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): March 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 presentation that Cellular Biomedicine Group, Inc. (the “Company”) expects to use in connection with its presentations to certain potential investors in the Company at the Regenmed Investor Day conference held in New York, NY on March 25, 2015.

Item 8.01. Other Events.

On March 25, 2015, the Company issued a press release announcing interim 24-week results from the Company’s Phase IIb trial for its ReJoin™ human adipose-derived mesenchymal progenitor cell therapy for knee osteoarthritis. A copy of the press release is attached hereto as Exhibit 99.2.

On the same day, the Company issued a press release announcing results from the Company’s Phase I trial for certain of its CAR-T cancer immunotherapy programs. A copy of the press release is attached hereto as Exhibit 99.3.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1 Presentation

99.2 Press Release, dated March 25, 2015

99.3 Press Release, dated March 25, 2015

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: March 25, 2015	By:	/s/ Bizuo (Tony) Liu
		Bizuo (Tony) Liu Chief Financial Officer

Exhibit 99.1

Exhibit 99.2

Cellular Biomedicine Group Announces Interim Results from Phase IIb Clinical Trial for Knee Osteoarthritis Stem Cell ReJoinTMTherapy

SHANGHAI, China and PALO ALTO, Calif., March 25, 2015 /GlobeNewswire/ -- Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced interim 24-week clinical data from the Phase IIb trial of its ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA). The data will be discussed by Dr. Wei (William) Cao, PhD, BM, Chief Executive Officer of Cellular Biomedicine Group at the 2015 Annual Regen Med Investor Day at the Metropolitan Club in New York City.

Dr. Cao commented, “We are very pleased to see that the KOA IIb interim data has confirmed observations from the Phase IIa trial and change in WOMAC scores in the ReJoinTM treatment arm, the primary endpoint of the Phase IIb trial, to be significantly higher than the randomized control therapy group. We remain optimistic about the efficacy of ReJoinTM treatment for KOA. With 57 million KOA patients in China, this treatment represents an opportunity to improve the quality of life for a meaningful number of patients.”

ReJoinTM Phase IIb 24-week Data Analysis

The 24-week interim data shows the primary and secondary endpoints of ReJoinTM therapy group have all improved significantly compared to their baseline, which has confirmed our Phase IIa report (view report here), although only the change (47.12%) of WOMAC, the primary endpoint, is significantly higher than that of the ARTZÒ control group (16.32%) (p=0.017). A trend of improvement of the secondary endpoints, including cartilage MRI quantification, is observable at the 24th week. The Company expects the final results to be available at the end of 2015.

About the Clinical Trial

The Phase IIb clinical research trial for KOA, registered with the U.S. National Institutes of Health (NIH) under the number NCT02162693 (click here to view), is led by Shanghai Renji Hospital, one of the largest teaching hospitals in China. The multi-center study enrolled 53 patients with knee osteoarthritis (Kellgren-Lawrence Grading Scale: grade II-III) to participate in a randomized, single blind trial.

The primary endpoints for the Phase IIb trial of ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) therapy for KOA were safety and knee-related pain, stiffness and function measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire. The secondary endpoints were patient safety and cartilage repair during the 24 weeks post-cell therapy, defined through changes of both knee joints’ cartilage volume measured with 3D SPGR quantitative magnetic resonance imaging (MRI) and read with a semi-automated segmentation method (ITK-SNAP) by three independent blind researchers, two of whom came from two independent third party institutes. In addition, Visual Analogue Scale Score (VAS), Short Form 36 and Lequesne Index of Severity for OA (ISOA) index scores were employed to assess knee pain, quality of life and joint function.

Further details of the clinical data may be viewed in the Company’s most recent presentation filed on Form 8-K with the SEC, which can be found on the Company’s website at the following link, http://cellbiomedgroup.com/investor-relations/investment-overview/ under SEC filings or presentations.

About Cellular Biomedicine Group

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight 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, but are not limited to, risk factors inherent in doing business. 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 Announces Phase I Results from CAR-T Immuno-Oncology Clinical Development Programs

SHANGHAI, China and PALO ALTO, Calif., March 25, 2015 /GlobeNewswire/ -- Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced clinical data from its CAR-T immuno-oncology clinical development programs. The data will be discussed by Dr. Wei (William) Cao, PhD, BM, Chief Executive Officer of Cellular Biomedicine Group, at the 2015 Annual Regen Med Investor Day on March 25 in New York City.

Dr. Cao commented, “We are very pleased with the efficacy and toxicity profile of our CAR-T technology, given the advanced stage of the cancer patients in the trials. With over 3.5 million new cancer patients diagnosed every year in China, developing safer and more effective cancer immunotherapy programs with leading hospitals will serve urgent unmet medical needs. We look forward to additional progress in advancing our CAR-T cell pipeline with further clinical development of our CD19, CD20, CD30 and EGFR-HER1 constructs”.

About the Trials

The CAR-T trials were designed and conducted by Chinese PLA General Hospital (“PLAGH”, Beijing, also known as “301 Hospital”), led by Principal Investigator Wei Dong Han, MD, PhD, head of PLAGH’s cancer immunotherapy department. They studied genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to available therapeutics. The studies recruited male and female subjects with CD19+ and CD20+ B cell malignancies with no available curative treatment options (such as autologous or allogeneic SCT) that had limited prognosis (several months to < 2 year survival) with currently available therapies.

CAR-T CD19 for Acute Lymphocytic Leukemia (B-cell ALL) Data Analysis

Nine adult patients with relapsed or chemotherapy-refractory B-cell lineage acute lymphocytic leukemia (B-cell ALL) were enrolled in this CAR-CD19 T cell therapy 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 71.5% (five out of seven patients) in the six CD19 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. Two of the nine patients with extramedullary lesions received allogeneic CAR-CD19 T cell therapy (CBM-C19.a1) and had converted mixed to complete donor chimerism at the onset of graft-versus-host disease (GVHD). One of those patients eventually died of GVHD, but the other gradually reached a complete hematologic remission and a partial regression of her extramedullary leukemic lesions. There were two Grade 2-3 toxicities and GVHD Grade 4 toxicities.

This study is registered at www.clinicaltrials.gov as NCT01864889.

CAR-T CD20 for Advanced Diffuse Large B Cell Lymphoma (DLBCL) Data Analysis

The Company also summarized the results of a Phase I clinical trial on CAR-CD20 T cell therapy (CBM-C20.1), which enrolled seven patients with chemotherapy refractory advanced diffuse large B cell lymphomas (DLBCL). One of the two patients with no bulky tumors achieved a 14-month durable and ongoing complete remission by cell infusion only, and another achieved a 6-month tumor regression achieving a complete response (CR) rate of 50% (one out of two patients) and an overall response rate (ORR) of 100% (two out of two patients). Of those patients with bulky tumor burden, four of five patients were evaluable for clinical efficacy. Of those four patients, three achieved three to six month tumor regression for an overall response rate (ORR) of 75% (three out of four patients).

Delayed toxicities related to CAR-CD20 cell infusion are directly correlated to tumor burden, and mainly included, but were not limited to, curable cytokine release symptoms and tumor lysis symptoms, and these results were achieved by combining de-bulking conditioning regimens in advanced DLBCL patients with bulky tumors. Overall there were three Grade 2-3 toxicities and one Grade 4 toxicity.

This study is registered at www.clinicaltrials.gov as NCT01735604. Publication source: Effective response and delayed toxicities of refractory advanced diffuse large B-cell lymphoma treated by CD20-directed chimeric antigen receptor-modified T cells. Clin Immunol. 2014 Dec;155(2):160-75. doi: 10.1016/j.clim.2014.10.002. Epub 2014 Oct 16.

Further details of the clinical data may be viewed in the Company’s most recent presentation filed on Form 8k with the SEC, which can be found on the Company’s website at the following link, http://cellbiomedgroup.com/investor-relations/investment-overview/ under SEC filings or presentations.

The Company expects to release Phase I clinical data in the third quarter of 2015 from its clinical studies of the CAR-T constructs targeting CD30-positive Hodgkin’s lymphoma and EGFR-HER1-positive advanced lung cancer.

About Cellular Biomedicine Group

Forward-Looking Statements