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 Myriad genetics presented its corporate presentation (Presentation, Myriad Genetics, JAN 16, 2024, View Source [SID1234639262]).

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On January 16, 2024 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported new data from Part A of the DeFianCe study, a Phase 2 study evaluating DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC), to be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place in San Francisco, CA and virtually on January 18-20, 2024 (Press release, Leap Therapeutics, JAN 16, 2024, View Source [SID1234639261]).

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"Data from Part A of the DeFianCe study demonstrates that the addition of DKN-01 to bevacizumab and chemotherapy can generate clinically meaningful response rates and durable tumor reductions with a favorable safety profile in second-line CRC patients, particularly those with rectal or rectosigmoid tumors," said Meredith Pelster, MD, Assistant Director of Gastrointestinal Research at Sarah Cannon Research Institute and a study investigator. "We are very interested in utilizing DKN-01 to modulate the Wnt pathway, which is active in a high percentage of CRC patients, particularly left-sided tumors, to overcome resistance to chemotherapy, and to decrease angiogenesis in order to enhance the activity of the standard of care bevacizumab plus chemotherapy regimens. These results provide a strong foundation for the randomized controlled Part B of this study, which is enrolling extremely well and expected to complete enrollment mid-year."

"In this heterogenous second-line population with several unfavorable characteristics, the DKN-01 plus bevacizumab and chemotherapy Part A ORR of 30%, with a disease control rate of over 90%, and enhanced activity in left-sided tumors and rectal tumors, with a 46% ORR and 9.4 month preliminary PFS, represent an encouraging efficacy signal," said Zev Wainberg, MD, Professor of Medicine and Co-Director of the GI Oncology Program at UCLA. "CRC is a heterogenous disease where the selection of therapy and expected outcomes vary based on whether the tumor is on the left or right side, the presence or absence of genetic mutations, microsatellite instability, and prior therapy. Physicians want to be able to select a second-line therapy combination based on the patient’s personalized tumor characteristics, which is what we hope to achieve by adding DKN-01 and understanding the subgroups with the greatest clinical benefit."

Leap will host a conference call on January 23, 2024 at 8:30 a.m. Eastern Time in which Dr. Pelster and Dr. Wainberg will further discuss the new data from the DeFianCe study.

Key Findings:

· As of the December 6, 2023 data cutoff, 33 patients enrolled in Part A of the DeFianCe study
· Across all evaluable patients with second-line microsatellite stable CRC (n=27):
o Objective response rate (ORR) was 30% and disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD)
o Median progression-free survival (PFS) was 6.3 months
o 9 patients remain on therapy beyond 8.5 months
· Analysis revealed a breadth of clinical activity across additional subgroups, including patients with left-sided tumors (n=25)
o 33% ORR and 100% DCR in response-evaluable population (7 PRs, 14 SDs)
o Preliminary median PFS of 8.6 months (9 patients continuing on therapy within subgroup)
· Patients with rectal/rectosigmoid carcinomas (n=15) represent an important subpopulation:
o 46% ORR and 100% DCR in response-evaluable population (6 PRs, 7 SDs)
o Preliminary median PFS of 9.4 months (6 patients continuing on therapy within subgroup)
o Higher baseline plasma DKK1 levels correlated with improved responses
· DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01 related events being low grade (Grade 1/2)
· Randomized controlled Part B of the study is underway with 54 patients currently enrolled

Conference Call:

Leap’s management team, together with Dr. Pelster and Dr. Wainberg, will host a conference call on Tuesday, January 23, 2024 at 8:30 a.m. Eastern Time to further discuss the data. The conference call will be broadcast live in listen-only mode and can be accessed via the website URL: View Source A replay of the event will also be available for a limited time on the Investors page of the Company’s website at View Source

About the DeFianCe Study

The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The Part A cohort enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. The study has expanded into a 130-patient Part B randomized controlled trial. The primary objective of the study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival.

On January 16, 2024 Instil Bio, Inc. ("Instil" or the "Company") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported a strategic update (Press release, Instil Bio, JAN 16, 2024, View Source [SID1234639260]).

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Instil has entered into an agreement with a collaborator that has a successful track record of manufacturing and dosing patients with cell therapies to conduct preclinical manufacturing feasibility studies in the ITIL-306 program. The feasibility studies have been initiated, and if the feasibility studies are successful, Instil’s collaborator may open an investigator-initiated clinical trial (IIT) to enroll patients with non-small cell lung cancer (NSCLC) in China. In the event the IIT generates compelling proof-of-concept clinical data in 2024, Instil may explore options for a potential transition of ITIL-306 to a US-based CDMO for manufacturing and clinical development primarily at US clinical trial sites.

With the objective of saving costs and improving time efficiency, the Company is announcing the closure of its UK manufacturing and clinical operations, thereby reducing its UK workforce which is expected to be substantially completed by the first half of 2024. Instil plans to retain key process development, research, and related personnel to advance early-stage pipeline development of CoStAR and other novel TIL technologies, and to support the company’s collaboration.

On January 16, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that Matthew P. Greving Ph.D., its Vice President and Head of Platform Technologies and Machine Learning, will give a podium presentation titled "Enhancing Bispecific T-Cell Engager Discovery, Potency, Safety, and Developability with Machine Learning and Mammalian Display" at the 23rd annual PepTalk Conference Jan. 16-19 in San Diego, California (Press release, iBioPharma, JAN 16, 2024, View Source [SID1234639259]). He will also moderate a BuzZ talk on the topic as part of the conference’s "Developability of Bispecifics" program.

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During the podium presentation, Dr. Greving will provide an overview of how iBio’s technology stack – including epitope engineering, human-diversity antibody libraries, EngageTx for bispecific optimization, and ShieldTx for antibody masking – potentially overcomes challenges in the discovery of bispecific T-Cell Engagers ("TCE"), a promising area of research in immunotherapies for cancer. He will present data demonstrating how iBio’s machine learning (ML)-driven epitope steering and mammalian-display antibody libraries efficiently discover diverse TCE arms tuned for potency, toxicity, developability, and cyno cross-reactivity. The presentation will take place Tuesday, Jan. 16 at 5:15 p.m. Pacific Time.

Before the presentation, Dr. Greving will moderate an informal, open discussion diving into topics including, but not limited to, improving discovery and productivity for bispecific TCE’s immune cell arm, advances in discovering difficult tumor-antigen arm targets and epitopes, enhancing T-cell engager safety with machine-learning derived mammalian display libraries, and large-scale bispecific activity and developability screening with mammalian display. The BuzZ session will occur on Tuesday, Jan. 16, at 3:15 p.m. Pacific Time.

iBio’s Drug Discovery Platform is a precision-driven and deeply integrated technology stack that aims to efficiently and consistently deliver antibody candidates against challenging targets and move them into the clinic faster. The Company uses its technology to advance candidates with partners and collaborators, and for its own proprietary pipeline.