On January 5, 2021 Mersana Therapeutics, Inc., (NASDAQ: MRSN) a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Anna Protopapas, President and Chief Executive Officer, will present a company overview at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:00 p.m. ET (Press release, Mersana Therapeutics, JAN 5, 2022, View Source [SID1234598232]).

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A live webcast of the presentation will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 30 days following the presentation.

On January 5, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-β therapeutics for oncology and virology, reported that it has submitted a clinical study protocol to the United States Food and Drug Administration ("US FDA") for the initiation of a Phase 1 Clinical Trial for CA4P, the Company’s Vascular Disrupting Agent, in combination with Anti-PD-1 (pembrolizumab) as a treatment for patients with Melanoma (Press release, Oncotelic, JAN 5, 2022, View Source [SID1234598259]).

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The Phase 1 Clinical Trial is designated as S101: Phase 1, Prospective, Multicenter, Open-Label, Single Arm Study of Safety and Initial Efficacy of CA4P in Combination with anti-PD1 (pembrolizumab) in Patients with Recurrent Metastatic Cutaneous or Uveal Melanoma.

CA4P has been evaluated in over 500 patients and treated in 17 clinical studies to date. These included multiple Phase 1 dose escalation studies, with dose cohorts up to 114 mg/m2, when used as monotherapy, 63 mg/m2 when used in combination with paclitaxel, and 63 mg/m2 when used in combination with bevacizumab. Based on the early Phase 1 studies, CA4P was further studied in larger Phase 2 studies including:

• Ovarian cancer – 60 mg/m2 CA4P in combination with 15 mg/kg bevacizumab (n=54) in combination with physician’s choice chemotherapy;

• Anaplastic thyroid cancer – 60 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=51);

• Platinum resistant ovarian cancer – 63 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=44);

• Non-small cell lung cancer – 60 mg/m2 CA4P in combination with bevacizumab and with paclitaxel and carboplatin q3wk (n=31).

CA4P was generally well tolerated in these studies, and toxicity did not appear to be significantly related to dose frequency. The Company believes that the combination of CA4P together with checkpoint inhibitors, such as pembrolizumab, could be synergistic. Mechanistically, the trial is also designed to assess the impact of CA4P on tumoral TGF-β signature which would allow us to integrate CA4P into our TGF-β platform as combination with checkpoint inhibitors, CAR-T, and vaccine/oncolytic viruses.

"This is the first of a series of planned clinical trials in melanoma patients to ultimately obtain marketing approval for CA4P in a Rare Pediatric Disease. The US FDA has previously granted the Company a Rare Pediatric Disease Designation for CA4P/ Fosbretabulin for the treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect pediatric patients." noted Dr. Vuong Trieu, Chairman and Chief Executive Office of Oncotelic.

On January 5, 2022 Median Technologies (ALMDT:PA) reported outstanding performance for its iBiopsy Lung Cancer Screening (LCS) CADe algorithm in detecting potentially cancerous lung nodules (Press release, MEDIAN Technologies, JAN 5, 2022, View Source [SID1234598282]).

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When screening for lung cancer, the entire lung must be scanned, which can generate hundreds of images for each patient to detect very small lung nodules. Time constraints and the very large numbers of images to review render it difficult for radiologists to exhaustively detect lung nodules without an automation tool. Without such automation tools, diagnostic errors may result when radiologists are dealing with fatigue. Automated detection tools can help radiologists read images and must offer high sensitivity to minimize false negatives and avoid missing nodules. These tools should also minimize the number of false positives to ensure that radiologists do not focus their attention and time on regions that are not clinically relevant, and will help to avoid lung biopsies as well as unnecessary follow up procedures for the patients.

iBiopsy LCS offers an integrated detection/diagnosis approach (CADe/CADx). The first step is detecting, as thoroughly as possible, all lung nodules in the CT scan images with minimal false negatives and false positives per scan. After automated detection, the diagnostic component (CADx) of iBiopsy LCS aims to reach high levels of sensitivity and specificity, accurately characterizing the presence of cancer while minimizing the false positive rate. False positives are one of the major barriers to adopting screening programs globally. It bears recalling that the outstanding characterization results of iBiopsy CADx were published on September 6, 2021 (performance characterizing cancerous nodules at all stages) and on November 23, 2021 (focus on stage 1 cancers).

The results released today by Median Technologies specifically focus on the lung nodule detection function, which applies Median’s proprietary deep learning algorithms to low-dose computed tomography (LDCT). They are based on a cohort of 888 patients from the LIDC/IDRI2 public database. The 10-fold cross-validation method was used for training (800 train/88 test patients). The overall result, obtained by aggregating the ten test fold results, showed a sensitivity of 94.9% for a false positive rate of 1 per CT scan.

According to publicly available data on the performance of lung CADe devices currently on the market, iBiopsy detection algorithms show the best combination of sensitivity/false positives per CT scan.

"After announcing iBiopsy’s first outstanding results for malignant vs. benign lung nodule characterization in 2021, we are proud to announce our detection algorithm’s performance," highlights Fredrik Brag, CEO and founder of Median. "These results give us reason to be optimistic as we enter the final phase of iBiopsy Lung Cancer Screening’s technological risk mitigation. We are now working on combining detection and diagnosis modules to determine integrated performance. We believe it is only by integrating these two functions in the same software as a medical device (SaMD) that we can remove the current barriers to implementing lung cancer screening programs. Large international trials have already shown the major impact of LDCT lung screening programs on mortality. In parallel, as demonstrated by studies such as the IASLC staging project and an I-ELCAP cohort study respectively, detecting and diagnosing the disease at its earlier stage, when lung nodules are still very small and manageable is key to drastically increasing the patient 5-year and 15-year overall survival rates, saving the lives of patients suffering from lung cancer," Brag added.

On January 5, 2022 Cyclenium Pharma, Inc. ("Cyclenium"), an emerging pharmaceutical company specializing in the discovery and development of novel therapeutic agents based on their proprietary macrocyclic chemistry, and Vuja De Sciences, Inc. ("Vuja De"), a biotechnology startup dedicated to discovering therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence, reported the signing of a drug discovery collaboration agreement (Press release, Cyclenium, JAN 5, 2022, View Source [SID1234598300]). The companies will screen and optimize lead candidates to advance treatments uniquely suited for preventing cancer metastatic recurrence, the biggest unmet need in oncology.

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The collaboration will exploit Vuja De’s proprietary anti-metastatic progression in vitro and ex vivo drug discovery screening platform and Cyclenium’s proprietary QUEST Library of next generation synthetic small-molecule macrocycles and associated optimization expertise to identify clinical candidates effective against dormant disseminated tumor cells for the prevention of metastatic cancer recurrence. Vuja De will be responsible for all screening efforts, while Cyclenium will be responsible for all medicinal chemistry efforts to generate new optimized macrocyclic compounds by employing its unique CMRT Technology.

"We are very excited about entering this collaboration with Vuja De," stated Helmut Thomas, Ph.D., President, Chief Executive Officer & Chief Scientific Officer of Cyclenium. "We are confident that our CMRT Technology and proven success in the macrocycle area combined with the innovative anti-metastatic progression platform and excellent research team at Vuja De will enable the discovery and development of novel macrocyclic therapeutic agents to effectively control metastatic progression."

"We highly appreciate Cyclenium’s expertise in the macrocycle area and their technology platform that is based on over 20 years of pioneering experience in small molecule macrocyclic chemistry," said David Warshawsky, Ph.D., Chief Executive Officer of Vuja De. "We are very pleased to work with Cyclenium on identifying and developing novel game-changing drug candidates that prevent metastatic recurrence, the most urgent need of most cancer patients," he added.

On January 5, 2022 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors have approved a first-quarter 2022 dividend of $0.18 per share (Press release, West Pharmaceutical Services, JAN 5, 2022, View Source [SID1234598354]). The dividend will be paid on February 2, 2022, to shareholders of record as of January 19, 2022.

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The Company’s Board of Directors authorized a share repurchase program for calendar-year 2022 of up to 650,000 shares of the Company’s common stock from time to time on the open market or in privately negotiated transactions, as permitted under Exchange Act Rule 10b-18. The number of shares to be repurchased and the timing of such transactions will depend on a variety of factors, including market conditions. The share repurchase program is expected to be completed by December 31, 2022. The Company’s previously authorized share repurchase program expired on December 31, 2021.