following changes were announced:

Eugene Williams, formerly Executive Chairman, takes on the role of Chairman and Chief Executive Officer ("CEO"), with immediate effect.
Dr. Elliot Goldstein resigned from his current role as CEO with immediate effect and continues to support us as President and special consultant to the CEO.
Gavin Malenfant joins our senior management team as Chief Operating Officer. Mr. Malenfant brings more than 30 years of biopharmaceutical experience to our team, with special focus on providing expert management and oversight of drug development programs. The top priority in the near term will be to support the timely development of the PMN310 program to completion of IND enabling activities, anticipated in the second half of 2022. He will be working with Mr. Williams and the leadership of the PMN310 project team, whose key members include:
Michael Grundman, MD, Senior Medical Adviser. Prior to joining the pharmaceutical industry, Dr. Grundman was Associate Director of the Alzheimer’s Disease Cooperative Study at the University of California, San Diego ("UCSD") and is currently an Adjunct Professor of Neurosciences at UCSD. Dr. Grundman previously served on the FDA Peripheral and Central Nervous System Advisory Committee.
Ernest Bush, PhD, Head of Pharmacology/Toxicology. Dr. Bush has 35 years of experience working in the field of biomedical research and development, driving development of innovative therapies for treatment of human diseases. He has served as a consultant in non-clinical development providing advice and insight into Investigational New Drug ("IND") enabling programs, pre-clinical data-set analysis for due diligence and evaluation and audits of Good Laboratory Practices ("GLP") bioanalytical and toxicology facilities and studies.
Dennis Chen, PhD, Head of Manufacturing. Dennis has more than 25 years of prior pharmaceutical experience in working with companies from virtual to global and all phases of development. Dennis provides Regulatory Affairs, Chemistry, Chemistry, Manufacturing and Controls ("CMC") and Biopharmaceutical Development support to ProMIS with expertise in peptides, proteins and oligonucleotides.
Financial Results

Results of Operations – Three months ended September 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended September 30, 2021 and 2020

On November 12, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that three posters with preclinical data of its innate cell engagers (ICE) are presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Affimed, NOV 12, 2021, View Source [SID1234595442]). The data highlight Affimed’s preclinical initiatives to further elucidate the mechanisms of action for its lead ICE candidates AFM13 and AFM24, providing evidence that both ICE molecules increased the number of NK cells which functioned as serial killers against cancer as well as the role of macrophages in the anti-tumor activity of AFM24.

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The poster based on abstract 894 displays data generated through a collaboration with Prof. Björn Önfelt’s group at the Karolinska Institutet, Stockholm. In the study, microchip technology was used for two ICE drug candidates, AFM13 and AFM24, at single cell resolution to better understand their mode of action. Both ICE molecules enhanced NK cell cytotoxicity and increased the number of serial killers, i.e. NK cells which kill a number of tumor cells sequentially. Shedding inhibition of the innate immune cell surface protein CD16 resulted in the maintained cytotoxic effect of either ICE molecule demonstrating that stabilization of CD16 is not required for effective tumor cell killing by ICE drug candidates. "Showing serial killing for AFM13- and AFM24-engaged NK cells in single cell resolution is impressive," said Prof. Björn Önfelt. "The microchip technology visualizes the cytotoxicity of AFM13- and AFM24-engaged NK cells and demonstrates that ICE activated NK cells can lead to multiple tumor cell killings by a single NK cell."

Two additional posters (abstracts 880 and 881) present data on AFM24’s ability to induce antibody dependent cellular phagocytosis (ADCP). AFM24, the bispecific ICE targeting EGFR and CD16A, led to enhanced macrophage-mediated ADCP on various EGFR-expressing tumor cell lines, irrespective of their EGFR-pathway mutational status.

To refine the prediction of in vivo tumor responses to AFM24, Affimed has established 2D and 3D assay conditions in patient-derived xenograft (PDX) cell lines. The 3D model is designed to replicate intrinsic physiological conditions. Early results show that AFM24 can induce ADCP in tumor cells in 2D PDX cell cultures, engaging M0, M1 and M2 macrophage subsets context-dependently. ADCP is potentially instrumental for AFM24’s mechanism of action, especially in macrophage-rich tumors.

"Our ICE AFM24 is in development for a number of solid tumor indications," said Dr. Arndt Schottelius, CSO of Affimed. "Considering that many solid tumors are rich in macrophages, it is very encouraging to see what role ADCP plays in its mechanism of action. The newly established 2D and 3D models will help to predict responses to AFM24 in certain tumor types."

AFM24 is currently investigated as monotherapy in a Phase 1/2a study in patients with EGFR-expressing solid tumors in need of alternative treatment options. In addition, Affimed and NKGen Biotech have initiated a clinical study to investigate AFM24 in combination with NK cells. Affimed expects to initiate an additional clinical study with an anti-PD-L1 checkpoint inhibitor before the end of 2021.

For the full abstracts, please go https://bit.ly/3HgWlIa. The posters can be found at View Source

About AFM13
AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at www.clinicaltrials.gov (NCT04101331).
In addition, The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored Phase 1 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas (NCT04074746).

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Affimed is evaluating AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. Details about the first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov (NCT04259450).
In 2021, Affimed also aims to initiate a Phase 1/2a study (AFM24-102), evaluating AFM24 in combination with Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor. A Phase 1/2a study (AFM24-103) of AFM24 in combination with NKGen Biotech’s autologous NK cell product, SNK01, has recently been initiated.