On October 28, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported that it will report its third quarter 2020 financial results on Thursday, November 5, 2020 (Press release, Deciphera Pharmaceuticals, OCT 28, 2020, View Source [SID1234569249]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 4:30 PM ET on Thursday, November 5, 2020, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 6048987. A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On October 28, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that the last patient in the low-dose cohort has completed six months of NOX-A12 therapy in the Phase 1/2 brain cancer clinical trial (Press release, NOXXON, OCT 28, 2020, View Source [SID1234569248]). The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external beam radiotherapy in newly diagnosed MGMT1 promoter unmethylated glioblastoma patients, a difficult-to-treat brain cancer.

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Patients participating in the study would not have benefitted clinically from the standard of care chemotherapy due to their MGMT promoter methylation status. They also all had tumor tissue remaining after surgical resection before being recruited into the study.

Tumor volume reductions were observed in two of three patients during the six-month treatment, and in the third patient in the period after a second surgery following continued NOX-A12 treatment. Maximum tumor volume reductions were 6% and 60% for the first two patients. The third patient experienced 23% tumor volume reduction relative to the post-second surgery baseline. Tumor volume reductions were reported as the average of two independent central MRI readers and results included unscheduled scans. Two of three patients had stable or decreasing tumor volumes for 16 weeks or longer (one following a second surgery) and both are currently in the treatment-free follow-up period. One patient deceased from tumor progression during the treatment period.

NOX-A12 steady-state plasma levels were in the targeted range following administration of 200 mg per week. With a data cutoff date of October 23, 2020, the adverse event profile was similar to that expected from radiotherapy alone in glioblastoma patients. Eighteen of 90 adverse events were noted as being potentially related to NOX-A12 and disease or radiotherapy. There were five adverse events potentially related only to NOX-A12 which were all mild or moderate (grade 1 or 2), confirming the manageable safety and tolerability profile for NOX-A12 in combination with radiotherapy.

"It is encouraging to see that two of the first three patients are responding to treatment with shrinking tumor volumes, indicating early signs of clinical activity, especially considering that this is the lowest NOX-A12 dose being tested. Next, we need to follow up with the patients to understand how their condition will evolve over time, especially after the completion of therapy after six months," said Dr. Jarl Ulf Jungnelius, Senior Medical Advisor to NOXXON Pharma.

Going forward NOXXON’s planned clinical development strategy for NOX-A12 will be focused on two indications: brain cancer and pancreatic cancer. Each indication will test a different combination strategy, thereby providing multiple possibilities to successfully advance the clinical development plan: NOX-A12 plus radiotherapy in brain cancer, and NOX-A12 plus immuno-/chemotherapy in pancreatic cancer.

In brain cancer, NOXXON plans to complete the ongoing Phase 1/2 study testing three doses of NOX‑A12 combined with radiotherapy. The company is considering expanding the dose cohort, which is finally chosen for the planned pivotal trial, in order to gain experience in a larger group of patients for discussions with regulatory agencies. The next planned trial will be a pivotal, randomized Phase 2 trial comparing NOX-A12 plus radiotherapy to standard of care in MGMT unmethylated first-line glioblastoma patients. MGMT unmethylated patients represent approximately 50% of all first-line glioblastoma patients, or approximately 6,000 patients per year in the EU and 5,000 patients per year in the US.

NOXXON’s planned clinical development strategy for pancreatic cancer will initially involve a two-arm clinical trial testing the combination of NOX-A12 plus anti-PD-1 immunotherapy in second-line patients. In each arm, a different second-line standard of care chemotherapy regimen will be combined with NOX‑A12 plus anti-PD1. This will allow NOXXON to choose the best combination therapy to move forward into a randomized, controlled pivotal trial.

On October 28, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and nine months ended September 30, 2020 (Press release, Odonate Therapeutics, OCT 28, 2020, View Source [SID1234569247]).

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As of September 30, 2020, Odonate had $188.3 million in cash, compared to $180.5 million as of December 31, 2019. This increase in cash resulted primarily from the receipt of $87.4 million of net proceeds from Odonate’s September 2020 underwritten public offering, less cash used in operating activities for the nine months ended September 30, 2020 of $81.6 million. Odonate’s net loss for the three and nine months ended September 30, 2020 was $30.5 million and $94.1 million, or $0.93 and $3.00 per share, respectively, compared to $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, for the same periods in 2019.

"We are pleased to have recently announced positive top-line results from CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "These results have been selected for an oral presentation at the 2020 San Antonio Breast Cancer Symposium in December. We continue to plan to submit a New Drug Application for tesetaxel to the FDA in mid-2021."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS.

On October 28, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company plans to present at the following conferences in November (Press release, Iovance Biotherapeutics, OCT 28, 2020, View Source [SID1234569246]):

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Next Generation CAR and T Cell Therapies Conference (Virtual) | Nov. 2-5, 2020
Date/Time: Monday, Nov. 2 at 5:20 p.m. EST
Credit Suisse 29th Annual Virtual Healthcare Conference | Nov. 9-12, 2020
Date/Time: Monday, Nov. 9 at 1:15 p.m. EST
SITC Annual Meeting (Nov. 9-14, 2020)
Poster Presentation (Abstract #353): Safety and efficacy of tumor infiltrating lymphocytes (TIL; LN-145) in combination with pembrolizumab for advanced, recurrent or metastatic HNSCC
Authors: A Jimeno, et al.
Dates/Times: Wednesday, Nov. 11, from 5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m. EST
Location: Virtual Poster Hall
Stifel 2020 Virtual Healthcare Conference | Nov. 16-18, 2020
Date/Time: Wednesday, Nov. 18 at 8:00 a.m. EST
Jefferies Virtual London Healthcare Conference | Nov. 17-19, 2020
Date/Time: Thursday, Nov. 19 at 12:35 p.m. EST
Live and archived webcasts of the investor conference presentations will be available in the Investors section of the Iovance website at View Source

On October 28, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported a corporate update covering the progress made in 2020 thus far as well as major milestones expected by year-end and in 2021 (Press release, Actinium Pharmaceuticals, OCT 28, 2020, View Source [SID1234569245]).

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Sandesh Seth, Actinium’s Chairman and Chief Executive Officer, said, "We have made material advances in our key clinical trials and programs for targeted conditioning and therapeutic combinations this year and anticipate several important milestones before year-end and in 2021. Collectively, as described in our recent shareholder letter, upcoming data events with our Iomab-B SIERRA trial and Actimab-A combination trials will bring into view the opportunity for a much larger and attractive opportunity in R/R AML than either drug candidate alone. Iomab-B, which is in the final quarter of enrollment of the Phase 3 SIERRA trial for targeted conditioning of older patients with R/R AML, has the potential to make potentially curative BMT accessible for patients not able to receive BMT with today’s conditioning approaches. Our CD33 program is focused on enhancing patient outcomes by leveraging the potentiating or mechanistic synergy of targeted radiation via our Antibody Radiation Conjugates (ARCs) with other therapeutic modalities.

"We have also made great strides with our Iomab-ACT program for targeted conditioning for the large and growing fields of cell and gene therapies with our recent collaboration with Memorial Sloan Kettering and their CD19 CAR-T therapy that has been awarded an NIH STTR Fast-Track Phase 1/2 grant. Armed with a highly differentiated technology, a strong balance sheet, enhanced R&D capabilities through our recently acquired research facility and motivated team, we are excited to execute on our vision and for the multiple upcoming clinical milestones that have the potential to transform Actinium."

Key ARC Program Highlights and Outlook:

Iomab-B SIERRA Pivotal Trial

The SIERRA trial reached seventy-five percent enrollment.
In the second quarter, the Company exercised a single ad hoc interim analysis, which was guided by the positive interim results from the first fifty percent of patients enrolled on the pivotal Phase 3 SIERRA trial for Iomab-B that were presented in February 2020 at the Transplant & Cellular Therapy Conference (TCT).
Additionally, the difference in number of patients potentially evaluable for the primary endpoint, measured by 100-day non-relapse transplant related mortality, has remained consistent at roughly 6x greater for the study arm at the 25% and 50% enrollment updates.
The Company will report safety and feasibility data from 75% enrollment in the Fourth Quarter. Additionally, the ad hoc interim analysis to be completed in the Fourth Quarter could result in a recommendation for early termination of the trial for futility of one of the arms, or a continuation of the trial.
Actimab-A and CLAG-M Phase 1 Combination Trial

Successfully completed third and final dose cohort of 1.0 uCi/Kg of Actimab-A marking the completion of the planned Phase 1 trial.
The Company has reported that the second dose cohort demonstrated an 86% complete remission rate in relapsed or refractory AML patients treated with Actimab-A plus CLAG-M, which is a 60% improvement over what is seen with CLAG-M alone. Further, the minimal residual disease or MRD negative rate was 71%, which is an indicator of deep remissions.
The Company expects to present results from the third dosing cohort in the Phase 1 trial in the fourth quarter of 2020.
Actimab-A and Venetoclax Phase 1/2 Combination Trial

Successfully completed first dosing cohort thus allowing the study to proceed to a second dose cohort of 1.0 uCi/Kg Actimab-A and venetoclax combination.
First in human data expected in 2020; the Company expects to report study proof of concept results in 2021.
Iomab-ACT CAR-T Program

Actinium was awarded a Fast-Track Phase 1/2 STTR grant by the National Institutes of Health (NIH) for a clinical collaboration of Iomab-ACT targeted conditioning with Memorial Sloan Kettering Cancer Center’s (MSK) CD19 CAR T-Cell therapy, 19-28z.
Results published in the New England Journal of Medicine showed an 83% remission rate with MSK’s 19-28z CAR-T utilizing chemotherapy-based conditioning. However, cytokine release syndrome and neurotoxicity were cited as a challenge for further development in the study which included patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Preclinical data supporting Iomab-ACT’s application in targeted lymphodepletion prior to ACT such as CAR-T was published in the journal Oncotarget. These results support the application of CD45-targeted radioimmunotherapy lymphodepletion with a non-myeloablative dose of Iomab-ACT prior to adoptive cell therapy.
The Company expects Phase 1 proof of concept data from collaboration in 2021.
Research Facility and Expanded R&D Capabilities

Launched R&D Lab with a focus on applying its Antibody Warhead Enabling (AWE) technology platform and scientific expertise in radioimmunobiology to the development of ARCs. The Company intends to leverage the new facility to better evaluate new assets for in-licensing, broaden potential uses of its clinical stage candidates and to secure collaborations and partnerships with biopharmaceutical companies.
Financial Condition

Actinium reported a cash balance of $48.2 million as of September 30, 2020 compared with $9.2 million as of December 31, 2019 and a net loss of $5.5 million for 3Q:2020. Based on current estimates, the current cash balance is expected to fund operations through clinical milestones including completion of the Pivotal Phase 3 SIERRA trial, completion of ongoing Phase 1/2 Actimab-A combination trials and planned R&D activity.