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 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company that aspires to develop medicines to make chemotherapy safer and thereby more effective to save more patients’ lives, reported a business update and outlined the company’s strategic priorities for 2022 (Press release, Aileron Therapeutics, JAN 5, 2022, View Source [SID1234598195]).

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"All cancer patients undergoing chemotherapy – still the standard of care for most patients – experience chemotherapeutic side effects to varying degrees, from unpleasant to fatal. Utilizing a biomarker strategy, we are developing ALRN-6924 as a selective chemoprotective agent to shift the paradigm from accepting these side effects to preventing them for patients with p53-mutated cancer regardless of type of cancer or chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "In 2022, we expect several key milestones may propel us toward this vision, including our planned initiation of a clinical trial in breast cancer patients receiving neoadjuvant chemotherapy in the first half of the year with interim results in the fourth quarter, as well as planned interim and topline data readouts for our ongoing NSCLC trial in the second and fourth quarters, respectively."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron employs a precision medicine approach to exclusively treat those patients with p53-mutated cancers who are receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and that is expected to improve efficacy of chemotherapy.

2022 Strategic Priorities and Business Update

Initiate clinical trial in neoadjuvant (pre-operative) breast cancer in 1H22, with interim results in 4Q22. Aileron plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow and other toxicities in ER+/HER2- breast cancer patients treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D’. The Phase 1b trial will enroll up to 30 patients in a parallel group design trial with a dose expansion cohort. Aileron will provide more details on the planned neoadjuvant breast cancer trial design at the time of trial initiation.
Advance ongoing NSCLC trial to interim (20-patient) and topline (60-patient) readouts, in 2Q22 and 4Q22, respectively. Aileron is currently enrolling patients in the US and EU with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. As previously guided, Aileron anticipates reporting interim results on 20 patients in 2Q22, and topline results on 60 patients in 4Q22. Aileron has dosed the first 10 patients in the trial and plans to conduct a blinded safety evaluation on these patients after one cycle in 1Q22, as previously guided.
Continue to progress ongoing Healthy Volunteer Study. Aileron is continuing to progress its ongoing Phase 1 pharmacology study which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The company presented initial data from the study in 2021, confirming the drug’s novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration. The aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated cancers. Aileron anticipates reporting additional findings from the study this year.

Expanded patent portfolio in 2021 with issuance of 11 new foreign and U.S. patents. Aileron was issued 7 new international patents and 4 U.S. patents over the past 12 months, including new patent protection for ALRN-6924 in China. These newly issued patents add to Aileron’s robust intellectual property portfolio, which includes over 170 U.S. and foreign patents, with another 47 applications in prosecution. These patents and applications include ALRN-6924 methods of manufacture, methods of use, drug product formulations, and compositions of matter (COM). The COM patent in the US expires in 2033 with up to 5 additional years subject to patent term extensions. Of note, Aileron maintains exclusive rights to its proprietary peptide drug technology and ALRN-6924 worldwide.