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): March 13, 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 March 13, 2015, ImmunoCellular Therapeutics, Ltd. (the “Company”) entered into an Agreement for GMP Manufacturing of ICT-107 (the “Agreement”) with PharmaCell B.V. (“PharmaCell”), pursuant to which PharmaCell will provide contract manufacturing services for the European production of ICT-107, a dendritic cell vaccine for the treatment of newly diagnosed glioblastoma multiforme.

The Company will pay for manufacturing services performed by PharmaCell under the Agreement pursuant to statements of work entered into from time to time. The Company may unilaterally terminate the Agreement upon 90 days’ written notice to PharmaCell, or 30 days’ written notice in the event of a clinical hold or other suspension or early termination of a clinical trial. PharmaCell may terminate the Agreement in certain circumstances upon 90 days’ written notice to the Company. 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. Absent early termination, the Agreement will continue until all services under applicable statements of work have been completed.

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 March 31, 2015.

The Company issued a press release on March 19, 2015 regarding the Agreement, a copy of which is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit		Description
99.1		Press Release, dated March 19, 2015.

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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: March 25, 2015		IMMUNOCELLULAR THERAPEUTICS, LTD.
		By:		/s/ Andrew Gengos
				Andrew Gengos
				President and Chief Executive Officer

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EXHIBIT INDEX

 

Exhibit		Description
99.1		Press Release, dated March 19, 2015.

Exhibit 99.1

 

Contact:

ImmunoCellular Therapeutics, Ltd.

Investor Relations

Jane Green

415.348.0010 direct

415.652.4819 mobile

jane@jmgcomm.com

PharmaCell B.V.

Chief Executive Officer

Alexander Vos

+31 43 350 99 10

a.vos@pharmacell.nl

ImmunoCellular Therapeutics Establishes Manufacturing Agreement with

PharmaCell B.V. for European Production of ICT-107

for Phase 3 Registration Trial

Los Angeles, CA and Maastricht, The Netherlands – March 19, 2015 – ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) today announced the establishment of an agreement with PharmaCell B.V. to provide contract manufacturing services for the European production of ICT-107, a dendritic cell-based cancer immunotherapy in development as a potential treatment for glioblastoma (GBM). This agreement with PharmaCell, a leading European contract manufacturing organization focuses on the production of human cell therapy products, and is designed to enable ImmunoCellular to access phase 3 supplies of ICT-107, manufactured with ImmunoCellular’s commercial-ready production process. ImmunoCellular intends to initiate a Phase 3 registrational program for ICT-107 in the US and in Europe in 2015.

“Securing high quality ICT-107 manufacturing in Europe is a key milestone on our way to initiating a phase 3 registrational trial later this year, and helps to lay the groundwork for seeking EMA regulatory approval, assuming a positive outcome to the phase 3 program and favorable regulatory review,” said Andrew Gengos, ImmunoCellular Chief Executive Officer. PharmaCell has an excellent reputation as a high-quality, full-service GMP manufacturer, with unique expertise in cancer immunotherapy products manufactured for the EU market. We believe that the start of this trial will bring us closer to our goal of building a leading cancer immunotherapy company.”

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Alexander Vos, Chief Executive Officer of PharmaCell BV, said: “We are excited that ImmunoCellular Therapeutics, a global leader in cancer immunotherapy, has decided to work with us. Their decision confirms that our new Geleen facility is indeed viewed by industry experts as meeting the requirements and client expectations for late clinical stage and commercial manufacturing for ATMPs. We look forward to supporting ImmunoCellular in its effort to develop ICT-107 for the benefit of European patients.”

ImmunoCellular plans to initiate a technology transfer process from its North American manufacturer to harmonize the EU and US methods of production of ICT-107 for the planned phase 3 registration trial. The technology transfer process is anticipated to begin as soon as practicable.

About PharmaCell

PharmaCell is a leading European-based CMO active in the area of cell therapy and regenerative medicine. PharmaCell has experience in supporting Phase I-III clinical trials, as well as commercialization projects, in terms of manufacturing, QC, QP batch certification, storage, in-outgoing logistics. The company is exclusively focused on providing contract services in the area of human cell therapy. Its services include process and assay-development to ensure GMP compliance, robustness and scalability of cell therapy manufacturing processes. PharmaCell operates two state-of-the art cGMP certified facilities situated in Maastricht and Geleen, The Netherlands, centrally located in Europe. The facilities covers 4500 square meters including clean rooms, grade A, B, C and D (Classes 100/10.000/100.000), R&D and QC laboratories including cryopreservation, warehouse and logistics areas. For more information about PharmaCell and its capabilities, please visit www.pharmacell.nl.

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 II trial of its lead product candidate, ICT-107, a dendritic cell-based cancer immunotherapy targeting multiple tumor-associated antigens for glioblastoma. ImmunoCellular’s pipeline also includes: ICT-121, a dendritic cell immunotherapy targeting CD133; ICT-140, a dendritic cell immunotherapy targeting ovarian cancer antigens and 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.

Forward-Looking Statements for ImmunoCellular Therapeutics

This press release contains certain forward-looking statements, including statements regarding the timing for the initiation of a registrational trial for ICT-107, development, manufacturing and commercialization of ICT-107 in the EU, including the initiation of a phase 3 study and potential for regulatory approval of ICT-107 by the EMA. These statements are based on ImmunoCellular’s current expectations and involve significant

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risks and uncertainties, including those described under the heading “Risk Factors” in ImmunoCellular’s most recently filed annual report on Form 10-K. Except as required by law, ImmunoCellular undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.