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."

On March 11, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that it has completed the acquisition of VCN Biosciences, S.L. (VCN) following the satisfaction of all closing conditions (Press release, Synthetic Biologics, MAR 11, 2022, View Source [SID1234609987]).

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VCN is a privately held clinical-stage biotech company focused on developing a new oncolytic adenovirus (OV) platform designed for intravenous (IV) and intravitreal (IVit) delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune-system. The acquisition transforms Synthetic Biologics’ pipeline with the addition of VCN’s lead clinical-stage drug candidate, VCN-01, as well as preclinical stage VCN-11, both of which are next-generation OVs in development for the treatment of cancers with high unmet need. VCN-01 was granted Orphan Drug Designation in 2011 by the European Medicines Agency (EMA) for the treatment of pancreatic ductal adenocarcinoma (PDAC), and in February this year was granted Orphan Drug Designation by the U.S. FDA for the treatment of retinoblastoma (RB). VCN-11 is a modified version of VCN-01 that incorporates a proprietary albumin binding domain in the virus outer shell and was designed to improve systemic delivery by enabling the virus to coat itself with host serum albumin and prevent inactivation by neutralizing antibodies.

"The acquisition of VCN positions us at the forefront of oncolytic virus development and propels the Synthetic Biologics pipeline forward," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "The therapeutic application of OVs has been limited, in part, by a need for local administration. Our OVs are designed for systemic administration to target primary as well as metastatic tumors. Once inside the tumor, our OVs are uniquely engineered to replicate selectively and aggressively within the tumor cells and to break down the tumor stroma through the expression of PH20, a differentiating benefit of VCN-01."

Mr. Shallcross continued, "We are highly encouraged by the promising clinical safety and efficacy data generated to date, and we plan to start a Phase 2 trial of VCN-01 in combination with gemcitabine/Abraxane standard of care chemotherapy in PDAC patients. The trial will be led by Dr. Manuel Hidalgo Medina, an internationally renowned physician, scientist and academic, with deep expertise in oncology, and a Member of the Board of Directors at Bristol Myers Squibb. Additionally, we plan to initiate a Phase 2/3 pivotal trial of VCN-01 as either an adjunct to chemotherapy or a potential rescue therapy in advanced RB pediatric patients. With a strong cash position and established collaborations with leaders in the field, we are poised to advance a robust multi-regional clinical program and maximize the clinical potential of our innovative product pipeline. We remain committed to driving shareholder value and look forward to providing updates on our progress as we work towards improving the lives of patients."

Transaction Details

As consideration for the purchase of VCN, at the closing of the transaction Synthetic Biologics paid US$4,700,000 to Grifols Innovation and New Technologies Limited, the owner of approximately 86% of the equity of VCN, and issued to the remaining shareholders and certain key employees and consultants of VCN 26,395,303 shares of common stock of Synthetic Biologics, representing 19.99% of the outstanding shares of Synthetic’s Biologics common stock on December 14, 2021, the date of the Share Purchase Agreement with VCN and its shareholders. In addition to the consideration described above, under the terms of the Share Purchase Agreement, Synthetic Biologics has also agreed to make the following milestone payments to Grifols Innovation and New Technologies Limited:

Milestone Payments

US$3MM upon VCN-01 US IND Safe to Proceed – PDAC (or other first indication)

US$2.75MM upon VCN-01 US IND Safe to Proceed – RB (or other second indication)

US$3.25MM upon VCN-01 US first patient dosed– PDAC (or other first indication) after receipt of VCN-01 US IND Safe to Proceed for PDAC being informed

US$3.25MM upon VCN-01 US first patient dosed – RB (or other second indication) after receipt of VCN-01 US IND Safe to Proceed for RB being informed

US$6MM upon VCN-01 US Phase 2 trial meets the primary endpoint or if a Phase 2 trial is not conducted and only a Phase 3 trial is conducted then upon a Phase 3 being initiated – PDAC (or other first indication)

US$8MM upon VCN-01 Pivotal Trial meeting the primary endpoint or upon BLA Submission – RB (or other second indication)

US$12MM upon VCN-01 US Phase 3 trial meeting the primary endpoint or upon BLA Submission – PDAC (or other first indication)

US$16MM upon VCN-01 BLA Approval – PDAC (or other first indication)

US$16MM upon VCN-01 BLA Approval – RB (or other second indication)
In addition, Synthetic Biologics agreed as a post-Closing covenant to commit to fund VCN’s research and development programs, including but not limited to VCN-01 PDAC Phase 2 trial, VCN-01 RB pivotal trial and necessary G&A within a budgetary plan of approximately US$27.8 million.

A.G.P./Alliance Global Partners served as exclusive financial advisor to Synthetic Biologics in connection with the transaction. Tungsten Advisors served as the exclusive financial advisor to VCN Biosciences SL.