On June 10, 2020 Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR bispecific technology platform, and Alligator Bioscience AB (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that new preclinical data for ALG.APV-527 are being presented at the PEGS Virtual Interactive Global Summit, on June 10, 2020 in an oral presentation entitled, "ALG.APV-527: Tumor-directed T-cell stimulation, in vivo tumor regression, and safety studies of a 4-1BB x 5T4 ADAPTIR bispecific antibody (Press release, Alligator Bioscience, JUN 10, 2020, View Source [SID1234560960])."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our latest preclinical data for ALG.APV-527 looks very encouraging and shows that ALG.APV-527 may overcome many of the limitations observed with other 4-1BB monoclonal antibody therapeutics by improving the biodistribution, efficacy and potential safety of this novel class of immunotherapies," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "Since ALG.APV-527 localizes at the tumor site, immune activation depends on binding with 5T4 tumor antigen to activate via 4-1BB, therefore limiting systemic activation seen with other 4-1BB agonists. Most interestingly, our latest preclinical data show the potential for a favorable safety profile for ALG.-APV-527. In a head-to-head comparison with a urelumab analogue in preclinical studies, ALG.APV-527 did not induce systemic T-cell activity at high doses, a key differentiator from other 4-1BB therapies."

ALG.APV-527 is a novel immunotherapeutic bispecific candidate intended for the treatment of multiple solid tumors expressing 5T4, a tumor-restricted antigen. 5T4 is an antigen that is highly expressed in a large percentage of solid tumors, including, non-small cell lung cancer (NSCLC), head and neck cancer and mesothelioma. ALG.APV-527 is designed to activate anti-tumor responses by inducing signaling through the co-stimulatory receptor 4-1BB (CD137), which is an immune receptor that is upregulated on activated T cells and natural killer (NK) cells.

The preclinical data presented at the PEGS Virtual Interactive Global Summit show that ALG.APV-527 may overcome many of the limitations of competitor 4-1BB antibodies as it selectively enhances the function of activated T cells and NK cells in the presence of the tumor antigen 5T4, as shown in vitro, and potently rejects tumors in an in vivo animal model.

In a high-dose toxicity human 4-1BB knock-in murine study comparing ALG.APV-527 with a urelumab analogue, ALG.APV-527 was well tolerated at high doses with no evidence of systemic T-cell activation and no impact on body or spleen weight, whereas the urelumab analogue induced weight loss, systemic activation of T cells, and signs of ulcerative dermatitis.

In summary, the data presented at PEGS demonstrate that ALG.APV-527:

Enhances CD8+ T cell and NK function and proliferation upon 5T4-mediated engagement
Accumulates at 5T4-positive tumors in preclinical models
In an in vivo human 4-1BB knock-in model:
Induces rejection of established bladder cancer cells at low doses
Induces anti-tumor immunological memory responses
Does not induce systemic T-cell activation at high doses, which were observed in a side-by side comparison with a urelumab analogue

Is well tolerated after repeated dosing in a GLP toxicology study and displays an antibody-like half-life with a mean half-life of 8 days
"Our data supports that ALG.APV-527 has the potential to induce a strong anti-tumor immune response without systemic toxicity, which is exactly what we hoped to see," commented Christina Furebring, Ph.D., Vice President Projects at Alligator.

About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo’s ADAPTIR bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD human scFv library. The ALG.APV-527 bispecific antibody consists of two moieties, one moiety activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other moiety binding to the 5T4 protein displayed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.

On June 10, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company that covers full-cycle cancer care, reported that it has entered into a strategic partnership agreement with Thermo Fisher Scientific ("Thermo Fisher") (Press release, Genetron Health Technologies, JUN 10, 2020, View Source [SID1234560978]). With plans to build on the sequencer Genetron S5 (Registration Number 20193220820), the partnership aims to enhance innovation, commercialization and promotion of next-generation sequencing (NGS) platforms in the field of molecular cancer diagnosis in China’s public hospitals.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The partnership will introduce the Company’s medium-throughput NGS system Genetron S5 to public hospitals across China, promoting the application and development of Genetron S5 in more fields, such as reproductive health, genetic disease, pathological microorganism testing, and other independent clinical lab testing and scientific research.

"Genetron Health is committed to leading and empowering the cancer diagnostics and treatment industry," said Wang Sizhen, Co-Founder and CEO of Genetron Health. "We have been working with Thermo Fisher, one of our world-class partners, to create open, flexible, convenient and accurate molecular diagnostic products, and to offer a comprehensive one-stop solution. Our products and solutions are designed to empower medical institutions continuously improve their diagnostic and treatment capabilities, bringing more accurate and speedy services to the public."

" Thermo Fisher’s memorandum of understanding with Genetron in this field will help further our companies’ work together to develop IVD solutions for the fast-growing Chinese market," said Tony Acciarito, president of Thermo Fisher Scientific China "We look forward to generating significant customer value and promoting precision medicine to improve public health throughout China."

Genetron Health has received National Medical Products Administration (NMPA) approval for clinical application of seven IVD products, which cover three major technology platforms: the NGS, dPCR and qPCR. The NGS platform, in particular, provides flexible combinations of products with low, medium and high-throughput. Genetron Health also offers overall R&D and commercialization solutions for in vitro diagnostic technologies available on multiple technology platforms and in various application scenarios, by fully exploring and tapping into the unique strength of each technology platform.

About Genetron S5

Genetron S5 platform approved by NMPA on November 1, 2019, is a medium-throughput NGS system that enables simple targeted sequencing workflows at an affordable price, without compromising on performance or reliability. Genetron S5 platform offers several throughput options, which provide the flexibility to scale from small to large projects, enabling multiple targeted sequencing applications on a single system. Based on the design, Genetron S5 is particularly suitable for hospitals as it offers more practical solutions and greater scalability.

On June 10, 2020 Celyad SA (Euronext & Nasdaq: CYAD), clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported the launch of its corporate rebranding, including changing its name to Celyad Oncology (Press release, Celyad, JUN 10, 2020, View Source [SID1234560961]). The new name highlights the Company’s significant progress with its next-generation CAR T programs and emphasizes its commitment to cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the rebranding, the Company also introduced a new logo and launched a new corporate website, www.celyad.com. The Company’s common stock will continue trading on the Euronext and Nasdaq Global Market exchanges under the ticker symbol "CYAD".

"Our rebranding under Celyad Oncology more accurately reflects our team’s expertise in developing innovative cell therapies against cancer," said Filippo Petti, CEO of Celyad Oncology. "As we embark on this next chapter, we look forward to our continued evolution as we strive to shape the future of our off-the-shelf and personalized CAR T cell therapies for cancer patients with unmet medical needs. In addition, today’s announcement offers us the opportunity to reiterate our strong position in the field of oncology and increased strategic focus in our allogeneic CAR T franchise on the heels of our recent update at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference, which featured our non-gene edited allogeneic candidates and technology platforms."

On June 10, 2020 bioAffinity Technologies, a privately held biotech company, reported its test validation trial for CyPath Lung resulted in specificity of 88% and sensitivity of 82%, similar to far more invasive procedures commonly used to diagnose lung cancer (Press release, BioAffinity Technologies, JUN 10, 2020, View Source [SID1234560979]). Overall accuracy of CyPath Lung was 87%.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It is important to note that our clinical trial compared two very similar and therefore difficult to distinguish cohorts – those at high risk with and without cancer – in contrast to the trials of some other lung cancer diagnostics that compare healthy individuals to cancer patients," said bioAffinity President and Chief Executive Officer Maria Zannes. "In an earlier study using our porphyrin marker to label sputum on microscope slides, we saw 100% accuracy in distinguishing sputum from healthy patients from those diagnosed with lung cancer. While impressive, the true test of a lung cancer diagnostic is its ability to distinguish those at high risk with and without cancer, which CyPath Lung has shown it can do. We are extremely pleased with our trial results."

CyPath Lung is a flow cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home, a particular benefit during the COVID-19 pandemic. The sample is shipped overnight to the laboratory for processing. Sample data is acquired by flow cytometry, a technique that can count, sort and profile individual cells with remarkable speed. Using an automated analysis with pre-set parameters, CyPath Lung profiles the lung environment including the presence of cancer-associated cells. Data acquisition and physician reports can be generated in minutes.

"We successfully tested our automated analysis program and found it to be fast and very robust in predicting what is cancer and what is high risk," Zannes said. "Physician reports can be generated immediately after flow cytometry acquires sample data in approximately 20 minutes per sample. Looking beyond lung cancer, we believe our automated platform can be successfully applied to cancer diagnostic tests for several other cancers, which will improve overall survival rates for patients through early diagnosis and treatment."

CyPath Lung’s automated flow cytometry analysis reveals four distinct predictors that distinguish the sputum collected from high-risk individuals from samples collected from patients with lung cancer. The Company’s proprietary porphyrin compound preferentially binds to cancer and cancer-related cells. Confirming results of an earlier clinical trial, the test validation trial found cells labeled by the porphyrin molecule are a significant predictor in the test’s automated analysis for lung cancer.

"CyPath Lung reveals the lung environment by profiling cell populations in sputum, meaning that the test analyzes whole cells and cell populations to find predictors of lung cancer in a sample that comes directly from the lung," explained Executive Vice President and Chief Medical and Science Officer Vivienne Rebel, MD, PhD. "Our technology has advantages over genomic approaches to diagnosing earlier stage lung cancers that search for circulating tumor cells or cell fragments in a much more dilutive blood sample."

The test validation trial compared sputum samples collected from individuals at high risk for lung cancer with sputum samples collected from lung cancer patients. Individuals at high risk for lung cancer have smoked the equivalent of one pack of cigarettes a day for 30 years or more, have not quit smoking in the past 15 years and are 55-80 years of age. Trial participants who had lung cancer collected their sputum sample prior to tissue biopsy that confirmed the cancer diagnosis. Trial results are based on analysis of 150 samples, including samples from 122 high-risk individuals and 28 people diagnosed with lung cancer.

The U.S. Preventive Services Task Force recommends that smokers and former smokers at high risk for lung cancer undergo annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be more successfully treated. The National Lung Cancer Screening Trial (NLCST) of more than 53,000 participants resulted in a 20% decrease in lung cancer–specific mortality when LDCT screening is performed in high-risk patients. However, screening by LDCT had a low 3.8% positive predictive value (PPV) which raises the risk of unnecessary, invasive, and costly procedures for those who test positive. In the NLCST, for every 100 people who received a positive LDCT, less than four of those individuals actually had lung cancer.

In the CyPath Lung validation trial, the non-invasive test showed a positive predictive value (PPV) of 62% and a 95% negative predictive value (NPV). Using CyPath Lung after a positive LDCT screen has the potential to significantly improve PPV compared to LDCT alone in the high-risk population. Early diagnosis of lung cancer followed by treatment can significantly increase survival. Studies have shown early diagnosis of lung cancer can increase the 10-year survival rate of the disease to 88% from the present overall 5-year survival rate of 19%.

"CyPath Lung proves to be a highly accurate test for the early detection of lung cancer," Zannes said. "Our test for lung cancer has high specificity and sensitivity, in contrast to other tests that claim high sensitivity and very low specificity, or vice versa."

CyPath Lung has been licensed by Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, TX. Precision Pathology Services anticipates certification and sale of CyPath Lung in 2020 as a Laboratory Developed Test (LDT). Following its certification as an LDT, physicians will order CyPath Lung for their patients at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.

On June 10, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody (Press release, Curis, JUN 10, 2020, View Source [SID1234560962]). Curis plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The clearance of our IND is an important step for the advancement of VISTA therapies, as CI-8993 becomes the first anti-VISTA antibody in development to enter clinical testing," said James Dentzer, President and Chief Executive Officer of Curis. "When activated, VISTA plays a critical role in suppressing T cell activity. Conversely, it has been shown in preclinical studies that blocking VISTA reduces the suppression of T cells and reactivates anti-tumor immune function. We are eager to leverage our extensive experience with VISTA and pioneer this first-in-class anti-VISTA antibody program."

Certain cancers, such as mesothelioma, triple negative breast cancer, non-small cell lung cancer, and gynecologic malignancies, are known to be highly driven by VISTA. These cancers may be amenable to monotherapy treatment with anti-VISTA therapy.

In other cancers, anti-VISTA therapy may be more effective as part of a combination approach. VISTA is independent of, and complementary to, other immune checkpoints, including PD1 and CTLA4. Published studies have shown that VISTA expression increases up to 5-fold as a compensatory mechanism following anti-CTLA4 or anti-PD1 treatment. Further preclinical studies have explored this relationship more deeply and support the potential of combining anti-VISTA therapy with anti-PD1 or anti-CTLA4 therapies.

The multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors will evaluate approximately 50 patients, with the goal of identifying a recommended dose and schedule. Curis expects to initiate this study in the second half of 2020.

About VISTA

VISTA is a novel negative checkpoint ligand that is homologous to PD-1/PD-L1 and suppresses T cell activation. VISTA relieves negative regulation by hematopoietic cells and enhances protective anti-tumor immunity, and is highly expressed on myeloid cells and T cells. Preclinically, VISTA monoclonal antibody treatment increased the number of tumor-specific T cells in the periphery, and enhanced the infiltration, proliferation and effector function of tumor-reactive T cells within the tumor microenvironment (TME). VISTA blockade alters the suppressive feature of the TME by decreasing the presence of monocytic myeloid-derived suppressor cells and increasing the presence of activated dendritic cells (DCs) within the TME leading to enhanced T cell mediated immunity. VISTA monoclonal antibody administration as a monotherapy has been shown to suppress the growth of both transplantable and inducible melanoma in preclinical models. Previous studies have demonstrated that VISTA blockade may be synergistic with peptide-based cancer vaccines to impair the growth of established tumors.