On May 9, 2020 Cinda Biopharmaceutical (Hong Kong Stock Exchange: 01801), an innovative drug dedicated to the development, production and sale of major diseases such as cancer, autoimmunity, metabolic diseases, etc. The biopharmaceutical company, and Eli Lilly (NYSE: LLY) reported : A randomized, innovative, and innovative PD-1 inhibitor Daboshu (Sindilimumab Injection) jointly developed by the two parties (Press release, Innovent Biologics, MAY 9, 2020, View Source [SID1234557375]). Double-blind, phase III controlled clinical study (ORIENT-12)-Daboshu (sindilimumab injection, hereinafter referred to as sinidiumab) combined with Gemcitabine (gemcitabine for injection, hereinafter referred to as gemcitabine) Platinum-based chemotherapy is used in the first-line treatment of advanced or metastatic squamous non-small cell lung cancer (NSCLC) to reach the primary study endpoint. This is the world ’s first randomized, double-blind, phase III clinical study evaluating PD-1 antibody combined with Gemcitabine (gemcitabine) and platinum for first-line treatment of squamous NSCLC.

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Studies have shown that Sindilimum combined with gemcitabine and platinum compared with placebo combined with gemcitabine and platinum, significantly prolonged progression-free survival (PFS), reached the preset study endpoint, PFS significantly benefited, safety characteristics and previous reports The research results of xindilimumab were consistent and there was no new safety signal. Detailed research results will be announced in subsequent academic conferences.

Cinda and Eli Lilly plan to communicate with the Drug Evaluation Center (CDE) of the State Drug Administration on the submission of a new indication for the application of cindilimumab combined with gemcitabine and platinum for first-line treatment of squamous NSCLC.

Professor Zhou Caicun, director of the Department of Oncology, Shanghai Pulmonary Hospital, said: "Lung cancer accounts for the first cause (25.2%) of all cancer deaths, of which NSCLC accounts for approximately 80% to 85%. About 35% of NSCLC are squamous NSCLC. Over the past two decades, the development of drugs for the treatment of NSCLC has mainly focused on non-squamous NSCLC. Due to the lack of driver genes and special tumor biological characteristics, drug development has been slow. The emergence of anti-PD-1 antibodies is This type of patient brings a new treatment. We see that the study of Sindilimum reached the preset primary study end point. The ORIENT-12 study compared with the KEYNOTE-407 study of pabolizumab Using different combination chemotherapy regimens, it is the first randomized controlled study in the world to confirm that PD-1 antibody combined with gemcitabine and platinum can significantly improve the benefit of progression-free survival in patients with first-line squamous NSCLC. "

Dr. Hui Zhou, Vice President of the Medical Science and Strategic Oncology Department of Cinda Biopharmaceutical Group, said: "Currently Cindylimumab is the only anti-PD-1 monoclonal antibody drug listed in the National Medical Insurance List. It was awarded the National Drug Administration in 2018 Approved by the Administration for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line chemotherapy. We are currently conducting a number of phase III randomized controlled studies on Sindrinimab. ORIENT-12 The results of the study are encouraging, and we foresee the potential of Sindilimumab to benefit more lung cancer patients. This is also the main study of Cinda Biological following ORIENT-11 (first-line non-squamous NSCLC randomized, double-blind, phase III study, NCT03607539) After the end point, the second successful randomized controlled study of lung cancer. "

Dr. Li Wang, senior vice president of Eli Lilly China and head of the Center for Drug Development and Medical Affairs, said, "Not long ago, the Drug Evaluation Center (CDE) of the State Drug Administration accepted Cindilimum for non-squamous non-small The application of new indications for first-line treatment of cell lung cancer (nsqNSCLC). And the exciting research results of ORIENT-12 have reflected the potential of Sindilimumab in the treatment of squamous non-small cell lung cancer. Here we think Thanks to all the patients and their families, researchers and clinical trial centers, and Cinda colleagues who participated in the study. We look forward to bringing this new treatment to lung cancer patients in China as soon as possible. "

About ORIENT-12 research

The ORIENT-12 study is a randomized evaluation of the efficacy and safety of Daboshu (sintilimab) or placebo in combination with Gemcitabine (gemcitabine) and platinum for first-line treatment of advanced or metastatic squamous NSCLC , Double-blind, Phase III controlled clinical study (ClinicalTrials.gov, NCT03629925). The primary study endpoint was progression-free survival (PFS) assessed by the Independent Imaging Review Committee (IRRC) according to the RECIST v1.1 standard. Secondary study endpoints include overall survival (OS) and safety.

A total of 357 subjects were enrolled in this study. They were randomized 1: 1 and received Daboshu (Sintilimab injection) 200 mg or placebo in combination with Gemcitabine (gemcitabine for injection) and platinum Treatment, given once every 3 weeks, after completing 4 or 6 cycles of combination therapy, enter Daboshu (sindilimumab injection) or placebo for maintenance therapy until disease progression, toxicity intolerance or other Circumstances where treatment needs to be terminated. After the disease progresses in the control group, it can be conditionally crossed to monotherapy of daboshu (sintilimab injection).

About squamous non-small cell lung cancer (sqNSCLC)

Lung cancer is the first malignant tumor in China that ranks first in both morbidity and mortality. NSCLC accounts for about 80% to 85% of all lung cancers, and about 70% of NSCLC patients are diagnosed as locally advanced or metastatic tumors that are not suitable for radical surgery. At the same time, a considerable proportion of early-stage NSCLC patients undergoing surgery will have recurrence or distant metastasis, and then die due to disease progression. About 35% of Chinese patients with NSCLC are squamous NSCLC. Squamous NSCLC lacks driver genes, and the effectiveness of first-line chemotherapy is about 30%. At present, only paclizumab combined with carboplatin and paclitaxel has been approved by the FDA and the National Drug Administration (NMPA) for this population. Treatment is still limited, and there are huge unmet medical needs.

About Daboshu (Sintilimab Injection)

Daboshu (Sintilimab Injection) is an innovative biopharmaceutical of international quality jointly developed by Cinda Biopharma and Eli Lilly in China. The first indication for its approval is relapsed / refractory classic Hodgkin’s lymphoma, which was included in the 2019 edition of the Chinese Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines. In April 2020, the National Drug Administration (NMPA) formally accepted the application for indications for the first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC) with dabershu (sintilimab injection). In the medical insurance country talks in 2019, Dabex (Sintilimab Injection) is the only PD-1 inhibitor that enters the National Health Insurance.

Dabshu (Sindilimumab Injection) is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking tumor immune tolerance The PD-1 / Programmed Death Receptor Ligand 1 (Programmed Death-Ligand 1, PD-L1) pathway reactivates the anti-tumor activity of lymphocytes to achieve the purpose of treating tumors. There are currently more than twenty clinical studies (of which more than 10 are registered clinical trials) are underway to explore the anti-tumor effect of sundilimumab on other solid tumors. Cinda Biotech is also conducting clinical research work on Cindylimumab injections worldwide.

On May 9, 2020 Avalon GloboCare Corp. (NASDAQ: AVCO), a clinical-stage global developer of cell-based technologies and therapeutics, reported that it has achieved significant milestones, advancing its next generation immune cell therapy using FLASH-CAR technology co-developed with the Company’s strategic partner Arbele Limited (Press release, Avalon, MAY 9, 2020, View Source [SID1234609546]). The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patient’s own cells, as well as off-the-shelf cell therapy from a universal donor.
Currently available Chimeric Antigen Receptor T (CAR-T) cellular immunotherapy involves a patient’s own T-cells—a type of white blood cell that protects against infections and other diseases including cancer—that are turned into personalized cancer fighting cells. The T-cells are removed from the patient, reprogrammed in the lab using a viral vector to target cancer cells, and infused back into the patient as a cancer immunotherapy.

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In contrast to these existing therapies, Avalon’s FLASH-CAR uses next generation CAR technology to modify patients’ T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector. Similar to T-cells, NK cells are a type of white blood cell, also able to attack cancer cells, but utilize different mechanisms. By using RNA molecules rather than a viral vector, Avalon’s RNA-based CAR technology is designed to rapidly create personalized CAR therapies in 1 to 2 days compared to the 10- to 14-day bio-manufacturing time necessary to generate currently available CAR-T cellular immunotherapy. Avalon’s FLASH-CAR technology is also designed to reprogram the immune cells to hone in on multiple crucial cancer cell targets, called tumor antigens, to potentially achieve superior therapeutic effect. Avoiding the use of viral vectors and complicated bio-processing procedures significantly reduces manufacturing costs, resulting in a more affordable and potentially breakthrough therapy for cancer patients. The FLASH-CAR technology can also be used to generate "off-the-shelf", universal cell therapy that has the potential to reach even more patients.

Avalon’s first FLASH-CAR platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells. Pre-clinical research on AVA-011, including tumor cytotoxicity studies, has been successfully completed and Avalon is immediately entering the process development stage to generate clinical-grade CAR-T and CAR-NK cells for use in human clinical trials. Avalon and Arbele have jointly filed for USPTO provisional and PCT patents for this RNA-based CAR platform cellular therapy and for other applications.

Avalon expects to begin a first-in-human clinical trial with AVA-011 for the treatment of relapsed or refractory B-cell lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma in the first quarter of 2021. The goal is to use AVA-011 as a bridge to bone marrow stem cell transplant therapy, currently the only curative approach for patients with these blood cancers.

"Avalon GloboCare is committed to decreasing the time it takes to deliver cellular immunotherapies to cancer patients, as well as lowering the cost of manufacturing by building on our unique RNA-based CAR platform that does not require using a viral vector," stated David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. "We are accelerating our innovative discovery and development plan, as well as delivering precise clinical execution and leadership in cellular immunotherapy. Our pre-clinical studies are encouraging and we are excited for AVA-011 to enter the clinical development stage, including multi-center clinical trials following completion of process development to generate the cell therapy," said Dr. Jin.

"Through this strategic partnership with Avalon GloboCare, we envision an accelerated scientific and clinical development of the RNA-based FLASH-CAR technology platform with great potential to generate "off-the-shelf" immune effector cell therapies to treat both hematologic and solid malignancies," said John Luk, Ph.D., EMBA, President and Chief Executive Officer of Arbele Limited.

On May 8, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number 6691054) entitled "Combined Preparations for the Treatment of Cancer" by the Japanese Patent Office (Press release, Immutep, MAY 8, 2020, View Source [SID1234557346]).

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This Japanese patent follows the grant of the corresponding European and Australian patents (announced 23 May 2019 and 21 June 2019, respectively) and protects Immutep’s intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a chemotherapy agent. The chemotherapy agent is oxaliplatin, carboplatin, or topotecan.

The new patent highlights the broad potential of efti as an immunostimulant and provides patent protection in Japan for a range of novel and highly relevant chemo-immunotherapies featuring efti that may be pursued in the future.

The patent expiry date is 19 December 2034.

On May 8, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that President Rajiv Malik and Chief Financial Officer Ken Parks will present at the BofA Securities Virtual Health Care Conference 2020 on Thursday, May 14, 2020 at 3:40 p.m. ET (Press release, Mylan, MAY 8, 2020, View Source [SID1234557433]).

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Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

On May 8, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2020 (Press release, Synlogic, MAY 8, 2020, View Source [SID1234557347]).

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"In the first quarter, we continued to advance our programs and enhance our Synthetic Biotic platform capabilities in synthetic biology, manufacturing and development. While the coronavirus pandemic necessitated we update a number of our development plans, I am very grateful to our dedicated employees who have enabled us to continue to execute on our strategy under challenging circumstances," said Aoife Brennan, M.B., Ch.B., Synlogic’s president and chief executive officer. "We look forward to showcasing our deep platform capabilities and expanding program portfolio at our upcoming virtual R&D event on May 27th, which will include more details on one of our newest and rapidly advancing programs in enteric hyperoxaluria."

2020 Priorities

Pipeline

Initiation of a Phase 2 clinical trial to evaluate a solid formulation of SYNB1618 in patients with phenylketonuria (PKU). SYNB1618 is an orally administered Synthetic Biotic medicine that is being developed as a treatment for PKU.
Synlogic intends to continue to work with sites to complete preparatory work, however as a result of the coronavirus pandemic it does not expect to be able to enroll subjects into its Phase 2 clinical trial of SYNB1618 until it is safe for patients to enter clinical trial sites.
The Phase 2 trial is designed to evaluate safety and tolerability of a solid formulation of SYNB1618 as well as its potential to lower blood phenylalanine levels in PKU patients. In addition, the study is expected to provide valuable information to validate predictive pharmacodynamic and preclinical modeling.
Evaluation of data from the monotherapy arm of the Phase 1 clinical study of SYNB1891 in patients with advanced solid tumors or lymphoma. SYNB1891 is an intra-tumorally administered Synthetic Biotic medicine engineered to produce cyclic di-AMP, an agonist of the STING pathway, that is designed to serve as a dual innate activator of the immune system as a potential treatment for solid tumors or lymphoma. SYNB1891 is being evaluated as a monotherapy in an ongoing Phase 1 open-label, multicenter, dose escalation clinical trial (NCT04167137) in patients with advanced solid tumors or lymphoma.
While this clinical trial and most clinical sites have remained open and enrolled patients have continued on study, Synlogic expects slower enrollment of new patients as a result of the coronavirus pandemic, which has the potential to impact the availability of data in 2020.
Continued development of patient and commercialization-appropriate drug presentations of SYNB1618.
Synlogic has developed and manufactured a solid formulation of its Synthetic Biotic SYNB1618 that it plans to use in future clinical trials and continues to evaluate and develop different drug presentations (e.g. capsule, pressed pill, sachet) for eventual commercialization.
Advancement of new Synthetic Biotic programs in metabolic diseases with high unmet medical need.
Synlogic is conducting preclinical studies of Synthetic Biotic medicines to treat enteric hyperoxaluria, an acquired metabolic disorder in which patients develop recurrent kidney stones due to elevated urinary oxalate levels and are at an increased risk of kidney failure. Synlogic expects to move a clinical candidate in its enteric hyperoxaluria program, into IND-enabling studies in 2020.
In addition, Synlogic is also developing Synthetic Biotic medicines for the treatment of other metabolic diseases, including maple syrup urine disease (MSUD), a rare inherited metabolic disease caused by defective enzymes that metabolize branched chain amino acids (BCAAs) which are components of protein.
Publication and presentation of data demonstrating the breadth and potential of its Synthetic Biotic platform.
On March 8th, Nature Communications published a Perspective authored by Synlogic scientists entitled, "Developing a new class of engineered live bacterial therapeutics to treat human diseases." The paper, which highlights the considerations for the design and development of engineered live bacteria, including Synthetic Biotic medicines, is available on the Synlogic website on the Presentations and Publications page of the Investors and Media section.
On May 27th, 2020 Synlogic will host its first virtual R&D event
The webcast event will highlight the Company’s progress in developing its platform capabilities and pipeline of rare metabolic disease programs for internal prosecution and programs in immunomodulation for potential partnering. Dr. David Goldfarb, Professor of Medicine and Physiology at NYU School of Medicine, Clinical Chief of the Nephrology Division at NYU Langone Health, and Chief of the Nephrology Section and Director of the Hemodialysis Unit at the New York VA Medical Center in Manhattan will also present an overview of enteric hyperoxaluria. A link to the live webcast will be available on Synlogic’s website on the News & Events page of the Investors and Media section.
First Quarter 2020 Financial Results
As of March 31, 2020, Synlogic had cash, cash equivalents, and short-term investments of $114.2 million.

For the three months ended March 31, 2020, Synlogic reported a consolidated net loss of $15.8 million, or $0.46 per share, compared to a net loss of $12.9 million, or $0.51 per share, for the corresponding period in 2019.

Research and development expenses were $12.7 million for the three months ended March 31, 2020 compared to $10.4 million for the corresponding period in 2019. The increase in expenses was primarily due to use of synthetic biology services provided under Synlogic’s collaboration with Ginkgo and increased clinical activities associated with the SYNB1618 bridging study and the SYNB1891 Phase 1 clinical trial.

General and administrative expenses for the three months ended March 31, 2020 were $3.8 million compared to $3.7 million for the corresponding period in 2019.

Revenue was $0.1 million for the three months ended March 31, 2020 compared to $0.3 million for the three months ended March 31, 2019. Revenue is associated with services performed under the Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 8:00 a.m. ET today, Friday, May 8, 2020. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 6869043. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.