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".

On March 21, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that it has established a global clinical collaboration with Bristol Myers Squibb to evaluate the combination of TST001, an investigational humanized monoclonal antibody targeting Claudin18.2 developed by Transcenta, with Opdivo (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) (Press release, Transcenta, MAR 21, 2022, View Source;gastroesophageal-junction-cancer-301507217.html [SID1234610496]).

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This collaboration includes two global phase I/II open-label, multi-center studies, one to be held in the U.S. and one to be held in China, to evaluate the safety, tolerability, and anti-tumor efficacy of TST001 in combination with Opdivo in patients with unresectable locally advanced or metastatic Claudin18.2 expressing gastric / gastroesophageal junction cancer with or without previous treatment.

Under the terms of the agreement, Transcenta will be the sponsor of the trials and Bristol Myers Squibb will supply Opdivo to Transcenta for use in its combination therapy studies with TST001.

Metastatic GC/GEJ is one of the highly prevalent cancer types globally and there is urgent need for new therapies that can improve patients’ survival. Claudin18.2 is a pan-cancer target and is highly over-expressed in gastric cancer, pancreatic cancer, gallbladder and biliary tract cancer, esophageal cancer, and other tumor types. TST001 is a high affinity humanized antibody developed by Transcenta in house, specifically targeting Claudin18.2 expressing tumor cells and can elicit strong NK cell mediated antibody dependent cellular cytotoxicity. The combination of TST001 with checkpoint inhibitor such as Opdivo could provide greater clinical benefits to patients with locally advanced or metastatic gastric /gastroesophageal junction cancer.

"TST001 is a high affinity humanized monoclonal antibody targeting Claudin18.2. It has shown to be safe in ongoing trials as monotherapy or in combination with chemotherapy and displayed encouraging anti-tumor activity signals in gastric cancer and other solid tumor patients expressing Claudin18.2. TST001 works through NK cell mediated antibody dependent cellular cytotoxicity to exert its anti-tumor activity, and the addition of PD-1 inhibitor and chemotherapy have resulted in synergistic effects in preclinical models. We are excited to test the combination of TST001 with Opdivo for the treatment of metastatic gastric / gastroesophageal junction cancer as a new potential treatment option for these patients." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta.

Opdivo is a trademark of Bristol-Myers Squibb Company.

About TST001

TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).