On October 12, 2022 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 Mr. James Nathanielsz, Propanc’s Chief Executive Officer, will attend the 43rd Meeting of the European Organization of Research and Treatment of Cancer (EORTC), Pharmacology and Molecular Mechanisms (PAMM) group. Professor Perán, Propanc’s Lead Joint Researcher, will also be presenting at the annual EORTC-PAMM meeting to be held in Florence, Italy, December 15 – 17 (Press release, Propanc, OCT 12, 2022, View Source [SID1234621963]). Topics covered will be innovation and application of pharmacological knowledge to cancer drug discovery and development, with particular regard to innovative and advanced drugs and their mechanisms of action, pharmacometrics and clinical application in oncology. Professor Perán, supported by Mrs. Belén Toledo Cutillas MSc and Mr. Aitor González from Professor Perán’s laboratory at Jaén University will present findings on the anti-cancer effects of the Company’s lead product candidate, PRP, effects on the tumor microenvironment and upscaling of synthetic recombinant protein production for a backup clinical compound for PRP.

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The EORTC is a prestigious and globally recognized organization with significant resources and outreach. Mr. Nathanielsz looks forward to attending the 43rd EORTC-PAMM meeting with Jaén and Granada Universities, as part of the Joint Research Collaboration Project. Propanc’s goal is to produce a non, toxic, long-term therapy for the treatment and prevention of metastatic cancer from solid tumors by targeting and eradicating cancer stem cells, and as an adjunct therapy to pre-treat resistant tumors.

"Attendance at the EORTC-PAMM meeting provides an exciting opportunity to meet with scientific experts and clinical researchers who are at the cutting edge of cancer drug development, which presents an opportunity to discuss recent scientific discoveries from our PRP, R&D project and its potential clinical applications as a pre-treatment with existing innovative cancer therapies," said Mr. Nathanielsz, Propanc’s Chief Executive Officer. "Professor Perán has uncovered how PRP treats and prevents metastatic cancer by targeting and eradicating cancer stem cells via differentiation (turning back), so they become benign and are no longer malignant, without affecting healthy cells. She is also investigating the effects of PRP on the tumor microenvironment, where resistant tumors become susceptible to standard therapies, post treatment with PRP. We are excited to present our research with Professor Perán as we investigate future clinical applications of PRP in controlled human studies."

The EORTC’s mission is to increase people’s survival and quality of life by testing new therapeutic strategies based on existing drugs, surgery and radiotherapy. The EORTC also helps develop new drugs and approaches in partnership with the pharmaceutical industry and in patients’ best interests. The EORTC research network consists of over 5,500 collaborators from all disciplines involved in cancer treatment and research in more than 930 institutions in 27 countries. Its research spans the entire spectrum from translational and preclinical research to large, prospective, multi-center, phase III clinical trials that evaluate new cancer therapies.

Propanc is currently undertaking two joint research and collaboration projects with the Universities of Jáen and Granada. The first project, POP1 (Proenzyme Optimization Project 1) Joint Research and Drug Discovery Program, is designed to produce a back clinical compound to PRP, which is targeting metastatic cancer from solid tumors. The second involves investigating the effects of proenzyme therapy and the impact on the tumor microenvironment, which is key to the development, invasion, metastatic spread and recurrence of solid tumors. This has potential implications for future clinical applications of PRP as a potential pre-treatment for resistant tumors. According to Emergen Research, the global metastatic cancer market is projected to be worth $111 Billion by 2027. Propanc is undertaking these challenging research projects in collaboration with the Universities of Jaén and Granada, led by Professors Perán and Juan Antonio Marchal MD, representing the Universities, respectively, and Dr Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

About the EORTC

As an independent, non-governmental, non-profit cancer research Organization established under the laws of Belgium, its mission is to coordinate and conduct international translational and clinical research to improve the standard of cancer treatment for patients.

EORTC aims ultimately to increase people’s survival and quality of life by testing new therapeutic strategies based on existing drugs, surgery, and radiotherapy. EORTC also helps develop new approaches with the pharmaceutical industry and in patients’ best interests.

In addition to independence, EORTC is recognized for scientific and methodological rigor bringing robust datasets to doctors and patients for therapeutic improvement. EORTC covers all disciplines to fight against cancer. EORTC research leaves no one behind and addresses all patients, including patients with rare tumors and specific patient populations.

About Professor Macarena Perán

Professor Macarena Perán graduated with a B. S. in Biology and a M.S. in Biochemistry and Molecular Biology in 1996 from the University of Málaga, Spain. She moved to the Neuroscience Department at Durham University, UK, where she was awarded with a Marie Curie Fellowship and graduated in 2000 with a Ph.D. She moved back to Spain and completed a postdoctoral program in the Faculty of Medicine at Granada University.

In 2005 and 2006 Macarena went to Bath University, UK, and was a short-term postdoctoral fellow in the Department of Biology & Biochemistry in Professor David Tosh’s laboratory, where she first studied the anti-cancer effects of proenzymes in collaboration with Propanc Biopharma Inc. Professor Perán is a Reader in Anatomy, University of Jaen, Spain and belongs to the Institute for Regenerative Medicine and Pathobiology (IBIMER).

On October 12, 2022 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company, and Aadi Bioscience, Inc. (Nasdaq: AADI), a commercial stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, reported a clinical collaboration to evaluate the combination of adagrasib, a KRASG12C selective inhibitor, and nab-sirolimus, a small molecule mTOR inhibitor complexed with human albumin in KRAS G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors (Press release, Mirati, OCT 12, 2022, View Source [SID1234621962]).

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The primary objective of this multi-center, single-arm, open-label Phase 1/2 trial is to determine the optimal dose and recommended Phase 2 dose for the combination of adagrasib and nab-sirolimus in patients with KRASG12C – mutant solid tumors. In addition, the study will investigate the safety, tolerability and efficacy of adagrasib and nab-sirolimus in combination in patients both with and without prior exposure to a KRASG12C inhibitor. The trial will build on preclinical data showing enhanced anti-tumor efficacy with the combination of adagrasib and nab-sirolimus relative to either agent alone.

"We are pleased to collaborate with Aadi on this clinical study of adagrasib and nab-sirolimus. Our collaborative preclinical work has demonstrated that combinatorial mTOR and KRAS inhibition addresses key bypass and feedback pathways associated with either drug target and also results in enhanced efficacy in tumor models harboring KRASG12C mutations. We believe the data from this trial may improve patient outcomes," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "This clinical collaboration is an example of how Mirati is aggressively advancing the study of adagrasib both as a monotherapy and in rational combinations as part of our expanding development portfolio to benefit people living with difficult-to-treat cancers."

"KRAS and mTOR are closely linked and key pathways in oncogenesis and resistance to treatment. This collaboration builds on strong preclinical and mechanistic rationale supporting the combination of the two drugs to potentially provide greater benefit for patients with KRASG12C mutant NSCLC and other cancers," said Neil Desai, Ph.D., founder, president and chief executive officer, Aadi Bioscience, Inc. "We look forward to working closely with our Mirati counterparts to bring this treatment to those in need."

Under the terms of the collaboration agreement, Mirati will be responsible for sponsoring and operating the Phase 1/2 study, and jointly with Aadi, will oversee and share the cost of the study.

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life, extensive tissue distribution and is well tolerated. Adagrasib has also shown, in clinical trials, CNS penetrance and single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors with KRASG12C mutations. Adagrasib is being evaluated in several clinical trials in combination with other anti-cancer therapies with strong scientific rationale in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information visit Mirati.com/science.

About nab-sirolimus
Nab-sirolimus is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is currently being evaluated in a tumor-agnostic registration-directed trial in mTOR inhibitor-naïve malignant solid tumors harboring TSC1 or TSC2 inactivating alterations. In November 2021, nab-sirolimus was approved by the U.S. Food and Drug Administration (FDA) as FYARRO for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

On October 12, 2022 Theriva Biologics, Inc. (NYSE American: TOVX), ("Theriva" or the "Company") reported that it is the new name of Synthetic Biologics, Inc. (NYSE American: SYN) (Press release, Synthetic Biologics, OCT 12, 2022, View Source,Theriva%20Biologics%2C%20Inc.&text=ROCKVILLE%2C%20Md.%2C%20Oct.,name%20of%20Synthetic%20Biologics%2C%20Inc. [SID1234621961]). The new name, logo and branding elements were introduced to better reflect Theriva’s position as a clinical-stage pharmaceutical company developing a novel oncolytic adenovirus (OV) platform to address devastating cancers with high unmet need. In addition, the Company announced its common stock is expected to begin trading on NYSE American under the new ticker symbol "TOVX" on Thursday, October 13, 2022.

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"The rebranding solidifies our strategic transformation and reflects our sharpened focus on advancing unique, oncolytic viruses optimized for IV administration," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We continue to build on the incredible progress made to date and are diligently advancing our OV pipeline. This includes lead clinical-stage program VCN-01, designed to break down the tumor stroma, and preclinical-stage program VCN-11, leveraging our proprietary Albumin Shield Technology to protect systemically administered oncolytic viruses from the host immune system. These two differentiated programs are intended to improve the anti-tumor effect of the oncolytic virus, co-administered chemotherapies and/or immuno-oncology therapeutics. Together, VCN-01 and VCN-11 position Theriva at the forefronts of oncolytic virus development. We are excited about Theriva’s path towards strategic growth, renewed corporate strategy and remain on track to deliver on upcoming value-driving milestones."

The rebrand includes a new logo and corporate website that more accurately reflect the Company’s vision, mission and values. The unveiling of the rebranding is the culmination of an extensive effort to illustrate the Company’s potential to address devastating cancers with high unmet need through innovative therapeutic solutions with differentiated mechanisms of action.

Anticipated Milestones:

VCN-01

Initiation of VCN-01 dosing in an investigator sponsored study of brain tumors at the University of Leeds (H2 2022).
Initiation of a Phase 2 study of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients (Q4 2022).
Clinical study initiation of VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma (H2 2023).
SYN-004

Initiation of the second cohort of the SYN-004 study in allo-HCT patients (H2 2022).

On October 12, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that an abstract describing non-clinical and clinical data supporting the immune activating activity of ST101 has been selected for presentation at the upcoming SITC (Free SITC Whitepaper) 37th Annual Meeting, taking place November 8-12, 2022 in Boston, MA (Press release, Sapience Therapeutics, OCT 12, 2022, View Source [SID1234621960]).

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Poster Presentation Details:
Title: "ST101, a peptide antagonist of novel I/O target CEBPβ, reprograms MDSC polarization and decreases tumor-associated Tregs, suggesting an immune component to observed clinical responses"
Abstract Number: 1173
Location: Poster Hall C
Date/Time: Thursday, November 10, 2022 – Friday, November 11, 2022, 9am-9pm

The SITC (Free SITC Whitepaper) website indicates that all accepted abstracts will be published as a supplement in the Journal for ImmunoTherapy of Cancer (JITC), the society’s global, open access, peer-reviewed journal, which will be published on Nov. 7, 2022 at 8 a.m. EST.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 dose expansion. In the ongoing Phase 2 dose expansion, Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, castration-resistant prostate cancer and locally advanced or metastatic hormone-receptor positive breast cancer. In the Phase 1 portion, ST101 demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a mRANO-confirmed partial response in a patient with recurrent GBM and evidence of long-lasting stable disease in several additional patients.

ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On October 12, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that the first patient has been enrolled in the randomized controlled Part C of the ongoing DisTinGuish study to evaluate DKN-01, Leap’s anti-Dickkopf-1 (DKK1) antibody, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy compared to a tislelizumab and chemotherapy control arm, in patients with gastric or gastroesophageal junction cancer (G/GEJ) (Press release, Leap Therapeutics, OCT 12, 2022, View Source [SID1234621959]).

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"We are excited to announce another important milestone for our DKN-01 clinical program in combination with our partner BeiGene’s tislelizumab, advancing this unique combination therapy into Part C of the DisTinGuish study," said Cynthia Sirard M.D., Chief Medical Officer of Leap Therapeutics. "The data to date from the DisTinGuish study show the DKN-01 plus tislelizumab combination therapy to be a compelling potential treatment for patients with G/GEJ cancer with response rates and survival outcomes that exceeded the benchmarks. This first randomized controlled study for DKN-01 will characterize the treatment effect in first-line patients, with a particular emphasis on those in the aggressive DKK1-high population."

The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. Part C of the DisTinGuish study will enroll approximately 160 first-line, HER2-negative patients. Patients will be randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy, compared to tislelizumab and SOC chemotherapy. The primary objective is progression-free survival (PFS) in DKK1-high patients. Secondary objectives of Part C include PFS in all patients regardless of DKK1 expression, as well as overall survival and objective response rate as measured by RECIST v1.1 in DKK1-high and all patients.

ABOUT DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways and has an important role in promoting tumor proliferation, metastasis, angiogenesis, and in mediating an immune suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.