On January 5, 2023 Akamis Bio (formerly PsiOxus Therapeutics), a clinical-stage oncology company leveraging its Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform to positively impact the lives of people living with cancer, reported a $30 million convertible note financing co-led by a group of leading US life science investors (Press release, PsiOxus Therapeutics, JAN 5, 2023, View Source [SID1234625938]). In addition, the company provided a progress update on its clinical pipeline programs, NG-350A and NG-641, while announcing a relaunch of the company as Akamis Bio building upon its ongoing corporate transformation. In conjunction with the corporate name change, the company has launched a new website at www.akamisbio.com.

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The $30 million convertible note financing was co-led by new US investors ARCH Venture Partners, the Parker Institute for Cancer Immunotherapy, and Westlake Village BioPartners. It will further fund development activities for the clinical stage NG-350A and NG-641 programs, as well as general corporate purposes.

"Over the last several years, we have undergone an incredible transformation as a company, and our new name reinforces this evolution and our focused commitment to oncology drug development. The $30 million financing will enable the continued advancement of our clinical pipeline of T-SIGn therapeutics and further establishes our US footprint," said Howard Davis, Ph.D., Chief Executive Officer of Akamis Bio. "As we relaunch the company today, we thank our existing and new investors for their support and shared commitment to leveraging our groundbreaking solid-tumor targeted T-SIGn therapeutics to turn the tide in the battle against cancer."

Akamis Bio, formerly PsiOxus Therapeutics, was founded and has grown with the support of leading global and European investors including SROne, IP Group, Hambro Perks, Lundbeckfonden, Sedgwick Yard, Mercia Asset Management, and Rosetta Capital Limited.

"We are excited to support the talented team at Akamis Bio in their efforts to bring a set of powerful new immuno-oncology therapeutics to people living with cancer," said Robert Nelsen, Co-founder and Managing Director of ARCH Venture Partners. "We are delighted to partner with Akamis Bio’s existing investors as the company advances its current clinical programs and continues to expand its pipeline of T-SIGn therapeutics."

Clinical Progress Update – NG-350A & NG-641

Akamis Bio’s T-SIGn therapeutics are viral vector-based, tumor gene therapies which have demonstrated the ability to specifically home to and replicate within primary and metastatic solid tumor tissue following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive intratumoral expression of multiple immunologically active biomolecules and therapeutic proteins to remodel the tumor microenvironment and trigger robust antitumor immune responses. Akamis Bio’s clinical pipeline of T-SIGn therapeutics is anchored by two Phase 1 programs: NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody; and NG-641, a stromal-targeted tumor gene therapy driving intratumoral expression of a FAP-CD3 bispecific antibody, CXCL-9, CXCL-10, and interferon alpha.

Across more than 200 patients with epithelial-derived solid tumors who have been treated in Akamis Bio’s clinical trials to date, T-SIGn therapeutics have been well-tolerated and demonstrated a consistent safety profile. In clinical studies, NG-350A and NG-641 have shown promising preliminary evidence of clinical activity including dose-dependent elevation of systemic immune response cytokines and dose-dependent increases in CD8+ immune cell infiltrates within the targeted solid tumor tissue.

As the ongoing clinical studies for NG-350A (FORTITUDE and FORTIFY) and NG-641 (STAR, NEBULA, and MOAT) advance in 2023, Akamis Bio will continue to assess safety, tolerability, and preliminary efficacy in both monotherapy and combination (with checkpoint inhibitors) settings, as well as the potential benefits of multiple cycles of T-SIGn therapeutic dosing. Akamis Bio anticipates the initiation of a set of expansion cohort studies for NG-350A and NG-641 in early 2024 to demonstrate clinical proof-of-concept in patient populations with a single type of epithelial-derived solid tumor.

Akamis Bio Corporate Relaunch

The company’s new name is derived from "Akamas," one of the warriors who was inside of the mythical Trojan Horse which facilitated the successful Greek attack on Troy from inside the city’s otherwise impenetrable walls. The name is a nod toward the "Trojan Horse" mechanism of action of its T-SIGn therapeutics which enter solid tumor cells and turn them into "drug factories" to facilitate the immune system’s attack on the tumor from the inside.

The company’s relaunch builds on the ongoing corporate transformation which has included the Q3 2022 hiring of a new US-based CEO in Howard Davis, Ph.D., as well as the company’s Q4 2022 establishment of its hub of US operations in Kendall Square in Cambridge, Massachusetts. In conjunction with the corporate name change, the company has launched a new website (www.akamisbio.com).

About T-SIGn

Akamis Bio’s Tumor-Specific Immuno-Gene (T-SIGn) therapeutics are chimeric group B adenoviral vector-based, tumor gene therapies which are capable of homing specifically to primary and metastatic solid tumors following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive intratumoral expression of multiple immunologically active biomolecules and therapeutic proteins encoded by the vector to remodel the tumor microenvironment and trigger robust antitumor immune responses. T-SIGn therapeutics have potential for use in the treatment of solid tumors as monotherapy, as well as in combination with other immuno-oncology agents (e.g., checkpoint inhibitors, antibody drug conjugates, bispecific T-cell engagers, and cell therapies) to enable and/or enhance the efficacy of those modalities in the solid tumor setting. Akamis Bio has an extensive and growing body of clinical experience with T-SIGn therapeutics with more than 200 patients treated across both the monotherapy setting, as well as in combination with checkpoint inhibitors. Across clinical studies, T-SIGn therapeutics have demonstrated a consistent safety and tolerability profile, as well as promising preliminary evidence of clinical activity.