On October 1, 2020 Teneobio, Inc. and its affiliate TeneoTwo, Inc. reported that their investigational new drug application (IND) for TNB-486, a bispecific T-cell engaging antibody for the treatment of B-Cell Non-Hodgkin’s lymphoma (B-NHL) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on September 30, 2020 (Press release, TeneoBio, OCT 1, 2020, View Source;utm_medium=rss&utm_campaign=teneobio-announces-us-fda-clearance-of-investigational-new-drug-application-for-tnb-486-and-the-initiation-of-phase-i-clinical-studies-in-patients-with-b-cell-malignancies [SID1234567881]).

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TNB-486 is a fully human bispecific antibody that binds CD19 with one arm and incorporates a unique anti-CD3 on the other. In preclinical studies, TNB-486 induced T-cell dependent killing of CD19-positive B-cell leukemia and lymphoma cells while inducing minimal cytokine secretion, a feature that could limit immune mediated toxicities while retaining cytotoxic activity.

Benjamin Buelow, CMO of Teneobio, Inc., added, "We are excited to bring our differentiated T-cell engager therapy to relapsed and/or refractory lymphoma patients, for whom a safe and effective therapeutic option remains an unmet need. The unique anti-CD3 arm in Teneobio’s T-cell engagers uncouples toxic cytokine release from tumor cell killing and is designed to maximize the therapeutic window for this class of therapies. TNB-486 also has a predicted half-life of over two weeks that enables a patient- and provider-focused dosing schedule. An off-the-shelf CD19-targeted therapy with a convenient dosing regimen will be a tremendous boon to the fight against this terrible disease."

On October 1, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, reported preliminary first cohort data from the Emory University physician-sponsored clinical trial being conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta by Dr. Tobey MacDonald, Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program (Press release, Moleculin, OCT 1, 2020, View Source [SID1234567908]). He is studying the use of WP1066 (AflacST1901), a proprietary Moleculin drug candidate, as a potential treatment for childhood brain tumors. The first three patients in the trial received treatment at a dose level of 4 mg/kg with no adverse events related to WP1066 and the study will now proceed to the next higher dose of 6 mg/kg. One of these patients with diffuse intrinsic pontine glioma (DIPG), showed an apparent response to the treatment with both clinical improvement and radiologic reduction of tumor size.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Dr. MacDonald stated, "We are very pleased that this trial has successfully completed the first cohort without any safety issues and will now progress to the second cohort at an escalated dose level. We must, of course, be very careful not to draw any conclusions from such preliminary data, but to have an objective response in a DIPG patient is frankly, unexpected."

Mr. Walter Klemp, Chairman and CEO of Moleculin, "When you look at the clinical trial history of DIPG, despite approximately 200 clinical trials, no drug has shown significant activity in this disease, so we find this initial activity particularly encouraging. WP1066 is an immuno-stimulating p-STAT3 inhibitor and has been shown to stimulate immune responses that successfully modulate oncogenic transcriptional activity in tumor cells and repress their ability to drive tumor growth. Coupled with the activity we have recently seen with WP1220, a close analog to WP1066, in its proof of concept clinical trial for the topical treatment of cutaneous t-cell lymphoma, we are more committed than ever to determine the full potential of this new class of p-STAT3 inhibitors. We now have six drug candidates, with three of them showing human activity, so we need to be careful not to confuse this p-STAT3 inhibitor pipeline with the recent announcement regarding our antimetabolites and their potential to treat viruses. We have placed a high priority on reducing risk for our investors by creating what we call ‘multiple shots on goal,’ and the events of this week are showing just how effective that strategy has been."

Mr. Klemp concluded, "Consistent with our history of providing clinical trial updates on a cohort-by-cohort basis, we look forward to updating investors on the continued progress of this trial as additional cohorts are completed. For more information regarding the design of this study, please refer to View Source;

On October 1, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open (Press release, Oncopeptides, OCT 1, 2020, View Source [SID1234567852]). Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients).

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The Expanded Access Program was initiated following the Company´s June 30 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple-class refractory multiple myeloma. The NDA and the sEAPort program are primarily supported by data from the pivotal phase 2 HORIZON study, which demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma who are hard to treat and have a poor prognosis, including patients with triple-class refractory multiple myeloma and patients with extramedullary disease.

"Despite therapeutic advances, multiple myeloma remains incurable," said Paula O’Connor, U.S. Head of Medical Affairs at Oncopeptides. "There is an urgent need for more therapies as patients become multi-resistant earlier in their treatment journey. Our Expanded Access Program enables us to provide access to melflufen as a potential treatment for eligible patients while our application is under review by the U.S. Food and Drug Administration."

EAPs are designed to provide patients living with serious or life-threatening conditions access to investigational medicines when no comparable or satisfactory treatment options are available, alternative therapies have been exhausted or the patient is ineligible for ongoing interventional trials.

Forty to fifty medical sites in the U.S. are expected to enroll 100-200 patients in the sEAPort program.

This information was submitted for publication at 08.00 (CET), October 1, 2020.

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

On October 1, 2020 Nascent Biotech, Inc. (OTCQB:NBIO) reported that It has continued to reduce its liabilities through stock conversion and payment of accounts payable and accrued liabilities (Press release, Nascent Biotech, OCT 1, 2020, View Source [SID1234567885]). The reduction was achieved through the conversion of debt to equity and the reduction of liabilities, including its last convertible note. The convertible note’s principal is now $11,250 down from $161,250, a reduction of $150,000.

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Nascent’s CEO Sean Carrick states," The reduction of debt puts Nascent in a stronger position to move forward with the clinical trials which are to begin soon. Further liability management is a primarily objective of the Company."

On October 1, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the first patient has been dosed in a Mustang-sponsored, open label, multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-102 (CD123-targeted CAR T cell therapy) in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (hrMDS) (Press release, Mustang Bio, OCT 1, 2020, View Source [SID1234567910]). Study sites include City of Hope, where the CAR T cell therapy was initially developed and where the clinical data were generated to support Mustang’s current multicenter trial, Dana-Farber Cancer Institute, Duke University and MD Anderson Cancer Center.

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The Phase 1 portion of the trial will determine the maximum tolerated dose of MB-102 for the Phase 2 portion of the trial. Safety will be assessed at each dose level before proceeding to the next. The Phase 2 portion of the trial may be divided into as many as three arms to evaluate the efficacy of MB-102 in relapsed or refractory BPDCN (Arm 1), relapsed or refractory AML (Arm 2) and demethylation resistant hrMDS (Arm 3). The primary outcome that will be studied is the response rate at day 28 post infusion in all arms. Secondary outcome measures include duration of response, progression-free survival, overall survival and incidence of treatment-emergent adverse events, which will be followed for up to three years.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "This is a momentous occasion for Mustang, as it is the first clinical trial under Mustang’s investigational new drug application (IND) in which a patient was dosed with cells processed in our own manufacturing facility. We look forward to advancing the development of MB-102 and providing updates on the trial as we seek to help address the needs of patients suffering from the devastating diseases of BPDCN, AML and hrMDS."

Additional information about the trial can be found on www.clinicaltrials.gov using the identifier NCT04109482.

About MB-102 (CD123-targeted CAR T Cell Therapy)
MB-102 is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndromes, as well as in hematologic malignancies, including AML, and BPDCN.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy in November 2018. Dose escalation continues at City of Hope in both indications. MB-102 has received Orphan Drug Designations from the U.S. Food and Drug Administration for AML and BPDCN.