On December 8, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that management will host a virtual event entitled "B -cell Lymphoma Franchise Update" on Tuesday, December 14, 2021 at 8:00 AM ET (Press release, Fate Therapeutics, DEC 8, 2021, View Source [SID1234596594]).

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The event will highlight interim Phase 1 clinical data from the Company’s FT516 and FT596 programs for the treatment of relapsed / refractory B-cell lymphomas.

The live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

The event is not an official program of the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of relapsed / refractory acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of relapsed / refractory B-cell lymphoma (NCT04023071).

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).

On December 8, 2021 Alpha-1 Biologics, a biotherapeutics company developing innovative treatments for cancers and immune deficiencies, reported that positive data was published in frontiers in Oncology demonstrating Alphataxin, a small molecule that elevates circulating and tumor-infiltrating CD4+ T cells, suppressed kidney cancer and suppressed metastasis in mice (Press release, Alpha Biologics, DEC 8, 2021, View Source [SID1234596614]). Orally available Alphataxin, is the first and only drug in development to increase formation of CD4+ helper T cells. Immune checkpoint inhibitor therapy, the vanguard of cancer therapy, promotes the ability of CD8+ T cells to kill tumor cells. However, CD8+ T cells are unable to kill tumor cells in the absence of chemical mediators secreted by CD4+ helper T cells. The data showed that Alphataxin treatment is efficacious as a monotherapy in kidney cancer in mice and enhances anti-PD-1 immune checkpoint inhibitor therapy, with the potential to expand the number of human cancer patients who respond to checkpoint inhibitor therapy.

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"We are pleased with these pre-clinical results, which have further increased our confidence in the promising potential of Alphataxin to treat cancers and immune deficiencies. Based on this positive data, the company plans to raise additional capital to rapidly advance the Alphataxin development program."

Cynthia L. Bristow, PhD, CEO of Alpha-1 Biologics said, "We are excited to announce this positive pre-clinical data, which showed that Alphataxin, orally delivered in combination with an injected immune checkpoint inhibitor, may provide a powerful approach that can produce long-term remission in kidney cancer and other T cell-responsive tumors. Alphataxin as a monotherapy and in combination with anti-PD-1 immune checkpoint inhibitor therapy significantly suppressed tumor growth in a mouse model of kidney cancer and significantly elevated the number of circulating and tumor-infiltrating CD4+ T cells."

In the study, following implantation of mouse kidney tumor cells within the kidney of mice, combination treatment of Alphataxin and anti-PD-1 therapy resulted in 100% elimination of tumor growth. Moreover, in mice implanted with ten times more tumor cells into the kidney, doubling the Alphataxin dose in combination treatment with anti-PD-1 led to 100% elimination of tumors in one-third of mice and 81% suppression of tumor growth in the remaining two-thirds of mice. Both anti-PD-1 and Alphataxin monotherapy showed decreased tumor growth as compared with untreated mice. Lung metastasis was present in monotherapy but eliminated in combination-treated mice.

The study also investigated the effects of Alphataxin on the immune system in healthy mice. The data showed that Alphataxin increased the normally circulating numbers of CD4+ T cells, Pre-T cells, and CD4/CD8 ratio indicating that Alphataxin acts to increase the formation of CD4+ helper T cells.

"This combination treatment of Alphataxin with an anti-PD-1 therapy addresses a high unmet medical need in patients with kidney cancer who have very low survival rates. The 5-year survival rate for patients with renal adenocarcinoma undergoing anti-PD-1 treatment is estimated to be 27.7%. However, despite the efficacy of checkpoint inhibitors in promoting the cytotoxic activities of tumor infiltrating CD8+ T cells, approximately 87% of cancer patients do not respond to immune checkpoint therapy," said Dr. Bristow. "Kidney cancer is often not diagnosed until after metastasis, a disease stage for which there are few effective treatment options; however, recent promising advances demonstrate that easily accessible blood-based tests provide early detection, and this means that Alphataxin has the potential to be transformative in providing long lasting remission in kidney cancer."

Ron Winston, President, Institute for Human Genetics and Biochemistry said, "We are pleased with these pre-clinical results, which have further increased our confidence in the promising potential of Alphataxin to treat cancers and immune deficiencies. Based on this positive data, the company plans to raise additional capital to rapidly advance the Alphataxin development program."

The full article in frontiers in Oncology can be accessed here: Alphataxin, a Small-Molecule Drug That Elevates Tumor-Infiltrating CD4+ T Cells, in Combination With Anti-PD-1 Therapy, Suppresses Murine Renal Cancer and Metastasis.

About Alphataxin

Alpha-1 Biologics discovered that the protein alpha-1 proteinase inhibitor (α1PI, alpha-1 antitrypsin) regulates the number of circulating CD4+ T cells by stimulating the locomotion of Pre-T cells. The orally available small-molecule drug Alphataxin acts as a surrogate for α1PI in this pathway. The Company is focused on the development of Alphataxin, which suppressed tumor growth in a mouse model of kidney cancer. Alphataxin, in combination with anti-PD-1 antibody, significantly elevated circulating and tumor-infiltrating CD4+ T cells. Because orally available Alphataxin is the first and only drug developed to increase CD4+ T cells, Alphataxin is eligible for FDA Breakthrough Designation. In combination with anti-PD-1, Alphataxin is a powerful therapeutic method that provides long-term remission in kidney cancer in mice and is being tested in other T cell-responsive cancer models.

On December 8, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that it has entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., through its subsidiaries, to evaluate the combination of SOT101, SOTIO’s IL-15 superagonist, and MSD’s KEYTRUDA (pembrolizumab) in patients with selected advanced/refractory solid tumors in the phase 2 AURELIO-04 study (Press release, SOTIO, DEC 8, 2021, View Source [SID1234596595]).

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"SOT101 in combination with KEYTRUDA has shown promising clinical efficacy across multiple indications in our ongoing phase 1/1b AURELIO-03 study," said Radek Špíšek, Ph.D., Global CEO of SOTIO. "We are excited to collaborate with MSD, a global leader in oncology, to continue studying the combination as part of the AURELIO-04 study for the treatment of certain patients with solid tumors while exploring the full potential of SOT101. We look forward to advancing SOT101 to the benefit of patients globally."

Under the terms of the agreement, SOTIO will conduct a Phase 2 open-label, multicenter study of SOT101 in combination with KEYTRUDA to evaluate efficacy and safety in patients with selected advanced or refractory solid tumors. The study is expected to treat up to 300 patients with a combination of SOT101 and a standard dose of KEYTRUDA. The study will enroll patients in the U.S. and selected European countries across six different indications, including second line non-small cell lung cancer, first and second line cutaneous squamous cell carcinoma, first line microsatellite instability-high colorectal cancer, second line hepatocellular carcinoma, first line metastatic castration-resistant prostate cancer, and second line ovarian cancer. MSD will supply KEYTRUDA for the study.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About SOT101
SOT101 (SO-C101) is a subcutaneously-administered IL-15 superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC.

On December 8, 2021 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations (Press release, Foundation Medicine, DEC 8, 2021, View Source [SID1234596615]). This approval makes FoundationOneCDx the only comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists.

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Melanoma is a serious form of skin cancer that accounts for an estimated 207,790 cases each year.1 BRAF mutations are the most common type of mutation in melanoma and are present in more than half of all melanoma cases.2 As a companion diagnostic for therapies targeting BRAFV600E and BRAFV600K mutations in melanoma, FoundationOneCDx offers oncologists flexibility when selecting the right therapy for their melanoma patients and ensures all treatment options are considered within these groups of therapies.

"As the first group therapy approval for any comprehensive genomic profiling test, this milestone reinforces our dedication to pioneering advances that expand the power of genomic testing in cancer care," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "This approval will allow oncologists to uncover all possible FDA-approved treatment options for these indications through just one test, providing more insights for physicians and patients, more efficiently than ever before."

This approval represents an innovative, more efficient regulatory approach that simplifies the companion diagnostic approval process for biopharma companies developing BRAF inhibitor therapeutics, while maintaining rigor and high-quality standards.

The first new therapeutics for which FoundationOneCDx is a companion diagnostic under the group approvals are Pfizer’s BRAFTOVI/MEKTOVI and Novartis Tafinlar (dabrafenib) + Mekinist (trametinib) combination therapeutics. Moving forward FoundationOneCDx will automatically become a companion diagnostic for future BRAF inhibitors that are approved by the FDA under these groups.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

On December 8, 2021 Propella Therapeutics, Inc. reported that it will be participating in the 11th Annual LifeSci Partners Corporate Access Event from January 5-7, 2022 (Press release, Propella Therapeutics, DEC 8, 2021, https://propellatx.com/2021/12/08/presentation-forthcoming-11th-annual-lifesci-partners-corporate-access-event-january-5-7-2022/ [SID1234596637]).

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