On November 1, 2021 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company reported that focused on the development of first-in-class T cell therapies to treat solid tumors (Press release, A2 Biotherapeutics, NOV 1, 2021, View Source [SID1234594037]). A2 Bio will make two presentations at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place virtually and in person on Nov. 10–14, 2021 at the Walter E. Washington Convention Center in Washington, D.C . The first presentation will focus on new preclinical in vitro and in vivo demonstrations of both CEA (A2B530) and MSLN (A2B694) Tmod T cell therapy. The second presentation will discuss an observational study, BASECAMP-1, to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH) for future Tmod CAR T cell therapies (NCT#04981119).

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"We are pleased to have been selected to present updates on our progress advancing the novel Tmod platform for the treatment of solid tumors, including supporting pre-clinical evidence for CEA (A2B530) and MSLN (A2B694) and an overview of our observational study BASECAMP-1 to identify patients that may benefit from future Tmod CAR T cell therapy," said Scott Foraker, chief executive officer at A2 Bio. "Our Tmod platform is a truly novel approach that has the potential to transform cancer treatment where current treatment approaches fall short, and we are working diligently to demonstrate this."

Julian Molina, MD, PhD, Professor of Oncology, Mayo Clinic, Rochester MN states, "BASECAMP-1 is a premier example of precision medicine. The goal is to identify incurable metastatic, unresectable locally advanced solid tumor patients that may benefit from future Tmod CAR T cell therapy. The pre-clinical Tmod CAR T cell therapy data is promising and we hope to translate this technology from bench to bedside to offer patients a potential treatment for solid tumors."

The two abstracts accepted for poster presentation at SITC (Free SITC Whitepaper) 2021 are:

Title: A powerful, precise targeting system controlled by tumor deletions transforms CEA and MSLN CAR-T cells into tumor-selective agents
Presenter: Alexander Kamb, PhD
Session: Poster
Date/Time: Saturday, November 13 at 7:00 am to 8:30 pm ET
Location: Hall E, Abstract 122

Title: BASECAMP-1: An observational study to identify relapsed solid tumor patients with human leukocyte antigen (HLA) loss of heterozygosity (LOH) and leukapheresis for future CAR T cell therapy
Presenter: Julian Molina, MD, PhD, Professor of Oncology, Mayo Clinic, Rochester MN
Session: Poster
Date/Time: Friday, November 12 at 7:00 am to 8:30 pm ET
Location: Hall E, Abstract 491

On November 1, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the Company’s CEO Dr. Pnina Fishman will deliver a poster presentation titled "Growth Inhibition of Hepatocellular Carcinoma (HCC) by CBD Rich T3/C15 Cannabis Fraction is Mediated via the A3 Adenosine Receptor" at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting during the Hepatobiliary Neoplasia: Experimental Hepatocarcinogenesis; Diagnostics and Liver Imaging session (Press release, Can-Fite BioPharma, NOV 1, 2021, View Source [SID1234594036]). The poster will be available for viewing by attendees throughout the entire meeting. The findings have been published in an abstract in the October 2021 supplement of HEPATOLOGY, a premier peer-reviewed publication in the field of liver disease published on behalf of the AASLD.

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The Liver Meeting, which takes place virtually on November 12 – 15, 2021, brings together clinicians, associates, and scientists from around the world to exchange information on the latest research, discuss new developments in liver treatment and transplantation, and network with leading experts in the field of hepatology.

Can-Fite is a global leader in discovering and developing drugs that target the A3 adenosine receptor (A3AR). In preclinical studies, Can-Fite showed that a CBD rich T3/C15 cannabis fraction inhibited the growth of liver HEP-3b hepatocellular carcinoma cells via the A3AR by inhibiting Wnt- and NF-kappa B-related regulatory pathways. The Company filed patent applications protecting its discovery of cannabinoid-based therapies where the A3AR target is overexpressed including liver cancer.

On November 1, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it will release financial results for the third quarter ended September 30, 2021 before the open of trading on Monday, November 15 (Press release, Biodesix, NOV 1, 2021, View Source [SID1234594035]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 9:00 a.m. Eastern Time on the same day. Dial-in and call details are as follows:

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On November 1, 2021 Provectus (OTCQB: PVCT) reported that updated response, safety, and immune correlative data from the Company’s ongoing Phase 1b clinical trial of cancer immunotherapy PV-10 (rose bengal disodium), in combination with Keytruda (pembrolizumab), for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (CB) (NCT02557321: first expansion cohort) will be presented at the SMR 2021 Virtual Congress (the Society for Melanoma Research annual meeting), which is being held online from October 28th to 31st (Press release, Provectus Biopharmaceuticals, NOV 1, 2021, View Source [SID1234594034]).

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Highlights of the SMR 2021 presentation:

Baseline characteristics
22 patients; 19 evaluable for efficacy
68% male; median age of 72 years (range 28-90); 50% Stage IV M1b-d
CB-refractory status: 9% CTLA-4, 32% PD-1, 59% CTLA-4+PD-1
Safety (22 patients)
Principally grades 1-2 injection-site reactions for PV-10
Principally grades 1-3 immune-mediated reactions for Keytruda
Best overall response (BOR) by RECIST 1.1 (19 patients)
5% complete response (CR), 26% objective response rate (ORR), 53% disease control rate (DCR)
Prior PD-1 (6 patients): 50% ORR, 67% DCR
Prior CTLA-4+PD-1 (12 patients): 8% CR, 17% ORR, 50% DCR
Durability of response
4.9 months median progression-free survival (mPFS)
Survival
34.1 months median overall survival (mOS)
Immune correlative assessment (6 patients)
Increases in damage-associated molecular pattern (DAMP) high mobility group box protein 1 (HMGB1) were consistent with the HMGB1 pattern of PV-10-treated CB-naïve melanoma patients
IFNγ expression of peripheral T cells demonstrates the induction of tumor-specific reactivity to HLA-matched cell lines, equivalent to that in CB-naïve melanoma patients
Immune correlative data substantiate the same PV-10 immune-mediated mechanism of action in CB-naïve monotherapy and CB-naïve and -refractory combination therapy melanoma patients
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Our melanoma drug development program has consistently and reproducibly shown PV-10’s unique innate and adaptive immune signaling mechanisms in single-agent and checkpoint blockade combination therapy clinical trials. To date, more than 50 patients have been treated with PV-10-Keytruda combination therapy for different melanoma indications. Current data notably demonstrate that cancer immunotherapy PV-10 can restore checkpoint blockade activity in patients who are refractory to this immunotherapy drug class."

Prior study data is also available on Provectus’ website:

Melanoma Bridge 2020, December 3-5: 14 evaluable patients, 7% CR, 29% ORR, 57% DCR,
European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, September 19-21: 11 evaluable patients, 9% CR, 36% ORR, 54% DCR, and
SMR 2019 Congress, November 20-24: 8 evaluable patients, 25% ORR, 50% DCR, 4.9 months estimated mPFS, mOS not reached.
About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory advanced cutaneous melanoma, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors. IL PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma).

Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a treatment for relapsed and refractory blood cancers.

Different formulations and routes of administration of PV-10 and rose bengal disodium are also undergoing clinical and/or preclinical study in virology, microbiology, ophthalmology, dermatology, and animal health.

On November 1, 2021 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 company has been awarded a grant of approximately $2 million from the National Cancer Institute of the National Institutes of Health ("NIH") (Press release, Mustang Bio, NOV 1, 2021, View Source [SID1234594032]). This two-year award will partially fund the Phase 1, Open Label, Multicenter Trial to Assess the Safety, Tolerability and Efficacy of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") or chronic lymphocytic leukemia ("CLL").

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In addition, the Office for Human Research Protections has approved Federalwide Assurance ("FWA") for Mustang’s research. FWA is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The NIH grant and FWA validate our scientific efforts as we continue to advance the development of MB-106. This grant will contribute to Mustang’s evaluation of MB-106 in clinical trials with the hope to bring this therapeutic treatment to patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia."

Research is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA265616. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHL and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.