On March 21, 2022 GT Biopharma, Inc. ("the Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary tri-specific natural killer (NK) cell engager, TriKE protein biologic technology platform, reported, preclinical data to be presented at the hybrid 48th European Society for Blood and Marrow Transplantation Annual Meeting (EBMT) (Press release, GT Biopharma, MAR 21, 2022, View Source [SID1234610501]). The poster presentation titled, "Tri-specific Killer Engager (TriKE) against B7-H3 enhances NK cell mediated killing of multiple myeloma," is presented by Aimee Merino, MD, PhD, Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota. GTB-5550 (B7-H3 TriKE) is the Company’s tri-specific killer engager (TriKE) with camelid single-chain Fv fragments against B7-H3 (CD276) and CD16 linked by IL-15 to enhance NK cell killing of myeloma. GTB-5550 is part of GT Biopharma’s portfolio of lead TriKE product candidates being investigated as a mono- and combination therapy against multiple myeloma.

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Dr. Gregory Berk, President of R&D and Chief Medical Officer noted, "Testing GTB-5550 across several multiple myeloma cell-lines has yielded preclinical evidence suggesting further investigation of this TriKE in the clinic. We continue to push the boundaries of the natural killing power of NK cells enhanced by the Company’s TriKE protein therapeutics across multiple types of liquid, solid and refractory cancer types. Additionally, this study further validates the potential of the Company’s TriKE assets both as a mono- and combination therapy, with NK cells and anti-cancer agents."

Poster Title: "Tri-specific Killer Engager (TriKE) against B7-H3 Enhances NK Cell Mediated Killing of Multiple Myeloma"

Background – Natural Killer (NK) cell-based therapies hold great promise in treating multiple myeloma. One method to enhance NK cell specificity against myeloma is antibody dependent cellular cytotoxicity through a CD16 receptor. B7-H3 (CD276) was targeted as its expression in myeloma is associated with decreased progression free survival, it exhibits low expression on healthy tissue, and it is expressed on myeloid derived suppressor cells (MDSC), which promote myeloma growth.

Study design and analysis – The study compared the ability of peripheral blood NK cells with or without GTB-5550 to kill myeloma cells in live imaging IncuCyte Zoom assays with escalating doses of TriKE. Maximal killing occurred with 3 nM concentration. Testing was performed across four different myeloma cell lines (H929, MM1S, RPMI-8226, U266). In the study, the efficacy of GTB-5550 was also tested in combination with the proteasome inhibitor bortezomib (10 nM) and the immunomodulatory drug lenalidomide (5 mM). Cytotoxicity curves were compared by repeated measures ANOVA and performed in triplicate.

Results – NK cell mediated killing increased statistically significantly across all multiple myeloma cell lines tested. Combination therapy with GTB-5550 and anti-cancer agent showed enhanced killing as compared to NK cells or TriKE alone.

Statistically significant increase in NK cell mediated killing across all lines when 3nM B7-H3-TriKE was added. Against U266 and MM1S, B7-H3-TriKE significantly enhanced killing at effector:target (E:T) ratios of 2:1 and 4:1. RPMI-8226 showed relatively high resistance to NK cell cytotoxicity but B7-H3-TriKE enhanced killing at E:T of 4:1. H929 cells were more potently killed in the presence of B7-H3-TriKE at E:T of 2:1 but there was no difference in killing at E:T 4:1 likely due to high natural cytotoxicity in both groups.

Combination therapy with GTB-5550, NK cells, and lenalidomide showed synergistic killing of H929 cells after 48 hours of live cell imaging (p=0.047) but combination with bortezomib did not further enhance killing as compared to NK cells and TriKE alone. Both lenalidomide and bortezomib showed a trend toward improved killing against MM1S when given with NK cells and B7-H3 TriKE but it did not reach statistical significance. Combination therapy with B7-H3-TriKE, NK cells, and lenalidomide or bortezomib showed synergistic killing of RPMI-8226 cells after 48 hours of live cell imaging (p<0.001 and 0.015 respectively). Bortezomib combined with GTB-5550 and NK cells enhanced killing in U266 cells (p=0.037).

Conclusion – B7-H3-TriKE significantly enhances NK cell mediated killing of myeloma cells, even in the relatively low B7-H3-expressing H929 line. Our data also shows it can reverse MDSC-induced myeloma growth.
The EBMT poster presentation details are as follows:

EBMT Poster Presentation Details

Title: A Tri-specific Killer Engager (TriKE) against B7-H3 enhances NK cell mediated killing of multiple myeloma
Abstract Number: AS-EBMT-2022-00508
Session: New Drugs- and Cell-Based Immune Therapies
Presentation Type: Poster
Session Date and Time: March 19, 2022 9:50 AM (CET)
Location: Prague Congress Center, Czech Republic
Poster Board Number: P153

Multiple Myeloma (Kahler’s disease) – is a cancer of the plasma cell. Normal plasma cells are a type of white blood cell that helps make up your immune system. They are located within the bone marrow – the spongy interior of bones that produces blood cells. When your body is fighting an infection, plasma cells produce antibodies (proteins) which attack viruses and bacteria. If a plasma cell becomes cancerous, it multiplies rapidly. This is multiple myeloma. Malignant plasma cells may crowd out normal blood-forming cells within the bone marrow, reducing the production of healthy blood cells. Additionally, rather than producing infection-fighting antibodies, the cancer cells begin to produce an abnormal antibody called a monoclonal protein (m protein) or paraproteins. In the urine, they are called Bence Jones proteins. These proteins do not fight against infection. For more information about multiple myeloma please click here.

On March 21, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported new Signatera data from the prospective, multi-center CIRCULATE-Japan trial, reported by Dr. Eiji Oki of Kyushu University in an oral presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care (Press release, Natera, MAR 21, 2022, View Source [SID1234610500]).

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CIRCULATE-Japan is the largest molecular residual disease (MRD)-guided clinical trial with more than 3,300 stage I-IV colorectal cancer (CRC) patients enrolled to date. This interim analysis at SSO, similar to the one previously presented at the 2022 ASCO (Free ASCO Whitepaper) GI symposium, analyzed 6-month and 12-month outcomes from 1,040 patients and showed that Signatera MRD-positive patients benefited significantly from adjuvant chemotherapy (ACT), while Signatera MRD-negative patients did not benefit from ACT.

Latest findings exclusive to SSO 2022 demonstrate 75% (45/60) detection of recurrence in stage II-III patients with a single blood draw at 4 weeks post surgery. The previous analysis from ASCO (Free ASCO Whitepaper) GI, which showed a single time point sensitivity of 68% (46/68), did not exclude non-cancer or treatment-related deaths. Prior studies have shown that serial monitoring further increases the detection rate of recurrence up to 88-93%.1,2

"Learnings from our study consistently suggest that stratifying post-surgical treatment decisions using Signatera can identify patients likely to benefit from adjuvant chemotherapy across stages," said the study’s Principal Investigator, Dr. Takayuki Yoshino, of the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. "We look forward to continuing to expand the study."

The presentation at SSO also indicates increasing interest in and adoption of Signatera among cancer surgeons, who are finding utility in personalized monitoring and MRD assessment to inform surgical decisions. Signatera has been shown in several studies3,4 to be predictive of treatment response in the neoadjuvant setting (before surgery) as well as the adjuvant setting (after surgery), across multiple cancer types.

In addition to presenting the latest CIRCULATE-Japan study data, Natera also announced the activation of the CIRCULATE-US trial, a national, prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early-stage CRC. The study, which is being conducted in partnership with NRG Oncology and funded by the National Cancer Institute (NCI), was recently granted an investigational device exemption (IDE) from the FDA after a thorough review of Natera’s clinical and analytical validation data.

"Natera is dedicated to continuing to drive improvement in MRD test sensitivity and improving CRC patient outcomes by executing definitive, practice-changing prospective studies," said Dr. Adham Jurdi, medical director of oncology at Natera. "We’re delighted to be at the forefront of MRD and colorectal cancer research and excited to see these landmark studies, like CIRCULATE-US, progress."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

On March 21, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), a late stage, oncology-focused drug development company reported that upcoming presentations at two international conferences (Press release, Kazia Therapeutics, MAR 21, 2022, View Source [SID1234610499]).

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American Association of Cancer Research Annual Scientific Meeting

Four abstracts relating to Kazia’s pipeline have been accepted for presentation at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Scientific Meeting, held in New Orleans, LA from 8th – 13th April 2022. Two abstracts relate to the ongoing phase I study of EVT801, a selective VEGFR3 inhibitor in development for advanced cancer. The other two pertain to paxalisib, a brain-penetrant PI3K inhibitor, currently in an international phase III clinical trial for glioblastoma and in exploratory studies for several other forms of brain cancer. All four posters are expected to be presented on Tuesday 12th April.

The AACR (Free AACR Whitepaper) Annual Scientific Meeting is one of the leading global academic conferences for oncology research. It is typically attended by more than 20,000 clinicians, researchers, industry executives, and investors, representing over 140 countries. The conference returns to an in-person format this year.

2022 Virtual Growth Conference, presented by Maxim Group LLC

In addition, Kazia CEO, Dr James Garner, will present a corporate update at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest, on 28th – 30th March 2022, from 9am – 5pm, ET. As well as providing an overview of the company, Dr Garner will summarise the important progress that the company has made in 2021 and outline a broad range of catalysts that are expected during 2022.

During the virtual conference, investors will hear from executives from a wide range of sectors including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITS, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/ Media/Telecom. The conference will feature company presentations, fireside chats, and roundtable discussions.

On March 21, 2022 Biond Biologics Ltd., a private, clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that the abstract on BND-67 was accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place on April 8 – 13, 2022, in New Orleans, Louisiana (Press release, Biond Biologics, MAR 21, 2022, View Source [SID1234610498]). BND-67 is a nanobody-based agent that targets CD28 shedding – a novel immune-regulatory mechanism found in cancer patients that serves as a potential resistance mechanism to anti-PD-1 therapy.

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Biond will give an oral presentation in the session of: "Experimental and Molecular Therapeutics -Elucidating Disease Biology and Drug Resistance Mechanisms". The presentation title is: "CD28 shedding is a novel resistance mechanism to anti PD-1 therapy", (Abstract #654) and it will be held on Sunday, Apr 10th, 2022, at 3:00PM.

BND-67 Oral Presentation at 2022 AACR (Free AACR Whitepaper) Annual Meeting

Anti-PD-1 drugs dominate the immunotherapy market for a decade now, yet resistance mechanisms to anti-PD-1 therapies remain poorly understood. There are indications that efficient anti-PD-1 therapies rely specifically on intact CD28/B7 signaling. Biond Biologics’ research demonstrated an unknown mechanism for active shedding of membranal CD28 by specific Matrix metalloproteinases (MMPs), upon T cell stimulation in humans. Soluble CD28 produced by this shedding mechanism was shown to counteract the efficacy of anti-PD-1 blocking antibodies in-vitro. In the oral presentation to be given at the AACR (Free AACR Whitepaper), Biond will present data demonstrating CD28-shedding process as a potential resistance mechanism to PD-1 therapies and will describe BND-67, an agent that can selectively and efficiently block this novel regulatory mechanism in cancer patients.

In addition to Biond’s BND-67 program, the company’s Immuno-Oncology (I-O) pipeline also includes BND-35, an anti Ig-Like Transcript 3 (ILT3) antibody, an immune checkpoint inhibitor that inhibits the activity of suppressive myeloid cells. Biond’s clinical I-O program, BND-22 (SAR444881), is an Ig-Like Transcript 2 (ILT2) receptor-blocking antibody that was partnered with Sanofi. BND-22 is in a phase 1 clinical trial in advanced cancer patients with select solid tumor types as monotherapy and in combination with Cetuximab and Pembrolizumab. Biond is also developing INspire, a transformative intracellular delivery platform for biologics, which will allow the targeting of well-known yet hard-to-target intracellular cancer-promoting pathways with biologics.

"The work that will be presented showcases the pioneering research conducted at Biond Biologics utilizing real-world patient and tumor samples, leading to the discovery of novel immune evasion and regulatory mechanisms", said Ilana Mandel, Ph.D., VP R&D at Biond Biologics.

"We’re excited to share at the upcoming AACR (Free AACR Whitepaper) annual meeting, this unique regulatory mechanism discovered at Biond, which can serve as a resistance mechanism to anti-PD-1 treatment. We will also present ways to overcome this mechanism with BND-67, a proprietary nanobody that targets CD28 shedding in cancer patients", added Motti Hakim, Ph.D., Immuno-Oncology director at Biond Biologics.

On March 21, 2022 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision medicine company with a patented, novel phosphoprotein-based assay for breast cancer reported that the American Medical Association (AMA) has recently issued a new, dedicated Proprietary Laboratory Analyses (PLA) code for the Theralink Assay for Advanced Breast Cancer (Press release, Theralink Technologies, MAR 21, 2022, View Source [SID1234610497]). The Theralink assay measures the tumor cell levels of activated proteins, which are the primary targets of most FDA-approved therapies and biopharmaceutical investigational drugs. The new PLA code is 0249U. In addition, Theralink has submitted information to the appropriate Medicare Administrative Contractors (MAC’s) that will help them in establishing an appropriate rate for the Theralink test.

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The Theralink Assay combines two well-established technologies: Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA). This combination of technologies identifies activated proteins that are the direct targets of cancer precision medicine therapies from enriched tumor material. As a result, Theralink can provide oncologists with a potential predictive molecular tool that may aid in the selection of appropriate therapies.

"We are extremely pleased that the AMA has approved a unique PLA code for our Theralink Assay for Advanced Breast Cancer," said Mick Ruxin, M.D., President & CEO of Theralink Technologies. "This is another important milestone for our company." Dr. Ruxin went on to say, "It also may provide incremental financial value to the Company as we intend to start billing with the new PLA code and its associated rate in the future".