On January 16, 2024 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a certificate of grant for the Company’s foundation patent was received from the Canadian Intellectual Property Office (Press release, Propanc, JAN 16, 2024, View Source [SID1234639263]). The foundation patent covers composition claims for the Company’s lead product candidate, PRP. In further news, the PRP dosing and method to treat cancer stem cells (CSCs) patents were validated in countries across Europe, resulting in the Company’s IP portfolio growing to 87 patents filed in major global jurisdictions.

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The Canadian foundation patent is the final application to receive a certificate of grant in the Company’s foundation patent family (there are two divisional patents remaining citing additional inventions in the US and Mexico further dividing an original patent,). This means that grant status has been secured in every jurisdiction in which the Company has filed a foundation patent application. Propan has achieved grant status for the foundation patent in over 30 different countries across North America, Europe, Asia, the Middle East and Japan.

The PRP dosing patent is an important part of the IP portfolio covering possible future clinical dosage ranges for PRP as the Company advances into early stage clinical development. For the CSCs patent, the claims cover a method to minimize the progression of cancer in a patient who has already received a first line treatment by detecting the presence of CSCs, followed by administering PRP. The future potential clinical application describes when a patient experiences a relapse and the cancer returns after primary standard of care has been applied. Europe is considered a major global region and in 2022, the worldwide pharmaceutical market was valued at approximately $1.48 trillion by Statista.com and accounted for 23.4% of global pharmaceutical sales in 2021, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).

"The advancement of our growing IP portfolio in these major regions gives us confidence that we are leading a novel approach using proenzyme technology as a long-term therapy for the treatment and prevention of metastatic cancer from solid tumors by targeting and eradicating CSCs," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Our lead product candidate, PRP, is unique from other approaches as it targets CSCs, but leaves healthy cells alone, making it less toxic compared to standard treatment approaches. Furthermore, PRP is known as differentiation therapy, which means it does not directly kill CSCs, but enforces them to return to a less malignant state so they die naturally. This means a less aggressive and toxic approach, providing a better quality of life for the patient, but we hope effective over a prolonged period, because you can treat them for longer, minimizing the threat of recurrence. We look forward to advancing PRP into the clinic, and together with our growing IP portfolio, establishing the Company as a pioneer in the way we treat this killer disease."

On January 16, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a commercial-stage biotech company, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company’s B-cell lymphoma-2 (BCL2) inhibitor, ICP-248 (Press release, InnoCare Pharma, JAN 16, 2024, View Source [SID1234639283]). This is InnoCare’s fifth innovative drug to enter the clinical stage in the U.S.

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This is a Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ICP-248 in hematologic malignancy patients.

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. The Phase I dose escalation trial of ICP-248 is ongoing in China, and the preliminary results demonstrated good efficacy and safety profiles.

BCL2 is an important regulatory protein of the apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 exhibits its anti-tumor effects by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, "ICP-248 would become an important asset for the Company’s globalization after orelabrutinib. The current study results will support ICP-248 to treat hematologic malignancies as a monotherapy or in combination with other therapies. Meanwhile, InnoCare is dedicated to building a leading franchise in hemato-oncology, and we have developed multiple drugs that cover a variety of important hemato-oncology targets such as BTK, CD19, CD20xCD3, BCL2 and E-3 ligase to address unmet medical needs."

On January 15, 2024 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds ("PDCs") for the safe and effective destruction of various cancers, bacteria and viruses reported an update regarding its Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II") (Press release, Theralase, JAN 15, 2024, View Source [SID1234639945]).

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To date, Study II has provided the primary study treatment for 63 patients.

In 2016, Kamat et al. stated in the Journal of Clinical Oncology that the International Bladder Cancer Group ("IBCG") recommended that, "Single-arm designs may be relevant for the BCG-unresponsive population. Here, a clinically meaningful initial complete response rate (for carcinoma in situ) or recurrence-free rate (for papillary tumors) of at least 50% at 6 months, 30% at 12 months and 25% at 18 months is recommended."[1]

Based on the 63 patients treated to date, the interim clinical data for Study II is presented below:

The Study II interim clinical data demonstrates a Complete Response ("CR") of 54% at 6 months, 38% at 12 months and 37% at 15 months, which exceeds the IBCG guidelines.

In addition, the Study II interim clinical data demonstrates that at the 90 Day Assessment Visit, 56% of Evaluable Patients achieved a CR and 63% achieved a Total Response (CR + IR), while at 450 days, 37% achieved a CR and 41% achieved a TR.

For evaluable patients in Study II, who received the optimized Study II Treatment (Post August 1, 2020), the interim clinical data is presented below:

The interim clinical data for patients who received the optimized Study II Treatment demonstrates that at the 90 Day Assessment Visit, 62% of Evaluable Patients achieved a CR and 68% achieved a Total Response (CR + IR), while at 450 days, 39% achieved a CR and 44% achieved a TR.

Notes:

Evaluable Patients are defined as patients who have been evaluated by a PI and thus the statistical analysis excludes a patient’s clinical data at specific assessment days, if that clinical data is pending.
Four patients have been enrolled and provided the primary Study II Treatment, but have not been evaluated at their 90 day assessment; therefore, 59 patients are considered Evaluable Patients at 90 days and 46 patients considered Evaluable Patients at 450 days.
The data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with clinical data still pending.
For patients who have been removed from Study II by the PI or have elected to discontinue from Study II their Last Observation Carried Forward ("LOCF") has been used in this statistical analysis.
A SAE is defined as any untoward medical occurrence that at any dose: Is serious or life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or results in death.
The Swimmer’s plot below is a graphical representation of the interim clinical results (n=63) graphically demonstrating a patient’s response to a treatment over time. As can be seen in the plot, clinical data is still pending for patients, who have demonstrated an initial CR at 90 days and continue to demonstrate a duration of that response.

The Swimmer’s Plot illustrates:

The Kaplan-Meier ("KM") Curve below represents the interim cumulative incidence of clinical events; including, the treatment efficacy occurring over a prespecified time in Study II.

According to the interim clinical data in the KM curve:

> 80% of patients remained in Study II after 90 days, following the initial Study II Treatment.
For all evaluable patients, 41% of Total Response ("TR") have a duration of response ≥ 450 days, while 37% of Complete Response ("CR") evaluable patients have a duration of response ≥ 450 days.
For optimized evaluable patients, 44% of TR patients have a duration of response ≥ 450 days and 39% of CR have a duration of response ≥ 450 days.
For 63 patients treated in Study II, there have been 13 Serious Adverse Events ("SAEs") reported:

Theralase believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.

In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study II Treatment, to be the first intravesical, patient-specific, light-activated, Ruthenium-based PDC for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary Ta/T1 tumours). FTD can lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met.

In mid-2023, the Company submitted a pre-BTD submission to the FDA and based on the FDA’s feedback, the Company is currently working with the Clinical Study Sites ("CSSs"), a central pathology organization, a biostatistics organization and a regulatory consulting organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 1Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval.

Theralase is working to complete enrollment and delivery of the primary Study II Treatment for all patients in 2024. If successful, this would allow clinical data lock in mid-2026 with a potential Health Canada and FDA approval by 2026 / 2027.

About Study II:

Study II utilizes the therapeutic dose of the patented Study II Drug ("RuvidarTM" or "TLD-1433") (0.70 mg/cm2) activated by the proprietary Study II Device ("TLC-3200 Medical Laser System"). Study II is focused on enrolling and treating approximately 100 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 CSSs located in Canada and the United States.

About RuvidarTM:

RuvidarTM is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.

On January 15, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually (Press release, Eisai, JAN 15, 2024, View Source [SID1234639236]). First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20. Eisai will also present research results in renal cell carcinoma (RCC) during the 2024 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (#GU24), which is taking place from January 25-27.

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Key Data from Eisai’s Pipeline and Portfolio to be Presented at ASCO (Free ASCO Whitepaper) GI 2024

Notable findings from Eisai’s pipeline include results from a single-arm Phase 2 trial evaluating tasurgratinib (formerly E7090) as a treatment for patients with fibroblast growth factor receptor 2 (FGFR2) gene fusion positive cholangiocarcinoma (NCT04238715(New Window); Abstract: #471). Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3. An analysis of tumor biomarkers in patients with advanced HCC from a Phase 1b study of E7386*1, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in combination with lenvatinib, will also be presented (NCT04008797(New Window); Abstract: #535).

Additional data from the LEAP (LEnvatinib And Pembrolizumab) clinical program include longer term efficacy and safety results from the Phase 3 LEAP-002 trial, which evaluated lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus pembrolizumab (KEYTRUDA*2), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, versus lenvatinib monotherapy as a first-line treatment for patients with unresectable HCC (NCT03713593(New Window); Abstract: #482).

The list of notable ASCO (Free ASCO Whitepaper) GI 2024 presentations is included below. These abstracts will be made available via the ASCO (Free ASCO Whitepaper) website on Tuesday, January 16, 2024, at 2:00 PM PST.

ASCO GI 2024
Cancer Type Study/Compound Abstract Title Abstract Type & Details
(Pacific Standard Time)
Pipeline
Gastrointestinal Cancer E7090 Pivotal single-arm, phase 2 trial of tasurgratinib for patients with fibroblast growth factor receptor-2 gene fusion-positive cholangiocarcinoma
Poster Session
Abstract #471
January 19, 2024
12:30-2:00 PM

E7386 Analysis of tumor biomarkers in patients with advanced hepatocellular carcinoma from a phase 1b study of E7386, a CREB-binding protein/β-catenin interaction inhibitor, in combination with lenvatinib
Poster Session
Abstract #535
January 19, 2024
12:30-2:00 PM

Lenvatinib Plus Pembrolizumab
Gastrointestinal Cancer LEAP-002 Lenvatinib plus pembrolizumab versus lenvatinib alone as first-line therapy for advanced hepatocellular carcinoma: longer-term efficacy and safety results from the phase 3 LEAP-002 study
Poster Session
Abstract #482
January 19, 2024
12:30-2:00 PM

　

Key Data from Eisai’s Pipeline and Portfolio to be Presented at ASCO (Free ASCO Whitepaper) GU 2024

Subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib plus pembrolizumab versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (aRCC), will be featured in a rapid oral abstract session (NCT02811861(New Window); Abstract: #364) and a network meta-analysis to assess the efficacy of lenvatinib plus pembrolizumab compared with other first-line treatment options for patients with aRCC will also be presented in a poster session (Abstract: #482). Extended follow-up results from the Phase 2 KEYNOTE-B61 trial evaluating the combination as a first-line treatment for patients with non-clear cell RCC will be shared in a poster presentation (NCT04704219(New Window); Abstract: #2) by Merck & Co., Inc., Rahway, NJ, USA. Finally, a poster featuring real-world evidence on the use of lenvatinib plus everolimus in previously treated patients with aRCC (Abstract: #437) will also be presented.

The list of notable ASCO (Free ASCO Whitepaper) GU 2024 presentations is included below. These abstracts will be made available via the ASCO (Free ASCO Whitepaper) website on Monday, January 22, 2024, at 2:00 PM PST.

ASCO GU 2024
Cancer Type Study/Compound Abstract Title Abstract Type & Details
(Pacific Standard Time)
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR Subgroup analyses of efficacy outcomes by baseline tumor size in the phase 3, open‐label CLEAR trial
Rapid Oral Abstract Session
Abstract #364
January 27, 2024
1:00-2:15 PM

Network Meta-Analysis Network meta-analysis to assess comparative efficacy of lenvatinib plus pembrolizumab compared with other first-line treatments for management of advanced renal cell carcinoma
Poster Session
Abstract #482
January 27, 2024
7:00 AM

KEYNOTE-B61 First-line pembrolizumab plus lenvatinib for non-clear cell renal carcinomas: Extended follow-up of the Phase 2 KEYNOTE-B61 Study
(Presented by Merck & Co., Inc., Rahway, NJ, USA)
Poster Session
Abstract #2
January 27, 2024
7:00 AM

Lenvatinib Plus Everolimus
Genitourinary Cancer Real World Evidence Lenvatinib plus everolimus in patients with pre-treated advanced renal cell carcinoma: Real world evidence
Poster Session
Abstract #437
January 27, 2024
7:00AM

　

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, pembrolizumab. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.

This release discusses investigational compounds and investigational uses for Food and Drug Administration (FDA)-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

On January 15, 2024 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that CT011, an autologous CAR T-cell product candidate against Glypican-3 (GPC3), has achieved Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for patients with GPC3-positive stage IIIa hepatocellular carcinoma who are at high risk of recurrence after surgical resection (Press release, Carsgen Therapeutics, JAN 15, 2024, View Source [SID1234639237]).

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Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, commented, "Hepatocellular carcinoma (HCC) stands as the predominant histologic subtype of primary liver cancer, ranking as the sixth most prevalent cancer type globally. We initially identified GPC3 as a viable target for CAR T-cell therapy and subsequently progressed it to clinical trials for the treatment of HCC. Case report has shown patients with advanced hepatocellular carcinoma have achieved disease-free survival for more than seven years. We will continue to explore the potential of CAR-T for solid tumors and bring new treatment options for patients."

About CT011

CT011 is an autologous GPC3 CAR T-cell product candidate for the treatment of hepatocellular carcinoma (HCC). CT011 received IND clearance from the NMPA in 2019 for the treatment of patients with GPC3-positive solid tumor which was China’s first IND clearance for CAR T-cell therapy against solid tumors. CARsgen have completed enrollment of a Phase I trial in China.