On September 18, 2023 Kintara Therapeutics, Inc. (NASDAQ: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal year ended June 30, 2023 and provided a corporate update (Press release, Kintara Therapeutics, SEP 18, 2023, View Source [SID1234635222]).

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RECENT CORPORATE DEVELOPMENTS

Awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC). (June 2023)
Hosted a Key Opinion Leader (KOL) event featuring Patrick Y. Wen, M.D. (Harvard Medical School) and John de Groot, M.D. (UCSF Health) who discussed the current treatment landscape for patients suffering from glioblastoma (GBM), the most common and lethal form of brain cancer, along with Kintara’s potential treatment solution with VAL-083, a potential first-in-class small molecule chemotherapeutic. (August 2023)
Announced that the Company will be presenting a poster at the 2023 European Association of Neuro-Oncology (EANO) Annual Meeting taking place in Rotterdam, Netherlands, September 21-24, 2023. The presentation will include data from its lead program, VAL-083, for the treatment of recurrent GBM. (September 2023)
"We are looking forward to presenting additional compelling VAL-083 data at the EANO Annual Meeting later this month and continue to anticipate announcing top-line data in the international registrational GBM AGILE Study before the end of calendar 2023," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "We were thrilled to be awarded a $2.0 million grant from the NIH to support the further development of REM-001 in CMBC and expect to enroll the first patient in our planned 15-patient study in the fourth quarter of calendar year 2023."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 YEAR ENDED JUNE 30, 2023

As of June 30, 2023, Kintara had cash and cash equivalents of approximately $1.5 million.

For the year ended June 30, 2023, Kintara reported a net loss of approximately $14.6 million, or $9.27 per share, compared to a net loss of approximately $22.7 million, or $25.80 per share, for the year ended June 30, 2022. The decreased net losses for the year ended June 30, 2023 compared to the year ended June 30, 2022 was largely due to lower research and development expenses, primarily lower clinical development costs. General and administrative costs were also lower during the same period primarily due to reduced level of staffing.

Selected Balance Sheet Data (in thousands)

June 30,

2023

June 30,
2022

$

$

Cash and cash equivalents

1,535

11,780

Working capital

188

9,268

Total assets

3,979

15,948

Total stockholders’ equity

731

11,795

Selected Statement of Operations Data (in thousands, except per share data)

For the year ended

June 30,

June 30,

2023

2022

$

$

Research and development

9,311

15,173

General and administrative

5,485

7,509

Other income

(147)

(21)

Net loss for the year

(14,649)

(22,661)

Series A Preferred cash dividend

(8)

(8)

Series C Preferred stock dividend

(362)

(2,462)

Net loss for the period attributable to common stockholders

(15,019)

(25,131)

Basic and fully diluted weighted average number of shares

1,620

974

Basic and fully diluted loss per share

(9.27)

(25.80)

Kintara’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: View Source

On September 18, 2023 Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, and Lenox Hill Hospital’s Department of Neurological Surgery reported the initiation of a Phase 2 study to assess the safety and effectiveness of azeliragon in combination with radiation therapy as a treatment for newly diagnosed unmethylated glioblastoma (Press release, Cantex, SEP 18, 2023, View Source [SID1234635221]).

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Glioblastoma is a highly malignant primary brain tumor for which current therapeutic options provide a limited life extension benefit. Unmethylated glioblastoma does not respond well to chemotherapy, further limiting the available treatment options for patients with this severe form of cancer. New treatments for glioblastoma are urgently needed.

"We are pleased to announce the initiation of patient enrollment at Lenox Hill Hospital, a world-class provider of neurosurgical and cancer treatment, into this important Phase 2 clinical study," said Stephen G. Marcus, M.D., Cantex’ Chief Executive Officer. "Azeliragon inhibits activation of a receptor known as ‘RAGE’ on the surface of glioblastoma cells. RAGE has been implicated in the progression of glioblastoma and its resistance to radiation therapy. In pre-clinical studies, azeliragon enhanced the effectiveness of radiation therapy. With this study, we seek to enhance the effectiveness of radiation therapy and delay or prevent disease progression."

"Through the initiation of this Phase 2 study at Lenox Hill Hospital, we seek to explore the safety and potential efficacy of azeliragon as a treatment of unmethylated glioblastoma, which is less responsive to chemotherapy. This potential therapy may be an option for patients who lack many other treatment alternatives," said John Boockvar, MD, Vice Chair and Professor of Neurosurgery at Lenox Hill Hospital, and adjunct Professor at Cold Spring Harbor Laboratory.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from whom Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex also has ongoing clinical trials in newly diagnosed glioblastoma, brain metastasis, neoadjuvant therapy of breast cancer, metastatic pancreatic cancer, and hospitalized COVID patients to prevent acute kidney injury. These trials are based on robust pre-clinical data as well as the extensive clinical safety information from randomized placebo-controlled clinical trials.

On September 18, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the initiation of the Phase 2 portion of its Phase 1/2 study evaluating its lead candidate, masofaniten (formerly known as EPI-7386), a first-in-class N-terminal domain androgen receptor inhibitor, in combination with Astellas and Pfizer’s antiandrogen enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens (Press release, ESSA, SEP 18, 2023, View Source [SID1234635220]).

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Updated results from the first four cohorts of patients from the Phase 1 dose escalation portion of the Phase 1/2 study have been selected for a poster presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Congress taking place October 20-24, 2023, in Madrid, Spain.

"Initiation of the randomized Phase 2 portion of this study investigating the combination of masofaniten and enzalutamide (the "Combination") is a significant milestone for ESSA and we look forward to reporting updated results from the Phase 1 dose equilibration portion of the study next month at ESMO (Free ESMO Whitepaper) 2023," stated David Parkinson, M.D., President and CEO of ESSA. "The favorable safety profile observed to date with the Combination has led the safety review board to agree that we can proceed forward into the head-to-head comparison portion of the study with the dose regimen studied in Cohort 4 as our recommended Phase 2 dose. We look forward to further elucidating the Combination’s potential to improve long-term clinical benefit for patients with mCRPC. We plan to provide guidance for timing of the public disclosure of initial data once the Phase 2 portion has been underway for several months."

The Phase 2 dose expansion portion of the study is a two-arm, randomized, open-label study (NCT05075577) that will evaluate the safety, tolerability and preliminary efficacy of masofaniten, and is expected to enroll approximately 120 patients. Patients will continue to receive androgen deprivation therapy and will be randomized 2:1 to receive either the combination of masofaniten (600mg twice-daily ("BID")) and enzalutamide (160mg once daily ("QD")) or enzalutamide (160mg QD) as a single agent. Patients may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.

Details for the ESMO (Free ESMO Whitepaper) 2023 Presentation
Title: Phase 1/2 Trial of Oral EPI-7386 in Combination with Enzalutamide (Enz) Compared to Enz Alone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Subjects: Current Phase 1 (P1) results
Speaker: Andrew L. Laccetti
Presentation #: 1813P
Date: Sunday, October 22, 2023

About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten’s unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

On September 18, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported it will present preliminary dose-escalation data from its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 at the 35th AACR (Free AACR Whitepaper)-NCI-EORTC (ANE) Symposium taking place October 11-15, 2023, in Boston, Massachusetts (Press release, Nuvalent, SEP 18, 2023, View Source [SID1234635219]).

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The presentation marks the first disclosure of data characterizing the safety and clinical activity of NVL-655 from the Phase 1 dose-escalation portion of the ongoing ALKOVE-1 Phase 1/2 clinical trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. NVL-655 has been designed with the aim to address challenges that limit clinical use of existing ALK tyrosine kinase inhibitors (TKIs), including treatment emergent resistance mutations, lack of brain penetrance, and off-target CNS adverse events. The ALKOVE-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial.

Nuvalent plans to host a conference call and webcast on October 13, 2023. Details for the conference call will be provided at a future date and available on the Nuvalent website at www.nuvalent.com.

Details for the presentation are as follows:

Title: Safety and preliminary activity of the selective ALK inhibitor NVL-655 in patients with ALK fusion-positive solid tumors
Abstract Number: 35177
Poster Number: B154
Session: Poster Session B
Session Date and Time: Friday, October 13, 12:30 pm-4:00 pm
Presenting Author: Jessica J Lin, Massachusetts General Hospital (MGH), Boston, MA

About NVL-655

NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients. NVL-655 is currently being investigated in the ALKOVE-1 clinical trial (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors.

On September 18, 2023 Medigene AG (Medigene, the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported that it has selected its lead candidate for MDG2011, a T cell receptor engineered T cell (TCR-T) therapy targeting KRAS (Kirsten rat sarcoma viral oncogene homologue) G12V with HLA-A*11 and being developed in combination with the Company’s PD1-41BB costimulatory switch protein (CSP) technology (Press release, MediGene, SEP 18, 2023, View Source [SID1234635218]).

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Medigene’s end-to-end (E2E) platform, has successfully generated not one but three KRAS G12V-HLA-A*11 TCRs, each with distinct, multiple HLA-A*11 subtype recognition patterns that exceed the Company’s selection criteria for highly specific, sensitive and potentially safer (3S) TCRs. After deploying Medigene’s proprietary algorithms for evaluation of the unique characteristics of each of the 3S TCRs, including peptide specificity, tumor cell recognition and off-target toxicity, the Company has prioritized one of the 3S TCRs as the lead to move forward to the pre-clinical stage for Medigene’s MDG2011 program.

"The unique approach of our E2E platform to generate and optimize 3S TCRs, has continued to deliver above expectations and we are delighted to have been presented with the positive challenge of having to select a lead from three strong candidates for our MDG2011 program targeting KRAS G12V-A11," said Dr. Selwyn Ho, Chief Executive Officer at Medigene.

"The selection of this first mKRAS (mutant KRAS) lead TCR further validates our capabilities to generate 3S TCRs across both neoantigens and cancer-testis antigens. By combining all our TCRs with our PD1-41BB or CD40L-CD28 costimulatory switch proteins, we remain convinced that our approach will consistently deliver best-in-class TCR-T therapies leading to improved outcomes for patients suffering from difficult-to-treat solid tumors. We look forward to presenting the first pre-clinical data on MDG2011 at upcoming scientific conferences in the last quarter of 2023."

The Company’s E2E platform continues to generate 3S TCRs with unique attributes that add additional dimensions to the potential of Medigene’s TCR-T therapies as well as to confirm the Company’s discovery research efforts. One such attribute is the identification of a TCR candidate demonstrating bi-specific recognition for both the KRAS G12V and G12C mutations. Directed TCR discovery efforts in the future will enable identification of an optimal KRAS G12C-specific TCR lead. The two remaining KRAS G12V-A11 TCRs not selected for the MDG2011 program will be added to Medigene’s KRAS TCR library for potential future programs that align the product vision with the profile of each TCR. Patents have been filed for each of the three TCRs.

MDG2011 is the first program of Medigene’s pipeline expansion into a library of neoantigens (also known as oncogenic driver mutations) that comprise multiple KRAS mutations and HLAs (human leukocyte antigens) including, but not limited to:

KRAS G12V-HLA-A*11 (MDG2011)
KRAS G12V-HLA-A*03 (MDG2012)
KRAS G12D-HLA-A*11 (MDG2021)

These TCRs will be combined with the PD1-41BB and/or the CD40L-CD28 costimulatory switch proteins to enhance penetration, proliferation, persistence and enhanced cytotoxic function of Medigene’s TCR-T cells while mitigating the immunosuppressive effects of the tumor microenvironment.

Neoantigens are tumor-specific antigens, which play a critical role in the growth and maintenance of tumors. These mutations are found in many solid tumors and their prevalence varies depending on the cancer type. Importantly, if present, these mutations are found in each tumor cell. KRAS mutations are widely recognized as the most common oncogene mutations in difficult to treat solid tumors existing in ~30% of solid tumors, such as pancreatic, colorectal, endometrial and non-small-cell lung cancer. Global incidence of solid tumors expressing KRAS mutations is estimated to be in excess of 300,000 patients.