On November 16, 2022 Horizon Therapeutics plc reported that it has entered a multi-year scientific collaboration with Johns Hopkins University School of Medicine to identify new disease targets and develop therapies for patients with serious autoimmune and inflammatory conditions (Press release, Horizon Therapeutics, NOV 16, 2022, View Source [SID1234624168]). The initial focus is the emerging field of immunometabolism, the study of metabolic processes in the body, that when dysregulated, can drive autoimmunity and inflammation. This is the first project in the collaboration, with additional projects to follow.

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"Collaboration is essential to move science forward and we are very pleased to begin working with Johns Hopkins University," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "By combining Johns Hopkins capabilities in pre-clinical research with Horizon’s expertise in autoimmunity, our teams will advance translational and research efforts to address the unique needs of different patient populations."

Horizon’s research scientists, in collaboration with Johns Hopkins University School of Medicine experts, aim to identify novel metabolic pathways that lead to chronic inflammation and autoimmunity in different subsets of myositis patients. This deeper pathway knowledge will then be used to identify novel drug targets that may be suitable for discovery of new medicines.

The collaboration comes as Horizon is increasing its presence in Maryland and will be the first tenant at the Alexandria Center at Traville Gateway campus in Rockville, Maryland. When completed, the state-of-the-art facility will support job growth and drive The Company’s continued efforts to develop new medicines.

"As Horizon deepens our footprint in the Maryland area, we believe this collaboration will bolster the world-class scientific thinking and technical capabilities that are found in the Maryland life sciences ecosystem," said Robert Stoffel, Ph.D., vice president, research, Horizon. "Working hand-in-hand with experts at Johns Hopkins University will allow our teams to better understand the biology of diseases we are investigating and identify new pre-clinical targets that could lead to novel therapeutics."

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].