On December 7, 2021 Immunicom, Inc., a clinical-stage biotech pioneering subtractive therapies for advanced cancers, reported that promising preliminary data from a clinical trial investigating Immunopheresis therapy for resistant melanoma and other solid cancers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021’s 36th annual meeting (Press release, Immunicom, DEC 7, 2021, View Source [SID1234596577]). The clinical trial is being conducted at Sheba Medical Center and uses Immunicom’s proprietary, subtractive LW-02 column to selectively remove immunosuppressive soluble tumor necrosis factor receptors (sTNF-Rs) via apheresis. By depleting TNF receptors from plasma, this therapy is designed to free the cytokine TNF-alpha, thereby unleashing its potent anti-cancer effects.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The basket oncology clinical trial (NCT04142931; n =30 patients), which is being conducted under the direction of Dr. Ronnie Shapira, MD, and Prof. Gal Markel, MD PhD, is evaluating the safety and the clinical effectiveness of Immunopheresis as a monotherapy, and in combination with Bristol Myers Squibb’s anti-PD-1 immune checkpoint inhibitor, OPDIVO (nivolumab), in heavily pretreated patients. Preliminary data were presented from Part A (Immunopheresis therapy alone) from six patients—three with melanoma, and three with triple negative breast cancer (TNBC)—who have failed multiple prior lines of standard chemo and immunotherapies. Of these six heavily pretreated patients, three completed the 12-week study regimen, and three were withdrawn due to clinical progression. Two patients are still alive after a year (median overall survival 26.6 weeks). Immunopheresis therapy was well-tolerated in these late-stage patients, and no treatment-related serious adverse events were reported. The therapy was demonstrated to significantly reduce the levels of sTNF-Rs in plasma. Immune profiling of blood and tumor specimens showed evidence of upregulation of protein biomarkers and cell populations that are associated with improved activity of the immune system. Specifically, the tumor specimens showed two developments: 1) an increased infiltration of CD8+ T cells, which are known to have anti-tumor cytotoxic effects, and 2) the expression of immune checkpoint proteins PD1 and PD-L1 that show evidence of turning "cold" tumors into "hot" tumors. Part B of the study—evaluating Immunopheresis therapy in combination with nivolumab—is currently ongoing. The SITC (Free SITC Whitepaper) 2021 Congress abstract is available on Immunicom’s Publications page.

"Our preliminary data, which show renewed immune modulation and intra-tumoral antitumor activity, support our hypothesis that Immunopheresis therapy has the potential to overcome immunotherapy resistance, which could be a significant breakthrough in refractory cancer patient care," said Professor Gal Markel, former Director of the Ella Lemelbaum Institute for Immuno-Oncology, and now Director of Davidoff Center & Deputy Director General, Rabin Medical Center at Clalit Health Services. "Immunicom’s innovative subtractive treatment approach to neutralize cancer’s ability to block the patient’s natural immune-defense mechanisms is especially attractive in these heavily pretreated patients, and it offers the potential for achieving much better clinical outcomes with fewer treatment side effects," added Dr. Ronnie Shapira, a melanoma expert, and Head of the Onco-Gynecological Cancer Unit at the Ella Lemelbaum Institute for Immuno-Oncology.

Speaking to the announcement, Amir Jafri, Immunicom’s Founder and CEO, added, "The clinical trial at Sheba Medical Center is one of three ongoing, groundbreaking clinical trials to assess Immunicom’s subtractive therapies. Right now, our other clinical trials are evaluating the LW-02 column for treating additional multiple cancers, including metastatic TNBC, non-small cell lung cancer, melanoma, and renal cell carcinoma."

Immunicom’s various clinical trials are being conducted in collaboration with world-renowned research organizations and thought leaders, including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokine receptors produced by cancer tumors. Selective removal of these targeted cytokine receptors is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms—which are significantly compromised in late-stage, metastatic disease—thereby re-energizing the immune system to aggressively fight the cancer. Immunopheresis is a "subtractive therapy" in contrast to drugs that are "additive." Subtractive therapy is designed to avoid the side effects, toxicity, and negative impact on a patient’s quality of life that are typical of other cancer treatments.

Based on Immunicom’s clinical program, the LW-02 column could be used either in combination with other therapies, or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA) and European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory TNBC. Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of Immunopheresis and how this breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

On December 7, 2021, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with ONE44 Capital LLC, ("ONE44"), pursuant to which ONE44 purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $170,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of ONE44 (Filing, 8-K, Propanc, DEC 7, 2021, View Source [SID1234597015]). The transaction contemplated by the Purchase Agreement is expected to close on or about December 13, 2021. The Company intends to use the net proceeds ($153,000) from the Note for general working capital purposes. The Note contains an original issue discount amount of $17,000.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The maturity date of the Note is December 7, 2022 (the "Maturity Date"). The Note shall bear interest at a rate of 10% per annum, which interest may be paid by the Company to ONE44 in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. ONE44 has the option to convert all or any amount of the principal face amount of the Note, starting on June 5, 2022, and ending on the later of the Maturity Date and the date of payment of the Default Amount (as defined below) is paid if an event of default occurs, for shares of the Company’s common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Conversion Price" shall mean 65% multiplied by the lowest closing bid price of the Company’s common stock as reported on the OTC Markets. Notwithstanding the foregoing, ONE44 shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by ONE44 and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 120 days from the issuance date, then the prepayment premium shall be 130% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, up to 180 from the issuance date, then the prepayment premium shall be 135% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from ONE44, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Other than as described above, the Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the Note.

Upon the occurrence and during the continuation of certain events of default, the Note will accrue an interest rate of 24%.

The Note was issued, and any shares to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing description of the Note and the Purchase Agreement does not purport to be complete and is qualified in their entirety by reference to the full text of the Purchase Agreement and the Note, which are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On December 7, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the European Commission has granted Orphan Drug Designation to VIP152, the Company’s PTEFb/CDK9 inhibitor, for the treatment of diffuse large B-cell lymphoma (DLBCL) (Press release, Vincerx Pharma, DEC 7, 2021, View Source [SID1234596540]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The granting of Orphan Drug Designation for VIP152 in DLBCL realizes another significant regulatory milestone for Vincerx," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "VIP152 has the potential to be an effective treatment for rare and highly refractory cancers, for which there is an unmet need in the current therapeutic landscape. We look forward to continued momentum with data presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which include complete disease regression in DLBCL mouse models and modulation of key biomarkers in high-grade B-cell lymphoma cell lines and patients. In addition, we are presenting supportive preclinical mechanistic data in chronic lymphocytic leukemia."

The European Commission grants orphan drug designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union and when no satisfactory method of diagnosis, prevention or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

Vincerx is currently advancing Phase 1b studies of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. The ongoing Phase 1b expansion, first-in-human (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

On December 7, 2021 Arbutus Biopharma Corporation (NASDAQ: ABUS), X-Chem, Inc. (X-Chem) and Proteros biostructures GmbH (Proteros) reported that Arbutus Biopharma has identified several molecules that inhibit the SARS-CoV-2 nsp5 main protease (Mpro), a validated target for the treatment of COVID-19 and potential future coronavirus outbreaks (Press release, Arbutus Biopharma, DEC 7, 2021, View Source [SID1234596557]). Upon achievement of this milestone, as part of their discovery and research agreement, Arbutus has obtained a worldwide exclusive license to the identified molecules. The parties will continue to accelerate the development of pan-coronavirus agents to treat COVID-19 and potential future coronavirus outbreaks.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our goal with this collaboration was to identify unique and differentiated pan-coronavirus assets targeting the main coronavirus protease which could deliver a much-needed oral antiviral treatment for SARS-CoV-2 and any potential future coronavirus outbreaks," stated Dr. Michael Sofia, Arbutus’s Chief Scientific Officer. "To have identified small molecule inhibitors that are potent and selective against Mpro just six months after commencing this collaboration demonstrates the importance Arbutus, Proteros and X-Chem are placing on quickly developing effective and safe therapies to successfully combat the COVID-19 pandemic. We are excited to have achieved this important milestone and to move this program forward into the lead optimization stage."

In connection with achievement of this development milestone, Arbutus obtained a worldwide exclusive license to the identified small molecule inhibitors. In exchange for that license, Arbutus shall make a milestone payment to X-Chem and Proteros.

In April 2021, Arbutus, X-Chem and Proteros entered into a discovery research and license agreement focused on the discovery of novel inhibitors targeting the SARS-CoV-2 nsp5 main protease. This collaboration brings together Arbutus’ expertise in the discovery and development of antiviral agents with X-Chem’s industry leading DNA-encoded library (DEL) technology and Proteros’ protein sciences, biophysics and structural biology capabilities and provides important synergies to potentially identify safe and effective therapies against coronaviruses including SARS-CoV-2.

On December 7, 2021 LiquidLung, Inc., a biotechnology company dedicated to radically improving the detection, diagnosis and treatment of pulmonary disease, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application No. 17/003,775 for claims related to the non-invasive diagnosis of lung cancer (Press release, LiquidLung, DEC 7, 2021, View Source [SID1234596578]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The technology, which is centered around a comprehensive portfolio of novel RNA biomarkers, developed in concert with Liquid Biosciences, a leading bio-analytics provider and dedicated partner to LiquidLung. The technology utilizes various mathematical gene expression signatures that uniquely span early detection and confirmatory diagnosis of lung cancer, both pre- and post-imaging, as well as the diagnostic classification of several prevalent histological subtypes of the disease.

In an independent validation study the lung cancer technology was applied to a blood-based dataset comprised of fully adjudicated in vivo patient samples consisting of patients with confirmed lung cancer and those without lung cancer, the technology achieved 97% sensitivity and 85% specificity for lung cancer detection.

Further, the technology correctly detected 100% of patients with stage I, 89.9% with stage II, 100% with stage III and 100% with stage IV. In addition to detecting lung cancer generally across all stages of disease, the technology also achieved strong sensitivity and specificity for distinguishing between small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), adenocarcinoma, squamous cell carcinoma and large cell carcinoma. Notably, all cited performance was derived from the biomarkers alone, with absolutely no mathematical or scientific value being derived from patient demographics, nodule information, smoking history or any other clinical risk factors, which introduces a defined opportunity to improve upon the already impressive early data with little investment in R&D.

"Imagine a non-invasive testing platform that can rule more high-risk patients with lung cancer into LDCT imaging for further evaluation earlier, reduce negative biopsy procedures for patients with suspicious pulmonary nodules discovered incidentally or through routine screening, and also accelerate the time to life-saving interventions and personalized treatments," stated Founder and Chairman, Marty Keiser. "The comprehensive nature of our to-be patented technology enables us to accurately and efficiently unlock value for patients across the entire care continuum for lung cancer, all while fitting nicely into existing workflows and standards of care."

LiquidLung is one of three companies created out of IV BioHoldings (IVBH), a bio innovation studio known for its progressive approach to R&D, company creation, productization and commercialization. IVBH made headlines in October when it aligned the public debut of its first-in-category pipeline of RNA technologies with the announcement of a strategic lab partnership with P4 Diagnostix, intended to accelerate clinical development and validation of the IVBH assets within lung cancer, non-alcoholic fatty liver disease (NAFLD) and breast cancer.

"The recent worldwide recognition and appreciation for the clinical utility of RNA, from prevention to detection to treatment, has created a timely tailwind for IVBH as we begin to publicly unveil the vast intellectual property portfolio that we have been quietly and strategically amassing since 2018," stated IVBH Chief Commercial Officer, Elizabeth Cormier-May, who also leads the studio’s women’s health company, Mammogen. "The USPTO decision is a significant milestone for LiquidLung and further establishes IVBH’s position as a leader in the rapidly accelerating RNA revolution," Cormier-May continued.

IVBH is currently scaling operationally to support the lung cancer, NAFLD and breast cancer programs through near-term clinical milestones with multiple phases of clinical data generation expected throughout 2022 across all programs.