On October 21, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported that it has entered into a second clinical trial collaboration agreement with F. Hoffmann-La Roche (Roche) to evaluate the combination of NeoImmuneTech’s NT-I7 (efineptakin alfa), a novel long-acting IL-7, and Roche’s atezolizumab (Tecentriq), a PD-L1 Checkpoint Inhibitor (CPI) (Press release, NeoImmuneTech, OCT 21, 2020, View Source [SID1234568740]). This new master agreement will now pivot to focus initially on a Phase 2 trial in previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC) patients, with the goal to evaluate anti-tumor efficacy and safety of the NT-I7 and atezolizumab combination. The results of this study will be used to further clinical development of this combination.

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"NT-I7 has the potential to address multiple immune resistance mechanisms by increasing the number of patients’ lymphocytes, expanding T cell repertoire, facilitating the infiltration of cancer-targeting lymphocytes into tumor microenvironments, and sustaining the anti-cancer immune response via memory development," said NgocDiep Le, MD, PhD, Executive Vice President and Chief Medical Officer of NeoImmuneTech (NIT). "As a result, adding NT-I7 to atezolizumab may increase the efficacy of single-agent atezolizumab and broaden the patient population who may benefit from the combination treatment."

"We are excited to enter into a second collaboration agreement with Roche and to continue advancing our T cell enhancer, NT-I7, in the clinic through multiple collaborations with the field’s leading cancer therapeutics such as atezolizumab," added Se Hwan Yang, PhD, Chief Executive Officer of NIT. "NSCLC is the leading cause of cancer deaths worldwide, and we are hopeful that adding NT-I7 to atezolizumab will yield promising results and provide a chemo-free treatment option for these patients."

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On October 21, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that an abstract for the TRIDENT-1 clinical study of its lead drug candidate repotrectinib has been selected for a mini-oral presentation on Jan. 31, 2021 at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (Press release, Turning Point Therapeutics, OCT 21, 2020, View Source [SID1234568737]).

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Additional details are anticipated to be released by IASLC, including presentation titles on Dec. 16 and abstracts on Jan. 12, 2021. For more information, visit View Source

On October 21, 2020 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the execution of an agreement with the Global Coalition for Adaptive Research (GCAR) for VAL-083’s participation in GCAR’s Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study (Press release, Kintara Therapeutics, OCT 21, 2020, View Source [SID1234568736]).

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This study was conceived by an international consortium of major thought leaders in the glioblastoma (GBM) space and is designed to more efficiently identify effective therapies for GBM patients. Since the launch of the study in 2019, GBM AGILE continues to gain momentum among the GBM medical community and has recently expanded the number of participating trial sites in the U.S. from 24 to 31 centers. Kintara is currently advancing two ongoing Phase 2 clinical trials in GBM with VAL-083 in adjuvant and recurrent MGMT unmethylated GBM, and in combination with radiotherapy in newly-diagnosed MGMT unmethylated GBM. Kintara expects to provide an update on these Phase 2 studies at the Society of Neuro-Oncology SNO 2020 Virtual Conference, November 19-21, 2020.

"The consummation of a definitive agreement with GCAR for VAL-083’s participation in GBM AGILE is a significant corporate and clinical milestone for the Company as it is expected to enable us to accelerate the facilitation of the final clinical stages and the regulatory process for our novel therapeutic candidate while enabling us to maximize financial and operational resources," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "The GCAR opportunity is a more robust, efficient, and cost-effective clinical trial solution than had we embarked on this effort independently and it provides multiple shots on goal via enrollment of three separate GBM patient subtypes enabled by GCAR’s FDA-approved adaptive design protocol."

Under the terms of the agreement, Kintara will supply GCAR with VAL-083 drug along with funding to support the VAL-083 arm of the GBM AGILE registrational study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment.

"We are pleased to have reached this major milestone with Kintara and look forward to including VAL-083 into GBM AGILE in the very near future. We are delighted to have a total of 31 U.S. sites already enrolling in GBM AGILE, and expect up to 40 total sites by the end of 2020 in the U.S. and Canada. We have plans to expand to Europe in 2021," commented Meredith Buxton, GCAR’s Chief Executive Officer. "Having such a high number of sites simultaneously enrolling upon initiation of the Kintara trial arm should expedite the rate of patient enrollment."

The GBM AGILE Study is an international effort in newly-diagnosed and recurrent GBM, utilizing an FDA-approved master protocol with multiple drugs to be tested simultaneously and over time against a common control arm. As an approved registrational study, results from the VAL-083 arm of GBM AGILE Study are intended to be utilized to file for FDA approval. This study employs a cost-efficient, adaptive trial design with a Stage 1 (Phase 2) learning and adapting phase and a Stage 2 (Phase 3) expansion and confirmation phase. The totality of the data from the Stage 1 and Stage 2 expansion would be used for the regulatory filing of an NDA. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR functions as the GBM AGILE Study sponsor, and provides financial support for the program infrastructure, as well as general trial oversight. Comprising some of the world’s foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited.

ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH

GCAR is a 501(c)(3) nonprofit organization, comprised of some of the world’s foremost physicians, clinical researchers and investigators united in expediting the discovery and development of cures for patients with rare and deadly diseases. As its first priority, GCAR is sponsoring GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE study effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research. These three nonprofit organizations are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovative approach to brain tumor treatment development.

On October 21, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that the National Institutes of Health has awarded Actinium a Small Business Technology Transfer grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center ("MSK") to study Iomab-ACT, Actinium’s CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK (Press release, Actinium Pharmaceuticals, OCT 21, 2020, View Source [SID1234568734]). The CD19 CAR-T has been previously studied by MSK in a Phase 2 trial with chemotherapy conditioning in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) or diffuse large B-cell lymphoma (DLBCL). MSK will lead this first of its kind study to utilize targeted radiopharmaceutical ARC-based lymphodepletion to replace chemotherapy-based conditioning prior to CAR T-cell therapy. The study will assess the feasibility of using Iomab-ACT targeted lymphodepletion prior to MSK’s 19-28z CAR-T and assess safety and efficacy outcomes relative to results with MSK’s CAR-T 19-28z in patients who had received chemotherapy-based lymphodepletion prior to CAR-T administration.

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(PRNewsfoto/Actinium Pharmaceuticals, Inc.)

Results published in the New England Journal of Medicine with MSK’s 19-28z CD19 CAR-T in 53 patients with R/R B-ALL reported complete remissions in 83% (44/53) of patients. Median event-free survival (EFS) was 6.1 months and median overall survival (OS) was 12.9 months at a median follow up period of 29 months (range 1 – 65 months) for all patients. Patients with low disease burden, defined as less than 5% blasts in the bone marrow, had markedly enhanced outcomes with increased median EFS of 10.6 months and median OS of 20.1 months. There was a 26% (14/53) rate of Grade 3 of greater cytokine release syndrome (CRS), with 1 patient death as a result, and 42% of patients experienced Grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS). In addition to improved duration of response and survival, patients with low disease burden prior to receiving CAR T-cell therapy had lower rates of CRS and neurotoxicity.1

"We are excited to be collaborating with MSK on this trial as they are a leader in the field of cellular therapies. We selected MSK’s 19-28z CAR T-cell therapy for this NIH grant funded collaboration because it has produced high response rates in patients with relapsed or refractory B-ALL who have previously undergone several lines of standard therapy. However, toxicities such as cytokine release syndrome and neurologic toxicity, as well as durability of response, remain a challenge as is the case with many other CAR T-cell therapies" commented Dr. Mark Berger, Actinium’s Chief Medical Officer. "Iomab-ACT enables the delivery of targeted radiation that selectively and specifically targets immune cells, including those implicated in the CAR-T-associated toxicities of cytokine release syndrome and neurotoxicity. We are hopeful that this study will demonstrate improvements in safety and outcomes with MSK’s CAR 19-28z as a result of Iomab-ACT targeted lymphodepletion and that this will allow clinicians to make important improvements in patients’ ability to receive CAR T-cell therapies."

CAR-T is a type of cellular therapy in which a patient’s own (autologous) T-cells are genetically engineered outside of the body to target the patient’s cancer cells and which are then reinfused back into the patient to seek out and kill cancer cells. Currently there are 2 approved CD19 targeted CAR-T therapies, which both require chemotherapy-based conditioning to deplete the patient’s lymphocytes, known as lymphodepletion, and many other CAR-T constructs in development that also use chemotherapy conditioning for lymphodepletion.

Iomab-ACT targets cells that express CD45, an antigen found on immune cells such as lymphocytes and macrophages as well as leukemia and lymphoma cancer cells and delivers the radioisotope warhead iodine-131 to achieve cell depletion. Iomab-ACT is intended to deplete CD45+ immune cells such as macrophages that are implicated in CAR-T related toxicities and may also have an anti-tumor effect on chemo-refractory cancers. Iomab-ACT is a low dose extension of Actinium’s lead program, Iomab-B, which is being studied in a pivotal Phase 3 trial for targeted conditioning prior to a bone marrow transplant. Preclinical data supporting Iomab-ACT’s application in targeted lymphodepletion prior to ACT such as CAR-T was recently published in the journal Oncotarget (https://www.oncotarget.com/archive/v11/i39/). In addition, clinical data with trace doses of Iomab-B has shown transient, reversible lymphodepletion in patients and drug clearance pharmacokinetics that fit within the vein to vein time of CAR-T manufacturing and administration.

Sandesh Seth, Actinium’s Chairman and CEO, said, "This clinical trial collaboration with MSK is a strong step forward for Actinium and our targeted conditioning program. The 19-28z CAR-T has already produced promising data and we look forward to working with MSK to explore Iomab-ACT’s potential to reduce toxicities and improve patient outcomes. As we advance towards the SIERRA interim analysis in the fourth quarter, we are focused on the continued expansion of our ARC-based targeted conditioning program for bone marrow transplant and cell and gene therapies with the goal of providing targeted conditioning regimens that are less toxic and more effective than current chemotherapy-based conditioning. With these therapies being administered in a select number of concentrated centers, we see a large and growing market opportunity where our ARC-based targeted conditioning can improve outcomes and increase access to these important curative treatment options."

On October 21, 2020 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its third quarter 2020 financial results before the market opens on Wednesday, October 28, 2020 (Press release, United Therapeutics, OCT 21, 2020, View Source [SID1234568733]).

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United Therapeutics will host a teleconference on Wednesday, October 28, 2020, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing (866) 209-9943 in the United States, with international callers dialing +1 (825) 312-2282. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing (800) 585-8367 in the United States, with international callers dialing +1 (416) 621-4642, and using access code: 8782637.

This teleconference is also being webcast and can be accessed via United Therapeutics’ website at View Source