On November 1, 2021 Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage oncology & inflammation-focused biopharmaceutical company, reported that it has commenced dosing in a multi-center, phase I/Ib trial to evaluate its novel poly (ADP-ribose) polymerase (PARP) inhibitor (RP12146) in patients with advanced solid tumors (Press release, Rhizen Pharmaceuticals, NOV 1, 2021, View Source [SID1234594038]). This two-part multi-center phase I/Ib study is being conducted in Europe and has been designed to initially determine safety, tolerability, maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of RP12146 and to subsequently assess its anti-tumor activity in expansion cohorts with HRR mutation-enriched ES-SCLC, ovarian and breast cancer patients.

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Rhizen indicated that RP12146 has shown preclinical activity and efficacy comparable to the approved PARP inhibitor Olaparib, and shows improved safety as seen in the preclinical IND-enabling toxicology studies; an advantage that Rhizen hopes will translate in the clinical studies. Rhizen also announced that its PARP program is part of a larger DNA Damage Response (DDR) platform effort, which includes a preclinical-stage polymerase theta (Polθ) inhibitor program. Rhizen expects the platform to enable novel proprietary combinations of its PARP and Polθ assets given the mechanistic synergy and opportunity across PARP resistant/refractory settings.

"PARP inhibitors are a great success story in the DNA damage response area, but they are not without safety concerns that have limited realization of their full potential. Although our novel PARP inhibitor is competing in a crowded space, we expect its superior preclinical safety to translate into the clinic which will differentiate our program and allow us to extend its application beyond the current landscape of approved indications and combinations", said Swaroop Vakkalanka, Founder & CEO of Rhizen Pharma. Swaroop also added that "Our PARP program is foundational for our DDR platform efforts and will be the backbone for several novel proprietary combinations that we hope to bring into development going forward."

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.