On May 6, 2020 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 business highlights and financial results for the first quarter of 2020 (Press release, Cellular Biomedicine Group, MAY 6, 2020, View Source [SID1234557168]).

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!

"We currently have six clinical assets in development. In Q1, China’s National Medical Products Administration (NMPA) accepted our Investigational New Drug (IND) application for B-cell maturation antigen (BCMA) Chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma (MM). Although early in the study, we are guardedly optimistic about the preliminary data of the 19 infused patients with only one patient being observed to have grade 3 cytokine release syndrome (CRS). We are excited to continue the development of this program and believe that our competitive advantages may be partially attributable to our proprietary manufacturing process with reduced vein-to-vein times. We are also conducting an Investigator-Initiated Trial (IIT) on our anti-CD19/CD20 BiCAR-T in non-Hodgkin’s lymphoma (NHL) in China and are seeing promising early data," said Tony (Bizuo) Liu, the Company’s Chief Executive Officer.

Mr. Liu added, "Together with our new Rockville, Maryland facility coming online in the latter part of the year, which will support the early phases of our U.S. clinical trials, and observation of the promising data in our China study, we are taking small steps to explore feasibility of a U.S. clinical trial for anti-CD19/CD20 BiCAR-T for non-Hodgkin’s lymphoma (NHL) as well as the tumor infiltrating lymphocytes (TIL) clinical trial for Non-Small-Cell Lung Cancer (NSCLC).

"Regarding our regenerative medicine program, with the COVID-19 outbreak tapering off in China, we have resumed patients’ enrollment for our knee osteoarthritis (KOA) Phase II allogenic (off the shelf AlloJoin) stem-cell clinical trial and are in the process of preparing for the Phase II autologous (ReJoin) trial as well.

"We are continuing to execute our vision to build a global platform of cutting-edge process development and incisive translational medicine, delivering innovative cell therapies to patients via personalized bespoke manufacturing processes. These transformative capabilities can bring not only fast vein-to-vein delivery but also safe and effective drugs to patients suffering with cancer and degenerative diseases. And amid the COVID-19 pandemic, we are pleased to have secured facilities to bolster our balance sheet to fund our clinical development."

First Quarter 2020 and Other Recent Corporate Developments

− Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma

• National Medical Products Administration of China (NMPA) accepted our IND application for Phase I clinical trial;

• 19 patients have been infused under investigator-initiated studies; 17 patients have evaluable data for clinical efficacy with only one grade 3 CRS observed;

− Anti-CD19/CD20 Bi-Specific CAR-T for Non-Hodgkin’s Lymphoma

• 4 patients have been infused under investigator-initiated studies; 3 patients have evaluable data for clinical efficacy;

− On April 30, 2020, we received approval for CNY 30 million line of credit (approximately USD $4.2 million).

First Quarter 2020 Financial Results

− Cash Position: Cash, cash equivalents and restricted cash of March 31, 2020 were $21.6 million, compared to $15.4 million as of December 31, 2019;

− Research & Development Expenses: R&D expenses were $7.8 million for the first quarter of 2020, compared to $6.0 million for the first quarter of 2019;

− General & Administrative Expenses: G&A expenses were $3.4 million for the first quarter of 2020, compared to $3.4 million for the first quarter of 2019;

− Net loss was $11.5 million for the first quarter of 2020, compared to $9.3 million for the first quarter of 2019;

− Executed a bridge loan of $16 million.

On May 6, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) the results of a phase 3 study in China. The ORIENT-12 trial of TYVYT (sintilimab injection) in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy in first-line advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) met the predefined primary endpoint of progression-free survival (PFS) (Press release, ImmunoGen, MAY 6, 2020, View Source [SID1234557167]). This is the first randomized, double-blind phase 3 study evaluating the combination of anti-PD-1 antibody with Gemzar and platinum chemotherapy in the world.

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!

TYVYT in combination with gemcitabine and platinum chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with gemcitabine and platinum chemotherapy, meeting the pre-defined endpoint. The safety profile of TYVYT in this trial was consistent with previously reported studies, and no new safety signals were identified. Relevant data will be presented at an upcoming medical conference.

Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) of China in the near future.

"Lung cancer is the leading cause of cancer death (25.2%), of which NSCLC accounts for 80-85 percent, with about 35 percent of those patients having the squamous subtype. In the past 20 years, drug development to treat NSCLC has been mainly focused on nonsquamous NSCLC, while drug development of sqNSCLC has been slower due to its lack of driving mutation and its unique epidemiological, histopathological and molecular characteristics," Professor Caicun Zhou, Head of Department of Oncology, Shanghai Pulmonary Hospital. "The emergence of the anti-PD-1 antibody has brought a new treatment modality for patients with sqNSCLC. We are delighted to see that TYVYT in combination with gemcitabine and platinum chemotherapy has met the predefined primary endpoint in the ORIENT-12 study. Different from the KEYNOTE-407 study in a different chemotherapy regimen, ORIENT-12 has demonstrated for the first time significant PFS benefit with a PD-1 inhibitor in combination with gemcitabine and platinum in first-line sqNSCLC."

"Sintilimab is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL). It was officially approved by the NMPA in 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent. "Currently, we have several phase 3 randomized clinical trials ongoing in lung cancer. With the encouraging result of ORIENT-12 we are hopeful that sintilimab has the potential to benefit more patients with squamous NSCLC. For Innovent, this is the second randomized study of NSCLC that met its primary endpoint; the first was ORIENT-11, a randomized Phase 3 study of 1L non-squamous NSCLC (NCT03607539)."

"The Center for Drug Evaluation, NMPA just recently accepted a new drug application for sintilimab in combination with pemetrexed and platinum chemotherapy as first-line treatment for nonsquamous NSCLC. The promising results we see in the ORIENT-12 study demonstrate sintilimab’s potential in sqNSCLC," said Dr. Li Wang, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center. "We would like to express our gratitude to the patients and their families, investigators and clinical trial sites participating in the study, and to our colleagues from Innovent. We look forward to bringing this new treatment option to lung cancer patients in China."

About the ORIENT-12 Trial

ORIENT-12 is a randomized, double-blind, Phase 3 study to evaluate the efficacy and safety of TYVYT (sintilimab injection) or placebo in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy as first-line therapy for locally advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT03629925). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The secondary endpoints include overall survival (OS) and safety profile.

A total of 357 subjects have been enrolled in ORIENT-12 trial and randomized in a 1:1 ratio to receive either TYVYT (sintilimab injection) 200mg or placebo in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy every 3 weeks for 4 – 6 cycles, followed by either TYVYT (sintilimab injection) or placebo maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About sqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, resulting in patients having little to no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 35 percent of NSCLC in China are squamous subtype. Squamous NSCLC lacks a driver mutation, and response rate of first-line chemotherapy is approximately 30 percent. So far pembrolizumab in combination with carboplatin and paclitaxel is the only regimen with PD-1 antibody approved by FDA and NMPA for first-line sqNSCLC. There remains still a huge unmet medical need.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

On May 6, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming RBC Capital Markets Global Healthcare Virtual Conference (Press release, ImmunoGen, MAY 6, 2020, View Source [SID1234557166]). The presentation is scheduled for May 19, 2020 at 10:20am ET.

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!

A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website on www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On May 6, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it will provide an overview of the Company at 3:40 p.m. EDT on Wednesday, May 13, at the BofA Securities Health Care Conference 2020 (Press release, Puma Biotechnology, MAY 6, 2020, View Source [SID1234557165]). The conference will be held in a virtual meeting format.

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!

A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On May 6, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported a $390 million Series D financing round (Press release, Grail, MAY 6, 2020, View Source [SID1234557164]). New investors including Public Sector Pension Investment Board (PSP Investments) and Canada Pension Plan Investment Board (CPP Investments), as well as two undisclosed investors, joined existing backers including Illumina, Inc. in this round of funding.

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!

"GRAIL is making significant progress with our blood-based, multi-cancer early detection test," said Hans Bishop, Chief Executive Officer at GRAIL. "Nearly 80 percent of cancer deaths result from cancers for which there is no screening test today, and GRAIL’s mission is to change that through the early detection and localization of more than 50 cancers. Enabling this through a single blood draw could improve patient access and adherence to cancer screening and address disparities in cancer care by improving access for rural, vulnerable, and under-served populations. We are delighted that such a high-quality group of investors share our vision and recognize the public health benefits of our technology."

The Series D funding adds to the company’s balance sheet and will support continued development and commercialization of GRAIL’s multi-cancer early detection blood test. Since early 2016, GRAIL has raised more than $1.9 billion in four rounds of equity financing to pursue reducing cancer mortality worldwide through multi-cancer early detection.

About GRAIL’s Multi-Cancer Early Detection Test

GRAIL’s multi-cancer early detection test is designed to detect cancers in early stages, when the chance of survival is higher than if cancer is detected after symptoms appear. Clinical data have shown the ability of this technology to detect more than 50 cancer types with a very low false positive rate of less than one percent. GRAIL’s test was designed to minimize false positives in order to limit associated harms, including patient anxiety and unnecessary diagnostic workups. When a cancer signal is detected, the test has been able to identify where in the body the cancer is located with high accuracy, an important step to guiding diagnostic next steps and care.

GRAIL’s methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL believes its sequencing database of cancer and non-cancer methylation signatures is the largest of its kind.