On February 14, 2022 Varian Biopharmaceuticals, Inc. ("Varian Bio"), a private, precision oncology company developing novel therapeutics for the treatment of cancer, and SPK Acquisition Corp. ("SPK") (NASDAQ: SPK), a special purpose acquisition company ("SPAC"), reported it has entered into a definitive merger agreement for a business combination that will result in Varian Bio becoming a publicly traded company (Press release, Varian Biopharmaceuticals, FEB 14, 2022, View Source [SID1234633283]). Varian Bio is developing a high-potency, specific atypical protein kinase C iota ("aPKCi") inhibitor that has the potential to be best-in-class as a treatment for various oncology indications with an initial focus on basal cell carcinoma (BCC) and molecularly targeted solid tumors.
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Varian Bio is developing rationally designed aPKCi small molecule inhibitor candidate that has been optimized for potency, selectivity and tolerability. aPKCi has been implicated as an oncogene in a number of human cancers, including BCC, cutaneous T-cell lymphoma (CTCL), non-small cell lung cancer (NSCLC), acute myeloid leukemia (AML), colorectal cancer, and pancreatic cancer, among others. aPKCi has also been demonstrated to have a role in allowing the immune system to recognize tumors, recruit immune cells into the area, and ramp up the anti-tumor response to kill cancer cells in the lab by shrinking their tumors. Varian Bio’s leadership team and scientific advisory board has extensive experience in the development of novel cancer therapeutics. including Jeffrey B. Davis, a serial entrepreneur with over two decades of experience in the biotechnology and specialty pharmaceuticals industry, and Jonathan Lewis, M.D., Ph.D., Chairman of Scientific Advisory Board, a surgical oncologist and cancer researcher.
The active pharmaceutical ingredient in VAR-101/102, an aPKCi inhibitor, has demonstrated dose dependent anti-tumor activity in murine and human BCC cell lines, as well as other cancer models. Varian Bio intends to develop VAR-101 in a topical formulation for BCC which has the potential to offer optimal clinical utility in BCC as a surgical neoadjuvant or adjuvant therapy. VAR-102, an oral formulation of the active aPKCi inhibitor, lends itself to broader applications in multiple tumor types. Varian Bio believes that VAR-101 and VAR-102, if approved, could represent significant medical and commercial opportunities.
Varian Bio – Developing A Portfolio of aPKCi Inhibitors from Cancer Research UK ("CRUK"), the World’s Largest Independent Funder of Cancer Research (www.cancerresearchuk.org)
Cancer is a global issue, the burden worldwide is on the rise, with almost 20 million new cases diagnosed in 2020 globally and approximately 30 million new cases projected for 2040. The Varian Bio portfolio of novel aPKCi inhibitors have been discovered and developed by CRUK. This has been under the leadership of Prof. Peter Parker, Ph.D., FRS. of the Francis Crick Institute, Kings College, and Cancer Research UK, with collaborators in the UK and US. Prof. Parker is widely regarded as one of the world’s leading scientific experts and investigators of the molecular and cell biology of Protein Kinase C in mammalian biology and cancer.
"We are studying cellular signals in great detail, focusing on molecules called kinases that relay messages within cells. There are more than 500 different kinases, each with a particular role, and many of them work together to form complex networks of signals that control cell growth, proliferation, death, movement and much more. Our work concentrates on a group of kinases known as the protein kinase C (PKC) family, which have been implicated in many types of cancer, stated Prof. Peter Parker, PhD, FRS, Emeritus Group Leader, Francis Crick Institute, Centre Director, Cancer Research UK, King’s College London and a member of the Varian Scientific Advisory Board. "We have investigated how these kinases work in healthy cells, as well as how faults or aberrant activation of kinases from the PKC family drive cancer cells to grow and spread through the body. We are using our findings to help patients by developing drugs that target PKC family members and take them forward into clinical trials."
"Based on the rigorous science of the Parker lab and the Cancer Research UK network, a well-developed molecular, cellular and non-clinical data package for Varian Bio’s drug candidates portends a high probability of clinical and biomarker signals in various cancer types," stated Jonathan Lewis, M.D., Ph.D., Chief Medical Officer and Chairman of the Scientific Advisory Board of Varian Bio. "We have assembled, and will continue to expand, a global team of leading scientific and oncology deep-domain experts as team members while we progress to first-in-human clinical trials."
Varian Bio, together with its collaborators, is initially developing two formulations of its lead aPKCi inhibitor that has been selected for potency, selectivity, biomarker activity and low toxicity in murine and large animal models.
VAR-101 is a dermatologic gel formulation of for the potential topical treatment Basal Cell Carcinoma (BCC). BCC is the most common human cancer in the World. There are 4.3 million cases of BCC diagnosed in the US each year, more than one million of whom undergo Mohs surgery. While Mohs has a low recurrence rate, the surgical approach is costly, time consuming, and can be disfiguring, requiring complex reconstructive surgery. Mohs surgery is the 5th most expensive and costly cancer treatment for Medicare in the United States. The active aPKCi inhibitor (VAR-101) has demonstrated dose-dependent in vitro BCC cell killing with concordant biomarker Gli-1 mRNA knockdown (dose dependent reduction). Gli-1 is present in BCC, but not normal basal cells and increases in hedgehog pathway inhibition resistance.
VAR-102 is an oral formulation of the aPKCi inhibitor for the potential treatment of multiple solid tumors, including non-small cell lung cancer, pancreatic, colorectal and other tumor types. An increasing body of scientific evidence implicates aPKCi as playing a central role in cancer cell growth and metastasis. Varian will pursue systemic tumor indications in a "basket" solid tumor Phase 1 trial. Molecular targeting and target engagement will be measured with associated biomarker exploration.
Precision oncology, whereby physicians use genomic, proteomic and phosphorylationomic testing to look for specific unique functional mutations and molecular pathways of tumors, holds the promise of much more targeted treatment recommendations with therapies designed to fight specific tumor types. A recently published global Precision Oncology Market analysis by Reports and Data found the global precision oncology market size amounted to US$49.9 billion in 2019 and is expected to grow at a CAGR of 9.9% over the next eight years to reach US$99.7 billion in 2027. Protein kinases are enzymes that are involved in various cellular functions including metabolism, cell cycle regulation, survival and differentiation. Dysregulation of protein kinases is implicated in the initiation of cancer formation, or carcinogenesis. Protein kinase inhibition in cancer therapy has led to a paradigm shift in how cancer is treated, and over 35 protein kinase inhibitors have been approved by the US FDA over the past two decades (Source: Expert Rev Anticancer Ther. 2018 Dec; 18(12): 1249-170).
Management Comments
"Targeted, small-molecule protein kinase inhibitors have been one of the most clinically successful classes of cancer drugs over the past 20 years, and we are excited by the opportunity to progress our novel candidates towards human clinical trials," says Jeffrey B. Davis, Varian Bio’s CEO. "Varian Bio has the support of leading cancer physicians and scientific institutions both in the US and abroad, and aPKCi is a unique protein kinase target whose inhibition could have a significant impact in a broad range of tumor types. Our merger with SPK will provide the capital needed to further the development of our proprietary, anti-cancer targeted therapies."
"Varian Bio represents an opportunity to advance novel anti-cancer therapeutics to address a broad range of potential tumor types, in large and growing global indications such as basal cell carcinoma and non-small cell lung cancer," said Sophie Ye Tao, CEO of SPK Acquisition Corp. "This transaction will provide the Varian Bio management team and Board of Scientific Advisors the financial resources to continue to innovate, to develop its lead drug candidates, and bring its novel therapies to fruition."
Transaction Overview
Pursuant to the merger agreement, Varian Bio will merge with a wholly owned subsidiary of SPK, with Varian Bio being the surviving entity of the merger and a wholly owned subsidiary of SPK. SPK, which currently holds approximately $50 million in gross proceeds from the trust account, will be renamed Varian Biopharma, Inc. following the merger. The cash proceeds from the transactions are expected to fund manufacturing, pre-clinical and IND-enabling toxicology studies, and "first-in-human" human clinical studies for an aPKCi inhibitor. This will include the continued development of VAR-101, a topical formulation of its lead aPKCi compound, for the treatment of BCC, and the development of VAR-102, an oral formulation thereof, for the treatment of solid malignancies. Following the closing of the transaction, the Company will be led by existing management from Varian Bio, including CEO Jeffrey B. Davis and CMO Dr. Jonathan Lewis.
The transaction has been approved by the Boards of Directors of both SPK and Varian Bio and is subject to the satisfaction of customary closing conditions, including the approval of SPK’s shareholders. The transaction is expected to close in the second quarter of 2022.
Additional information about the proposed business combination, including a copy of the merger agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by SPK with the Securities and Exchange Commission (the "SEC") and available at www.sec.gov. In addition, SPK Acquisition Corp intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.
Advisors
LifeSci Capital is acting as financial and capital markets advisor to SPK
Loeb & Loeb LLP is acting as legal counsel to SPK
Dorsey & Whitney LLP is acting as legal counsel to Varian Bio