SALE OF IGENICA, INC.
Gerbsman Partners has been retained by Igenica, Inc. to solicit interest for the acquisition of all, or substantially all, the assets of Igenica, Inc.
Igenica Biotherapeutics (Igenica) is a privately held biotechnology company located in Burlingame, California, founded in 2009. Igenica is harnessing the natural tumor microenvironment to deliver a pipeline of high-impact antibody-based cancer therapeutics.
The acquisition of Igenica enables immediate access to proprietary technology and preclinical drug candidates. To date, Igenica has raised six rounds of private financing totaling $83 million in venture capital funded by a premier team of life science investors including The Column Group, OrbiMed, 5AM Ventures and Third Rock Ventures.
Igenica Biotherapeutics has a patent portfolio that consists of twelve (12) families which include twenty-four (24) patent and provisional applications and seven (7) international PCT applications with the intent to protect the company’s antibody platform (so as to make sure this platform is different from the ADC Technology), ADC technology, preclinical and clinical assets.
Igenica has developed:
· A novel technology (sTAg) for Identifying overexpressed proteins on tumor cell surfaces
· A novel method (iTAb) to generate tumor antigen specific monoclonal antibodies
· A novel antibody dependent conjugation platform (SNAP) including a proprietary linker
· Several well characterized drug candidates that show promise in preclinical studies
· One clinical drug candidate, IGN523, which halted development post a phase I dose escalation trial due to lack of efficacy in AML. The company believes that IGN523 may show promise as a combination therapy or for an indication other than AML
· A large, pending patent estate which has ongoing prosecution, but no issued patents as of this date
Igenica has no recurring revenues, product or collaboration related. Its value lies in the preclinical and clinical assets produced by its underlying and proprietary technology.
IMPORTANT LEGAL NOTICE:
The information in this memorandum does not constitute the whole or any part of an offer or a contract.
The information contained in this memorandum relating to Igenica’s Assets has been supplied by Igenica. It has not been independently investigated or verified by Gerbsman Partners or its agents.
Potential purchasers should not rely on any information contained in this memorandum or provided by Igenica, or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.
Igenica, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Igenica’s or Gerbsman Partners’ negligence or otherwise.
Any sale of the Igenica Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Igenica or Gerbsman Partners. Without limiting the generality of the foregoing, Igenica and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Igenica Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.
This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.
Historical Company Information
Igenica’s foundational vision was to build a biopharmaceutical company with a complete suite of technologies supporting the discovery of antibody-based therapeutics. Our rigorous approach to target discovery and antibody development considers patient profile, tissue expression, the tumor micro-environment and antibody function as primary factors.
Our target discovery platform, sTAg (surface Tagged Antigen), systematically profiles proteins found on the cell surface of primary tumors to identify antibody-accessible antigens as candidate targets. Tumor-specific surface proteins are identified and quantified by applying advanced mass spectrometry analysis.
To identify functional antibodies that are specific to target candidates, we developed a platform, iTAb (in vivo anti-Tumor Antibody), that generates diverse antibodies and screens Ab candidates in vivo, to select antibodies with the most potent anti-tumor activity. This platform has been applied to develop naked functional antibodies, including next-generation immune-oncology therapies for cancer.
Our proprietary site-specific ADC platform technology, SNAP, addresses the major limitations of current and competitive approaches by providing a simple, elegant, chemically-driven method for linking a functional Ab and small molecule cytotoxin. Our SNAP technology results in a highly flexible bi-functional linker that, by design, yields homogeneous ADCs armed with the optimal toxin payload. SNAP is also a highly flexible system that is amenable to any antibody, linker or toxin, and can tune the drug-to-antibody ratio (DAR) to specifically 2, 3, or 4, making it an ideal technology for internally and externally generated programs.
Igenica Company Profile
Igenica is focused on the discovery and development of immune-modulating antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer. We are the only biotherapeutic company that fully powers the ADC development spectrum from a clinically relevant approach to target and functional antibody discovery to ADC creation, accelerating development and the delivery of effective therapies to patients.
Founded in 2009, Igenica is led by a proven team of leaders that have demonstrated success in antibody drug discovery, clinical development and commercialization. Based in Burlingame, Calif., we were well-funded by a premier team of life science investors including The Column Group, OrbiMed, 5AM Ventures and Third Rock Ventures.
Igenica Biotherapeutics has a patent portfolio that consists of twelve (12) families which include twenty-four (24) patent and provisional applications and seven (7) international PCT applications with the intent to protect the companies’ platform, ADC technology, preclinical and clinical assets.
Impact of Technology on the Market and Why Igenica Assets are Attractive
We are focused on the development of innovative immunotherapies, functional antibodies directed to the tumor, and antibody-drug conjugates for the treatment of cancer. All of Igenica’s product candidates were discovered using our proprietary product engine.
· iTab platform generates high-affinity antibodies with broad epitope coverage and in vivo anti-tumor efficacy in preclinical models
· SNAP platform can provide homogeneous drug-to-antibody ratios (DARs) of 2, 3, or 4, is adaptable to all payload classes and reduces manufacturing risks of ADCs
· Igenica’s antibodies are of high affinity and cover various elements of immunotherapy
· Combination therapy with Igenica antibodies have the potential to significantly impact anticancer immunotherapy
· Igenica antibodies have been tested in preclinical efficacy models and/or cynomolgus monkeys for safety
· Intellectual Property
· Numerous preclinical studies demonstrating anti-tumor efficacy in various tumor models, safety and PK/PD assessments in non-human primates
· Procedures and methods for target identification, antibody generation and antibody drug conjugation chemistry
Igenica developed IGN523 (anti-CD98) for the treatment of multiple hematologic and solid tumors. Expression of CD98 has been shown to be upregulated in a variety of hematologic malignancies, including AML, and in several types of solid tumors, particularly squamous cell carcinomas. Its elevated expression is correlated with poor prognosis and patient outcome. Previous studies have demonstrated that CD98 functions both in integrin signaling and amino acid transport processes, which support the proliferation, anchorage-independence, invasion, and metastasis of tumor cells (Cancer Cell 2016; 30(5): 792-805; Int. J. Cancer 2015; 137(3): 710-720).
· IGN523 is a high affinity antibody that works through multiple mechanisms of action potentially reducing the risk of developing treatment resistance
· IGN523 has been in a Phase 1 clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML). The trial has been designed to assess the safety, pharmacokinetics, and clinical activity of IGN523
· Preclinical studies indicate that in addition to AML non-small lung cancer patients express high levels of CD98 and could benefit from IGN523 treatment
· Immunohistochemical staining reagents are available to be developed as a patient stratification tool
· IGN523 can be readily produced as master cell bank with contract manufacturer is available
IGN381 forms the basis for an innovative approach to immunotherapy by targeting an immune checkpoint target called VISTA or c10orf54 that plays a complimentary role in the tumor micro-environment to other known immune checkpoints. Igenica developed an active antibody program and has humanized a lead candidate. We believe this program is well positioned to complement existing immunotherapy approaches.
· IGN381 is a high affinity mAb with data supporting immune checkpoint inhibition differentiation relative to lead competitor mAb
· Safety of IGN381 has been assessed alone and together with anti-PD1 antibody (pembrolizumab) in a PK/PD 6 weeks repeat-dose study in non-human primates
· Strong evidence of VISTA immune regulatory function in a non-redundant, MDSC-mediated immune regulatory axis
· Extensive expression profiling reveals that VISTA expression pattern is consistent with extensive role on MDSCs and unique among immune checkpoint regulators
· Increased expression in immune infiltrates within tumors may result in decreased overall survival of NSCLC patients
· Igenica has identified a putative heterophilic binding partner for VISTA
· Patent applications on these antibodies and other novel aspects of this program have been filed
Discovered using Igenica’s sTAg protoemics technology, SAIL (c16orf54) has not been studied or described in humans previously. Given the expression profile of this target, IGN786 has the potential to be an exquisitely specific targeted therapy for multiple cancer indications with high unmet medical need, including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), multiple myeloma, and pancreatic cancer. Igenica developed IGN786 as an antibody-drug conjugate using Igenica’s proprietary ADC technology. Igenica has filed patent applications with claims protecting multiple unique aspects of this novel therapeutic agent (Blood Cancer J 2015; 5: e316).
· SAIL is a highly novel ADC target derived from a proteomics-based target discovery approach
· IGN786 leverages Igenica’s SNAP ADC technology to optimally target SAIL-expressing tumors
· Based on the expression profile of SAIL, IGN786 is being developed to address high unmet medical need in multiple hematologic and solid tumor indications
· IGN786 induces tumor regression in multiple AML xenograft models
· IGN786 displays a favorable toxicology profile in non-human primates (NOAEL of 20 mg/kg)
· Strong evidence CD39 immune regulatory function through purinergic signaling within the CD39/CD73/adenosine pathway
· CD39 expression profile reveals higher levels of expression in tumors, Tregs and myeloid cells within the TME relative to normal tissues
· 9-8B mAb is a high affinity anti-CD39 mAb with data supporting functional blocking of CD39 ATPase activity (Am J Trans Res 2015; 7(6): 1181-1188)
· 9-8B inhibits tumor growth through cell killing in vivo
· 9-8B mAb has been humanized in silico
· Patent applications have been filed on Igenica’s antibodies and methods of treatment
The assets of Igenica will be sold in whole or in part (collectively, the “Igenica Assets”). The sale of these assets is being conducted with the cooperation of Igenica. Igenica and its consultants will be available to assist purchasers with due diligence and a prompt, efficient transition to new ownership.
Igenica, Inc. Key Personnel
· Edward van der Horst — Senior Director Preclinical Drug Development: Edward van der Horst, Ph.D., joined Igenica in 2010 as director of preclinical development, bringing in-depth knowledge of oncology and 15 years of experience in the development of monoclonal antibody therapeutics, target discovery, selection and validation. His contributions and discoveries have led to the development and clinical evaluation of anti-DLL4 and anti-NOTCH2/3 antibodies at OncoMed Pharmaceuticals, Inc., the first clinical stage anti-HER3 antibody at U3 Pharma GmbH (acquired by Daiichi-Sankyo), and Igenica’s first IND filing. Dr. van der Horst studied chemistry at the Heinrich-Heine University, Düsseldorf and the Ludwig-Maximilian University of Munich. For his master’s thesis he conducted research at the Max-Planck Institute of Neurobiology, Munich and holds a Ph.D. in biochemistry from the Max-Planck Institute of Biochemistry, Munich. Dr. van der Horst completed his postdoctoral studies at Tularik, Inc., acquired by Amgen, Inc. in 2004.
· Hans van Houte — CFO: Hans van Houte joined Igenica in 2011 and brings broad financial and operational experience with biotechnology companies. Prior to Igenica, Mr. van Houte served in senior financial roles, including vice president, finance and administration for Trubion Pharmaceuticals, where he led the company’s private financing efforts and managing its IPO preparation. Prior to Trubion, Mr. van Houte was the controller, assistant treasurer and principal accounting officer for Vertex Pharmaceuticals, where he helped build the organization post-IPO to support growth from a $100 million company to a multibillion market cap. Mr. van Houte holds a B.S. in finance and management from Babson College.
Igenica, Inc. Board of Directors
David Goeddel, PhD: Chairman of the Board, Managing Partner, The Column Group.
Mark Goldsmith, MD, PhD: Partner, Third Rock Ventures.
John Diekman, PhD: Founding Partner 5AM Ventures.
Robert Schreiber, PhD: Igenica Co-founder, Alumni endowed Professor of pathology and immunology, Professor of molecular microbiology, co-leader of the tumor immunology program for the Siteman Comprehensive Cancer Center at Washington University School of Medicine and founding Director of the Washington University center for human immunology and immunotherapy programs. Schreiber played a key role in developing the iTAb platform and is an acknowledged leader in the field of cancer immunology and immunotherapy.
The Bidding Process for Interested Buyers
Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and intellectual capital teams and the due diligence “war room” documentation (the “Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has an opportunity to inspect and examine the Igenica Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Igenica, Inc., Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and neither Igenica nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes any representations as to the accuracy or completeness of the same.
Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Igenica Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Tuesday, February 14, 2017 at 3:00 p.m. Pacific Time (the “Bid Deadline”) at Igenica’s office, located at 863A Mitten Road Ste. 100B2, Burlingame, California 94010. Please also email firstname.lastname@example.org with any bid.
Bids should identify those assets being tendered for in a specific and identifiable way. The attached Igenica fixed asset list may not be complete and Bidders interested in the Igenica’s Assets must submit a separate bid for such assets. Be specific as to the assets desired.
Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase where applicable. All bids must be accompanied by a refundable deposit check in the amount of $200,000 (payable to Igenica, Inc.). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.
Igenica reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.
Igenica will require the successful bidder to close within 7 business days. Any or all of the assets of Igenica will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.
All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Igenica Assets shall be the sole responsibility of the successful bidder and shall be paid to Igenica at the closing of each transaction.
For additional information, please see below and/or contact:
Steven R. Gerbsman