Presentation (forthcoming): 11th Annual LifeSci Partners Corporate Access Event (January 5-7, 2022)

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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IsoPlexis to Present IsoLight® Single-Cell Proteomics Data at ASH 2021 Conference

On December 8, 2021 IsoPlexis (NASDAQ: ISO), the leader in functional single cell proteomics, reported that new data generated on its IsoLight platform will be presented at the 63rd annual American Society of Hematology (ASH) (Free ASH Whitepaper) conference, taking place December 11-13 at the Georgia World Congress Center in Atlanta, Georgia (Press release, IsoPlexis, DEC 8, 2021, View Source [SID1234596629]).

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At ASH (Free ASH Whitepaper), IsoPlexis’ presented data will outline how to leverage unique powerful single-cell subsets of highly functional "superhero" cells, critical to driving longer term response in cell and immune therapies via functional proteins. The presentation will highlight how to fully leverage these superhero cells for optimization of CAR-T manufacturing, as well as clinical combination immunotherapies for hematologic malignancies and functional biomarkers of potency, durability, and survival.

The presentation, titled "Single-Cell Functional Biomarkers of Potency, Durability, and Survival in Cell Therapy Optimization and Combination Immunotherapies for Hematologic Diseases," will be given on Saturday, December 11 from 1:30 p.m. – 1:45 p.m. eastern time. The presentation will be located in Theater 5 of Exhibit Hall – Building B at the Georgia World Congress Center.

Additionally, the following poster presentations from Stanford University, Medical College of Wisconsin, and Atara Biotherapeutics will also highlight novel applications in acute graft-versus-host disease (aGvHD), bispecific CAR-T cells, and off-the-shelf allogenic T-cell therapies, respectively:

P#1684: Combinatorial Cytokine Secretion Signature of Donor-Derived T Cells Infused with the Graft: A New Potential Biomarker of Acute Graft-Versus-Host Disease in Aβt-Cell/CD19 B-Cell Depleted Hematopoietic Stem Cell Transplant Recipients
P#1728: Bispecific LV20.19 CAR T-Cells Expanded in IL-7 and IL-15 Have Greater Polyfunctionality and Polyfunctional Strength Than CAR T-Cells Expanded in IL-2
P#2809: Comprehensive Activation Profiling of the Tabelecleucel Library, and Off-the-Shelf, Allogeneic EBV-Specific T-Cell Therapy

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-422 for the Treatment of Advanced Breast Cancer

On December 8, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast cancer (Press release, Nuvation Bio, DEC 8, 2021, View Source [SID1234596628]). The FDA accepted the Company’s first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM). The Company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). The Company is continuing to enroll patients in the Phase 1 dose escalation portion of the study.

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"FDA clearance of our second IND application for NUV-422 is an important milestone for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We are encouraged by the differentiated and broad potential of NUV-422 to address multiple tumor types. We look forward to sharing data from the Phase 1 dose escalation portion in the second half of 2022."

With the clearance of this IND in advanced breast cancer, Nuvation Bio will be initiating a Phase 1/2 study in patients with HR+/HER2- advanced breast cancer who have received prior hormonal therapy combined with an approved CDK 4/6 inhibitor. This study (Protocol NUV-422-03) will begin with a Phase 1b dose escalation portion designed to evaluate safety and tolerability of the NUV-422 plus fulvestrant combination and to determine a recommended Phase 2 combination dose of NUV-422. The Phase 2 portion is a randomized, non-comparative study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy.

GT Biopharma Demonstrates Novel B7-H3 Targeting Dual Camelid Nanobody BiKE and GTB-5550 Induce NK Cell Activation Against Broad Spectrum of Tumors at ESMO IO Congress 2021

On December 8, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that the Company’s mini-poster presentation abstract is now broadly available on the European Society for Medical Oncology ("ESMO") Immuno-Oncology ("IO") Congress 2021 abstracts webpage (Press release, GT Biopharma, DEC 8, 2021, View Source [SID1234596627]). The congress is being held from December 8-11, 2021, in Geneva Switzerland.

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"B7-H3 is a checkpoint molecule under intense investigation as an immune therapy target for solid and hematologic tumors. These proof of concept data via in vivo animal models validates GTB-5550’s candidacy for further investigation, noted Dr. Gregory Berk, President of R&D, Chief Medical Officer and Interim Chief Executive Officer. GT BioPharma’s diverse but focused pipeline of TriKE Nanobodies are highly targeted natural killer cell engagers, resulting in potent activation, proliferation, and persistence of the patient’s NK cells, without activation of T-cells, which are often responsible for the side effects of T-cell directed therapies. As such, we look forward to continuing the Company’s progress in the new year including the advancement of GTB-3650, second-generation TRIKE for patients with relapsed/refractory Acute Myelogenous Leukemia (AML) and high-risk Myelodysplastic Syndrome (MDS)."

The study was conducted by Dr. Jeff Miller’s lab, University of Minnesota where functional assays were conducted with various ovarian, prostate, and hematologic malignancy cell lines with varying levels of B7H3 expression from none to very high levels. Dr. Miller’s lab previously showed that dual camelid nanobody tri-specific killer engager (TriKE) (GTB-5550) specifically bound B7-H3 on PC3/C4-2 prostate cancer (PCa) cells and activated peripheral blood (PB) NK cells. We have since developed a dual camelid bispecific killer engager (BiKE) targeting B7-H3 and show that both GTB-5550, which harbors wild-type IL-15, and BiKE display broad activity against B7-H3-expressing tumors. Compared to monomeric IL-15, GTB-5550 shows CD16-dependent metabolic activation of NK cells.

Presentation highlights from the mini-poster titled, "Novel B7-H3 Targeting Dual-Nanobody NK Cell Engagers Display Robust Activity" include:

Study Background
BiKE and GTB-5550 were manufactured in a mammalian expression system and purified from supernatants.
Models were used to evaluate how the BiKE and GTB-5550 induce NK cell degranulation (CD107a) and interferon gamma production through a variety of cell lines including PCa cells harboring enzalutamide resistance with divergent mechanisms including 22RV1 (androgen ligand-independent AR-V7 splice variant) as well as a spontaneously resistant LNCaP model (AR hyper activation), as well as a CREB5 overexpressing (epithelial to mesenchymal transition) LNCaP model.
Metabolic stimulation was measured in NK-92 cell lines.
PB NK cells were robustly activated, compared to controls, when treated with GTB-5550 or BiKE and cultured with enzalutamide resistant PCa, osteosarcoma (U2OS, SaOS2), rhabdomyosarcoma (RH30), ovarian carcinoma (MA148, OVCAR8), AML (MV4;11, THP-1) and multiple myeloma (MM1S) cell lines.
GTB-5550 was approximately 2 times more potent than NCI IL-15 in terms of metabolic stimulation of CD16+ NK-92 cells, but not CD16- NK-92 cells. Spheroid killing assays and deeper metabolic analyses are in progress.
Results of the Study
The data demonstrated that the novel dual camelid nanobody BiKE and GTB-5550 induce NK cell activation against a broad spectrum of tumors expressing B7-H3. Furthermore, B7-H3 is expressed at high levels on prostate cancer cell lines demonstrating enzalutamide resistance, thus inducing efficient targeting of these therapy PCa refractory lines. This B7-H3 targeting NK platform demonstrates broad translational potential. GMP production of GTB-5550 has been initiated.
ESMO IO 2021 presentation details

e-Poster Display Title (#126P): Novel B7-H3 targeting dual nanobody NK cell engagers display robust activity against a broad spectrum of solid and hematologic malignancies

The full abstract has been published on ESMO (Free ESMO Whitepaper)-IO website and the Company has published the poster on the company’s website in the "Presentations" section of its corporate website.

For event details please visit: View Source

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

About GTB-5550

GTB-5550 TriKE product candidate is being developed for the treatment of B7H3+ solid tumor cancers. GTB-5550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-B7H3 antibodies and human IL-15.

About GTB-3650

GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

EPIC sciences platform Demonstrates compelling Value of Cell Analysis in data Presented AT San Antonio Breast Cancer Symposium 2021

On December 8, 2021 Epic Sciences, Inc. (Epic)’s comprehensive liquid-biopsy platform reported that continues to deliver compelling cancer profiling information as data presented during the San Antonio Breast Cancer Symposium 2021 demonstrate (Press release, Epic Sciences, DEC 8, 2021, View Source [SID1234596626]).

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"These findings represent just some of the useful information novel liquid biopsies can provide" says Dr. Joyce O’Shaughnessy, Celebrating Women Chair of Breast Cancer Research, Baylor University Medical Center and Chair of Breast Cancer Program, Texas Oncology and the US Oncology Network. "Once patients begin treatment for metastatic disease, the cancer remodels itself to evade therapy, and it is difficult to assess the molecular changes that enable this process. New targeted therapies are driving heterogeneous resistance mechanisms, and insights from liquid biopsies analyzing circulating tumor cells can help oncologists decide when to change therapy, and how to sequence therapies."

Since 2018, the Epic platform has been providing clinically validated predictive information about selective hormone therapy resistance for patients with metastatic prostate cancer. Top academic and pharmaceutical research teams have leveraged the Epic platform to track drug target engagement, monitor response to treatment protocols, and select or stratify patients based on cell characterization.

"Epic’s comprehensive liquid-biopsy platform is uniquely suited to elucidate metastatic breast cancer biology", says Dr. Richard Wenstrup, Chief Medical Officer, Epic Sciences, Inc. "Frequent tissue biopsies from metastatic patients are usually not medically practical, but it is critical to obtain information about the current state of the patient’s disease. Genome-based liquid-biopsy options address a small part of this challenge, but it is the cell-based liquid biopsy analysis that completes the picture.

It has previously been shown that certain types of cell-based morphology confer poor prognosis for metastatic prostate cancer patients, and this data now confirms similar results for metastatic breast cancer patients. This cell imaging analysis identified heterogeneous disease and specific morphological phenotypes that predict for shortened survival.

"This is one of several of Epic’s collaborative studies that will produce new insights about metastatic breast cancer from the blood. Look for our forthcoming announcement about new breast-cancer offerings in our clinical lab and for our research partners," adds Lloyd Sanders, President and CEO, Epic Sciences.

Poster P2-02-03 Circulating tumor cells (CTCs), CTC heterogeneity and distinct morphological CTC phenotypes predict worse survival in metastatic breast cancer (MBC)