On November 4, 2021 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of cellular immunotherapy, and Shoreline Biosciences, a biotechnology company developing allogeneic off-the-shelf, standardized, and targeted natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC) for cancer, reported an alliance to advance the future of iPSC-derived cellular therapies (Press release, Shoreline Biosciences, NOV 4, 2021, View Source [SID1234594522]).

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The alliance leverages Dendreon’s extensive manufacturing, process development and end-to-end logistics expertise for the advancement of Shoreline’s pipeline of iPSC-derived cellular therapies. Dendreon is providing scalable cGMP manufacturing support for certain programs through clinical development and launch, enabling Shoreline to rapidly advance multiple products in parallel.

"With more than a decade of proven expertise in cell therapy manufacturing and an established supply chain and logistics infrastructure, Dendreon is well positioned to support Shoreline in manufacturing from Phase I clinical trials through commercialization," said Maria Cho, Vice President of Business Development and Corporate Strategy. "We are thrilled to partner with Shoreline to enable the future of cell therapy and change the way serious diseases are treated."

"We are excited to partner with Dendreon, a leader in cell therapy, to manufacture cost-efficient, highly-scalable product candidates," said Mohammad El-Kalay, Ph.D., Senior VP & Head of CMC for Shoreline. "Through our partnership with Dendreon, we are accelerating the commercialization of our next generation NK cell and macrophage products to bring scalable, allogeneic, "off the shelf" therapies to more patients in need."

On November 4, 2021 ArsenalBio, a privately held programmable cell therapy company focused on building advanced CAR T therapies for solid tumors, reported that it will present pre-clinical data from AB-X, the company’s integrated circuit T cell therapy program for the treatment of ovarian cancer (OC), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 in Washington D.C., and virtually (Press release, Arsenal Bio, NOV 4, 2021, View Source [SID1234594521]).

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The accepted abstract titles are now available on the SITC (Free SITC Whitepaper) website. Details of the poster are as follows:

Title: AB-X integrated circuit T cells demonstrate improved potency, expansion, and specificity compared to unaugmented MSLN CAR T cells
Poster Number: 213
Presenter: Stephen Santoro, Ph.D., Senior Director, Program Lead, ArsenalBio
Date and Time: The ePoster will be released virtually on Friday, Nov. 12, 2021 at 7:00 a.m. ET. Full text of the abstract will be released on the SITC (Free SITC Whitepaper) website on Tuesday, Nov. 9, 2021 at 8:00 a.m. ET.

About AB-X

AB-X is ArsenalBio’s lead discovery program for ovarian cancer. In the United States, ovarian cancer ranks fifth in cancer deaths among women and accounts for more deaths than any other cancer of the female reproductive system. T cell infiltration into tumors correlates with improved survival, but existing CAR T cell therapies have demonstrated modest benefits, suggesting Arsenal’s approach could transform the treatment paradigm. AB-X leverages a dual antigen sensing logic gate approach, targeting ALPG/P and MSLN, which are co-expressed in over 70% of primary ovarian cancers, for enhanced tumor specificity and improved safety. This dual logic gate ensures that the T cell killing is only activated at the site of the tumor. In addition, AB-X is engineered to knockdown FAS and PTPN2, two critical regulators of T cell function and persistence. Knockdown of FAS and PTPN2 results in CAR T cells that are resistant to FAS-mediated apoptosis, demonstrate enhanced expansion in vivo and show greater efficacy compared with unaugmented MSLN CAR T cells. As such, AB-X integrated circuit T cells are expected to be more specific and more potent than conventional CAR T cell approaches. We intend to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for AB-X in 2022.

On November 4, 2021 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported a collaboration with Bristol Myers Squibb on a clinical trial of a combination therapy using RGX-104 (abequolixron), the Company’s small molecule agonist of the Liver X Receptor/Apolipoprotein E ("LXR/APOE") pathway, and Yervoy (ipilimumab), Bristol Myers Squibb’s Cytotoxic T-Lymphocyte Associated protein 4 (CTLA-4) inhibitor (Press release, Inspirna, NOV 4, 2021, View Source [SID1234594520]). Under the terms of the agreement, Bristol Myers Squibb will provide ipilimumab for a Phase 1b/2 expansion study investigating the combination therapy for the 2nd and 3rd line treatment of patients with metastatic endometrial cancer whose genomes possess the E2 or E4 APOE genetic biomarker, including those patients who have progressed on prior checkpoint inhibitor therapy. Inspirna will sponsor the study and be responsible for study costs.

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RGX-104 is an orally administered LXR agonist that potently activates APOE protein expression in tumors to inhibit cancer progression. Approximately 40% of the human population harbors either the E2 or E4 variants of the APOE gene in their genomes. These APOE genetic variants can be readily identified by analyzing DNA from blood samples. The presence of either of the E2 or E4 variants has been shown to increase the likelihood of a favorable clinical response to RGX-104 treatment in some cancers, including endometrial cancer, in a Phase 1 clinical trial, thus providing a potential biomarker for RGX-104 therapy. RGX-104 is currently being investigated in a Phase 1b/2 clinical trial in combination with standard-of-care regimens in several lung cancer indications that are enriched for dysregulation of the APOE gene, including small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

"We are proud to embark on this collaboration with Bristol Myers Squibb to uncover an additional possible application of RGX-104 beyond our current areas of study," said Masoud Tavazoie, M.D., Ph.D., and Chief Executive Officer of Inspirna. "This collaboration validates the work we are doing with RGX-104, and follows our recent phase 1 combination dose escalation trial results, in which treatment with RGX-104 combination regimens resulted in a 60% response rate in patients with relapsed or refractory cancers that had progressed on prior checkpoint inhibitor therapy and possessed the E2 or E4 APOE genetic biomarkers. We look forward to working with Bristol Myers Squibb and unlocking the potential of RGX-104 as we aim to improve the lives of people suffering with cancer."

Yervoy is a trademark of Bristol Myers Squibb Company.

About RGX-104 (abequolixron)

RGX-104 (abequolixron) is an orally administered small molecule agonist of the Liver X Receptor (LXR) which activates expression of the APOE tumor suppressor protein. APOE expression becomes dysregulated (silenced) in the tumors of select patients with solid cancers. APOE dysregulation results in increased tumor angiogenesis (tumor blood vessel growth) as well as a shifting of the tumor myeloid cell population from immune-stimulatory to immune-suppressive, which are both counteracted by RGX-104. RGX-104 is currently being tested in a Phase 1b/2 clinical trial in combination with standard-of-care regimens in several lung cancer indications that are enriched for APOE dysregulation, including SCLC and NSCLC. Inspirna expects to present data from this clinical study in 2H 2022.

On November 4, 2021 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the first patient has been dosed in its global ACE-Breast-03 Phase 2 clinical study of ARX788 in patients with HER2-positive metastatic breast cancer (Press release, Ambrx, NOV 4, 2021, View Source [SID1234594519]).

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ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumors. The FDA has granted ARX788 Fast-Track Designation for the treatment of HER2-positive metastatic breast cancer in December 2020.

"Dosing the first patient in this Phase 2 study of ARX788 in patients with HER2-positive metastatic breast cancer marks an important milestone for Ambrx," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "We have made excellent progress with our clinical development pipeline over the last few months, highlighted by our positive data of ARX788 for HER2-positive gastric cancer, as well as the dosing of the first patient in a Phase 1 trial of ARX517 for PSMA expressing tumors. Our growing clinical programs, coupled with an influx of capital from our IPO in June 2021, leaves Ambrx well-positioned to potentially attain several near-term clinical and corporate milestones."

The global ACE-Breast-03 Phase 2 clinical study is a multicenter study to evaluate the efficacy and safety of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. The primary outcome measure of the study will be the objective response rate.

On November 4, 2021 Primmune Therapeutics reported that it has received $8.4 million in a second tranche of the Company’s Series A financing. The total proceeds for the equity raised in the Series A was $31.4 million (Press release, Primmune Therapeutics, NOV 4, 2021, View Source [SID1234594518]). These funds will be used to support the further clinical development of PRTX007 as a TherAjuvant for acute viral diseases, pre-cancerous lesions, and advanced cancer. PRTX007 is a novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonist that has both therapeutic and adjuvant properties.

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"Given the initial results from our Phase 1 study in healthy volunteers, we achieved our target clinical milestone that triggered a second tranche of $8.4 million from our existing investors. These funds will be used to set the stage for Primmune’s expansion into multiple definitive efficacy studies," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "In 2022, we intend to study PRTX007 in ambulatory respiratory syncytial virus (RSV), outpatient SARS-CoV-2, human papilloma virus (HPV) driven high-grade squamous intraepithelial lesions (HSIL) of the cervix, and in the neo-adjuvant setting in combination with checkpoint inhibitors in advanced cancer."

About TherAjuvants

Primmune Therapeutics coined the term TherAjuvants to reference its lead candidate PRTX007, a toll-like receptor 7 (TLR7) agonist with a combination of therapeutic and adjuvant mechanisms of action. PRTX007 is designed to provide immediate benefit to patients through controlled stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 uniquely engages TLR7 and targeted immune cells without exacerbating inflammation, a critical feature in treating respiratory viral infections. TherAjuvants differ from therapeutic vaccines in that the source of the antigens presented to the patient’s immune system come from the treated pathology. Additionally, TherAjuvants differ from most small molecule approaches in that they target the patient’s immune system and not tumor cells or virally encoded targets.