On November 16, 2022 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson’s Disease, PDAC, DIPG, and COVID-19, reported the publication of the presentation materials from SITC (Free SITC Whitepaper) 37th annual meeting held in Boston, MA on November 10th-12th, 2022 on our website (www.oncotelic.com) (Press release, Oncotelic, NOV 16, 2022, View Source [SID1234624167]).

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Abstract Number 599: Mechanism of Action for OT-101 TGF-ß immunotherapy. View Source

"This was a rare opportunity to engage many of the key opinion leaders in the field of immuno-oncology addressing, in particular, Oncotelic’s promising anti-TGF-β antisense therapy and discuss the series of planned IIS studies including a robust and thorough assessment of various pre and post therapeutic changes in relevant genes and biomarkers" said Dr. Anthony Maida, Chief Clinical Officer – Translational Medicine, Oncotelic.

"With the successful formation of the JV, we are accelerating our clinical programs in multiple indications supported by various stakeholders including Key Opinion Leaders (KOLs). Pancreatic cancer is dear to our hearts with our previous successes ie. Abraxane and Cynviloq. We are confident that the exceptional single agent activity reported here with OT-101 would be confirmed in the coming clinical trials" opined Osmond D’Cruz PhD DABT, coauthor and Director of Drug Safety, Oncotelic.

About Dr. Osmond D’Cruz:

Dynamic, accomplished certified toxicologist with over 15 years of preclinical drug development experience in academic and biopharmaceutical settings in multiple therapeutic areas, including: oncology, HIV, contraception and immune infertility. PUBLICATIONS: 120 peer-reviewed scientific papers; 105 published Meeting Abstracts.

PATENTS AWARDED: 26 issued Patents; 18 issued US Patents. Prior Experience | Abraxis BioScience, Celgene Corporation, Sorrento Therapeutics, Children’s Hospital Los Angeles, Paradigm Pharmaceuticals, University of Oklahoma Medical Center, Oklahoma Medical Research Foundation

On November 16, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical stage biotechnology company developing intratumoral immunotherapies that stimulate the patient’s immune system to target cancer cells and eradicate disease, reported early clinical data from an investigator-sponsored trial (IST) conducted by Dr. Ahmad Tarhini at the H. Lee Moffit Cancer Center & Research Institute (Press release, OncoSec Medical, NOV 16, 2022, View Source [SID1234624166]). This IST is evaluating TAVO, OncoSec’s proprietary interleukin 12 (IL-12) encoding plasmid delivered by intratumoral electroporation (TAVO-EP), in combination with intravenous nivolumab. Interim data were presented as a poster (abstract #617) at the 37th Annual Meeting of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Boston, Massachusetts on November 10th. The poster entitled, "Neoadjuvant Immunotherapy with intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with intravenous nivolumab in patients with operable locoregionally advanced melanoma", is available on OncoSec’s website.

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OncoSec Medical Incorporated logo (PRNewsfoto/OncoSec Medical Incorporated)

The trial enrolled patients with high-risk operable locoregional advanced stage IIIB-D or stage IVA melanoma. By the time of data cutoff, 10 of 12 patients had completed the neoadjuvant phase of up to three 4-week cycles of TAVO-EP on days 1 and 8 (with an optional third treatment on day 15) concurrently with 480 mg nivolumab administered every 4 weeks. Following the neoadjuvant treatment period, surgery was performed and adjuvant nivolumab was continued for up to 1 year. A preoperative overall response rate (ORR) by RECIST v1.1 was observed in 7 of 10 patients (70%) consisting of 4 patients with complete response (CR) and 3 patients with partial response (PR). Two patients had stable disease (SD) and 1 patient showed progressive disease (PD). One patient with a RECIST v1.1 PR declined surgery due to significant response after neoadjuvant treatment. At time of surgery, 8 of 9 (88.9%) evaluated patients had a major pathologic response (pMR; ≤10% viable tumor cells in the analyzed surgical specimen), 6 of 9 patients (66.7%) had a pathological CR (pCR). No disease recurrence has been observed at a median follow up of 7 months from the date of surgery.

Tumor-relevant immune biomarkers, analyzed pre-treatment for 6 patients, included CD8+ tumor infiltrating lymphocytes (TILs), PD-L1 expression levels and tumor inflammation signature (TIS) in the tumor lesions. This analysis identified four patients with low CD8+ TIL, low PD-L1 and low TIS; a biomarker signature that is negative predictive for response to immunotherapy. Of note, all four of these patients achieved pCR. Among the 12 patients with safety data, there were no grade 4/5 treatment-related adverse events; 1 patient experienced a grade 3 event of hyponatremia. Overall, the combination treatment was well tolerated, and no patient discontinued neoadjuvant treatment due to toxicity. Patients continue to enroll.

"We are encouraged with these early data in neoadjuvant melanoma because the expected pathological CR rate with single agent nivolumab in this treatment setting is around 30%. The pCR of 66.7% observed with the addition of TAVO-EP to nivolumab suggests that intratumoral expression of IL-12 is adding to nivolumab efficacy. OncoSec is looking forward to the results from additional patients enrolling in Dr. Tarhini’s trial. Based on these observations, a small randomized controlled clinical trial testing TAVO-EP in combination with anti-PD-1 therapy to establish proof-of-concept would be a next crucial step to develop TAVO in this setting" said Sandra Aung, Ph.D., Head of Clinical Development at OncoSec."

Ahmad Tarhini, MD PhD, Professor, Senior Member and Director of Cutaneous Clinical and Translational Research at the H. Lee Moffitt Cancer Center & Research Institute commented that "patients with locoregionally advanced operable melanoma carry a high risk of morbidities with the upfront surgical approach and continue to have a high risk of disease relapse and death. Therefore, there is an urgent need to develop novel immunotherapeutic approaches that are tolerable and safe in the neoadjuvant setting. TAVO-EP is uniquely positioned as neoadjuvant therapy due to the focal intratumoral delivery of plasmid IL-12 directly into the lesion. It is particularly exciting that all patients that were predicted to be non-responders to immune checkpoint blockade by biomarker analysis prior to treatment appear to respond to TAVO + nivolumab, supporting further the mechanism of action of IL-12. Patients are actively enrolling into this trial, and I am looking forward to presenting clinical data updates on more patients at a future medical conference"

On November 16, 2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care reported financial results for the third quarter ended September 30, 2022 (Press release, Allarity Therapeutics, NOV 16, 2022, View Source [SID1234624162]).

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Balance Sheet: As of September 30, 2022, Allarity’s cash was $3.9 million, as compared to $19.6 million as of December 31, 2021.

R&D Expenses: Research and Development (R&D) expenses were $3.0 million for the three months ended September 30, 2022, as compared to $1.4 million for the three months ended September 30, 2021.

G&A Expenses: General and Administrative (G&A) expenses were $1.6 million for the three months ended September 30, 2022, as compared to $2.6 million for the three months ended September 30, 2021.

Net Loss: Net loss was $5.0 million for the three months ended September 30, 2022, compared to $1.4 million for the comparable period in 2021.

Liquidity, Capital Resources and Plan of Operations: As of September 30, 2022, the Company’s cash deposits of $3.9 million were determined to be insufficient to fund its current operating plan and planned capital expenditures beyond the year ending December 31, 2022. These conditions give rise to substantial doubt over the Company’s ability to continue as a going concern.

The Company is currently in discussions with the holder of its Series A Preferred Shares regarding a potential bridge loan to extend the Company’s cash runway beyond December 31, 2022, in order to provide the Company with more time to complete the process of amending its organizational documents in order to facilitate additional capital investments. No assurance can be given that the discussions will be successful or that the Company will be able to raise additional capital on favorable terms, or at all.

For more information about the Company, reference is made to the Company quarterly report on Form 10-Q for the quarterly period ended September 30, 2022, as filed with the SEC.

On November 16, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression and addiction disorders, reported that Avani Kanubaddi, President & COO of Enveric Biosciences, will participate in A.G.P.’s Virtual Biotech Conference to be held from November 30, 2022 – December 1, 2022 (Press release, Enveric Biosciences, NOV 16, 2022, View Source [SID1234624161]).

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For more information about the conference, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate representative, or send an email to A.G.P. at [email protected], or KCSA Strategic Communications at [email protected].

On November 16, 2022 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients (Press release, Monopar Therapeutics, NOV 16, 2022, View Source [SID1234624160]). The data is displayed in the poster Monopar will be presenting later today at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting, which is bringing together the world’s leading sarcoma specialists. Monopar has made the poster available on its website at the following link:

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View Source

Camsirubicin Background

Doxorubicin is one of the most widely used cancer drugs worldwide. Unfortunately, although higher doses of doxorubicin are known to be more effective at treating cancer, the risk of irreversible heart damage increases with the cumulative dose and limits the lifetime amount that a patient can receive. As a result, even if patients are responding, they discontinue doxorubicin treatment typically after only 6 to 8 cycles (~6 months or less). The hypothesis behind camsirubicin is straightforward: molecularly modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better patient outcomes.

The prior exploratory clinical studies of camsirubicin in cancer patients showed the potential to treat patients with high doses for a year or longer. The preclinical and exploratory clinical studies also showed no irreversible heart toxicity with camsirubicin. The current Phase 1b study is designed to evaluate whether camsirubicin can be dosed even higher than previously achieved and continue for longer than doxorubicin.

Camsirubicin Phase 1b Clinical Trial Design

The Phase 1b trial is an open label dose escalation design to determine the maximum tolerated dose of camsirubicin in advanced soft tissue sarcoma (ASTS) patients. The average life expectancy of ASTS patients at diagnosis is about 12 to 15 months, and doxorubicin is the current first-line standard of care treatment for most types of ASTS.

The starting dose for the first three patients was set at 265 mg/m2, the highest dose previously tested in the exploratory clinical trials. With a positive recommendation from the trial safety review committee at the completion of each dose level, the trial is allowed to then treat at least three new patients at the next dose level, which is 25% higher.

Clinical Trial Results To-Date

The Phase 1b clinical trial has enrolled 11 patients (8 female and 3 male) to-date ranging in age from 26 to 81 years (median = 49 years). 5 of 10 patients have exhibited stable disease (SD, as defined by RECIST 1.1 criteria) at 12 weeks. 1 patient met the criteria for SD at the first CT scan (6 weeks) but unfortunately died due to COVID-19 and was not evaluable at the 12-week CT scan. The ASTS subtype patients achieving stable disease on camsirubicin are in line with those also more likely to respond to doxorubicin.

These encouraging results are in the face of all patients in the trial, at the time of enrollment, having had an Eastern Cooperative Oncology Group (ECOG) performance score of 1, or "strenuous physical activity restricted". This suggests that the patients enrolled in this Phase 1b trial are more medically complex and challenging than those in other recent ASTS studies. The majority of patients enrolled in first-line ASTS trials of the past few years have had no physical activity impairments, with only a minority having an ECOG score of 1 or worse. Worse ECOG scores at the time of enrollment for advanced cancer patients are associated with reduced patient survival.

The trial is presently at the fourth dose-level cohort (520mg/m2), almost twice the trial’s starting dose. No drug-related clinical cardiotoxicity has been observed in any patient, as tracked by left ventricular ejection fraction, an industry standard measure of cardiotoxicity. In line with the hypothesis of reaching a higher dose, the trial is continuing to enroll and dose-escalate, as there have been no signs of having yet hit the maximum tolerated dose.