On March 11, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported that the Company’s CEO, Dr. Pnina Fishman, will deliver a poster presentation titled "Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv which takes place March 14 – 15, 2022 (Press release, Can-Fite BioPharma, MAR 11, 2022, View Source [SID1234610005]). The abstract will additionally be published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids. Can-Fite will conduct 1×1 meetings with companies in the cannabis field regarding potential licensing and partnership opportunities.

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Cannabinoids bind to CB1 and CB2 receptors regulating the function of multiple organs and tissues of the body. Interestingly, cannabinoids also bind to Can-Fite’s platform technology’s primary target, the Gi protein associated A3 adenosine receptor (A3AR) which is up-regulated in inflammatory and tumor cells.

Can-Fite’s extensive body of research shows that A3AR agonists can knock down inflammation and cancer via the specific induction of apoptosis in these cells.

The study findings to be presented at CannX and published in Medical Cannabis and Cannabinoids highlight the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and de-regulation of the Wnt/β-catenin pathway.

"These findings open a novel therapeutic opportunity in liver cancer and fibrosis with minute CBD concentrations and low content of psychotropic THC fraction," stated Dr. Fishman. "We have filed patent applications on our discovery of cannabinoid-based therapies where the A3AR target is overexpressed including in liver cancer."

On March 11, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data further demonstrating the performance of DecisionDx-Melanoma and i31-SLNB to provide improved risk prediction of sentinel lymph node (SLN) positivity, compared to using T-stage factors alone, in patients with cutaneous melanoma (Press release, Castle Biosciences, MAR 11, 2022, View Source [SID1234610004]). The data will be shared in a poster presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care, being held in Dallas and virtually, March 9-12, 2022.

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"While the sentinel lymph node biopsy (SLNB) surgical procedure is a common technique in determining possible tumor metastasis, our current criteria for biopsy may be overestimating a person’s risk of having a positive node. This means we may be doing more sentinel node biopsies than necessary; and while we certainly don’t want to miss any lymph node metastases, we also don’t want to do procedures unnecessarily," said study author Joseph Bennett, M.D., Chief of Surgical Oncology and Director of the Melanoma and Sarcoma Multidisciplinary Clinic at ChristianaCare Helen F. Graham Cancer Center & Research Institute, Newark, Del. "The study data show that DecisionDx-Melanoma has the ability to more accurately stratify risk for melanoma patients, which can help guide risk-aligned discussions about which patients should be offered the SLNB procedure and which can forgo it, based on their personal, biologic risk of a positive SLN. We expect that by using DecisionDx-Melanoma and i31-SLNB in addition to standard criteria, we can avoid doing SLNB procedures in many low-risk patients without missing melanoma metastases."

The poster, titled "Integrating the 31-gene expression profile test with clinical and pathologic features can provide personalized precision estimates for sentinel lymph node positivity," evaluated the performance of DecisionDx-Melanoma’s proprietary i31-SLNB algorithm in predicting the risk of SLNB positivity in 156 melanoma patients with known SLN outcomes at the ChristianaCare Helen F. Graham Cancer Center & Research Institute.

In the study, the DecisionDx-Melanoma test outperformed T-stage in identifying patients with low-risk tumors who could forgo SLNB, with an Area Under the Curve (AUC) of 0.89 versus 0.78 for T-stage in patients with T1-T2 tumors, indicating that DecisionDx-Melanoma provides improved predictions compared to those of the T-stage system. Additionally, the test accurately identified all patients with T1-T2 tumors who had a low risk (<5%) of SLN positivity (all of whom had negative SLNB results) with 100% negative predictive value, 100% sensitivity and significantly improved specificity compared to T-stage (37.5% vs. 2.5% for T-stage). Using T-stage alone, only two patients (T1a with no other high-risk tumor features) were accurately identified as low risk (<5%) of SLN positivity.

"The results of the study demonstrate that DecisionDx-Melanoma, with its proprietary i31-SLNB algorithm, can allow for more precise and personalized management of melanoma patients and improve patient selection for the SLNB surgical procedure, thus potentially enabling a reduction in unnecessary healthcare costs," said Derek Maetzold, president and chief executive officer of Castle Biosciences.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through Dec. 31, 2021, DecisionDx-Melanoma has been ordered 90,154 times for use in patients with cutaneous melanoma.

On March 11, 2022 Prestige BioPharma Limited (950210: KRX), a Singapore-based biopharmaceutical with operations in USA and South Korea, reported that positive efficacy and safety results of the Phase 3 study for HD201 (TROIKA), a biosimilar to Herceptin (trastuzumab), published in JAMA Oncology on March 4, 2022 (Press release, Prestige BioPharma, MAR 11, 2022, View Source [SID1234610003]).

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The publication highlights comparative efficacy and safety data for patients who received 1-year of treatment with HD201 or referent trastuzumab and completed a median follow-up of 31 months. The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the two groups was not significant at −3.8% (95% CI, −12.8% to 5.4%) and fell within the predefined equivalence margins. The results regarding secondary endpoints bpCR, overall response, and response based on mammography, ultrasonography, or clinical tumor evaluations supported the comparable efficacy between HD201 and referent trastuzumab. Similar safety, PK and immunogenicity results were reported for the two treatment arms.

The final analysis for the 3-year Event-free survival (EFS) and Overall survival (OS) results is currently ongoing. The preliminary results of the current final analysis indicate highly comparable 3-year EFS and OS rates for HD201 and reference trastuzumab.

Tuznue has secured global distribution partnerships in major markets including Europe, the Middle East, South America, and Asia. It is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.

Prestige’s robust pipeline in clinical stage also includes an Avastin biosimilar HD204 (Vasforda) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We are pleased to demonstrate HD201’s excellence through the Phase 3 study results published in JAMA Oncology" and "the company will accelerate global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need".

On March 11, 2022 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (ANPC), a biotechnology company with operations in the United States and China focused on early cancer screening and detection, reported that on March 8, 2022, it received a written notice (the "Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the minimum bid price requirement of US$1.00 per share under the Nasdaq Listing Rules (the "Listing Rules") (Press release, Anpac Bio, MAR 11, 2022, View Source [SID1234609994]). Based on the closing bid price of the Company’s listed securities for the last 30 consecutive business days from January 24, 2022 to March 7, 2022, the Company has failed to meet the minimum bid price requirement set forth in Listing Rule 5450(a)(1) during that period. The Notice is only a notification of deficiency. It is not a notice of imminent delisting, and it has no current immediate effect on the listing or trading of the Company’s securities on the Nasdaq Capital Market.

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The Notice states that under Listing Rule 5810(c)(3)(A) the Company is provided with a period of 180 calendar days, or September 5, 2022, to regain compliance with the Listing Rules. To regain compliance with the Listing Rules, the Company’s listed securities price must be at least US$1.00 for a minimum of ten consecutive business days. In the event the Company does not regain compliance by September 5, 2022, the Company may be eligible for additional time to regain compliance or may face delisting.

As previously announced, the Company has a separate Nasdaq Global Market deficiency in the requirement that it maintain a minimum Market Value of Listed Securities ("MVLS") of US$50 million. The Company has until March 23, 2022 to regain compliance with the MVLS requirement. Also as previously announced, the Company has a separate Nasdaq Global Market deficiency in the requirement that it maintain a minimum Market Value of Public Held Shares ("MVPHS") of US$15 million. The Company has until July 18, 2022 to regain compliance with the MVPHS requirement. Resolving any of the minimum bid price deficiency, MVPHS deficiency and MVLS deficiency will not resolve any of the other deficiencies. In addition, although the Company may be eligible for a further extension of up to 180 calendar days to return to compliance with continued listing requirements, such extensions are contingent on the absence of any other deficiencies.

The Company intends to continue to monitor the closing bid price of its ordinary shares between now and September 5, 2022, and to evaluate its available options to regain compliance within the compliance period. The Company fully intends to resolve the deficiency and regain compliance with the Listing Rules.

On March 11, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that the Company and Cedars-Sinai Medical Center have agreed under their Master Collaboration Agreement to co-fund and codevelop a novel immuno-oncology treatment designed to promote the destruction of cancer cells by a patient’s own "killer" T-cells (Press release, AIkido Pharma, MAR 11, 2022, View Source [SID1234609988]).

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The Company and Cedars-Sinai will share costs, expenses and management of the drug co-development and will leverage the talent of Cedars-Sinai Technology Ventures and the lead scientists who originated the novel treatment. The parties will also share in the proceeds of any commercialization of the treatment.

The compounds to be codeveloped target the cellular pathway that causes CD8+ T-cells to enter an "exhausted state," rendering them ineffective against cancer cells. The new treatment targets and blocks recently discovered transcription factors essential for T-cells to enter the "exhausted state," the goal of which is to strengthen the ability of a patient’s T-cells to retain their capacity to destroy cancer cells.

Anthony Hayes, CEO of AIkido, stated, "Our agreement with Cedars-Sinai to collaborate in the funding and monetization of novel disease treatments is a major step for the Company. I am thrilled that Cedars-Sinai will be co-funding this project and providing its exceptional staff of scientists to advance this new cancer treatment, which I believe speaks volumes about its potential."