Oxford, UK April 17th, 2024. Theolytics, a biotechnology company developing next-generation oncolytic viral therapies, today announced it has successfully closed its latest financing round, raising a total of £19M ($24.5M) with the addition of Sound Bioventures as a new investor. Sound Bioventures joins a strong international syndicate of existing investors participating in the round that includes M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises and the University of Oxford.

The proceeds from this financing round further strengthen the company’s position as it advances its lead oncolytic adenovirus – THEO-260 – into clinical trials in ovarian cancer. The first trials are planned for this year and will aim to demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients.

Following this investment, Thomas Tan, Principal at Sound Bioventures, will join Theolytics’ Board of Directors.

Charlotte Casebourne Stock, Chief Executive Officer of Theolytics, said; “We’re on the brink of a potential step-change for the oncolytic adenovirus field. Our lead asset THEO-260 will be entering the clinic this year, and at this key juncture we are pleased to complete this significant financing and welcome Sound Bioventures as a new investor alongside our existing investors. Sound Bioventures’ extensive oncology experience, network, operational expertise and collaborative approach will bring important benefits to Theolytics and I am delighted to welcome Thomas Tan to our Board.”

Thomas Tan, Principal at Sound Bioventures, added; “The oncolytic virus modality is rapidly evolving, and we believe that Theolytics is well positioned at the forefront of this exciting therapy area. With THEO-260 about to enter the clinic, we see a significant opportunity to help bring an important and potentially practice-changing therapy to the many women suffering from this fatal disease. I look forward to working with the Board and management team bringing our hands-on approach to support the company’s unwavering fight against cancer.”

“THEO-260 has the potential to bring a much-needed new therapy to ovarian cancer patients and their families that are impacted by this devastating disease,” said Mike Grey, Executive Chair of the Board. “Theolytics is at a pivotal point as it approaches its first clinical trial and we are delighted to welcome Sound Bioventures, a highly knowledgeable and experienced investor with extensive oncology and company building expertise, to our group of leading international investors.”

About Ovarian Cancer (OC)

It is estimated that around 7,500 women in the UK and 20,000 women in the US will be diagnosed with ovarian cancer in 2024. More than 75% of cases will be diagnosed at an advanced stage (grade-III/IV) with less than 25% of patients expected to survive for more than five years.

Standard-of-care, first-line treatments combine cytoreductive-surgery, platinum-based chemotherapies, and paclitaxel. Although initially effective, more than 70% of patients relapse within three years and become resistant to platinum-based therapies. There are no effective treatments for platinum-resistant OC and at this point patients have a life-expectancy of less than 12 months.

About THEO-260

THEO-260 is a next-generation oncolytic adenovirus for the treatment of (platinum-resistant) ovarian cancer. It is highly efficacious in killing cancer cells and cancer-associated fibroblasts in ovarian cancer patient tumour samples. The destruction of cancer-associated fibroblasts, in addition to cancer cells, is a potentially differentiating feature of THEO-260 as cancer-associated fibroblasts in stromal-rich tumours are a barrier to the effectiveness of many cancer treatments. THEO-260 is being explored as a therapeutic for intravenous and intraperitoneal delivery.

About Theolytics

Theolytics is working to develop next-generation oncolytic viral therapies. The company has pioneered a new approach to develop efficacious, targeted candidates suitable for systemic intravenous delivery.

The company is focused on the advancement of its lead program THEO-260 into the clinic with the ambition of providing better outcomes for patients with ovarian cancer, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and hematological malignancies where there remains significant unmet need.

Theolytics, which was founded in 2017 and is headquartered in Oxford, UK, is backed by international life sciences investors M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises, Sound Bioventures and the University of Oxford.

www.theolytics.com

About our Investors

For more information on our investors please see the following websites:
M Ventures 
Taiho Ventures 
Epidarex Capital 
Oxford Science Enterprises
Sound Bioventures
The University of Oxford

Contacts

Theolytics
enquiries@theolytics.com

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting




MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

Findings validate clinical proof of mechanism of MTL-CEBPA as a combination therapy in solid tumor cancers

Company to initiate out-licensing activities of its immuno-oncology portfolio, including MTL-CEBPA

LONDON–(BUSINESS WIRE)–MiNA Therapeutics Limited, the pioneer in small activating RNA (RNAa) therapeutics, will present positive updated biomarker data from its Phase 1a/b TIMEPOINT study of MTL-CEBPA in combination with the anti-PD1 checkpoint inhibitor, pembrolizumab, in adults with advanced solid tumors at the annual meeting of the American Association of Cancer Research (AACR) in Orlando, Florida. Findings from the Phase 1b portion of the study validate the clinical proof of mechanism of MTL-CEBPA as a combination treatment and identify a novel predictive biomarker of clinical response. The data will be presented on Tuesday, April 18, during a late-breaking research session beginning at 9:00 am EDT.

MTL‑CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cells. Dysregulated myeloid cells are implicated in several diseases including solid tumor cancers. MTL-CEBPA is designed to improve the effectiveness of checkpoint inhibitors and other immunotherapies by enhancing the body’s immune response and ability to attack the cancerous cells. Interim data from an open-label, multi-center study demonstrated the safety, tolerability, immunological and clinical activity of MTL-CEBPA in combination with pembrolizumab.

“Anti-PD1 checkpoint inhibition has significantly advanced the treatment of cancer, but many patients are resistant to treatment and present with tumors that resemble an ‘immune-desert’,” said Robert Habib, CEO of MiNA Therapeutics. “The updated analysis of TIMEPOINT shows that MTL-CEBPA used in combination with anti-PD1 checkpoint inhibitors profoundly reprograms the tumor microenvironment, reducing resistance and enabling infiltration of disease-fighting T-cells.”

The TIMEPOINT study also identified a novel predictive biomarker of clinical response to the combination treatment, presenting an opportunity for further evaluation as a potential companion diagnostic. The novel biomarker predicted clinical response across multiple tumor types.

MiNA plans to explore out-licensing opportunities for its immuno-oncology portfolio, which uniquely combines the capability to specifically restore or boost any dysregulated gene target with clinically validated in vivo delivery to myeloid immune cells.

MiNA’s immuno-oncology portfolio includes the following programs:

• MTL‑CEBPA, which has been cleared for evaluation in a global Phase 2 clinical trial in combination with the tyrosine kinase inhibitor, sorafenib, in advanced hepatocellular carcinoma (HCC or liver cancer) and in a Phase 1 clinical trial in pediatric patients with MPS1 Hurler Syndrome
• MTL-STING currently in pre-clinical development
• Additional programs currently in discovery

About TIMEPOINT

TIMEPOINT is a global Phase 1a/b clinical study in patients with solid tumor malignancies to assess the safety and tolerability of MTL‑CEBPA in combination with pembrolizumab in patients who are ineligible or resistant to standard therapies. The study has received clearance from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). To learn more about the TIMEPOINT clinical study, visit ClinicalTrials.gov (NCT04105335).

The poster presentation at AACR entitled, “MTL-CEBPA in combination with pembrolizumab converts an immune desert to an inflamed TME in solid tumors resistant to checkpoint blockade,” will be available on MiNA’s website in the Publications section under “RNA Activation”.

About MTL-CEBPA

MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases, and in solid tumor cancers these cells have been identified as a critical barrier to induction of clinical response for many therapies. In pre-clinical studies, MTL-CEBPA has been shown to improve the anti-tumor activity of cancer therapies by targeting dysregulated myeloid cells and reducing or eliminating their suppressive effect on immune response and therapies in the tumor microenvironment.

About MiNA Therapeutics

MiNA Therapeutics is the global leader in small activating RNA therapeutics or RNAa. Harnessing innate mechanisms of gene activation, RNAa therapeutics are a revolutionary new class of medicines that can restore or boost normal function of genes and thereby protein-modulated pathways in patients’ cells. We are advancing a proprietary pipeline of new medicines with an initial focus on genetic medicine, while collaborating with leading pharmaceutical companies to apply our technology platform across a broad range of other therapeutic areas. Based on our unique know-how in RNA activation, we are expanding the possibilities of RNA-based medicine for patients. www.minatx.com

Contacts

MiNA Therapeutics

Peter Bains, CBO

+44 208 811 6700

bd@minatx.com

Media:
Mike Beyer

Sam Brown, Inc.

mikebeyer@sambrown.com
+1 312-961-2502