IMUC EOM Pharmaceutical Holdings Inc (PK)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): June 12, 2015

 

 

IMMUNOCELLULAR THERAPEUTICS, LTD.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		001-35560		93-1301885
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S. Employer Identification No.)

23622 Calabasas Road, Suite 300

Calabasas, California 91302

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (818) 264-2300

 

 

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 (see General Instruction A.2. below):

 

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

 

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

 

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

 

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

 

 

 

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Item 1.01.

Entry into a Material Definitive Agreement.

On June 12, 2015, ImmunoCellular Therapeutics, Ltd. (the “Company”) entered into a Services Agreement (the “Agreement”) with PCT, LLC, a Caladrius Company (“PCT”), a subsidiary of Caladrius Biosciences, Inc.

Pursuant to the terms of the Agreement, PCT will provide current good manufacturing practice (“cGMP”) services for the Phase III manufacture of ICT-107 and Phase II manufacture of ICT-121. PCT will provide, among other things, a controlled environment room on a semi-dedicated basis and qualified personnel to conduct runs as the parties mutually agree in writing and schedule. PCT’s facilities are registered with the U.S. Food and Drug Administration (the “FDA”) for testing; packaging; processing; storage; labeling and distribution of Peripheral Blood stem and Somatic Cell therapy products, and maintain cGMP-compliant quality systems.

The Company has agreed to pay monthly fees in connection with the use of a controlled environment room on a semi-dedicated basis and monthly fees for PCT personnel performing services under the Agreement.

Services to be performed under the Agreement terminate on the earlier of (i) December 31, 2018, (ii) the date the parties mutually agree, (iii) at any time following the earlier of the one year anniversary of the date on which the Company notifies PCT that services in the semi-dedicated controlled environment room are to commence and August 1, 2016, on the last day of the month following at least 120 days’ written notice from the Company to PCT, or (iv) the last day of the month following at least 60 days’ written notice from the Company to PCT that the Company has received a clinical hold issued by the FDA ordering the Company to suspend clinical trials for ICT-107. Either party may terminate the Agreement in the event of the other party’s insolvency or for the other party’s material breach of its obligations under the Agreement if such breach remains uncured after 30 days of receiving written notice of such breach.

The foregoing is only a summary description of the terms of the Agreement, does not purport to be complete and is qualified in its entirety by reference to the Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending June 30, 2015.

 

Item 8.01.

Other Events.

On June 15, 2015, the Company issued a press release titled, “ImmunoCellular Therapeutics Enters into Manufacturing Agreement with PCT LLC, a Caladrius Company, for US Production of ICT-107 for Phase 3 Registration Trial,” a copy of which is attached as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit		Description
99.1		Press Release, dated June 15, 2015, titled “ImmunoCellular Therapeutics Enters into Manufacturing Agreement with PCT LLC, a Caladrius Company, for US Production of ICT-107 for Phase 3 Registration Trial.”

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SIGNATURES

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

 

Date: June 18, 2015				IMMUNOCELLULAR THERAPEUTICS, LTD.
				By:		/s/ David Fractor
						David Fractor
						Vice President of Finance and Principal Accounting Officer

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EXHIBIT INDEX

 

Exhibit		Description
99.1		Press Release, dated June 15, 2015, titled “ImmunoCellular Therapeutics Enters into Manufacturing Agreement with PCT LLC, a Caladrius Company, for US Production of ICT-107 for Phase 3 Registration Trial.”

Exhibit 99.1

 

Contact:

For ImmunoCellular Therapeutics, Ltd.

Jane Green

Investor Relations

415.348.0010

jane@jmgcomm.com

ImmunoCellular Therapeutics Enters into Manufacturing Agreement with PCT LLC, a Caladrius Company, for US Production of ICT-107 for Phase 3 Registration Trial

Los Angeles, CA – June 15, 2015 – ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced the selection of PCT, LLC, a subsidiary of Caladrius Biosciences, Inc. (“Caladrius”) (NASDAQ:CLBS), as the US manufacturer for ImmunoCellular’s ICT-107 phase 3 registrational clinical program in newly diagnosed glioblastoma, anticipated to begin in the second half of 2015. Under the terms of the multi-year agreement, PCT will provide current good manufacturing practice (cGMP) services for the manufacture of clinical supplies of ICT-107, a dendritic cell-based immunotherapy targeting six tumor-associated antigens. PCT, which was previously engaged by ImmunoCellular to manufacture clinical supplies of ICT-107 and the Company’s other cancer immunotherapy clinical programs, is also working with ImmunoCellular’s European contract manufacturer, PharmaCell B.V., to perform a technology transfer process to harmonize the EU and US methods of production of ICT-107 for the planned phase 3 registration trial. PCT’s facilities are registered with the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps) facilities, and maintain GMP-compliant quality systems.

“Selecting our US manufacturer for the ICT-107 phase 3 trial is an important step toward initiation of our registration program,” said Andrew Gengos, ImmunoCellular Chief Executive Officer. “We have been pleased with PCT’s ability to provide high quality, cost-effective and consistent manufacturing, and have confidence in their ability to support our phase 3 trial. Over the coming weeks, we look forward to announcing additional key milestones toward initiating the phase 3 trial, which have the potential to be major value-creating events for our Company. We expect to be in position to begin patient enrollment in the late third quarter or early fourth quarter of this year.”

“We are extremely pleased that the leadership team at ImmunoCellular has chosen to develop a long-term relationship partnership with PCT in order to maintain the cell therapy manufacturing reliability, quality, and cost efficiencies they have come to

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expect,” said Dr. Robert A. Preti, President of PCT, and Chief Technology Officer of Caladrius. “We feel our clients significantly reduce their clinical development risk by manufacturing with PCT and leveraging our Innovation and Quality infrastructure.”

About ImmunoCellular Therapeutics, Ltd.

ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. ImmunoCellular has concluded a phase 2 trial of its lead product candidate, ICT-107, a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. ImmunoCellular’s pipeline also includes: ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen on stem cells in recurrent glioblastoma; ICT-140, a dendritic cell immunotherapy targeting antigens on ovarian cancer stem cells; and the Stem-to-T-cell research program which engineers the patient’s hematopoietic stem cells to generate antigen-specific cancer-killing T-cells. To learn more about ImmunoCellular, please visit www.imuc.com.

About Caladrius Biosciences, Inc. (formerly NeoStem, Inc.)

Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. To learn more about Caladrius, please visit www.caladrius.com.

Forward-Looking Statements for ImmunoCellular Therapeutics

This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that ICT-107 can be further successfully manufactured, developed or commercialized. Additional risks and uncertainties are described in IMUC’s most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as required by law, IMUC undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.