On January 24, 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 its anti-cancer drug Namodenoson significantly inhibits the growth of pancreatic carcinoma as a stand-alone treatment (Press release, Can-Fite BioPharma, JAN 24, 2023, View Source [SID1234626487]). In combination with the leading chemotherapy used in pancreatic cancer, gemcitabine, Namodenoson demonstrated a significant additive effect. These pre-clinical studies were conducted on advanced pancreatic carcinoma patient cells. Namodenoson’s molecular mechanism of action in pancreatic cancer involves the regulation of the NF-κB /IκB /STAT3-mediated pathway.

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

"Following Namodenoson’s successful results in advanced liver cancer, we continue to develop our oncology drug for the treatment of additional aggressive tumors including pancreatic cancer. There is a dire need for a safe and effective treatment for patients with pancreatic carcinoma where Namodenoson has an advantage due to its protective effects on the cardiovascular system, liver, and bone marrow," stated Can-Fite CEO Dr. Pnina Fishman "Our pre-clinical Namodenoson studies in pancreatic cancer, combined with the clinical data from liver cancer, may open the door for an effective and safe treatment in this devastating disease which accounts for nearly a half-million diagnoses and deaths each year."

Based on these findings, Can-Fite has filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer.

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 January 24, 2023 BioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) reported publication of "Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning" detailing results of the Company’s clinical trial for its non-invasive diagnostic CyPath Lung in Respiratory Research, one of the leading peer-reviewed open access journals in the field of respiratory medicine (Press release, BioAffinity Technologies, JAN 24, 2023, View Source [SID1234626486]).

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CyPath Lung showed 92% sensitivity and 87% specificity in high-risk patients who had nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%. Overall, the test resulted in specificity of 88% and sensitivity of 82%, similar to far more invasive procedures currently used to diagnose lung cancer. More than half of those in the cancer cohort had early Stage I or II lung cancer. CyPath Lung detected multiple forms of cancer including adenocarcinoma, squamous cell carcinoma and small cell lung cancer.

"The fact that CyPath Lung can accurately predict lung cancer at an early stage in patients with small nodules is particularly important. Findings of lesions between six and 20 millimeters as a result of lung cancer screening can lead to unnecessary invasive procedures or a ‘watchful waiting’ period for patients," said Vivienne Rebel, MD, PhD, bioAffinity Chief Medical and Science Officer and Executive Vice President. "Our test is intended for use with patients who display these indeterminant nodules to increase the accuracy of lung cancer screening and provide certainty for patients and their physicians."

"CyPath Lung uses an automated flow-based approach combined with machine learning that can be put into routine lab use without requiring expert evaluation of samples or being subject to operator bias," said Madeleine Lemieux, PhD, who is first author and led development of the automated analysis used in CyPath Lung. "The entire sample is rapidly analyzed which ensures maximal sensitivity. The automated, numerical analysis captures complex interactions between lung cancer and the micro-environment to reliably predict the presence of lung cancer that would not be possible for even expert individuals to do from visual flow data."

Before working with bioAffinity Technologies, Dr. Lemieux was a computational biologist at the Dana Farber Institute and Harvard Medical School. She has contributed to more than 40 publications leveraging data from high-throughput platforms. Dr. Lemieux and Dr. Rebel began their successful collaboration during their doctoral studies.

CyPath Lung uses flow cytometry, a method able to interrogate individual cells in a fraction of a second, and automated analysis to identify parameters in sputum that are indicative of cancer. Unlike genomic or other molecular markers used in liquid biopsies, bioAffinity’s CyPath technology does not collect genetic material for evaluation. Instead, CyPath Lung analyzes the lung micro-environment and identifies whole cell populations that indicate cancer is present in the lung.

On January 24, 2023 Vividion Therapeutics, Inc., (Vividion) a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Bayer AG, reported that current President and Head of Research and Development Aleksandra Rizo, M.D., Ph.D., will assume the role of President and Chief Executive Officer of Vividion and will join the Board of Directors (Press release, Vividion Therapeutics, JAN 24, 2023, View Source [SID1234626485]). Jeffrey Hatfield, current Chief Executive Officer, will transition to the position of Chairman of the Board of Directors at Vividion. Vividion will continue its mission to unlock high value, traditionally undruggable target biology with precision therapeutics for cancers and immune disorders.

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Under Jeffrey Hatfield’s leadership since 2020, Vividion has grown from a small, research startup to a mid-sized successful biotech company with nearly 200 employees. The company is already advancing multiple novel biology, first-in-class programs towards the clinic and has more than a dozen similar pipeline opportunities emerging in early discovery. In his new role, Jeffrey Hatfield will continue to take an active role in the growth and maturation of Vividion towards a clinical-stage company, providing guidance and support on both corporate and R&D strategy.

"It is an incredibly exciting time at Vividion, as we are starting to advance multiple programs from our chemoproteomics platform in the clinic and our research pipeline and strategic partnerships continue to accelerate, said Jeffrey Hatfield. "I’m deeply grateful for the opportunity over the past two years to lead this world-class team at Vividion, and to partner with Bayer to realize our full potential. In my new role as Board Chair, I look forward to continuing to work with the Board and Aleksandra to bring our precision therapeutics to the patients who desperately need them."

"Jeff has been a key driving force behind Vividion’s growth. We are very grateful for his visionary leadership and pleased that he will continue to work closely with us in his new role as Chairman of the Board," said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division. "With Aleksandra as the new CEO, I am certain Vividion will continue to thrive and advance in its mission to bring transformative treatments to patients. We are excited about the future ahead and look forward to working with this highly-respected leader."

Since joining Vividion in 2022, Aleksandra Rizo has been the leader of the company’s Research and Development organization, helping to shape the portfolio and advance the chemoproteomics platform. To aid in the transition to Vividion’s next phase of growth, Aleksandra Rizo has extensive industry leadership experience building a small biotech as well as a deep understanding of how to work and thrive within a large pharmaceutical ecosystem. An accomplished clinician and oncology expert with a true entrepreneurial spirit, Aleksandra Rizo has brought various programs from discovery, through clinical development to submission, a critical skill as the Vividion pipeline matures.

"We have begun our journey to change medicine and remove the boundaries of druggability for a variety of diseases including cancer and immune disorders," states Aleksandra Rizo. "Our programs are nearly all targeting proteins the industry has previously viewed as undruggable and indicate the potential to deliver enormous value to patients, if successful. I look forward to working with Jeff and the Board as we continue to excel in our discovery efforts and transition into a clinical-stage company. I cannot imagine a more exciting time to lead Vividion."

On January 24, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that data from its Phase 1 UNIVERSAL trial of ALLO-715, an anti-BCMA AlloCAR T product candidate for relapsed/refractory (r/r) multiple myeloma (MM) has been published in Nature Medicine (Press release, Allogene, JAN 24, 2023, View Source [SID1234626484]).

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UNIVERSAL is the first and only allogeneic CAR T study to demonstrate that significant responses can be achieved with a single dose in patients with relapsed/refractory multiple myeloma. These initial study results published in Nature Medicine reinforce our belief that ALLO-715 can induce deep, clinically meaningful responses in patients with an allogeneic cell therapy. AlloCAR T product candidates may be able to meaningfully reduce the barriers faced by patients with multiple myeloma when seeking to access cell therapy," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene.

"While new autologous CAR T therapies are a significant advance for patients with multiple myeloma, challenges inherent to those treatments remain, including manufacturing constraints and out-of-specification product, lengthy vein-to-vein time requiring bridging therapy or prolonged courses of treatment. These groundbreaking results demonstrate the potential for an off-the-shelf cell therapy to be delivered on demand to patients at scale," said Sham Mailankody, MBBS, Clinical Director of Cellular Therapy Service and Associate Attending Physician, Memorial Sloan Kettering Cancer Center in New York, New York. "It is my hope that this publication demonstrating significant proof-of-concept for allogeneic CAR T will set the stage for many more advances in the field of cell therapy for myeloma."

The Phase 1 UNIVERSAL study is a dose escalation trial in patients with heavily pretreated r/r MM. The Nature Medicine publication includes data from the first 48 patients enrolled with a data cutoff of October 2021. All patients treated were refractory to their last line of treatment and no bridging therapy was used in this trial. Data demonstrated the ability for an allogeneic CAR T to achieve response rates in line with certain approved autologous CAR T therapies and durable remissions with a manageable safety profile while treating 92% of all enrolled patients and all product manufactured and released as per product specifications.

Updated data from the UNIVERSAL study were presented at the Company’s R&D Showcase in November 2022 and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022.

On January 24, 2023 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, and Immedica Pharma AB, a pharmaceutical company focused on commercialisation of rare and specialty care products, reported that the companies have entered an exclusive long-term license and distribution agreement for the commercialisation of two cancer supportive care products indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) in core European markets : AKYNZEO (Netupitant-Palonosetron fixed combination) and ALOXI (Palonosetron) (Press release, Helsinn, JAN 24, 2023, View Source [SID1234626482]).

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Under the licence and distribution agreement Immedica will commercialise AKYNZEO in Portugal, Spain, France, Switzerland, the Netherlands, Belgium, Luxembourg and Liechtenstein, ALOXI in Switzerland, Belgium, Liechtenstein.

Anders Edvell, CEO of Immedica commented: "We are very pleased to have signed this agreement with Helsinn. Side-effects of cancer treatments have a significant impact on the quality of life of these severely ill patients. AKYNZEO and ALOXI are also an important addition to Immedica’s Oncology & Haematology portfolio."

Dr. Melanie Rolli, Helsinn Group CEO, commented: "This partnership will provide important treatment options for CINV across Europe. We look forward to working closely with Immedica in the months and years ahead to ensure more and more patients can access these important supportive care products."