On November 10, 2022 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development company, and Acuitas Therapeutics, a private biotechnology company focused on the development of delivery systems for nucleic acid vaccines and therapeutics based on lipid nanoparticles (LNP), reported the signing of an agreement to evaluate the combination of IMUNON’s PLACCINE nucleic acid vaccine constructs formulated with Acuitas’ proprietary lipid delivery technology (Press release, IMUNON, NOV 10, 2022, View Source [SID1234623819]). Under the agreement, IMUNON will evaluate administration of its vector constructs formulated in various Acuitas LNP formulations for gene expression and immunogenicity in murine models.

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"We are delighted to enter into this technology evaluation agreement with Acuitas Therapeutics, an organization renowned for its delivery technology capabilities, particularly with its LNP systems for mRNA vaccines," said Corinne Le Goff, Ph.D., President and Chief Executive Officer of IMUNON. "In light of the recent successes with our PLACCINE technology and promising proof-of-concept SARS CoV-2 data in non-human primates, we believe the time is right to explore the expansion of our technology to other types of delivery systems as we position our nucleic acid-based modality as the future of vaccinology."

IMUNON has demonstrated initial proof-of-concept of its PLACCINE nucleic acid vaccine platform in rodent and non-human primate models through intramuscular (IM) administration of PLACCINE plasmid DNA constructs expressing single or multiple SARS-CoV-2 antigens in combination with the PLACCINE delivery system. In October 2022, IMUNON reported partial results from an ongoing non-human primate study that examined a single plasmid DNA vector containing the SARS-CoV-2 Alpha variant spike antigen formulated with a synthetic DNA delivery system. In the study, Cynomolgus monkeys were vaccinated with the PLACCINE vaccine or a commercial mRNA vaccine on Day 1, 28 and 84.

Analysis of blood samples for IgG and neutralizing antibodies showed evidence of immunogenicity in both PLACCINE- and mRNA-vaccinated subjects. PCR analysis of bronchoalveolar lavage showed viral clearance by >90% of the non-vaccinated controls. In a majority of vaccinated animals, viral clearance from nasal swab followed a similar pattern and a similar clearance profile was observed when viral load was analyzed by the tissue culture infectious dose method. In an ongoing stability study, the physio-chemical properties and immunogenicity of PLACCINE vaccine did not change during storage at 4° C for up to six months.

Thomas Madden, Ph.D., President and Chief Executive Officer and co-founder of Acuitas Therapeutics, said, "We are excited to collaborate with IMUNON to evaluate nucleic acid-based vectors delivered using our LNP technology."

Acuitas Therapeutics was founded by Drs. Pieter Cullis, Michael Hope and Thomas Madden, who in September 2022 received Canada’s Governor General’s Innovation Award. This prestigious award recognized their work in developing LNP systems to deliver cancer drugs to tumors and to enable RNA- and DNA-based drugs for therapeutic use. Among other achievements, their work resulted in the LNP system that enables COMRINATY, the Pfizer/BioNTech COVID-19 mRNA vaccine.

About the PLACCINE Platform

PLACCINE, part of IMUNON’s proprietary nucleic acid technology with synthetic delivery systems platform, is the subject of multiple patent applications that cover a broad range of next-generation nucleic acid vaccines. An adaptation of the Company’s TheraPlas technology for therapeutic proteins, PLACCINE is a modality for prophylactic vaccines characterized by a single nucleic acid vector with multiple coding regions. The vaccine vector is designed to express multiple pathogen antigens along with the option to include a potent immune modifier. PLACCINE has potential to be easily modified to create vaccines against a multitude of infectious diseases, with benefits including:

Durability of protection – Durable antigen expression induces robust immunological response
Breadth of protection – Multi-cistronic vectors increase the breadth of immune response and allows for combination vaccines
Transmission advantage – Option for co-expression of potent immune modifiers increases the immune response and lowers the risk of viral shedding
Safe and convenient – Synthetic delivery systems present no risk of genotoxicity (i.e., no virus or cytotoxicity) and require no device; it also allows for convenient handling for pandemic control
Flexible manufacturing – Versatile platform enables rapid response to changing pathogens; stability at normal refrigerator temperatures simplifies handling and distribution

On November 10, 2022 Corner Therapeutics, a biotechnology company exploiting a new scientific paradigm to boost memory T cell responses to disease, reported with presentation of data on its dendritic cell hyperactivation (hDC) platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 8-12, 2022 in Boston, Massachusetts (Press release, Corner Therapeutics, NOV 10, 2022, View Source [SID1234623787]).

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Corner has developed a new therapeutic modality—DC hyperactivators—which induce the production of polyclonal populations of long-lived memory T cells that exhibit durable protective immunity to cancer. Using proprietary chemicals and formulations, Corner’s DC hyperactivators mimic the molecular signals dendritic cells naturally experience during virulent infections.

The resulting hyperactive dendritic cells exhibit migratory capacity that is 30 times greater than what can be elicited by current FDA-approved immunostimulants. This enhanced migration enables far more antigen to be delivered to lymph nodes and a diversification of the resulting T cell responses that mediate protective immunity. DC hyperactivators also induce production of cytokines from dendritic cells that Toll-like Receptor (TLR) and other known immunostimulants cannot elicit, such as the key memory T cell inducing cytokine interleukin-1 (IL-1). The combination of these activities enables Corner’s DC hyperactivators to stimulate human memory T cells 1000 times more effectively than TLR-based dendritic cell stimuli. Preclinical models of cancer revealed that DC hyperactivators diversify the repertoire of antigens that T cells can target and enable mice to eradicate tumors that are resistant to PD-1 based checkpoint blockade.

"We are pleased to be sharing data on the use of Corner’s proprietary immunotherapy platform at SITC (Free SITC Whitepaper)’s annual meeting, revealing this new paradigm that can enable a class of immunotherapies," said Steven M. Altschuler, M.D., CEO and Board Chair of Corner. "Rather than simply enhancing the T cells that patients already have, Corner is exploring therapy that is designed to enable the generation of new and robust inflammatory anti-tumor T cells. This innovation opens the door to the next level of treatment for patients suffering from cancers and infectious diseases."

Corner’s platform was developed with foundational science that came out of the Kagan and Karp labs at Harvard Medical School. The company has received seed funding from Ziff Capital Partners.

"Dendritic cells are the key to the generation of new and effective T cell responses against cancer, but durable immunity is only achieved if immunotherapies stimulate DCs properly," said Jonathan Kagan, Ph.D., Scientific Co-founder and Advisor to Corner. "Unlike approaches of the past, Corner’s technology boosts the migration and T cell memory-inducing activities of DCs. These innovations may enable us to realize the common goal of immunotherapies—to protect for life."

"Corner is moving quickly towards broad, transformative impact on oncology and infectious disease built on a powerful platform," said Nick Seaver, founding member and Managing Director from Ziff Capital Partners. "We are thrilled to partner with Corner as they advance their therapeutic pipeline toward the clinic."

On November 10, 2022 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported a partnership with HDX Corporation (HDX) to bring TLS’s targeted radiation therapy to South Korea for the treatment of difficult-to-treat cancers, such as brain, head and neck cancers and melanoma (Press release, TAE Life Sciences, NOV 10, 2022, View Source [SID1234623786]).

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Under the terms of the partnership, HDX, a premier distributor of radiation therapy medical equipment and clinical services based in Seoul will provide primary sales, marketing, services, and distribution channel for the TLS Alphabeam System, including radiation oncology equipment, software and boron target drugs in South Korea.

"I am very pleased to announce the partnership with HDX. HDX is the ideal partner that has deep relationships with major hospitals in South Korea, a strong sales organization, and the established capability to provide clinical and technical support to our future customers," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "South Korea has a strong history in adoption of advanced radiation therapy solutions. Our cutting-edge Alphabeam System provides both an in-hospital neutron source technology and the boron target pharmaceuticals that are required for a comprehensive BNCT system."

TLS will provide support and training to HDX and intends to work with HDX to develop a local-language training and clinical education base in the future.

"Our partnership with TAE Life Sciences underscores the global expansion of BNCT as a unique cancer treatment for difficult-to-treat cancers," Sang-Jin Jung, CEO of HDX. "We are excited to work alongside TAE Life Sciences to provide this personalized radiation therapy in South Korea."

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On November 10, 2022 Seagen Inc. (Nasdaq: SGEN) reported that data from the company’s diverse pipeline of targeted cancer therapy candidates will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting being held November 8-12 in Boston (Press release, Seagen, NOV 10, 2022, View Source [SID1234623785]). The presentations highlight data from multiple ongoing clinical and preclinical research studies that employ Seagen’s proprietary antibody-drug conjugate (ADC) technology, as well as other novel cancer targeting approaches.

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"Seagen has a deep heritage in pioneering first-in-class antibody-drug conjugates. We are encouraged by initial results from a clinical study of SGN-B6A, a wholly owned investigational antibody-drug conjugate that demonstrated antitumor activity with an acceptable safety profile in previously treated patients with non-small cell lung cancer, head and neck cancer, and esophageal cancer," said Megan O’Meara, M.D., Senior Vice President of Early-Stage Development at Seagen. "We are also sharing new data demonstrating enhanced preclinical activity of enfortumab vetodin in combination with immune checkpoint inhibitors, as well as preclinical data that support the initiation of a first-in-human study of a bispecific molecule called SGN-BB228."

Highlights From SGN-B6A Program Presented at SITC (Free SITC Whitepaper)

Data from an ongoing Phase 1 study of SGN-B6A, an ADC directed to integrin beta-6, which is overexpressed in multiple solid tumors, showed early efficacy signals in at least three cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal squamous cell carcinoma (ESCC).

Dose escalation cohorts enrolled 79 participants with metastatic or unresectable solid tumors, whose disease had relapsed or was refractory to standard of care therapies and had not previously received an MMAE-containing agent or agent targeting integrin beta-6. Participants had received a median of 3 lines of therapy for metastatic disease prior to enrollment in the study. SGN-B6A demonstrated a manageable and tolerable safety profile at the explored dose levels and schedules. Intermittent dosing schedules (2Q3W, 2Q4W) are being evaluated further. The initial anti-tumor activity observed in heavily pre-treated patients is encouraging and has triggered expansion cohorts in NSCLC, HNSCC, and ESCC, which are currently ongoing. SGN-B6A is an investigational agent, and its safety and efficacy have not been established.

Additional Details of Seagen Presentations at SITC (Free SITC Whitepaper) Annual Meeting 2022

All posters will be available at the beginning of the session, both in-person and virtually.

On November 10, 2022 CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, reported new updated data from its global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG) (Press release, CG Oncology, NOV 10, 2022, View Source [SID1234623782]).

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The results were announced in an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, held virtually and in person in Boston, MA.

"We’re excited to present these results, which continue to support CG0070’s promise in patients with bladder cancer unresponsive to BCG, a difficult-to-treat patient population," said Arthur Kuan, Chief Executive Officer, CG Oncology. "We are seeing continued positive results for CG0070 in combination with pembrolizumab in NMIBC patients unresponsive to BCG. Enrollment in this study is now completed, and data readout on all patients through a minimum of 12 months is expected in 2023."

Summary of Interim Clinical Results

Abstract #666 – Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

The new data for CORE1 adds to that presented at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting earlier this year and continues to show both promising early anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG-unresponsive NMIBC.

As of the interim analysis, based on a data cutoff on October 10, 2022, 32 patients were evaluable for efficacy with a minimum of 3-month follow up.
88% of patients evaluable for efficacy (n=28/32) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 88% (n=23/26) have also maintained a CR through 6 months, 86% (n=18/21) through 9 months and 73% (n=11/15) at the 12-month assessment.
CG0070 in combination with pembrolizumab has been generally well tolerated with the adverse event profile consistent with that observed in prior studies of each agent alone. The most common treatment-related adverse events reported include transient grade 1-2 local genitourinary symptoms.
"There is a critical unmet need for efficacious bladder-sparing therapies for patients with BCG-unresponsive bladder cancer," said Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center. "CG0070 has continued to show very promising results, more than doubling CR rates previously seen with immune checkpoint inhibitors. With a unique dual-mechanism of action that first engages an immune response and then amplifies that response with immune checkpoint blockade, this novel combination of CG0070 with pembrolizumab could potentially change the outlook for patients with BCG-unresponsive bladder cancer."

About the CORE1 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 in combination with pembrolizumab, CORE1, which has completed enrollment of 35 total patients, is to evaluate the safety and efficacy of CG0070 plus pembrolizumab for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About CG0070

Our lead candidate, CG0070, is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. CG0070 is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO (nivolumab).