On June 14, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase biology platform, reported that new findings from its platform will be presented in a poster today at the Keystone Symposia Tissue Fibrosis and Repair: Mechanisms, Human Disease and Therapeutics in Keystone, CO (Press release, aTyr Pharma, JUN 14, 2022, View Source [SID1234615971]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster presents findings from aTyr’s innovative tRNA synthetase platform, whereby selected fragments of Alanyl-tRNA Synthetase (AARS) and Aspartyl-tRNA Synthetase (DARS) were found to bind to the surface of specific human cell types via novel binding partners. Additionally, the target receptor of the fragment AARS-1 was identified as fibroblast growth factor receptor 4 (FGFR4), indicating that AARS-1 may have therapeutic potential in fibrosis, inflammation and cancer. Moreover, the methods utilized in the study can be further employed to identify and validate new molecular targets from aTyr’s tRNA synthetase platform.

Details of the poster presentation appear below. The poster will be available on the aTyr website once presented.

Title: Identification of key extracellular binding proteins implicate role in inflammation and fibrosis for alanyl- and aspartyl-tRNA synthetases
Authors: Ryan A. Adams, Tarsis F. Brust, Yeeting E. Chong, Ann L. Menefee, Andrew Imfeld, Michaela Ferrer, Zachary Fogassy, Alison G. Barber, Suzanne Paz, Leslie A. Nangle. aTyr Pharma, San Diego.
Poster Number: 2022
Poster Session: Poster Session 2
Date: Tuesday, June 14, 2022

"We are very pleased that our novel approach to drug discovery has yielded the identification of a receptor target for yet another tRNA synthetase from our platform," said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. "The target receptor identified for the fragment AARS-1, FGFR4, is involved in many cellular processes including cell proliferation, differentiation and tissue repair. FGFR4 is known to play a role in diseases related to inflammation and fibrosis, including conditions where unchecked fibrosis can precede the development of certain cancers. We look forward to further interrogating the interaction between AARS-1 and FGFR4 and the implications for disease in order to explore this synthetase fragment as a potential pipeline candidate.

On June 10, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s lead product candidate, PRP, targets solid tumors, which accounts for 80 – 90% of cancer cases, according to the National Cancer Institute (Press release, Propanc, JUN 14, 2022, View Source [SID1234615970]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, is leading research into a novel approach to prevent recurrence and metastasis from solid tumors using pancreatic proenzymes that target and eradicate cancer stem cells (CSCs), which are a small subpopulation of cells within tumors capable of self-renewal, differentiation and tumorigenicity when transplanted into an animal host. CSCs is the mechanism by which cancer is able to return and spread, even post standard treatments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Kenyon explains that metastasis occurs because a program inside the cell, called the Epithelial-Mesenchymal Transition (EMT) is activated. The EMT is a biological process associated with wound healing and embryogenesis, but when associated with cancer, causes epithelial (organ originating) cancer cells to become invasive and stem cell like, features which then allow CSCs to spread and metastasize. PRP reverses the transition to a CSC and as such, reduces the metastatic potential of the tumor cells. Furthermore, traditional cancer therapies act on replicating cells, but not CSCs, so they rebuild the tumor mass and can migrate to start a new tumor in another organ. PRP stops CSCs so that a tumor loses the ability to generate new cells and the tumor disappears without the option to form a metastatic tumor elsewhere.

Dr Kenyon believes that PRP will be most effective against tumors which consist of a high percentage of CSCs, therefore less differentiated, more aggressive tumors which spread rapidly and often leads to a poor prognosis for the patient. These tumors are often a largely underserved patient population. Also, the EMT process which leads to cells transitioning to a mesenchymal (skeletal) state, implies that sarcomas, which is a cancer that originates in supportive and connective tissues such as bones, tendons, cartilage, muscle and fat, which are mesenchymal, could also be treated with PRP. Generally occurring in young adults, the most common sarcoma often develops as a painful mass on the bone. Sarcomas are particularly challenging tumors for which there are no effective treatments other than surgery in early stages. According to Dr Kenyon, these highly mesenchymal tumors would be likely to respond to PRP. This would be a breakthrough in the treatment of these types of tumors.

Dr Kenyon said, "Based on the mode of action, PRP targets 80 to 90% of all cancers, which is highly significant. Furthermore, sarcomas are a largely underserved patient treatment population with a poor prognosis for sufferers. I have reviewed early 19th century published clinical cases, when enzyme therapy was first proposed, including a 23 y/o female, with a large fibrosarcoma of the tongue, who was successfully treated, despite 3 unsuccessful surgeries due to recurrence. Over 100 years later, we have been able to elucidate a mechanism of action which explains why, and which tumors to target. Our scientific research over the last 15 years gives me great confidence about the potential of PRP as a breakthrough therapy for the treatment of metastatic cancer, which I believe will be tremendously impactful for humankind."

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.

On June 14, 2022 Pascal Biosciences Inc. ("Pascal" or "the Company") (TSXV:PAS) (OTC:PSCBF) (FSE: 6PB-FF) reported a renewed and expanded emphasis on the consulting and contract research component of the business. Pascal has previously had success by providing resources to other biotech companies (Press release, Pascal Biosciences, JUN 14, 2022, View Source [SID1234615969]). In particular, the Company worked with SoRSE Technology last year, bringing over $600,000 into the company. Pascal scientists have, combined, over 80 years of experience in biotechnology projects and have been involved in the discovery, preclinical, and clinical development of drugs approved by the FDA. Our intent is to leverage this expertise to provide consulting and research services to customers with projects primarily in the post-discovery to Phase I period of development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Drug development has long timelines and, unless new drug candidates are forthcoming, preclinical teams tend to become redundant once a drug enters clinical studies." stated CEO Dr. Brian Bapty. "By providing virtual preclinical services, Pascal can provide the direction, experience, and facilities to efficiently support multiple preclinical programs." As with the SoRSE contract, Pascal will provide shared expertise and infrastructure so Biotech clients benefit from economies of scale while limiting fixed costs.

Pascal is in process of updating the website to reflect these changes. Pascal will continue development of internal programs notably, for Acute Lymphoblastic Leukemia which is funded by an NIH Grant, and glioblastoma which will be supported by funds from operations.

On June 14, 2022 Nascent Biotech Inc (OTCMKTS: NBIO) reported that it is making a steady run northbound off its base at a nickel and saw some of its biggest gains while the overall markets saw steep declines (Press release, Nascent Biotech, JUN 14, 2022, View Source [SID1234615968]). NBIO is a low float biotech whose lead product Pritumumab (PTB) targeting Glioblastoma is being studied in Phase I clinical trials. On Friday the Company announced the completion of the Third cohort in dosing patients for its Phase I trial for Brain Cancer. After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pritumumab works by binding to a target on the surface of cancer cells called ectodomain vimentin (also referred to as cell-surface vimentin). The target, generally referred to as an antigen, is prevalent in many different tumor types and is not being targeted by any other biopharmaceutical companies. By binding to this target, Pritumumab is able to make the tumor cells "known" to the body’s immune system, resulting in potentially several types of immune responses, including anti-idiotype, apoptosis, antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to death of the cancer cells and overall depletion of the tumor.

Nascent Biotech Inc (OTCMKTS: NBIO) operating out of Vero Beach, Florida is a clinical-stage biotech company pioneering the development of monoclonal antibodies to be used in the treatment of various cancers and viral infections, helping people worldwide. Its products are not yet commercially available. The Company’s lead candidate, Pritumumab (PTB), is a monoclonal Antibody (Mab) that the Company is developing as a treatment for epithelial cancers (which includes lung, breast, colon, brain, and pancreas). Currently Pritumumab (PTB) has received FDA orphan drug status and is being studied in Phase I clinical trials for the treatment of Brain Cancer. The Company is led by CEO Sean Carrick who has an extensive track record of success with a career that spans more than 30 years of building and leading successful Life Science Companies in large, mid-cap and venture-backed stages

Current brain cancer therapeutic strategies include chemotherapy drug Temodar, surgery, and/or radiation. Even when removed, most brain tumors come back within one-year post-surgery. With current standards of care, only 58% of brain cancer patients live past the first year after diagnosis with certain types, anaplastic astrocytoma and glioblastoma, the five-year survival rates are 27% and 5%, respectively

Based on pre-clinical and clinical studies, the Company believes Pritumumab may offer an advantage over existing treatments. Nascent has addressed manufacturing questions by re-engineering antibody production into the commonly used CHO cell expression system. Pritumumab works by binding to a target on the surface of cancer cells called ectodomain vimentin (also referred to as cell-surface vimentin). The target, generally referred to as an antigen, is prevalent in many different tumor types and is not being targeted by any other biopharmaceutical companies. By binding to this target, Pritumumab is able to make the tumor cells "known" to the body’s immune system, resulting in potentially several types of immune responses, including anti-idiotype, apoptosis, antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, leading to death of the cancer cells and overall depletion of the tumor.

Nascent expects to amplify on the past clinical development strategy during the next 12 months plan to: complete Phase I clinical trials in the United States, establishing safety and the optimal dose of Pritumumab for treatment of patients with brain cancers. Commence Phase 2 clinical trials in the United States and China with Pritumumab for the treatment of lung cancer and breast cancer that has metastasized to the brain and continue to evaluate the application of Pritumumab in the treatment of other ectodomain vimentin positive cancer types (pancreatic, lung and colon) where there may be unmet medical needs.

On December 7, 2018, Nascent received FDA clearance to begin clinical trials with its first drug product lot but left the Company on partial clinical hold for the bulk substance lot. On December 1, 2020, the Company received FDA clearance to begin clinical trials with the second lot. The Company commenced the Phase I trial. In March 2021, the Company enrolled its initial patient. In May 2021, the first three patient cohort was enrolled.

On June 7 NBIO announced the completion of the Third cohort in dosing patients for its Phase I trial for Brain Cancer. After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort. As the fourth cohort is underway, Nascent will also be performing PK studies to help determine if a fifth cohort is needed. Patient enrollment will continue for Phase I. Anyone interested may review trial requirements at www.clinicaltrials.gov, then search Pritumumab.

Nascent CEO Sean Carrick announced "Having completed the first three cohorts, we are excited to move to our fourth and possibly final cohort in the Phase I trial. The third cohort took longer than expected but the data received is very useful moving forward," noted Nascent CEO, Sean Carrick, further stating that,

According to a recent ResearchAndMarkets report the global brain tumor drugs market is expected to grow from $3.17 billion in 2021 to $3.49 billion in 2022 at a compound annual growth rate (CAGR) of 10.2%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $4.84 billion in 2026 at a CAGR of 8.5%.

Currently trading at an $18 million market valuation, NBIO has 113,063,175 shares outstanding, 57,804,675 of which are restricted leaving 55,258,500 free trading NBIO shares worth $9 million. NBIO is fully reporting OTCQB and recent filings show the entire NBIO management team acquiring and exercising stock options at $0.05 in April. Since than the stock has been rising steadily as the Pritumumab (PTB) Phase I trials progress. Pritumumab targets the Glioblastoma market worth $3.5 billion globally. On Friday the Company announced the completion of the Third cohort in dosing patients for its Phase I trial. After reviewing the data gathered from the first three cohorts, this milestone will allow the trial to advance to the fourth and possibly final cohort. The Company hopes to progress to Phase 2 clinical trials in the United States and China with Pritumumab for the treatment of lung cancer and breast cancer that has metastasized to the brain and continue to evaluate the application of Pritumumab in the treatment of other ectodomain vimentin positive cancer types (pancreatic, lung and colon).

On June 14, 2022 Clovis Oncology, Inc. (NASDAQ: CLVS) reported an oral presentation detailing initial Phase 1 data from the Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study (NCT04939610) investigating the safety, pharmacokinetics, dosimetry, and preliminary antitumor activity of its targeted radiotherapy candidate, FAP-2286 labelled with lutetium-177 (177Lu-FAP-2286) (Press release, Clovis Oncology, JUN 14, 2022, View Source [SID1234615965]). Overall, in nine patients treated in the first two dose cohorts,177Lu-FAP-2286 demonstrated a manageable safety profile and encouraging evidence of activity, including a confirmed RECIST partial response in one patient. In addition, updated data from an investigator-initiated Phase 1 study of FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) as a novel imaging agent to identify metastatic cancer in patients with solid tumors are also being presented today (NCT04621435). These datasets will be presented in oral presentations by Jonathan McConathy, M.D., Ph.D., Associate Professor and Director of the Division of Molecular Imaging and Therapeutics in the University of Alabama at Birmingham Department of Radiology in the Marnix E. Heersink School of Medicine, and Brad Kline, Clinical Research Coordinator at the University of California, San Francisco (UCSF), respectively, at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting 2022 in Vancouver, British Columbia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FAP-2286 targets fibroblast activation protein (FAP), a promising theranostic target with expression across many tumor types. FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP to enter clinical development and is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent 177Lu-FAP-2286 to identify the recommended Phase 2 dose and schedule. The safety and tumor uptake of the imaging agent 68Ga-FAP-2286 is also being evaluated, with plans for Phase 2 expansion cohorts in multiple tumor types to initiate in Q4 2022.

"These initial results demonstrate that FAP is a promising theranostic target with expression across many types of solid tumors," said Jonathan McConathy, M.D., Ph.D., Associate Professor and Director of the Division of Molecular Imaging and Therapeutics in the University of Alabama at Birmingham Department of Radiology in the Marnix E. Heersink School of Medicine. "These LuMIERE data from the first two dose cohorts demonstrated a manageable safety profile, with some preliminary evidence of activity, both of which are encouraging as we seek to better understand the potential of FAP-2286 as a treatment and imaging agent across a wide range of malignancies."

Initial results from the Phase 1 portion of the ongoing Phase 1/2 LuMIERE study found treatment-emergent adverse events (TEAEs) to be generally mild to moderate among the nine patients in the safety population receiving 3.7 or 5.55 GBq/dose of the investigational therapeutic agent 177Lu-FAP-2286. Three patients (33.3%) had a Grade ≥3 TEAE of back pain (11.1%), abdominal distension (11.1%), increased bilirubin (11.1%) and hyponatremia (11.1%); none were judged as related to 177Lu-FAP-2286. There was one serious adverse event (SAE) of back pain not related to 177Lu-FAP-2286. No dose-limiting toxicities were observed in the 3.7 or 5.55 GBq cohorts (n=3 evaluable in each cohort).

At the two dose levels evaluated to date, organ dosimetry revealed target organ exposure within the expected range to support administration of multiple doses. There was tumor uptake across a range of tumor types with prolonged tumor retention of 177Lu-FAP-2286 after dosing.

A confirmed RECIST partial response was reported in one heavily pre-treated patient in the 3.7 GBq dose cohort with pseudomyxoma peritonei of appendiceal origin who completed six administrations of 177Lu-FAP-2286. A decrease in the level of the serum tumor marker carcinoembryonic antigen (CEA) was also observed in the patient over the course of 177Lu-FAP-2286 administration.

Recruitment for the third dose cohort (7.4 GBq) is ongoing.

"This first presentation of data from the Phase 1/2 LuMIERE study supports the hypothesis that FAP-2286 gets to the tumor, stays in the tumor, and avoids off-target tissue, and these initial Phase 1 data further support the potential clinical utility of FAP-2286 as a targeted radionuclide therapy to treat a variety of advanced solid tumors," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to presenting additional clinical data from the LuMIERE study at another nuclear medical meeting and initiating Phase 2 expansion cohorts in multiple tumor types later in 2022."

Presentation of the initial LuMIERE Phase 1 data, titled "177Lu-FAP-2286 in Patients With Advanced or Metastatic Solid Tumors: Initial Data From a Phase 1/2 Study Investigating Safety, Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity (LuMIERE)" (Abstract #2271), is scheduled for Tuesday, June 14 at 11:00 am PT, as part of the Basic Oncology: Early Phase Human Studies I session from 10:00 – 11:30 am PT.

Presentation of the investigator-initiated imaging study, titled "First-in-human evaluation of 68Ga-FAP-2286, a fibroblast activation protein targeted radioligand" (Abstract #2279), evaluating the ability of imaging agent 68Ga-FAP-2286 to detect metastatic cancer in patients with solid tumors, is scheduled for Tuesday, June 14 at 1:50 pm PT, as part of the Basic Oncology: Early Phase Human Studies II session from 1:00 – 2:30 pm PT.

These presentations can also be viewed at View Source following their presentations on June 14.

For more information about FAP-2286, targeted radionuclide therapy (TRT), or Clovis’ TRT development program, please visit targetedradiotherapy.com.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.