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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On January 5, 2023 iOnctura, a clinical-stage biotech developing selective cancer therapies against targets that play critical roles in multiple tumor survival pathways, reported an update on IOA-244, its lead cancer drug, which is in development for solid and hematologic malignancies including uveal melanoma, a rare cancer arising within the uveal tract of the eye (Press release, iOnctura, JAN 5, 2023, View Source [SID1234625936]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

After assessing the novel chemical and biological properties of IOA-244, and the promising signals of clinical activity seen to date in patients with uveal melanoma, the US FDA granted Orphan Drug Status for IOA-244. This grants certain benefits during development and commercialization. Uveal melanoma is a disease in which cancer originates in the tissues of the eye, causing symptoms such as blurred vision or a dark spot on the iris. When the cancer metastases, which it does in approximately 50% of patients, there are limited treatment options and projected overall survival is only a year.

A PI3Kδ inhibitor, IOA-244 recently received the proposed name roginolisib and is being investigated in the DIONE-01 trial, a two-part, first-in-human Phase I study (ClinicalTrials.gov, identifier NCT04328844). Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. Part B is an ongoing cohort-expansion of the biologically-effective dose (BED) of 80mg in solid and hematologic malignancies including a recently opened non-Hodgkin´s lymphoma cohort.

As of December 2022, 38 patients (including 23 with metastatic uveal melanoma and eight patients with follicular lymphoma) have been treated with IOA-244. Across all patients treated to date, roginolisib given at the BED showed less than 5% Grade 3 or Grade 4 toxicities, with these toxicities being transient in nature. There have been no dose-limiting drug reductions or interruptions and long-term (over six months) administration of IOA-244 is well tolerated.

Clinical activity, including partial and complete responses, are being seen in patients with both solid and hematologic malignancies. Further details on clinical responses will be released at a future international clinical conference in 2023. Fourteen of 38 patients (including 11 of 23 uveal melanoma patients) are still on treatment, with two patients having been on treatment for more than two years. The one-year OS rate is currently 70%; median OS has not been reached.

Catherine Pickering, Chief Executive Officer of iOnctura, said: "We are delighted to provide these positive updates on IOA-244, our lead clinical program. These important new data, taken together with previous findings, show a drug with a game-changing clinical safety and activity profile. These data demonstrate for the first time that a semi-allosteric inhibitor of PI3Kδ can be given to patients safely for long durations with no serious adverse events. We are excited to take IOA-244 forwards into a monotherapy registration study in uveal melanoma and to further explore its potential both in lymphoma and solid tumors such as NSCLC."

On January 5, 2023 Esperovax, an innovative developer of oral mRNA biologics, and Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, reported a partnership to develop circular RNAs (circRNAs) for a variety of therapeutic applications (Press release, Esperovax, JAN 5, 2023, View Source [SID1234625934]). Initially, Ginkgo and Esperovax will work to develop circRNAs harboring payloads to specifically target colorectal cancer by inducing cell death only in cancerous cells.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CircRNAs represent an emerging, powerful mechanism for delivering therapeutics and vaccines due to their protein-coding potential and improved stability in comparison to their linear mRNA counterparts. This partnership aims to further exploit circRNAs by developing a novel mechanism to facilitate RNA circularization specifically in colorectal cancer cells. This would result in extended expression of the toxic payload solely in cancer cells, reducing toxicity and resulting side effects from the death of normal cells. By combining omics datasets, computational approaches, and high-throughput screening capabilities, Ginkgo will design, build and screen large numbers of RNA designs that leverage and optimize Esperovax’s novel mechanism of cell-type specific circularization. Through its growing portfolio of programs in cell and gene therapy and RNA therapeutics, and recent acquisition of Circularis, Ginkgo is uniquely positioned to enable new solutions in these areas with circRNA.

"One of the most exciting things about being at Ginkgo is the opportunity to work together with startups like Esperovax in the early stages of development and collaborate on such incredible innovations as circular RNA technology," said Narendra Maheshri, Head of Mammalian Foundry at Ginkgo Bioworks. "Building off of Esperovax’s novel mechanism for circularization, we’re thrilled to use our platform to further develop and optimize it to enable advancements in the therapeutics space – a core area of our work."

"Given therapeutic developments in recent years, the idea of inducing a suicide gene therapy system in a tissue-specific manner has gained traction," said Randy Wayne Schekman, a Nobel Prize recipient in Physiology or Medicine and Advisor at Esperovax. "As we aim to build off that traction with the ultimate goal of improving cancer patient outcomes, Ginkgo’s momentum and achievements in the therapeutics space made the company an essential and trusted team to partner with, giving us the confidence that we can eventually make this goal a reality."

On January 5, 2023 Jnana Therapeutics, a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, reported that Joanne Kotz, Ph.D., Co-founder and Chief Executive Officer, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 3:30 p.m. PT (6:30 p.m. ET) (Press release, Jnana Therapeutics, JAN 5, 2023, View Source [SID1234625933]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 5, 2023 A trial led by City of Hope, one of the largest cancer research and treatment organizations in the nation, contributed to the U.S. Food and Drug Administration’s reported approval of mosunetuzumab (commercial name: Lunsumio), the first bispecific antibody to treat people with relapsed or difficult to treat follicular lymphoma (FL), a type of non-Hodgkin lymphoma, after they have received two or more standard therapies (Press release, City of Hope, JAN 5, 2023, View Source [SID1234625931]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mosunetuzumab is a CD20xCD3 T cell engaging bispecific antibody and represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available for infusion, allowing patients to start treatment soon after diagnosis in an outpatient setting.

Instead of concentrating on a singular target, bispecific antibodies are therapeutics that act on two cellular targets simultaneously. In the case of mosunetuzumab, one "arm" targets the CD3 protein on T cells, an immune cell that fights against cancer once engaged; a second "arm" binds to CD20, a protein commonly found on lymphoma cells.

"This approval is a significant milestone for people with relapsed or refractory follicular lymphoma and signifies the beginning of a new treatment modality for lymphoma since mosunetuzumab is the first bispecific antibody approved for lymphoma," said Elizabeth Budde, M.D., Ph.D., hematologic oncologist and associate professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and the mosunetuzumab pivotal trial principal investigator. "At City of Hope, the integration of scientific research and clinical trials allows us to deliver groundbreaking science and treatments from laboratory to patient. Mosunetuzumab is a first in class T cell engaging bispecific antibody and could change the way advanced follicular lymphoma is treated."

Budde led a multicenter Phase 2 study in people with heavily pretreated FL, including those who were at high risk of disease progression or whose disease didn’t respond to prior therapies. Results from the study showed high and durable response rates and an impressive benefit-risk profile.

An overall response rate, which is the combination of a complete response rate, or the disappearance of all signs and symptoms of cancer, and a partial response rate was seen in 80% of patients treated with mosunetuzumab, with a majority maintaining responses after 24 months. The median duration of response among those who responded was not reached. A complete response rate was achieved in 60% of patients.

The most common side effects were cytokine release syndrome, which occurred in 44% of patients. Other common side effects included fatigue, rash, pyrexia and headache.

"The two cell groups are pulled together, with mosunetuzumab serving as a kind of bridge," Budde said. "Being in such close proximity allows the now activated T cells to better recognize and attack the lymphoma cells."

Ninety patients with follicular lymphoma, who ranged in age from 29 to 90 years old, were enrolled in the multicenter international trial. The patients received mosunetuzumab, a Genentech medicine, intravenously every 21 days for a minimum of eight cycles and up to 17 cycles.

Juan Yee, 49, of San Diego was one of the patients in the City of Hope trial whose lymphoma had relapsed for a second time.

"I couldn’t go through chemo again," said Yee. He was first diagnosed in 2012 with FL and relapsed in 2016. He experienced weight loss, easy fatigue and persistent night sweats. "It was painful, and I was tired. I was done."

But thanks to one last try with mosunetuzumab, Yee has been in complete remission for nearly five years now.

"When I was going through treatments, I would ask God why this was happening to me," Yee said. "And now I think it’s so that I could do this (mosunetuzumab) trial and help other people. I can share my positive experience and let people know they shouldn’t give up. Have faith."

Follicular lymphoma is the most common slow-growing form of non-Hodgkin’s lymphoma, accounting for about 1 in 5 cases. It typically responds well to treatment, but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2022, and more than 100,000 people are diagnosed with FL each year worldwide.

City of Hope is a leader in blood cancer immunotherapies. The National Cancer Institute-designated comprehensive cancer center has performed more than 18,000 bone marrow/stem cell transplants and is a leader in chimeric antigen receptor (CAR) T therapy, with more than 1,000 patients treated with immune effector cells, including CAR T therapy, and more than 70 open trials.