On June 17, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported that it has initiated its Phase I Clinical Trial of anti-CD20 Chimeric Antigen Receptor T-cell ("CAR-T") targeting anti-CD19 treated, relapsed diffuse large B-cell lymphoma ("DLBCL") and small B-cell lymphoma patients in China, and dosed the first CD19 CAR-T relapsed DLBCL patient (Press release, Cellular Biomedicine Group, JUN 17, 2019, View Source [SID1234537107]).

"DLBCL is a very aggressive form of lymphoma that advances quickly in both men and women. Based on our research and development, we believe CD20 is a promising target for CD19 CAR-T relapsed and small B-cell lymphoma patients who currently have no viable treatment options," said Tony (Bizuo) Liu, Chief Executive Officer of the Company. "This CD20 CAR-T therapy is one of the multiple assets that CBMG is advancing amongst our oncology-hematology pipeline, which includes anti-BCMA CAR-T targeting relapsed and refractory Multiple Myeloma ("MM"). We continue to enroll MM patients in our anti-BCMA clinical trial."

"We intend to initiate the Alpha Fetoprotein T-cell Receptor ("AFP-TCR-T") program and recruit Hepatocellular Carcinoma patients as soon as practicable. As previously announced, we plan to conduct the next generation Tumor Infiltrating Lymphocytes (TIL) for the treatment of non-small cell lung cancer (NSCLC) and other solid tumor indications clinical trials in both the U.S. and in China. Our goal is to provide expeditious, safe and effective therapies to cancer patients who currently have limited treatment options," concluded Mr. Liu.

About the Phase I CD20 CAR-T Clinical Study
This Phase I interventional clinical study, conducted in leading clinical centers in China will enroll 12 patients initially to evaluate the safety and efficacy of Anti-CD20 CAR-T therapy.

About Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse Large B-Cell Lymphoma (DLBCL) is the most common form of Non-Hodgkin Lymphoma (NHL) with DLBCL representing approximately 30% of newly diagnosed NHL cases in the United States and an even higher percentage of newly diagnosed NHL cases in China. DLBCL is an aggressive form of lymphoma that advances quickly and occurs in both men and women although slightly more common in men. The incidence of DLBCL increases with age with most patients over the age of 60. The current treatment options include chemotherapy, anti-CD19 targeted therapy, radiation and stem cell transplantation. However, for patients with refractory DLBCL (failed to respond to treatment) the dismal clinical response rates of 20%-30% with median overall survival of approximately 6 months represents a significant unmet medical need.

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On June 17, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the clinical results of CT103A, the potential best-in-class therapy of fully-human BCMA CAR-T co-developed by Innovent and Nanjing IASO Biotherapeutics (IASO BIO), was presented by oral presentation and poster at two of the most prestigious clinical meetings in the worlds of hematology and oncology, the 24th Congress of the European Hematological Society (EHA) (Free EHA Whitepaper) [Abstract #S827; Saturday, June 15, 12:35 PM – 12:45 PM CEST] and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago Illinois [Abstract #8013; Tuesday, June 4, CDT] (Press release, Innovent Biologics, JUN 17, 2019, View Source [SID1234537123]). The IIT study was conducted at Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology.

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CT103A is an anti-BCMA CAR-T co-developed by Innovent and IASO BIO for the treatment of Relapsed/Refractory Multiple Myeloma (RRMM). The data of CT103A presented at both conferences show an impressive efficacy results, persistence and safety profile and an objective response rate (ORR) of 100%. The data are especially encouraging for patients who relapsed from a prior CAR-T treatment with mouse-based antibody, thus providing a viable option for this group of tough-to-treat patients.

Multiple myeloma is a malignant hematologic cancer with abnormal proliferation of clonal plasma cells, which has no medical cure so far. In many countries, myeloma is the second most common blood cancer. The American Cancer Society estimates that in the United States (U.S.), about 32,110 new cases will be diagnosed this year. In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018. Among them, 40 percent of patients are diagnosed with moderate or high-risk multiple myeloma, and their median survival is less than five years.

As of the data cutoff (22 May 2019), the objective response rate (ORR) was 100% (CR-64%, VGPR-36%) with strong persistence and high expansion of the CAR-T in-vivo. All patients (100%) experienced CRS. The onset of CRS occurred within 2-5 days (median-2.6) and resolved within 14 days. Mostly grade 1 and 2, at the lowest dosage levels, CRS was routinely managed with Tocilizumab and steroids. Interestingly, the 11 patient study included 4 patients having previously relapsed from a prior CAR-T therapy, a murine anti-BCMA CAR-T.

"RRMM is associated with a poor prognosis," said Dr. Chunrui Li of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. "Many patients who receive CAR-T treatments have had their disease recurrence, and with a non-human scFv, re-treatment may not be an option due to immunogenicity. With a fully-human BCMA scFv, CT103A provides an effective option for these patients. This data suggests they should not be excluded from the benefit of future trials."

About RRMM

For newly treated patients with multiple myeloma, the common first-line treatment drugs include proteasome inhibitors, immunoregulatory drugs and alkane agents. For most patients, the commonly used first-line treatment can stabilize the patient’s condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled. Relapse patients are patients who have reappeared after complete remission of the disease. Refractory patients are patients with primary drug resistance or the patients who have finished with first-line treatment do not achieve remission, or the patients whose disease progress within 60 days after achieving minimal response. For the majority of patients with effective treatment, they will inevitably enter the stage of relapse and refractory after 3-5 years of disease stabilization. For these patients, the overall effective rate of existing second-line treatment is about 40% to 70%, with short remission time.

About CT103A
CT103A is an innovative therapy co-developed by IASO BIO and Innovent. Previous studies indicate patients with RRMM who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully-human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent.

About Nanjing IASO Biotherapeutics

Founded in 2017, IASO BIO is a clinical stage biotechnology company advancing the development of innovative therapies for cancer. IASO BIO stands out in fierce competition through innovation, a world class facility, and an internationally renowned clinical research team. IASO BIO is dedicated to curing cancer using engineered autologous/allogenic T cell therapies designed to enhance the immune system’s ability to recognize and eradicate cancer cells. Currently, IASO BIO is developing over 10 high-potential high-end biopharmaceutical products, targeting hematological tumors, solid tumors and virus associated tumors. For more information, please visit： www.iasobio.com.

On June 17, 2019 2019 BioNTech SE, a biotechnology company focused on the clinical development of patient-specific immunotherapy for the treatment of cancer and other serious diseases, reported the launch of DuoBody PD-L1x4-1BB product candidate clinical development (Press release, BioNTech, JUN 17, 2019, View Source [SID1234539089]). PD-L1x4-1BB is a bi-specific antibody developed in collaboration with Genmab A / S. The Phase I / IIa trial will test the bi-specific antibody in patients with metastatic or surgically non-removable solid tumors that can not be treated with standard care. The DuoBody PD-L1x4-1BB is the first co-developed product candidate to reach the clinical phase. The costs and profits of the partnership are shared 50 to 50 times.

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"The launch of the Phase I / IIa clinical trial with a product candidate that was developed in just four years confirms our highly productive partnership with Genmab," said Prof. Dr. med. Ugur Sahin, CEO of BioNTech . "The dual-immunostimulatory mechanism of action of the DuoBody PD-L1x4-1BB can address a variety of cancers, as well as providing an additional level of treatment options in our cancer therapy portfolio. We also strengthen BioNTech’s strategy of using new targets and mechanisms to unlock the full potential of the immune system for cancer immunotherapy. "

The DuoBody PD-L1x4-1BB is a novel bi-specific antibody that combines the checkpoint blockade of the inhibitory PD-1: PD-L1 signaling axis with the conditional stimulation of T cells by activating the 4-1BB receptor and thereby increase the proliferation of activated T cells for the efficient control of cancer cells. The original idea and the concept of combining the two mechanisms are based on scientific studies conducted by BioNTech. The unblinded study with the DuoBody PD-L1x4-1BB (ClinicalTrials.gov Identification Number NCT03917381) is carried out at several sites and consists of two parts: a dose-escalation study (Phase I, First-in-Human) and a dose-expansion study (Phase IIa). Primary endpoints include, above all, safety assessment, including the review of dose-limiting toxicity and adverse events.

On June 17, 2019 Boehringer Ingelheim and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors (Press release, Boehringer Ingelheim, JUN 17, 2019, View Source [SID1234537108]). The Phase 1 study is a dose finding study of BI 765063, a myeloid checkpoint inhibitor, administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor.

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"We are very pleased with the progress achieved on BI 765063’s program and having the first patient dosed marks a significant milestone in the product’s development. The advancement of a myeloid cell checkpoint blocking monoclonal antibody into the clinic exemplifies Boehringer Ingelheim’s commitment to the next wave of innovation in cancer immunology therapies, with the goal of meaningfully improving outcomes for patients with difficult-to-treat cancers," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim.

"We are excited to begin first-in-human testing with this novel SIRPα-targeting compound, which we believe has first-in-class potential in the treatment of solid tumors," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics. "This marks one of many anticipated milestones in the collaboration agreement with our partner Boehringer Ingelheim, and we look forward to advancing rapidly this potentially transformative treatment through the clinic. Milestones such as this one for the novel compounds our R&D teams develop have provided OSE with a stable financial base to grow steadily our first-in-class immuno-oncology pipeline."

The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063. Under the terms of the collaboration and license agreement, the clinical trial authorization obtained in March 2019 and dosing of the first patient in this Phase 1 trial triggers milestone payments of a total of €15 million to OSE Immunotherapeutics from Boehringer Ingelheim. This trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumours.

ABOUT BI 765063 (formerly OSE-172)
BI 765063 is a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPα. BI 765063 prevents the SIRPα ligand CD47, from binding to SIRPα thereby preventing cellular signalling that can reduce the anti-tumorigenic properties of myeloid cells such as macrophages and dendritic cells. In March 2019, OSE Immunotherapeutics received Clinical Trial Authorization for a Phase 1 study by two health agencies (France and Belgium) to evaluate BI 765063 in patients with advanced solid tumors. The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063, originally signed in April 2018.

On June 17, 2019 Candel Therapeutics (a.k.a. Advantagene, Inc.) reported that it has completed enrollment of the "ULYSSES" trial, a Phase 2 study of ProstAtak for prostate cancer patients choosing Active Surveillance (PrTK04- NCT02768363) (Press release, Candel Therapeutics, JUN 17, 2019, View Source [SID1234537124]). Enrollment is still open for prostate cancer patients choosing radiation therapy as their primary treatment (PrTK03- NCT01436968). ProstAtak is Gene Mediated Cytotoxic Immunotherapy (GMCI – aglatimagene besadenovec (AdV-tk) plus oral valacyclovir) for treatment of prostate cancer. GMCI is an "off the shelf", low-toxicity immunotherapy that stimulates a patient’s own immune system to generate a robust and precise response against their cancer.

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In the USA, about 175,000 men are diagnosed with localized prostate cancer each year. Approximately one third of these patients choose Active Surveillance (AS), a strategy to monitor rather than radically treat their disease. If the disease progresses, radical surgery or radiation are still options. AS is chosen primarily to avoid or postpone the significant risk of urinary incontinence and sexual dysfunction often associated with radical treatments. The number of patients on AS has been steadily increasing over the past 5 years.

The ULYSSES study enrolled 190 patients at 22 clinical sites. The size of the study was expanded from an originally planned 156 patients due to investigator and patient demand. The primary endpoint for the trial is change in tumor-risk markers such as tumor grade and extent of disease. Other endpoints of interest include time to radical treatment and safety. Topline data is expected late next year.

"Men with low-risk prostate cancer benefit from active surveillance but a significant proportion have cancer progression and ultimately require surgery or radiation therapy," said Dr. Scott Eggener, Professor of Surgery and Radiology and Director of the Prostate Cancer Program at University of Chicago and a lead investigator in the Ulysses study. "It would be very exciting if there was an easily delivered and safe intervention that significantly lowers the likelihood of these men ever requiring surgery or radiation."

Candel is also conducting PrTK03, a registration trial with ProstAtak for the treatment of intermediate-high risk localized prostate cancer patients undergoing radiation under a Special Protocol Assessment approved by the U.S. Food and Drug Administration. If proven efficacious, ProstAtak will be the first and only therapeutic pharmaceutical available for newly diagnosed prostate cancer. The company is conducting additional GMCI clinical studies in pancreas, lung, and brain cancers with impressive clinical results to date.

"We are thrilled with the progress of the Ulysses study," stated Dr. Estuardo Aguilar-Cordova, Chief Executive Officer of Candel, "we are grateful to the patients and doctors that are participating and are very hopeful that their efforts will result in better outcomes for future cancer patients. With side effects similar to those of a flu shot, ProstAtak could one day become a first-line ‘Pro-Active Surveillance’ option for the thousands of men diagnosed with low-risk prostate cancer every year."