On November 7, 2023 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, reported financial results for the third quarter ended September 30, 2023 and key operational updates (Press release, MAIA Biotechnology, NOV 7, 2023, View Source [SID1234637199]).

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"Our successful and productive third quarter was punctuated by the outstanding data on our lead asset THIO that we recently revealed, and an accelerating pace of enrollment in our THIO-101 Phase 2 trial," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We are expanding our trial in Europe, and with the FDA’s recent clearance for THIO studies in the U.S. as part of THIO-101, we have reached an essential milestone in the clinical development of THIO. Preliminary efficacy data from the trial is excellent and includes an unprecedented disease control rate (DCR) of 100% in second-line NSCLC treatment, far surpassing the standard of care DCR of 53-64%. We achieved the pre-determined statistical requirements to proceed to the next stage of the trial earlier than expected, and we look forward to sharing our continuing progress in the coming months and into 2024."

Third Quarter Business Highlights and Recent Developments

THIO Program

Announced 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data: 100% preliminary DCR was observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the THIO-101 Phase 2 trial.

Highly Potent Anticancer Activity in Gliomas: MAIA’s lead asset THIO showed highly potent anticancer activity in models of glioma, an aggressive type of brain tumor that originates from glial cells and is among the most difficult-to-treat cancers. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the-art care temozolomide (TMZ).

THIO as Potential Therapy for Pediatric Brain Cancer: Study data showed THIO’s potent anticancer activity in diffuse intrinsic pontine glioma (DIPG), one of the most aggressive tumors affecting the central nervous system in children. The treatment resulted in noticeably increased tumor sensitivity to immune or ionizing radiation therapies.

Higher Anticancer Potency of Next Generation THIO Conjugates: Positive Investigational New Drug-enabling study data on telomere-targeting agents derived from lipid-modified THIO molecules warrant further in vivo in-depth investigation of THIO-like agents as second generation cancer therapies.

THIO-101 Phase 2 Clinical Trial

U.S. FDA Clearance of THIO IND Application: The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application enabling THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced non-small cell lung cancer (NSCLC). THIO is being tested in sequential combination with a checkpoint inhibitor (CPI) to evaluate anti-tumor activity and immune response in NSCLC patients.

Strong Pace of Enrollment in THIO-101: 49 patients have been dosed to date at a pace of enrollment that is currently exceeding the average enrollment pace in similar NSCLC trials. Out of the 49 patients dosed, 37 have already completed at least one post baseline assessment.

Continuing Positive Preliminary Survival Data: The first 2 subjects dosed on trial (both receiving 3rd line of treatment) reported long term survival of 14.6 and 12.5 months, respectively, at the latest post baseline assessment with no new anti-cancer treatment initiated. Follow up was ongoing for the first subject at the time of data cut-off.

Third Quarter 2023 Financial Results

Cash Position: Cash totaled approximately $6.1 million as of September 30, 2023, compared to $10.9 million in cash as of December 31, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended September 30, 2023, compared to approximately $2.3 million for quarter ended September 30, 2022. The increase was primarily related to an increase in scientific research expenses.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million for the quarter ended September 30, 2023, compared to approximately $1.7 million for the quarter ended September 30, 2022. The increase for the quarter was primarily related to an increase in professional fees related to the write-off of deferred offering costs and an increase in investor relations costs.

Other Income, Net: Other income was approximately $0.08 million for the quarter ended September 30, 2023, compared to other income, net of $0.19 million for the quarter ended September 30, 2022, primarily related to a change in the fair value of warrant liability.

Net Loss: Net loss was approximately $4.9 million, or $0.36 per share, for the quarter ended September 30, 2023, as compared to net loss of approximately $4.9 million, or $0.48 per share, for the quarter ended September 30, 2022. Weighted average shares outstanding were 13,675,802 in the third quarter of 2023, compared to 10,165,622 in the third quarter of 2022.

For additional information on the Company’s financial results for the quarter ended September 30, 2023, please refer to the Form 10-Q filed with the SEC.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD-1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On November 7, 2023 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported that three research studies done in collaboration with Weill Cornell Medicine will be presented as poster presentations at the 20th International Cancer Genome Consortium (ICGC) Scientific Workshop/ 7th Accelerating Research in Genomic Oncology (ARGO) meeting (Press release, BostonGene, NOV 7, 2023, View Source; [SID1234637198]). The event, scheduled for November 7 – 9 in New York, is hosted by Weill Cornell Medicine’s Englander Institute for Precision Medicine and will provide updates on genomic profiling of cancers and underscore the global mission to eradicate the burden of cancer.

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Details of the presentations are as follows:

Title: Reconstruction of the Metastatic Castration-Resistant Prostate Tumor Microenvironment with Comprehensive Profiling Reveals Unique Subtypes
Presenter: Ahmed Elsaeed, MD, Weill Cornell Medicine

Metastatic castration-resistant prostate cancer (mCRPC) that is not dependent on the androgen receptor accounts for approximately 25-30% of fatal prostate cancer cases. In this study, BostonGene’s transcriptome-based tumor microenvironment (TME) classification approach identified five previously unidentified subtypes in both a meta-cohort and an independent cohort. These subtypes exhibit distinct molecular features and are linked to histological traits, sample origins, and clinical information, thereby offering the potential for enhanced molecular stratification with clinical-pathological relevance.

Research conducted in collaboration with Weill Cornell Medicine

Title: Reconstruction of the Glioblastoma (GBM) Tumor Microenvironment (TME) with Comprehensive Profiling Reveals Unique Subtypes
Presenter: Majd Al Assaad, MD, Weill Cornell Medicine

Understanding tumor heterogeneity is critical to improve cancer therapies in glioblastoma (GBM), the most common primary brain cancer in adults. Using transcriptomic profiling, five novel tumor microenvironment (TME) subtypes were identified in a GBM meta-cohort and an independent cohort. These subtypes are characterized by variations in gene expression and cellular composition and are linked to histological features, sample origins, and clinical prognosis.

Research conducted in collaboration with Weill Cornell Medicine

Title: The intratumor Microbiome Profile in Prostatic Adenocarcinoma is Consistent within Different Metastatic Sites
Presenter: Jeremy Miyauchi, MD, Weill Cornell Medicine

The tumor microbiome is composed of tumor-type-specific intracellular bacteria and may be associated with cancer progression and resistance to chemotherapy. An analysis of microbiome using RNAseq revealed strong correlations among microbiomes across different metastatic tumor sites within prostate cancer patients. Characterizing microbiome profiles in different sites can aid in treatment selection and help to understand clinical outcomes.

Research conducted in collaboration with Weill Cornell Medicine

Click here to learn more about the 20th International Cancer Genome Consortium Scientific Workshop/ 7th Accelerating Research in Genomic Oncology (ARGO) meeting.

On November 7, 2023 AdvanCell, a radiopharmaceutical company developing a pipeline of Targeted Alpha Therapies for cancer patients, reported the first patient was treated with 212Pb-ADVC001, a Targeted Alpha Therapy in development for the treatment of PSMA-positive metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, Advancell, NOV 7, 2023, View Source [SID1234637197]).

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"We believe that 212Pb is the ideal radioisotope to realise the full therapeutic power of Targeted Alpha Therapy. This promise is strongly supported by preclinical results for 212Pb-ADVC001, which demonstrate the potential for best-in-class safety and efficacy."

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"The first patient dosed with an AdvanCell therapeutic candidate represents a major milestone for the Company, our scientists, clinical trial sites, and our patients," said Andrew Adamovich, CEO of AdvanCell. "We believe that 212Pb is the ideal radioisotope to realise the full therapeutic power of Targeted Alpha Therapy. This promise is strongly supported by preclinical results for 212Pb-ADVC001, which demonstrate the potential for best-in-class safety and efficacy."

"Patients with metastatic prostate cancer continue to benefit from advances in radiopharmaceutical treatment options," said Ken Herrmann, MD, AdvanCell Advisory Board member and Chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen in Germany. "We are excited to be moving this 212Pb-based therapy forward in the TheraPb clinical study."

Since November 2020, AdvanCell has:

Developed the world’s first 212Pb-based Targeted Alpha Therapy to enter clinical trials in metastatic prostate cancer.
Invented proprietary platform technology that enables scalable manufacture of 212Pb, the ideal radioisotope to treat cancer.
Signed a letter of intent with a world-class radiopharmaceutical company to collaborate on a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network.
Developed a proprietary target discovery and ligand development program encompassing a robust pipeline of Targeted Alpha Therapies to treat cancer.
Raised US $13M from world-class investors including Morningside and awarded $10M in non-dilutive grant funding,
Participated in the Cancer Lethality Lead Collaboration, which was awarded $10M from the Prostate Cancer Foundation’s TACTICAL Awards program, in collaboration with the Peter MacCallum Cancer Centre, Uniklinik Essen, University of California Los Angeles, and University of California San Francisco.
Built a 25-person world-class team across Australia and the United States and secured a 35,000-square-foot flagship manufacturing facility with plans to expand globally.

About 212Pb-ADVC001
212Pb-ADVC001 was designed to bind to PSMA, a clinically validated cell surface target highly expressed in prostate cancer. The proprietary drug candidate has been optimised for safety and efficacy and has demonstrated potential best-in-class attributes in preclinical studies.

About TheraPb Clinical Trial
The Phase I/II trial of 212Pb-ADVC001 is a multicentre, open-label study evaluating safety and efficacy in patients with PSMA-positive mCRPC. The trial’s primary objectives are to assess safety and tolerability and identify a recommended Phase II dose. Secondary objectives include measures of dosimetry, rPFS by RECIST and PSMA PET-CT, and PSA response. Multiple sites for the Phase I/II clinical trial of ADVC001 are now open for enrolment. For more information, visit clinicaltrials.gov (NCT05720130).

On November 7, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that 50 patients have now been imaged with 64Cu-SAR-Bombesin in its United States-based diagnostic trial, SABRE (NCT05407311)[1], for participants with PSMA-negative prostate cancer (Press release, Clarity Pharmaceuticals, NOV 7, 2023, View Source [SID1234637196]).

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SABRE, which derives from "Copper-64 SAR-Bombesin in Biochemical Recurrence of prostate cancer" is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin. The primary objectives of the trial are to investigate the safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer.

Andrei Iagaru, MD, the Lead Principal Investigator for the trial, commented, "We are very excited to have successfully imaged 50 participants in the SABRE trial which further explores the clinical benefits of the innovative SAR-Bombesin product. Preclinical and clinical findings thus far indicate that SAR-Bombesin holds significant potential for improving the diagnosis and treatment of prostate cancer, giving hope to clinicians and patients who have no other suitable diagnostic options available. Being able to now visualise the gastrin-releasing peptide receptor (GRPr) expressing lesions with SAR-Bombesin has the potential to change the entire treatment paradigm for patients. With more tools to detect prostate cancer that may not be visible with other imaging agents, we may be able to better diagnose and offer more effective treatment for their disease.

"Unique to Clarity’s SAR Technology is the ability to image patients at later timepoints due to the optimal half-life of 64Cu. As such, 64Cu-SAR-Bombesin enables imaging not only on the day of product administration, but also at later timepoints, which may add utility to the diagnosis of cancerous lesions. We look forward to analysing data from the SABRE trial in hopes of continuing to validate the benefits associated with this agent and better managing the patients that have few options at present in the face of a devastating diagnosis."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are pleased to have reached our recruitment target in our Phase II SABRE trial with the 64Cu-SAR-Bombesin imaging product. SAR-Bombesin has already resulted in improvements to the management of prostate cancer for patients with PSMA-negative or low PSMA expressing lesions through our clinical program. We believe this product has immense potential, both as a theranostic and as a stand-alone diagnostic, as it targets GRPr, which is present in a number of cancers, potentially broadening its use beyond PSMA-negative prostate cancer.

"The successful C-BOBCAT and BOP investigator-initiated trials have already showed the utility of SAR-Bombesin and its potential to identify disease in some patient subgroups where conventional diagnostic imaging has failed. We look forward to reporting further data relating to the potential advantages of SAR-Bombesin and, subject to these results, moving this product into a registrational Phase III trial."

About SAR-Bombesin

SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in up to 100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)[2-6]. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

64Cu-SAR-Bombesin and 67Cu-SAR-Bombesin are unregistered products. Individual results may not represent the overall safety and efficacy of the products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide[7]. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease[8].

Approximately 20% of prostate cancers with BCR are PSMA-PET negative[9-12]. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.

On November 7, 2023 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay) reported that the first patient has been dosed in the Phase I Clinical trial of BRY812, a third-generation antibody-drug conjugate (ADC) targeting LIV-1 for the treatment of advanced malignant tumors (Press release, BioRay Pharmaceutical, NOV 7, 2023, View Source [SID1234637195]). The leading institution of this clinical trial is Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the principal investigators are academician Song Erwei and Professor Yao Herui.

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LIV-1, also known as SLC39A6 or ZIP6, is a multipass transmembrane protein belonging to the ZIP superfamily of zinc transporters, possesses zinc transporter and metalloproteinase activities. LIV-1 directly participates in the homeostasis metabolism of intracellular zinc ions, facilitating the transport of zinc ions from the extracellular space or intracellular organelles to the cytoplasm, influencing cell growth. To date, there are no approved drugs worldwide that target LIV-1, making BioRay’s BRY812 the first LIV-1 ADC in China and the second to enter clinical trials globally.

BRY812 uses the proprietary CysLink irreversible chemical conjugation technology platform and highly stable linker to conjugate the antibody with the toxin. BRY812 has shown significant tumor growth inhibition in preclinical studies, and demonstrated excellent anti-tumor activity that is potentially superior to similar drugs. Compared to other drugs of the same class, it exhibits higher circulation stability, effective release of the payload within the tumor while significantly reducing toxin shedding and exchange in serum. This provides BRY812 with a great safety profile and an improved therapeutic window. Furthermore, BRY812 can also induce immunogenic cell death (ICD) and enhance the anti-tumor effects of immunotherapies such as anti-PD-(L)1.

Dr. Zhu Wei, CMO of BioRay, stated, " The significant market potential of ADCs requires differentiation in the market competition and expanding coverage to a broader patient population. As the first domestic ADC targeting LIV-1 to enter clinical trials, BRY812 is expected to treat various advanced malignant tumors, meet more clinical medication needs, and provide more treatment options for patients."