On May 2, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that it discovered the mechanism of action (MOA) involved with the significant anti-cancer effect of Namodenoson in pancreatic carcinoma (Press release, Can-Fite BioPharma, MAY 2, 2023, View Source [SID1234630830]). Namodenoson de-regulates the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.

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 discovery was made when analyzing results from pre-clinical studies conducted on advanced pancreatic carcinoma patient cells exposed to Namodenoson, which had a significant anti-cancer effect. This is the same MOA at work for Namodenoson in liver cancer.

Namodenoson is currently under a pivotal Phase III study for the treatment of advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free 6 years after starting treatment.

"Knowing Namodenoson’s mechanism of action in pancreatic cancer is an important step in moving this indication toward potential partnerships. Our findings inform potential dosage and study design and increase the probability of success in human trials," stated Can-Fite CEO Dr. Pnina Fishman.

The highest incidence rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately $6.6 billion by 2030.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On May 2, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in the Bank of America Securities 2023 Healthcare Conference in Las Vegas, Nevada on Tuesday, May 9, 2023 (Press release, Bristol-Myers Squibb, MAY 2, 2023, View Source [SID1234630828]). Adam Lenkowsky, Executive Vice President, Chief Commercialization Officer, will answer questions about the company at 8:40 a.m. PT/11:40 a.m. ET.

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!

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On May 2, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the BofA Securities 2023 Health Care Conference on Wednesday, May 10, 2023, at 1:40 p.m. PDT (Press release, Bio-Techne, MAY 2, 2023, View Source [SID1234630827]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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!

On May 2, 2023 Be Biopharma, Inc. ("Be Bio"), a company pioneering the discovery and development of Engineered B Cell Medicines (BeCMs), reported that it will present new data from preclinical research and collaboration programs at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting taking place May 16-20, 2023, in Los Angeles, Calif (Press release, Be Biopharma, MAY 2, 2023, View Source [SID1234630826]).

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!

A late-breaking abstract was selected for oral presentation from Be Bio’s collaboration study with the National Heart, Lung, and Blood Institute, National Institutes of Health in which homing and engraftment of plasma cells were observed from peripheral B cells without preconditioning in immune competent non-human primates. In a separate oral presentation, the precise engineering of B cells using Be Bio’s proprietary engineering platform will be featured. Additionally, a poster presentation will show the stable expression and continuous secretion of therapeutic proteins in vitro and in vivo. Finally, Be Bio’s scientific co-founders and collaborators from the Seattle Children’s Research Institute will present findings in which engineered B cells produced Bi-specific T cell engagers that mediated T cell activation and showed in vivo anti-tumor efficacy in a patient-derived xenograft model.

"Data from our preclinical research programs support the ability of Be Bio’s platform to unlock the power of B cells as the basis for a prolific and versatile product engine," said Dr. Rick Morgan, Chief Scientific Officer, Be Bio. "We are inspired by the potential to transform patient lives with B cell medicines as we progress our lead candidate towards an investigational new drug application and advance our novel pipeline programs in rare disease and oncology."

Details of the presentations are as follows:

Abstract 575, Poster Presentation: Human Plasma Cells Engineered to Produce Bi-Specific T Cell Engagers Show In Vivo Anti-Tumor Efficacy
Presenter: Tyler Hill, MSTP, Seattle Children’s Research Institute

Session Date/Time/Location: Wednesday, May 17, 12:00- 2:00 p.m. PT, Exhibit Hall A

Abstract 119, Oral Presentation: Precise CRISPR/Cas9 Genome Engineering of Primary Human B Cells Enables a New Class of Cellular Medicines Designed for Sustained Delivery of Therapeutic Biologics
Presenter: Dr. Anja Hohmann, Senior Director, Cell Engineering, Be Bio

Session Date/Time/Location: Thursday, May 18, 2:15 – 2:30 p.m. PT, Concourse Hall 152 & 153

Late Breaking Abstracts 1, Oral Presentation: Rhesus Antibody Secreting Cells Differentiated Ex Vivo from B Cells Engraft without Preconditioning in an Autologous Host and Represent a Novel Modality for Cell and Gene Therapy
Presenter: Dr. David Young, National Heart, Lung, and Blood Institute, National Institutes of Health

Session Date/Time/Location: Friday, May 19, 9:30 – 9:45 a.m. PT, Room 515 AB

Abstract 1453, Poster Presentation: Development of an Ex Vivo Gene Engineered B Cell Medicine Platform with Precision, Modularity, and Broad Therapeutic Utility
Presenter: Dr. Hanlan Liu, Senior Vice President, Rare & Early Pipeline Research, Be Bio

Session Date/Time/Location: Friday, May 19, 12:00 – 2:00 p.m. PT, Exhibit Hall A

About B Cells – A New Class of Cellular Medicines
Imagine what could "Be?" In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCMs). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

On May 2, 2023 Arvinas, Inc. (Nasdaq: ARVN) and Quantum Leap Healthcare Collaborative reported that Arvinas’ vepdegestrant (ARV-471), a novel PROTAC estrogen receptor (ER) protein degrader being co-developed with Pfizer Inc. will be evaluated in the ongoing I-SPY TRIAL endocrine program sponsored by Quantum Leap (Press release, Arvinas, MAY 2, 2023, View Source [SID1234630825]). This study targets patients with newly diagnosed ER positive invasive cancer. Vepdegestrant is in Phase 3 clinical development for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

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 I-SPY-2 Endocrine Optimization Platform (EOP) study (NCT01042379) will include a vepdegestrant monotherapy arm and a vepdegestrant in combination with letrozole arm. This study is focused on patients with clinically high-risk (stage 2/3) ER+/HER2- breast cancer, but molecularly low risk (MammaPrint low risk signature), a subset of patients with substantial risk for late recurrence.

Quantum Leap opened the EOP program in 2021 to specifically assess treatment options for this subset of patients, and work to find an early endpoint to measure the success of therapy. EOP is a sub-study within the main I-SPY-2 clinical trial utilizing neoadjuvant endocrine therapy in patients whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit.

"I-SPY TRIALs focus on high-impact experimental treatments that may benefit patients, providers, and researchers, and Arvinas is thrilled to be part of this innovative I-SPY-2 clinical trial," said John Houston, Ph.D., president and chief executive officer at Arvinas. "There is an unmet medical need for novel agents in life-threatening diseases and this research is vital to advancing patient outcomes. In all of our investigational research, our commitment is to patient safety and care, and we are excited by vepdegestrant’s potential to become a new standard of care for patients with ER+/HER2- breast cancer."

"The heart of the I-SPY TRIALs is to change how new breast cancer treatments are developed, to find treatments that are more personalized, effective, and less toxic, faster. We are excited to be partnering with Arvinas and investigating the potential positive benefits of vepdegestrant. Women need better and more tolerable options for extended endocrine therapy. We hope this will be one of them." said Dr. Laura Esserman, co-principal investigator of the I-SPY TRIAL and founder of Quantum Leap.

Arvinas will provide vepdegestrant and financial support to Quantum Leap for this investigational study. Quantum Leap is the sponsor of the I-SPY program, which includes 41 open sites. All I-SPY sites have the EOP program open.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally-bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.

In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.