Current Report Filing (8-k)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 25, 2015

CELLULAR BIOMEDICINE GROUP, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-36498		86-1032927
(State or other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

530 University Avenue, #17 Palo Alto, California		94301
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (650) 566-5064

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

Attached as Exhibit 99.1 to this Current Report is the form of poster session that Cellular Biomedicine Group, Inc. (the “Company”) used in connection with its presentations relating to the Company’s Phase I clinical trial on Chimeric Antigen Receptor-Modified T Cells for the immunotherapy of patients with Her-1 expressing advanced relapsed/refractory Non-Small Cell Lung Cancer (“NSCLC”), to certain potential investors in the Company at the European Cancer Congress 2015 held in Vienna, Austria from September 25-29, 2015.

Attached as Exhibit 99.4 to this Current Report is the form of presentation that Cellular Biomedicine Group, Inc. (the “Company”) used in connection with its presentations to certain potential investors in the Company at the 5th World Congress on Cancer Therapy in Atlanta, Georgia on September 28, 2015.

Item 8.01. Other Events.

On September 28, 2015, the Company issued a press release announcing Phase I clinical data from its Chimeric Antigen Receptor-Modified T-Cells (“CAR-T”) immunotherapy “(CBM-EGFR.1”) for the treatment of patients with EGFR expressing advanced relapsed/refractory NSCLC. A copy of the press release is attached hereto as Exhibit 99.2.

Also on September 28, 2015, the Company issued a press release to respond to inquiries from investors and the scientific community about its Immuno-Oncology cell therapy platform as it relates to information surrounding its CD19, CD20 and CD30 technologies. A copy of the press release is attached hereto as Exhibit 99.3.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description

99.1		Poster Session for the European Cancer Congress 2015

99.2		Press Release, dated September 28, 2015

99.3		Press Release, dated September 28, 2015

99.4		Presentation

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Cellular Biomedicine Group, Inc.

Date: September 28, 2015	By:	/s/ William Cao
		William Cao
		Chief Executive Officer

Exhibit 99.1

Exhibit 99.2

Cellular Biomedicine Group Announces Positive Results from CAR-T EGFR Immunotherapy in Advanced Relapsed/Refractory Patients with Solid Tumors

SHANGHAI, China and PALO ALTO, Calif., September 28, 2015 /GlobeNewswire/ -- Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced results from an expanded Phase I/II clinical trial evaluating the safety, feasibility and anti-tumor activity of its Chimeric Antigen Receptor-Modified T-Cells (CAR-T) immunotherapy (CBM-EGFR.1) targeting wild type EGFR (Epidermal Growth Factor Receptor) for the treatment of patients with EGFR expressing advanced relapsed/refractory solid tumors. Based on the results from 24 patients treated with CBM-EGFR.1 (17 patients with non-small cell lung cancer (NSCLC), 5 patients with cholangiocarcinoma, 1 patient with pancreatic cancer and 1 patient with renal cell carcinoma (RCC)), the early results showed that CBM-EGFR.1 immunotherapy was safe, well tolerated, and had positive signal of clinical activity in several indications. The data was selected for a late-breaking oral presentation entitled EGFR-Targeted Chimeric Antigen Receptor-Modified T Cells Immunotherapy for Patients With EGFR-Expressing Advanced or Relapsed/Refractory Solid Tumors at the 5th World Congress on Cancer Therapy in Atlanta, Georgia on September 28, 2015. The abstract can be viewed online here. The results from the first 11 NSCLC patients in the trial outlined in the abstract, entitled Chimeric Antigen Receptor-Modified T-Cells for the Immunotherapy of Patients with HER-1 Expressing Advanced Relapsed/Refractory Non-Small Cell Lung Cancer was presented at the 2015 European Cancer Congress’ (ECCO) annual meeting held in Vienna, Austria from September 25-29, 2015. The abstract can be viewed online here.

About the Trial

The CBM-EGFR.1 phase I/II trial was designed and conducted by Chinese PLA General Hospital (“PLAGH”, Beijing, also known as “301 Hospital”), led by Principal Investigator Wei Dong Han, M.D., Ph.D., head of the cancer immunotherapy department and director of molecular immunology department of the life science institute of PLAGH. The trial enrolled 24 EGFR positive (defined as at least 50% membrane staining of EGFR based on immunohistochemistry), advanced, relapsed/refractory patients with NSCLC, cholangiocarcinoma, RCC or pancreatic cancer. Most of the NSCLC patients failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment. All patients provided written informed consent before enrollment, and received dose escalating infusions of CBM-EGFR.1 cells with or without conditioning chemotherapy. Autologous CBM-EGFR.1 cells were generated from 50 to 80 ml peripheral blood after a 10 to 12-day in vitro expansion, and the total CAR-expressing T cell number of 1×106/kg was set as an output control. The presence of EGFR positive cells in tumor tissues was evaluated by means of immunohistochemistry (IHC). Serum cytokines such as IL-6, IL-2, TNF-a, copy numbers of CAR-EGFR.1 transgene in peripheral blood and biopsied tissues, were monitored periodically according to assigned protocol. Clinical responses were evaluated using RECIST 1.1 and adverse events were graded by CTCAE 4.0.

This study is registered with the U.S. National Institute of Health (NIH) here.

Highlight of Phase I/II clinical trial for CBMG CAR-T products in multiple advanced, refractory/relapsing solid tumors

●	First known report of positive safety and signal of clinical activity of EGFR CAR-T in multiple solid tumor indications

●	Most NSCLC patients treated with CBM-EGFR.1 failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment

●	Overall disease control rate (DCR) is 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17)

●	Objective response rate (ORR) of 25% in combined indications: 2 complete response (CR) and 1 partial response (PR) in cholangiocarcinoma, 2 PR in NSCLC and 1 PR in pancreatic cancer

The clinical responses were evaluated with RECIST1.1 and immune-related response criteria by a team of experts, and adverse events were graded with CTCAE 4.0. Of the 24 patients with evaluable clinical outcome, the overall DCR was 79% (19 of 24). Under standard protocol, an independent review of the clinical data by a separate team of experts will commence at the end of the trial. Of the 5 cholangiocarcinoma patients reported here, 2 achieved CR, 1 achieved PR, and 2 had stable disease (SD). The single pancreatic cancer patient had a PR and a single RCC patient achieved SD. Of the 17 NSCLC patients treated, 2 had PR, 10 had SD, and 5 had progressive disease. Of the 26 adverse events experienced by patients, only 1 was grade 3-4 where the patient experienced serum lipase increase. No patients experienced drug related deaths. Grade 1-2 pruritus was the most frequent adverse event experienced by patients (9/26; 35%). Desquamation and constipation are the other two frequently observed adverse events in the trial (4/26 each; 15%). Only 3 out of 24 patients exhibited Grade 2 cytokine release syndrome within one week post infusions. The median dose of transfused CBM-EGFR.1 cells was 1.18×107 cells/kg (IQR, 0.76 to 1.43×107 cells/kg). The transgene copies measured by PCR in both blood and biopsy tissues post CBM-EGFR.1 infusions indicated the trafficking of CART cells into the tumor tissues. Pathological eradication of EGFR positive tumor cells after CBM-EGFR.1 treatment was observed in tumor biopsies, along with clear evidence of the CBM-EGFR.1 cells detected in tumor-infiltrating T cells in all patients with available tumor biopsies post treatment.

Yihong Yao, Ph.D., Chief Scientific Officer of the Company commented, “The early signal of clinical activity, especially those observed in patients with late stage cholangiocarcinoma, and those with late stage NSCLC that failed prior EGFR-TKI therapy, are very encouraging. To our knowledge this is the first report of positive safety and tolerability data of EGFR CAR-T in multiple solid tumor indications. We are moving forward to confirm the safety and tolerability profile of CBM-EGFR.1 in cholangiocarcinoma and NSCLC, and will actively explore the opportunities in other solid tumor indications by implementing state-of-the-art translational medicine strategy in the clinical development. We are determined to look for early possibilities of conducting multi-center Phase IIb trials to validate the clinical activity from early observations. We have also begun to evaluate potential partners to develop an immunohistochemistry based diagnostic assay to aid in the patient selection whenever needed. We are optimistic that CBM-EGFR.1 will be able to provide late stage cancer patients with another option to extend their lives.”

The Company also previously announced positive clinical data results for its Phase I clinical trials for CBM-CD19.1, CBM-CD20.1 and CBM-CD30.1 CAR-T assets targeting late-stage hematological cancer. Clinical trial data for all three constructs can be found registered with the U.S. National Institute of Health (NIH) here: NCT01864889, NCT01735604, NCT02259556.

“We are extremely excited by the recent developments resulting from the collaboration between CBMG and PLA General Hospital. These two reports on CBM-EGFR.1 therapy for late stage solid tumors have clearly demonstrated our ability to innovate, advance boundaries between basic research and translational medicine and streamline the manufacture of CAR-T and clinical treatment. We are confident and determined to be at the forefront of clinical development of these breakthrough CAR-T therapies for late stage cancer patients with solid tumors,” concluded Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group.

About Cellular Biomedicine Group

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility in China, consisting of six independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com

Forward-Looking Statements

Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

Contacts:

Sarah Kelly

Director of Corporate Communications, CBMG

+1 650 566-5064

sarah.kelly@cellbiomedgroup.com

Vivian Chen

Managing Director Investor Relations, Grayling

+1 347 481-3711

vivian.chen@grayling.com

Exhibit 99.3

Cellular Biomedicine Group Responds to Inquiries from Investors and the Scientific Community About Its Immuno-Oncology Cell Therapy Platform

Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group commented, “We are taking a proactive approach to addressing inquiries from the investment and scientific community on the Company’s Immuno-Oncology cell therapy platform on a more real-time basis. This area has been well followed and we would like to take this opportunity to expand on frequently asked questions and dispel misinformation in the marketplace. We will continue to keep our stakeholders apprised of ongoing business and pipeline developments.”

Can CBMG clarify what constructs were a part of the acquisition from PLA General Hospital’s (“PLAGH”) Chimeric Antigen Receptor T cell (CAR-T) therapy and was CART-33 a part of this acquisition?

As the Company had previously announced on February 9, 2015, the recombinant expression vectors CD-19, CD-20, CD-30 and Human Epidermal Growth Factor Receptor’s (EGFR or HER1) were the only constructs acquired in addition to its respective patent applications and Phase I clinical data. At no time has CBMG acquired CART-33, which is a classification of which the Company is unaware. Details related to the acquisition and the respective constructs can be found in the Company’s Form 8-Ks filed February 9, 2015, March 25, 2015, May 26, 2015; the Form 10-K filed March 31, 2015; and the Form 10-Qs filed on May 15 and August 13, 2015. Any statement made otherwise is simply false.

In order for the community to better benchmark CBMG’s data relative to its competitors, can the Company clarify CBMG’s lead drug as it relates to patients enrolled with chemotherapy refractory advanced diffuse large B cell lymphomas (DLBCL) and the respective indications of each construct?

Different from other clinical trials that have been published, CBMG’s lead drug candidate is CD-20 CART and not CD-19 CART for DLBCL. At this time we would like to reiterate that the clinical trial data presented for CD-19 CART was for B-cell Lineage Acute Lymphoblastic Leukemia (B-cell ALL); CD20 CART was for Advanced Diffuse Large B Cell Lymphoma (DLBCL) and CD30 CART was for Hodgkin’s lymphoma. It is important to note here that comparing clinical outcomes from two different drugs that target two different tumor antigens could be misleading if the detailed background of the trials are not provided. Clinical trial data for all three constructs can be found registered with the U.S. National Institute of Health (NIH) at the following links: NCT01864889, NCT01735604, NCT02259556.

What is the accurate overall response rate (ORR) for CD-19 CART?

As we had previously announced on March 25, 2015, nine adult patients with relapsed or chemotherapy-refractory B-cell lineage acute lymphoblastic leukemia (B-ALL) were enrolled in this CAR-CD19 T cell therapy trial. Different from other competitive trials, pediatric patients were not enrolled as part of this trial. Results showed a complete response (CR) rate of 22.2% (two out of nine patients) and a partial response (PR) rate of 44.4% (four out of nine patients) for an overall response rate (ORR) of 66.7% (six out of nine patients). Further subgroup analysis showed an overall response rate (ORR) of 71.4% (five out of seven patients) in the six CD-19 patients with extramedullary involvement and one patient with no extramedullary lesions and treated with autologous CAR-CD19 T cell therapy. In the six CD19 patients with extramedullary leukemia involvement or bulky adenopathy, an overall response rate (ORR) of 66.7% (four out of six patients) was achieved. It should be noted that 2 out of the 9 patients were infused with allogeneic CD-19 CART. When comparing clinical trial results that were carried out with autologous CART only, the patients infused with allogeneic CART should be excluded to allow meaningful comparison.

Can the Company clarify the overall response rate (ORR) for its CD-20 CART and CD-30 CART?

As the Company had previously reported on March 25, 2015, the results for CAR-CD20 T cell therapy trial showed an overall response rate (ORR) of 83% with five of six patients with evaluable clinical efficacy achieving complete response (CR) or partial response (PR). The Company had also previously reported on May 22, 2015, the results for CAR-CD30 T cell therapy trial showed overall response rate (ORR) of 71% with five of seven patients achieving CR or partial response PR.

Can the Company explain which vector was used in the genetic modification of patients’ T cells with anti-CD19 CAR and anti-CD20 CAR?

The transduction method utilized in the genetic modification of patients’ T cells is in fact the lentiviral vector transduction method. The Company made an error in the filing with clinicaltrials.gov and will rectify the situation immediately.

What is the next major clinical milestone for CBMG?

The Company will present CAR-T Phase I/II clinical trial data for Non Small Cell Lung Cancer (NSCLC) and Cholangiocarcinoma (CC or CCA) at the 5th World Congress on Cancer Therapy on September 28 in Atlanta, Georgia.