On April 26, 2022 Isleworth Healthcare Acquisition Corp. (NASDAQ: ISLE) ("Isleworth"), a special purpose acquisition company (NASDAQ: ISLE, ISLEW) and Cytovia Holdings, Inc.("Cytovia"), a biopharmaceutical company empowering natural killer (NK) cells to fight cancer through stem cell engineering and multispecific antibodies reported they have entered into a definitive business combination agreement (Press release, Cytovia Therapeutics, APR 26, 2022, View Source [SID1234612994]). Upon consummation of this combination, Isleworth will be renamed Cytovia Therapeutics, Inc. (the "combined company") and its common stock and warrants are expected to remain listed on NASDAQ under the ticker symbols INKC and INKCW, respectively .
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The combined company will continue Cytovia’s operations and remain focused on developing and manufacturing complementary NK cell and NK engager antibody platforms.
The combined company will be led by Dr. Daniel Teper, the Co-Founder, Chairman, and Chief Executive Officer of Cytovia.
"We are grateful for the strong support from new and existing investors and the team of seasoned entrepreneurs at Isleworth. We expect this transaction to accelerate the execution of Cytovia’s vision to advance NK therapeutics towards a cure for cancer" said Dr. Teper. "We are encouraged by our preclinical data recently presented at AACR (Free AACR Whitepaper), which supports advancing development of our iPSC-derived NK cells (iNK) and Flex-NK cell engagers for the treatment of Hepatocellular Carcinoma."
Bob Whitehead, Isleworth’s CEO, said: "Isleworth evaluated multiple life science companies and was most impressed by the talent and technology assembled by Cytovia. We believe Cytovia is one of the most advanced, innovative cell therapy companies involved with the development of new cancer treatments. Cell therapies in oncology have already brought hope to millions. Cytovia’s approaches could conceivably make similar approaches more conveniently ‘off-the-shelf’ and affordable."
Cytovia’s Therapeutic Approach
Cytovia aims to accelerate patient access to transformational cell therapies and immunotherapies, addressing several of the most challenging unmet medical needs in oncology.
The company focuses on harnessing the innate immune system by developing complementary and disruptive NK-cell and NK-engager antibody platforms. Specifically, Cytovia is developing three types of iNK cells: unedited iNK cells, TALEN gene-edited iNK cells with improved function and persistence, and TALEN gene-edited iNK cells with chimeric antigen receptors (CAR-iNKs) to improve tumor-specific targeting. The second complementary cornerstone technology is a quadrivalent multispecific antibody platform designed to engage NK cells by targeting the NKp46 activating receptor using a proprietary Flex-NK technology.
These two technology platforms are being used to develop treatments for patients with Hepatocellular Carcinoma (HCC) and solid tumors. Clinical studies are expected to initiate by the end of 2022.
Headquartered in Aventura, FL, Cytovia operates R&D laboratories in Natick, MA and a cGMP cell manufacturing facility in Puerto Rico and has scientific partnerships with Cellectis, CytoImmune Therapeutics, the Hebrew University of Jerusalem, INSERM, the New York Stem Cell Foundation, the National Cancer Institute, and the University of California San Francisco (UCSF). Cytovia Therapeutics has recently formed CytoLynx Therapeutics, a strategic partnership focused on research and development, manufacturing, and commercialization activities in Greater China and beyond.
Cytovia Pipeline
Cytovia is the first immune-oncology company with the capabilities to combine gene edited iPSC-derived NK Cell and Flex-NK cell engager antibody platforms to develop the next generation of immunotherapies for both hematological and solid tumors.
Cytovia’s portfolio includes targets and indications with a balanced risk profile.
GPC3 is a promising novel target for solid tumors, particularly hepatocellular carcinoma, where the unmet medical need is most significant. Cytovia’s lead program aims to develop first-in-class HCC therapies targeting GPC3. The initial four product candidates will be evaluated as monotherapies and as combination therapies. CYT-303, Cytovia’s GPC3 Flex-NK engager, is a tri-specific antibody that binds to HCC tumor cells through GPC3 and to NK cells through NKp46 and CD16a. For patients with either an impaired number or function of NK cells, Cytovia will evaluate the addition of iNK cells, CYT-100, to possibly unlock the full potential of this treatment strategy. Cytovia is also developing CYT-150, gene-edited iNK cells, to improve tumor infiltration and cell persistence, that may also be combined with CYT-303. In addition, CYT-503, a GPC3-targeting CAR-iNK cell therapeutic, is designed to improve specificity for tumor targeting. Cytovia expects to file INDs for CYT-303 and CYT-100, followed by INDs for CYT-150 and CYT-503.
CD38 is a well-established clinical and commercial target for Multiple Myeloma. Cytovia is developing CYT-338 and CYT-538 which are, respectively, CD38-targeting Flex-NK cell engagers and CAR-iNK cells for the treatment of Multiple Myeloma in patients that have failed CD38 antibody therapies and agents targeting B-cell maturation antigen (BCMA).
Cytovia is also developing an intracranial EGFR CAR iNK candidate to target both wtEGFR and EGFR vIII to address a significant medical need in the management of the currently untreatable Glioblastoma multiforme.
Cytovia has established collaborations with academic institutions and industry partners including Cellectis for TALEN gene-editing. TALEN gene-editing is a technology pioneered and controlled by Cellectis, a clinical-stage biotechnology company using its gene-editing platform to develop life-saving cell and gene therapies. The TALEN gene-edited patents controlled by Cellectis in the field of iNK and CAR-iNK are licensed from Cellectis by Cytovia and Cytovia holds global development and commercial rights to these patents.
Planned Milestones and Use of Proceeds
Proceeds from private placements (the "PIPE"), funds in Isleworth’s trust account (net of redemptions), and proceeds from other prospective financings, in the aggregate amount of up to one hundred million dollars, would provide Cytovia with capital for up to 2 years to further develop its gene-edited iNK and Flex-NK cell engager technologies. Cytovia plans to focus on multiple milestones, including:
Filing the first two INDs for Flex-NK CYT-303 and iNK CYT-100
Initiating Phase I/II clinical trials to evaluate CYT-303 and CYT-100, alone and in combination, for the treatment of HCC
Obtaining and presenting initial clinical data for CYT-303 and CYT-100 in HCC
Filing INDs for CYT-150 and CYT-503 and initiating Phase I/II clinical trials
Continuing to enhance iNK & Flex-NK technologies and advance the pipeline with multiple therapeutic candidates
Summary of Transaction
The transaction would value the combined company at a pro forma equity value of $602 million, assuming a $10 per share price, no Isleworth stockholder redemptions and no additional financing obtained prior to the closing of the transaction. As a result of the transaction, the combined company would have up to $227 million in gross proceeds from a combination of approximately $207 million in cash held in Isleworth’s trust account (assuming no Isleworth stockholders exercise their redemption rights at closing) and $20 million from PIPE financing of new investors, and without considering the proceeds of any additional prospective financing.
All existing Cytovia equity holders will roll the entirety of their equity holdings into the combined company and are expected to hold approximately half of the issued and outstanding equity of the combined company immediately following the closing (assuming no Isleworth shareholders exercise their redemption rights at closing).
The transaction, which has been approved by each of Isleworth’s and Cytovia’s Boards of Directors, is expected to be completed in the third quarter of 2022, subject to approval by Isleworth’s and Cytovia’s shareholders and satisfaction, or the waiver of, customary closing conditions identified in the business combination agreement.
Isleworth and Cytovia have agreed in the business combination agreement to take all necessary action to cause the board of directors of the combined company immediately following the closing to consist of seven directors, of whom two individuals will be designated by Isleworth and five individuals will be designated by Cytovia. Each designee will meet the director qualification and eligibility criteria of the Nominating and Corporate Governance committee of the board of directors of Isleworth, and a number of Cytovia designees will qualify as independent directors as determined by the board of directors of Isleworth such that a majority of the directors as of immediately following the closing will qualify as independent directors.
I-Bankers Securities, Inc. is serving as capital markets advisor and placement agent to Isleworth. Truist Securities is acting as financial advisor, placement agent and capital markets advisor to Cytovia. BTIG LLC is acting as capital markets advisor to Cytovia.
Cooley LLP is serving as legal advisor to Cytovia. ArentFox Schiff LLP is serving as legal advisor to Isleworth. Goodwin Procter is serving as legal advisor to Truist Securities in its role as placement agent.