On June 8, 2021 Orion Corporation and the Finnish Red Cross Blood Service reported that they have concluded an agreement on research collaboration with the aim of developing chimeric antigen receptor (CAR) T-cell therapy (Press release, Orion , JUN 8, 2021, View Source [SID1234583716]).

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Cancer immunotherapies, with CAR T-cell therapy as one form of therapy, have introduced entirely new possibilities for cancer treatment. In CAR T-cell therapy, the patient’s own white blood cells are genetically modified to attack the cancer and kill it. CAR T-cells are currently used to treat certain haematological cancers.

The first T-cell therapies received marketing authorisation in the USA in 2017 and in Finland in 2019 for the treatment of recurrent acute lymphocytic leukaemia and B-cell lymphoma. Despite the good treatment results, development needs have been identified in CAR T-cell therapies, which is why research related to CAR-T cell therapy is being pursued.

The Blood Service has considerable experience in cell research, in the supply of cord blood and stem cell grafts classified as tissue products, and in the preparation of ATMP cell products classified as medicinal products. The Blood Service also has expertise and the necessary clean rooms for the research and high-quality production of therapeutic cells.

Orion has a solid research infrastructure and has introduced several proprietary drugs to the market in different therapy areas. Orion’s oncology therapy area researches and develops novel proprietary drugs for the treatment of cancer. In recent years, Orion has expanded its research activities to include immuno-oncology therapies.

New possibilities for cancer treatment

The research collaboration is based on new innovations to improve the structure of the CAR T-cell product. Matti Korhonen, Senior Medical Officer, who leads the research at the Blood Service, believes that the collaboration offers a great opportunity to develop new cell therapy products for patient care. According to Oliver Cooper, Ph.D., director of Discovery Sciences at Orion’s R&D, Orion’s drug development expertise will provide the necessary momentum for this project.

"Targeted immunotherapy has opened up entirely new possibilities for the treatment of cancer, and it is important to advance this development in Finland, too. I also believe that as a result of the development work, more and more patients will be able to benefit from this effective treatment," says Matti Korhonen

Project managers Satu Juhila from Orion and Jan Koski from the Blood Service say that the collaboration has got off to a good start: "Both parties are very enthusiastic regarding the opportunities of the collaboration and about advancing the development of cell therapy in Finland. We believe that the collaboration will provide plenty of new opportunities for the development of cell therapy products."

On June 8, 2021 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported the enrollment of the first patient in an open-label, multicenter Phase II clinical study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) (Press release, InflaRx, JUN 8, 2021, View Source [SID1234583715]).

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The Phase II clinical trial is expected to enroll approximately 70 patients at sites in Europe, the U.S. and elsewhere. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.

Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx, said: "We are pleased to initiate the first clinical trial to evaluate vilobelimab in cancer. Scientific data suggest C5a involvement in tumor formation and progression, as well as in immunosuppression. Additionally, there is pre-clinical evidence of synergies between PD-1 and C5a/C5aR inhibitors in inducing anti-tumor responses. Based on this, we believe that vilobelimab has the potential alone and in combination with the PD-1 checkpoint inhibitor pembrolizumab to treat the advanced stages of this potentially deadly skin cancer."

The C5a/C5aR pathway has been implied as a potential driver for tumorigenesis, metastases and avoidance of immune cell destruction, particularly in the context of cSCC.

Several independent pre-clinical studies showed that the combination of a C5a or C5aR pathway inhibitor with inhibition of the PD-1/PD-L1 axis leads to an antitumoral effect, which was stronger than inhibition of one of the axes alone. This provides a pre-clinical rationale for the combined blockade of PD-1 and C5a to restore antitumor immune responses and to inhibit tumor cell growth.

About cutaneous squamous cell carcinoma (cSCC)

cSCC is the second most common form of skin cancer and, if caught early, it is generally curable. In the U.S. alone, according to the Skin Cancer Foundation, an estimated 1.8 million cases are diagnosed each year, which translates to about 205 cases diagnosed every hour. The incidence of cSCC has increased up to 200 percent in the past three decades. Over 15,000 people in the U.S. die each year from this disease. Approximately 5% of patients with cSCC develop locally advanced or metastatic disease. These forms of cSCC have a poor prognosis with low survival rates.

About vilobelimab (IFX-1):

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and COVID-19 pneumonia.

On June 8, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received a special prize at the Platinum Career Award 2021 (Press release, Eisai, JUN 8, 2021, View Source [SID1234583714]). The awards ceremony was held via online at the symposium on June 8, 2021.

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The Platinum Career Award was established in 2019 with the aim of commending companies that aspire to provide opportunities for employees to develop their career and play an active role, in order to realize career paths that Japanese employees are aiming for in the era of the 100 years’ life. (This event was held with sponsorship and planning by Mitsubishi Research Institute, Inc., planning by Mitsubishi UFJ Trust and Banking Corporation, support by the Ministry of Health, Labour and Welfare, Japan, and Tokyo Stock Exchange, Inc., and cooperation from TOYO KEIZAI INC.). Eisai received a special prize dedicated to companies that are implementing "new working styles initiated to adjust with the era of Corona (COVID-19 Pandemic)".

Eisai defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," in the articles of incorporation, which we call our human health care (hhc) philosophy.

Eisai will enhance the development of self-reliant talents, so that each and every employee who sympathize with its corporate philosophy can adapt themselves to any changes and contribute to the creation of new social value through working independently with high motivation. By promoting work and learning style reforms to achieve this goal, Eisai attempts to transition from a company-led career development style to a proactive career development style based on the diversity of values of individual employees and their willingness to take on challenges. In addition, Eisai will work on expanding the range of individual discretion in choosing work locations and working hours, as well as implementing new measures for utilizing IT tools in terms of both hardware and software, such as efficiently providing training opportunities for all employees to independently learn new skills and acquire new working experiences, adopting a special paid leave system that can be used for self-development and social contribution activities, and promoting online dialogue between members inside and outside the organization.

Eisai will make continuous efforts based on the hhc philosophy to further contribute to increasing the benefits of patients and their families around the world.

On June 8, 2021 Compugen Ltd. (Nasdaq: CGEN) a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that updated data from its Phase 1 dose escalation and expansion study of COM701 as a monotherapy, and in a dose escalation combination study with Opdivo (nivolumab) in an oral presentation at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting, being held virtually on June 4-8, 2021 (Press release, Compugen, JUN 8, 2021, View Source [SID1234583713]). COM701 is a first-in-class investigational therapeutic antibody targeting PVRIG, a novel immune checkpoint discovered computationally by Compugen.

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"These new data from our COM701 clinical program are meaningful for two key reasons," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "First, durability data show multiple patients on treatment beyond one year, strengthening our confidence that PVRIG blockade through COM701 may provide meaningful clinical benefit in tumor types typically unresponsive to immune checkpoint inhibitors, including in patients with prior progression on these treatments. Our ongoing confirmed complete response from the combination arm is particularly noteworthy given it was achieved in a patient with anal squamous cell carcinoma with prior progression on Opdivo and is on study treatment now out to 22 months. We believe these results support our hypothesis that dual blockade of PVRIG and PD-1 may be key to driving immune responses in certain patient populations."

Dr. Cohen-Dayag continued, "Second, preliminary biomarker data provide important insights into the mechanism of COM701 immune activation. A trend of increased peripheral immune cell proliferation of CD8+ effector memory T cells and NK-T cells was observed in the monotherapy and combination arms. In addition, increased levels of the key antitumor cytokine IFNγ, observed with increasing doses of COM701, suggest that the demonstrated immune activity is derived from the combination regimen and not the effect of Opdivo alone. Furthermore, our biomarker data suggest that COM701 as monotherapy, and in combination with Opdivo, has the potential to drive durable clinical activity in patients with PD-L1 low, PVRL2 positive tumors. Specifically, data obtained from an archival biopsy of a primary peritoneal cancer patient support this, showing that COM701 monotherapy has the potential to drive tumor shrinkage and increased peripheral proliferation of immune cell subsets and IFNγ secretion in a patient with an immune desert, non-inflamed tumor microenvironment. Together, these clinical and preliminary biomarker results provide an important foundation of data that are supportive of our DNAM axis hypothesis, which we are evaluating comprehensively in the clinic across monotherapy, dual and triple combination studies."

Daniel Vaena M.D., Director of Experimental Therapeutics Program at West Cancer Center Research Institute (Memphis, TN), said, "Although these results are very preliminary, they suggest that targeting PVRIG may extend the benefit of immunotherapy to patient populations and tumor types which are typically unresponsive to existing immunotherapy agents. Achieving durable responses in patients with progression on immune checkpoint inhibitors is encouraging and speaks to the potential of this novel immune checkpoint inhibitor to improve clinical outcomes for patients with significant unmet medical need."

Data highlights with a cut-off of April 15 2021 from the presentation titled, "COM701 with or without nivolumab: Results of an ongoing Phase 1 study of safety, tolerability and preliminary antitumor activity in patients with advanced solid malignancies", presented by Daniel Vaena, M.D., West Cancer Center Research Institute, include:

COM701 and Opdivo combination arm dose escalation:

In 15 evaluable patients, COM701 in combination with Opdivo was well-tolerated with no reported dose-limiting toxicities up to the fifth and final dose cohort of COM701 20 mg/kg and Opdivo 480 mg, both IV Q4 weeks.
The disease control rate (DCR) was 66.7% (N=10) with best responses of complete response (CR) 6.7% (N=1), partial response (PR) 6.7% (N=1) and stable disease (SD) 53.3% (N=8).
Previously reported patient with anal squamous cell carcinoma with confirmed CR remains on treatment at 96 weeks (22 months). This patient had three prior lines of therapy and enrolled within one month after progression on Opdivo monotherapy.
Previously reported patient with renal cell carcinoma with best response of SD remains on treatment at 75 weeks.
A patient with microsatellite stable (MSS)-colorectal cancer with durable confirmed partial response previously reported at AACR (Free AACR Whitepaper) 2020 remained on study treatment for 44 weeks.
COM701 monotherapy arm:

Overall 36 patients enrolled. 16 patients, all comers in dose escalation and 20 patients in dose expansion; four patients of each: endometrial cancer, NSCLC, ovarian cancer, breast cancer and colorectal cancer (MSS).
The disease control rate (DCR) was 47.2% (N=17) with best responses of partial response (PR) 2.7% (N=1) and stable disease (SD) 44.4% (N=16).
Previously reported patient with primary peritoneal cancer (platinum resistant, MSS) with confirmed PR remains on study treatment at 79 weeks (18 months). Patient had three prior lines of standard-of-care treatment.
– Archival pre-treatment biopsy data revealed the patient was PD-L1 negative, with PVRL2 expression on tumor and endothelial cells, with an immune desert phenotype (i.e, no immune cells detected prior to treatment).
– Peripheral blood assessment showed immune activation as measured by immune cell proliferation and IFNγ induction prior to tumor shrinkage.
Demonstrated durable antitumor activity in extensively pretreated population:

Durable responses to treatment (CR, PR or SD ≥ 6 months) in 10/51 (19%) patients.
Best responses of CR, PR, or SD were observed in 11/21 (52%) patients with prior treatment refractory disease.
Best response of CR, PR or SD were observed in 13/18 (72%) patients with prior treatment with immune checkpoint inhibitors.
Preliminary biomarker results demonstrate immune activation with COM701 treatment:

Peripheral pharmacodynamic changes were measured via immune cell proliferation and cytokine levels in peripheral blood before and on treatment.
After one treatment cycle, patients treated with COM701 monotherapy showed a trend of increased proliferation of effector memory CD8+ T cells (average change 87%), an immune cell population that expresses high level of PVRIG and are critical in driving anti-tumor immunity. Similar results were observed in the combination arm.
Proliferation of NK-T cells, an immune cell population that expresses high level of PVRIG and plays a role in antitumor activity, increased significantly one day after COM701 monotherapy treatment, with a similar trend observed in the combination arm.
Levels of IFNγ, a cytokine which plays a key role in antitumor immunity, were upregulated following combination treatment of COM701 with Opdivo, with a dose response trend with increasing doses of COM701, suggesting the observed activity is derived from the combination treatment and not Opdivo alone.
Anti-tumor activity was observed in PD-L1 low, PVRL2 positive patients, suggesting COM701 treatment may drive anti-tumor immunity even in patients with less inflamed tumor microenviroment.
The presentation presented at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting can be found at the Company’s website and is not considered a part of this press release.

On June 8, 2021 CytoSMART Technologies reported the launch of two new fluorescence live-cell imaging systems – the Lux3 FL Duo Kit and the Multi Lux3 FL (Press release, Lifescience Newswire, JUN 8, 2021, View Source [SID1234583712]). The CytoSMART Lux3 FL Duo Kit is a compact and cost-effective imaging system consisting of two fluorescence microscopes, designed for side-by-side comparison of cell cultures. The CytoSMART Multi Lux3 FL fluorescence live-cell imaging system consists of four compact Lux3 FL devices, equipped with two fluorescent (green and red) and one brightfield channel, and designed for long-term comparative studies and larger research teams.

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Both systems operate from within a standard CO2-incubator or hypoxia chamber, allowing to analyze cells in their desired culture environment. Each system of two and four microscopes is connected to a single laptop, maximizing precious laboratory space. Monitoring and analysis of the running experiments can be done at any time from anywhere via the CytoSMART Cloud.

Said Jan-Willem van Bree, CTO at CytoSMART Technologies, "Last year we launched our first fluorescence live-cell imager, the CytoSMART Lux3 FL, and our customers were pleased with its performance and expanded research possibilities. This year we decided to scale up fluorescence live-cell imaging possibilities by launching two new advanced systems: the Lux3 FL Duo Kit and the Multi Lux3 FL. We always aim to develop and offer versatile and flexible solutions to life scientists. For example, the Multi Lux3 FL allows to run up to four individual imaging experiments simultaneously, without affecting the time-lapse imaging experiments of other lab members. This is a very convenient lab equipment for every research group that studies cell viability, co-culture models, single-cell migration, and many other cell-based assays can benefit from it."

The main features and benefits of the CytoSMART fluorescence live-cell imaging systems include:

Ideal for comparative studies – directly compare fluorescently-labeled cell cultures.
Versatile – expand the number of variables you can examine using fluorescent labeling.
Flexible – connect devices to the same laptop and control them individually.
Incubator-friendly – study cells in their desired culture environment.
Full remote access via the CytoSMART Cloud – no need to enter the lab to inspect cell cultures.
Indispensable tool for long-term comparative studies – run up to four experiments simultaneously for days or weeks.
Cost-effective and efficient solution – two or four fluorescence imaging devices connected to one laptop, including unlimited storage and unlimited number of user accounts.
Visit the official CytoSMART website for more information on the CytoSMART Lux3 FL Duo Kit and the CytoSMART Multi Lux3 FL.