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Akoya Biosciences Announces Peer-Reviewed Publication Using Ultrahigh-Plex Spatial Phenotyping of Head and Neck Cancer to Identify Distinct Immune and Metabolic Signatures

On October 17, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that researchers from Akoya Biosciences and The University of Queensland’s Frazer Institute have comprehensively mapped the spatial proteome of head and neck squamous cell carcinoma (HNSCC) using ultrahigh-plex spatial phenotyping (Press release, Akoya Biosciences, OCT 17, 2023, View Source [SID1234636053]). Spatial phenotyping consists of whole-slide imaging of tissue sections at single-cell resolution to visualize and quantitate biomarker expression and reveal how cells interact and organize across the entire tissue landscape.

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The study, published in GEN Biotechnology in an article titled "Mapping the Spatial Proteome of Head and Neck Tumors: Key Immune Mediators and Metabolic Determinants in the Tumor Microenvironment" identified a high degree of intra- and inter-tumoral heterogeneity intrinsic to head and neck cancers and advances the understanding of the mechanistic basis of variable clinical responses.

The study analyzed head and neck cancer tissues from a patient with varying responses to immune checkpoint inhibitor (ICI) therapy. The analysis was conducted using a panel of 100+ biomarkers to measure key cancer hallmarks of tumor and immune biology with Akoya’s PhenoCycler-Fusion system. The PhenoCycler-Fusion is the fastest spatial biology solution available which enables rapid imaging of whole slides at single-cell resolution.

"This study represents a significant advancement in multiplexed imaging and, to our knowledge, is the first single-cell spatial proteomic dataset integrating information from immune, metabolic and stress pathways to provide a holistic view into the biology of heterogenous HNSCC tumors" noted Niyati Jhaveri, PhD, Head of Applications at Akoya Biosciences. "It provides an analytical framework for future spatial studies leveraging the resolution, plex and speed of Akoya’s solution to decipher the complex nuances of human tissues in homeostasis and disease."

A pivotal discovery in the study highlighted the divergent enrichment of functionally specialized immune cell subsets, as well as distinct metabolic and stress signatures organized within specific spatial domains in the tumor. This overarching observation in the paper underscored the existence of heterogeneous niches and competitive microenvironments, potentially serving as defining factors for clinical response and resistance.

"Immune checkpoint inhibitors have shown promising results in recurrent and metastatic cases of HNSCC," said Dr. Arutha Kulasinghe, of The University of Queensland’s Frazer Institute, leader of the Clinical-oMx Lab, and one of the paper’s authors. "Durable treatment results, however, are observed in only 30% of patients, indicating that new biomarkers for stratification of responders and non-responders are needed. The dichotomy of immune activation-induced death and tumor progression we observed in an individual patient’s tissue sample correlated with the partial response seen with ICI therapy. We believe that the approach outlined in this study will pave the way towards a new understanding of tumor microenvironment features associated with response and sensitivity to immune checkpoint inhibitor therapies in head and neck cancer and other solid malignancies."

AIM ImmunoTech Engages Business Development Firm, Azenova, LLC to Catalyze Partnering, Development and Commercialization Efforts for Ampligen® Pipeline Programs

On October 17, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM") reported that it has entered into an agreement with Azenova, LLC ("Azenova"), a professional business development (BD) consulting firm, to support efforts to partner AIM’s pipeline programs with a particular focus on the company’s lead asset, Ampligen, for the treatment of various malignant solid tumors (Press release, AIM ImmunoTech, OCT 17, 2023, View Source [SID1234636052]).

Azenova has been engaged to assist AIM with its BD efforts with the goal of entering into a partnership, out-license or other transaction whereby a biopharmaceutical company takes on the further development and commercialization of Ampligen with the goal of maximizing value to AIM. This process may not result in any transaction and the company does not intend to disclose additional details unless and until it has entered into a definitive agreement.

"With our growing body of compelling clinical data, we believe Ampligen has significant potential to provide a therapeutic solution for a wide range of cancers, immune disorders and viral diseases. We believe the timing of our engagement with Azenova perfectly aligns their BD expertise with our strategic vision to maximize the opportunities for our Ampligen pipeline programs and to unlock significant value in the asset," commented AIM Chief Executive Officer Thomas K. Equels.

Azenova provides a wide range of services to support clients in their partnership, licensing, and other transactional activities. This includes determining opportunities for partnership (assets and technologies), identification and assessment of potential partners and leading all steps involved in engaging partners and establishing definitive BD transaction agreements. Azenova’s principals, Jeff Southerton, PhD, MBA, and Stacy Evans, MD, MBA, have more than 50 years of combined BD experience in the biopharmaceutical industry leading transactions across a wide range of deal structures in multiple therapeutic areas, including significant experience in oncology.

"With AIM’s emerging data showing the promise of Ampligen as a therapeutic across a pipeline of malignant and often end-stage solid tumors, Azenova is excited to be formally engaged by AIM to assist the company with materializing a potential value inflecting BD transaction for the company," commented founder of Azenova, Jeff Southerton.

ImmuneOnco’s clinical trial application for humanized antibody drug IMM47 targeting CD24 was approved by the National Medical Products Administration (NMPA)

On October 16, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco""the company’, Hong Kong Stock Exchange stock code: 01541.HK) reported that the company’s independently developed humanized IgG1 CD24 antibody(Project number: IMM47) was approved by the National Medical Products Administration (NMPA) for clinical trials (Press release, ImmuneOnco Biopharma, OCT 16, 2023, View Source [SID1234655694]). This is another milestone achievement in the rapid development of ImmuneOnco.

IMM47 had also made a number of progresses previously by the efforts of the ImmuneOnco team. On September 27, the Australian phase I clinical trial of IMM47 successfully completed the enrollment of the first subject and officially entered the clinical research stage. The preclinical research results of the IMM47 project were published in "Antibody Therapeutics" on September 9. So far, IMM47 has obtained two authorized patents in China, and Japan, two pending patent applications in the United States and the European Union, and one pending patent application that may enter multiple approval of PCT patent of contracting countries in the future. In addition, we are ready to submit an IND application for IMM47 to the U.S. Food and Drug Administration (FDA) in near future.

CD24 is widely expressed in a variety of solid tumors including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, ovarian cancer, and lymphoma, and is considered as an important marker of poor prognosis in these cancers which exhibits great clinical research potential.

With high specificity and high affinity to CD24 expressed on tumor cells, IMM47 can block immunosuppressive signals transmitted from the CD24/Siglec-10 pathway to macrophages, natural killer cells (NK) and T cells. By genetically engineered improved IgG1 Fc, IMM47 effectively activates macrophage and natural killer cell immune responses through powerful ADCP and ADCC. In preclinical animal in vivo efficacy studies, IMM47 showed to significantly increase the number of M1 macrophages in tumor tissues and downregulate CD24 expression in tumor cells, which also provide chances in combination with PD-1/PD-L1 immune checkpoint inhibitors and other drugs.

Dr. Tian, Wenzhi, founder and chairman of Immune Onco, said:" We are very pleased to see that our clinical trial application for IMM47, a humanized monoclonal antibody targeting CD24 for cancer treatment, was approved by the National Medical Products Administration (NMPA). The antibody screening for CD24 was quite challenging due to its small size of extracellular domain which exhibits weaker immunogenicity. We persevered through the accumulation of a lot of trivial work and finally got the IMM47 molecule with high affinity and specificity. With differentiated molecular design, IMM47 can specifically bind to CD24 and effectively activate macrophages and natural killer cell immune responses. Preclinical studies have shown that IMM47 has strong anti-tumor activity with great clinical development value. We will quickly advance the clinical trial of IMM47 to benefit more patients."

SOTIO Further Expands Next-Generation ADC Platform with License to Synaffix’s ADC Technology

On October 16, 2023 SOTIO, a clinical-stage immuno-oncology company owned by PPF Group, reported a license and option agreement with Synaffix B.V., a Lonza company, to develop next-generation antibody-drug conjugates (ADCs) for the treatment of solid tumors (Press release, SOTIO, OCT 16, 2023, View Source [SID1234649863]). SOTIO will leverage Synaffix’s ADC technology platform to develop up to three novel ADCs targeting distinct tumor-associated antigens.

"At SOTIO, we are building a broad pipeline of next-generation ADCs to address the challenges of solid tumors – and access to Synaffix’s ADC platform technologies will ensure we remain at the leading edge of this space," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "This collaboration combining SOTIO’s deep expertise in solid tumor drug development with Synaffix’s clinical-stage platform technology will drive important new innovations for the benefit of patients."

The deal enables SOTIO to combine its proprietary antibodies with Synaffix’s ADC technology platform in order to deliver innovative new ADCs that can overcome the challenges of treating solid tumors. In addition to GlycoConnect and HydraSpace, the deal also includes Synaffix’s potent linker-payload platform including multiple different payloads.

"Synaffix’s ADC technology perfectly complements the technologies already in SOTIO’s ADC platform, including the iADC technology licensed from NBE-Therapeutics and the ConjuALL technology licensed from LegoChem," said Martin Steegmaier, chief scientific officer of SOTIO. "The addition of Synaffix’s capabilities will greatly expand our ability to select and tailor the most suitable ADC technology and payload for the needs of a particular target and particular solid tumor indication."

Under the terms of the agreement, Synaffix is eligible to receive upfront and potential milestone payments worth up to $740 million, plus single-digit royalties on net sales. SOTIO will be responsible for research, development, manufacturing and commercialization of the ADC products, while Synaffix will closely support SOTIO’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect, HydraSpace, and linker-payload technologies.

Peter van de Sande, head of Synaffix, added, "The selection of our ADC technologies by a seasoned ADC player like SOTIO is a strong recognition of the potential of these technologies to maximize the therapeutic index of ADCs. We look forward to partnering with SOTIO, and believe that with their singular focus on cancer immunotherapies and robust clinical pipeline, this partnership can deliver innovative medicines for patients in areas of high unmet medical need."

SOTIO is advancing a pipeline of novel ADCs tailored to address the treatment needs of specific solid tumor types. SOT102, the company’s most advanced ADC program, is a CLDN18.2-targeting ADC in Phase 1/2 development for the treatment of gastric, pancreatic and other cancers that have very few targeted treatment options available. The company is progressing dose-finding studies in the trial’s monotherapy arm, with SOT102 as a later-stage treatment, and recently announced the initiation of the trial’s combination therapy arm in first-line treatment of gastric and pancreatic cancer patients. SOTIO additionally has two other ADC programs in preclinical development.

Theralase Provides Update on Bladder Cancer Clinical Study

On October 16, 2023 Theralase reported an update to its Phase II Bacillus Calmette Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected Ta / T1 papillary disease) clinical study ("Study II") (Press release, Theralase, OCT 16, 2023, View Source [SID1234636147]).

To date, Theralase has enrolled and provided the primary Study II Treatment for 62 patients.

The Study II Endpoints have been defined as:

Primary: Efficacy – Defined as Complete Response ("CR") rate at any point in time (CR is defined as at least one of the following:

Negative cystoscopy and negative (including atypical) urine cytology
Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology
Negative cystoscopy with malignant urine cytology, if urothelial cancer is suspected in the upper tract or prostatic urethra and random bladder biopsies are negative)
Secondary: Duration of CR – Defined as 12 months post initial CR assessment

Tertiary: Safety – Defined as the incidence and severity of Adverse Events ("AEs"), Grade 4 or higher, directly related to the Study Drug or Study Device, that do not resolve within 450 days post primary Study II Treatment; whereby: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening or disabling, Grade 5 = Death.

In addition, survival surveillance for all patients, who achieve a CR or Indeterminate Response ("IR") (negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies) at 450 days and remain in Study II will be monitored past 450 days.

In performance to the primary, secondary and tertiary endpoints, refer to the clinical data below.

Achieved Primary Objective (n) Achieved Primary Objective (%) Achieved Secondary Objective (n) Achieved Secondary Objective (%) Achieved Tertiary Objective (n) Achieved Tertiary Objective (%)
Complete Response ("CR") 37 65% 14 33% 57 100%
Indeterminate Response ("IR") 5 9% 2 5% 0 0%
Total Response (CR and IR) 42 74% 16 38% 57 100%
Evaluable Patients 57 42 57

Note: Evaluable patients are defined as patients who have been assessed by a principal investigator during a particular assessment visit.

The CR, IR and Total Responders are detailed below by assessment visit.

TLD 1433-2 Clinical Study (Evaluable Patients)
Assessment 90 Day 90 Day 180 Day 180 Day 270 Day 270 Day 360 Day 360 Day 450 Day 450 Day
# % # % # % # % # %
Complete Response ("CR") 33 58% 31 56% 23 46% 16 36% 14 33%
Indeterminate Response ("IR") 4 7% 8 15% 6 12% 2 4% 2 5%
Total Responders (CR and IR) 37 65% 39 71% 29 58% 18 40% 16 38%
Total Evaluated 57 55 50 45 42

On August 1, 2020, the Company optimized the Study II Treatment. For patients that received the optimized Study II Treatment the CR, IR and Total Responders are detailed below by assessment visit.

TLD 1433-2 Clinical Study (Evaluable Patients) (Optimized: Post August 1, 2020)
Assessment 90 Day 90 Day 180 Day 180 Day 270 Day 270 Day 360 Day 360 Day 450 Day 450 Day
# % # % # % # % # %
Complete Response ("CR") 29 64% 28 62% 20 50% 13 37% 11 34%
Indeterminate Response ("IR") 3 7% 7 16% 5 13% 2 6% 2 6%
Total Responders (CR and IR) 32 71% 35 78% 25 63% 15 43% 13 41%
Total Evaluated 45 45 40 35 32

Theralase is currently working with its clinical study sites in Canada and the United States to compile information requested by the Food and Drug Administration ("FDA") for re-submission of a pre-Break Through Designation ("BTD").

If the pre-BTD submission is successful, this could lead to BTD approval.

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated, "Theralase is delighted in its latest clinical data analysis. The Theralase RuvidarTM-based Anti-Cancer Therapy ("ACT") has shown remarkable single-agent activity by proving to be safe and effective on a very difficult to treat BCG-Unresponsive patient population that has been diagnosed with high-grade NMIBC CIS, with or without resected Ta / T1 papillary tumours. These patients have failed the standard of care, such as BCG therapy and a large majority of them have failed treatment with various modern immunotherapy drugs. Theralase has been able to demonstrate strong efficacy in the form of a CR or IR, with a well-tolerated safety profile, after predominately one treatment. This ACT technology, pending successful regulatory approval and commercialization, will be very attractive to patients, uro-oncologists and the insurance companies that insure these patients."

Mr. Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer of Theralase stated, "To date, the Theralase Study II clinical data has demonstrated best-in-class performance for a single agent, providing high efficacy, durable response and a high safety profile, with no serious adverse events directly related to RuvidarTM or the TLC-3200 Medical Laser System. Theralase hopes to complete patient enrollment with accompanying administration of the primary Study II Treatment by year end 2024. If successful, this will allow the Company the ability to complete assessment of the primary, secondary and tertiary endpoints of these patients by 2026. Based on the clinical data to date, Theralase is investigating potential partnerships for commercialization, financing and distribution of this ACT technology on an international basis. Theralase looks forward to commercializing this world-class technology for the benefit of all shareholders."