Biodexa Pharmaceuticals Enters Non-binding Letter of Intent for Proposed Acquisition of Varian Biopharmaceuticals

Biodexa Pharmaceuticals recently announced it has signed non-binding letter of intent to potentially acquire Varian Biopharmaceuticals, Inc., a private US precision oncology company developing novel therapeutics for the treatment of cancer.

In recent communications, the company has referenced a shift in strategy from a drug delivery company to a therapeutics company. Currently, the company’s only clinical asset is MTX110, which is being developed for three intractable rare and orphan brain cancers. The company’s intention is to add to and diversify its development pipeline with a continued focus on rare and orphan products and/or oncology therapeutics, and VarianBio represents the first of such opportunity.

VarianBio is developing a high-potency, specific atypical protein kinase C iota (aPKCi) inhibitor with best-in-class potential as a treatment for various oncology indications with an initial focus on basal cell carcinoma (BCC) and molecularly targeted solid tumors.

VarianBio’s rationally designed aPKCi small molecule inhibitor candidate 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.

The active pharmaceutical ingredient in VAR-101/102, a novel aPKCi inhibitor, has demonstrated dose dependent anti-tumor activity in murine and human BCC cell lines, as well as other cancer models. VAR-101 will be developed in a topical formulation for BCC which has the potential to offer optimal clinical utility as a surgical neoadjuvant or adjuvant therapy. Following completion of IND-enabling skin toxicology studies, VAR-101 is targeting to start a Phase I proof-of-concept study in the first quarter of 2024. VAR-102, an oral formulation of the active aPKCi inhibitor, lends itself to broader applications in multiple tumor types. The company believes that VAR-101 and VAR-102, if approved, could represent significant medical and commercial opportunities.

Under the non-binding letter of intent, VarianBio will merge into an acquisition subsidiary of the company, and it is proposed that VarianBio equity and debt holders (together, VarianBio Securityholders) will receive 10MM of the company’s American Depositary Shares (ADSs), at close as initial consideration. On a pro forma basis, prior to the planned financing discussed below, VarianBio Securityholders will own approximately 34% of the post-acquisition company. VarianBio Securityholders will receive up to a further 6MM ADSs, issuable in two phases: 3MM upon the commencement of the first pivotal registration study of a VarianBio product and an additional 3MM upon the first FDA approval of a VarianBio product.

In addition, pursuant to the non-binding heads of terms, the company plans to raise not less than $7 MM, net of expenses, which will be used to fund VAR-101 through its Phase 1 proof-of-concept study that VAR-101 is targeting to commence in the first quarter of 2024. The acquisition agreement is also expected to contain other customary conditions, including shareholder approval, and appropriate representations and warranties by the parties.

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical-stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain. The company’s lead candidate, MTX110, is being studied in aggressive rare/orphan brain cancer indications including recurrent glioblastoma and diffuse midline glioma. MTX110 is a liquid formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour, by-passing the blood-brain barrier and avoiding systemic toxicity. Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information, visit www.biodexapharma.com.

Varian Biopharmaceuticals, Inc. is private precision oncology company developing novel therapeutics for the treatment of cancer. Precision oncology, whereby physicians use DNA testing to look for genetic mutations of the unique tumors, holds the promise of 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 $49.9 billion in 2019 and is expected to grow at a CAGR of 99% over the next 8 years to reach $99.7 billion in 2027. VarianBio is developing a best-in-class high-potency, specific atypical protein kinase C iota (aPKCi) inhibitor for the treatment of various tumor types in multiple formulations. Recent scientific publications have characterized aPKCi as an oncogene whose activity may play a fundamental role in the regulation of cancer-associated transcription factors including GLI-1 and K-RAS. VarianBio’s lead drug candidate, VAR-101, is being developed in a topical formulation for the treatment of basal cell carcinoma. VAR-102, an oral formulation, is being developed for the treatment of a wide variety of solid tumors where studies have shown potent aPKCi inhibition would be impactful, including non-small cell lung cancer (NSCLC), pancreatic cancer and colorectal cancer. For more information, visit www.varianbio.com.