On March 21, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the company has achieved its enrollment target of 40 patients in the EXP-6 cohort of the phase 1/2 registrational TRIDENT-1 study (Press release, Turning Point Therapeutics, MAR 21, 2022, View Source [SID1234610484]). EXP-6 is comprised of NTRK-positive TKI-pretreated advanced solid tumor patients.

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"I am incredibly proud of our team as we have completed enrollment of the NTRK-positive TKI-pretreated EXP-6 cohort ahead of our internal projections, driven by another strong quarter of enrollment in the TRIDENT-1 study. Separately we remain on track to provide our top line data across ROS1-positive TKI-naïve and TKI-pretreated NSCLC cohorts and to conduct our first pre-NDA meeting for repotrectinib, both anticipated in the second quarter of 2022," said Athena Countouriotis, M.D., president and chief executive officer. "We will now begin preparations for our second repotrectinib pre-NDA meeting to discuss the NTRK-positive population, which we anticipate will take place in the first quarter of 2023."

Enrollment across all six cohorts of the study remains open and continues to progress steadily.

Repotrectinib has been granted Breakthrough Therapy designation for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and have no satisfactory alternative treatments. Repotrectinib has also been granted Fast-Track designation for the treatment of NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments.

Repotrectinib has also been granted Breakthrough Therapy designation in ROS1- positive metastatic NSCLC patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as three additional Fast-Track designations in: ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; and ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy.

There are currently no approved targeted therapies for patients with NTRK-positive TKI-pretreated advanced solid tumors.

In a Type B meeting with the United States Food and Drug Administration (FDA) in the fourth quarter of 2021, the FDA noted that data from EXP-5, NTRK-positive patients without prior TRK TKI treatment, may be used to support the efficacy data for EXP-6, or potentially could be pooled with data from EXP-6 to support a broader indication.

The company has previously reported in October 2021 encouraging preliminary data in EXP-6 as of a cutoff date of August 26, 2021, including two responders who confirmed subsequent to the data cutoff date, with a confirmed objective response rate (ORR) of 48% (n=23, 95% CI 27-69%), and within patients with solvent-front mutations, a confirmed ORR of 62% (n=13, 95% CI 32-86%).

On March 21, 2022 EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, reported that it will release its financial results for the fourth quarter ended December 31, 2021 after the markets close on Wednesday, March 30, 2022 (Press release, EDAP TMS, MAR 21, 2022, View Source [SID1234610483]).

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An accompanying conference call and webcast will be hosted by Marc Oczachowski, Chairman of the Board and Chief Executive Officer, Ryan Rhodes, CEO of EDAP U.S., and François Dietsch, Chief Financial Officer. The call will be held at 8:30am ET on Thursday, March 31, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

On March 21, 2022 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its Board of Directors has authorized the following cash dividends to holders of XOMA’s Series A and Series B Cumulative Preferred Stock (Press release, Xoma, MAR 21, 2022, View Source [SID1234610482]):

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Holders of the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) shall receive a cash dividend equal to $0.53906 per share.

Holders of depositary shares, each representing 1/1000 of a share of XOMA’s 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO), shall receive a cash dividend equal to $0.52344 per depositary share.

The preferred dividends will be paid on or about April 15, 2022, to respective holders of record at the close of business on April 1, 2022.

On March 21, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Cellectar Biosciences, MAR 21, 2022, View Source [SID1234610481]).

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Fourth Quarter and Recent Corporate Highlights

·Presented data from 11 multiple myeloma patients from the company’s ongoing Phase 2 CLOVER-1 study of iopofosine I-131 (iopofosine) at the 63rd ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The patients included in this report were triple class refractory had a median 7.2 prior lines of therapy, 50% classified as high risk, showed a mean overall response rate (ORR) of 45.5%, clinical benefit rate (CBR) of 72.7% and disease control rate (DCR) of 100% were observed. A subset of 5 quad/penta drug refractory patients had an ORR of 80%, a CBR and DCR of 100%. Median progression free survival (PFS) for all 11 patients was 3.4 months. Treatment emergent adverse events were mostly limited to bone marrow suppression in line with prior observations. No patients experienced a treatment emergent adverse event of neuropathy, arrhythmia, cardiovascular event, bleeding, ocular toxicities, renal function, alterations in liver enzymes, or infusion-site reactions.

·Announced initial responses from patients in the company’s Phase 1 study of iopofosine in children and adolescents with relapsed and refractory high-grade gliomas (HGGs) and soft tissue sarcomas, with patients exhibiting positive changes in various tumor parameters. Patients received doses up to 60 mCi/m2 and initial response and tumor uptake were confirmed by further therapeutic responses as evidenced by changes in tumor parameters. These include patients with relapsed HGGs experiencing over 5 months of PFS. The independent data monitoring committee advised that based upon the initial data, the study could initiate the 75 mCi/m2 dosing cohort.

"The data presented from our ongoing trials continue to be very encouraging, and we believe iopofosine has the potential to provide a meaningful therapeutic benefit for patients with Waldenstrom’s macroglobulinemia (WM) and other treatment refractory B-cell lymphomas. We continue to make significant strides in our clinical trials as we enroll patients in our ongoing pivotal trial in WM and our Phase 2 CLOVER-1 study," said James Caruso, president and CEO of Cellectar. "We look forward to sharing our planned interim data safety monitoring assessment from our WM pivotal trial. In the near-term our efforts are supported by a strong balance sheet that will fund our expected clinical and regulatory milestones into the second half of 2023."

2021 Financial Highlights

·Cash and Cash Equivalents: As of December 31,2021, the company had cash and cash equivalents of $35.7 million, compared to $57.2 million at December 31, 2020. Cash used in operating activities during the twelve months ended December 31, 2021 was approximately $22.6 million. The company believes its cash on hand is adequate to fund basic budgeted operations for at least 12 months from the filing of the 2021 financial statements.

·Research and Development Expense: R&D expense for the year ended December 31, 2021 was approximately $17.6 million, compared to approximately $10.1 million for year ended December 31, 2020. The overall increase in R&D expense of approximately $7.5 million was a result of an increase in planned clinical project costs primarily related to the company’s WM pivotal study. Manufacturing and related costs remained relatively consistent year over year.

·General and Administrative Expense: G&A expense for year ended December 31, 2021 was $6.6 million compared to approximately $5.2 million for the year ended December 31, 2020. The increase of $1.4 million in G&A costs was primarily a result of an increase in professional fees and insurance, personnel costs and stock-based compensation expense.

·Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2021 was ($24.1) million, or ($0.43) per share, compared to ($15.1) million, or ($0.76) per share, in 2020.

On March 21, 2022 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that new preclinical data demonstrating solid tumor elimination when dosing AU-007, a monoclonal antibody computationally designed by Biolojic Design (Press release, Aulos Bioscience, MAR 21, 2022, View Source [SID1234610480]). Data were presented at a recent antibody biology and engineering conference.

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"These preclinical data strongly support AU-007’s unique mechanism of action as an antibody that can promote anti-cancer activity, including complete tumor elimination when used with checkpoint inhibitors in a murine model of cancer," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "AU-007’s ability to redirect IL-2 toward immune activation and away from immune suppression and vascular endothelium is a novel approach to long-standing obstacles in immunotherapy. The new data underscore the potential we see in AU-007 as we prepare to initiate a Phase 1/2, first-in-human clinical trial of AU-007 in solid tumor indications."

To address the challenges of existing interleukin-2 (IL-2) treatments, Biolojic Design used its artificial intelligence platform to computationally design AU-007, a human antibody that precisely blocks IL-2 from binding to CD25 in trimeric receptors while preserving IL-2’s binding to dimeric CD122/CD132 receptors. Through this differentiated mechanism of action, AU-007 could promote immune effector activation while preventing T regulatory (Treg) cell expansion and vascular leak syndrome driven by IL-2. AU-007 has also been shown to break the autoinhibitory loop caused by endogenous IL-2 secreted from activated CD4 T helper cells and CD8 T effector cells that would otherwise lead to Treg expansion and immune suppression.

The new data demonstrate strong anti-cancer activity in murine models when AU-007 is dosed with a single dose of human IL-2 (hIL-2), as well as in combination with a single dose of hIL-2 and checkpoint inhibitors. In a recent murine preclinical study, AU-007 with a single loading dose of hIL-2 and PD-1 antibody demonstrated MC38 colorectal tumor regressions, with complete tumor elimination achieved in five of 10 cases. Additionally, AU-007 with a single loading dose of hIL-2 and PD-L1 antibody similarly demonstrated tumor regressions, with complete tumor elimination achieved in five of nine cases. AU-007 has been shown to be safe and well tolerated in primate toxicology studies (data not presented), does not cross-react with human tissues, and is on track to become the first computationally designed human antibody to enter clinical development.

In February, Aulos Bioscience announced it had received approval from the Monash Health Human Research Ethics Committee (HREC) to initiate a Phase 1/2, first-in-human trial of AU-007 in Australia. Aulos anticipates initiating enrollment and dosing in the first half of 2022.

The poster presentation is available on the Aulos Bioscience website.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.