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).

On March 21, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a Rare Pediatric Disease (RPD) designation by the US Food and Drug Administration (FDA), for the treatment of neuroblastoma (Press release, Ascentage Pharma, MAR 21, 2022, View Source [SID1234610495]). To date, alrizomadlin has received a total of six Orphan Drug Designations (ODDs) and two RPDs by the FDA.

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The Food and Drug Administration Safety and Innovation Act (FDASIA), came into effect in 2012, established the rare pediatric disease priority review voucher (PRV) program to reward sponsors for the development of novel therapies for the treatment of rare pediatric diseases. FDASIA defines RPDs as rare diseases or conditions (diseases with a prevalence of less than 200,000 patients in the US) primarily affecting individuals aged from birth to 18 years, including age groups from neonates, infants, children, to adolescents. Being qualified for the PRV is one of the main benefits of the RPD designation, as sponsors who are rewarded with the PRV are eligible for priority review of future New Drug Applications or Biologics License Applications, and they may also choose to have the PRV transferred to another sponsor, at an estimated value around several hundred million US dollars.

Neuroblastoma is a type of embryonic tumor arising from the peripheral sympathetic nervous system. It is the most common extracranial solid tumor in children and the third most common pediatric cancer[1]. According to the American Cancer Society (ACS), there are about 700 to 800 new cases of neuroblastoma each year in the United States. This number has remained about the same for many years. Due to its aggressive nature and high risk of metastasis, neuroblastoma accounts for up to 15% of all deaths caused by pediatric cancers[2]. It is mostly diagnosed in infancy with 41% of patients diagnosed in the first three months after birth, and most patients are diagnosed by the age of 5 years with a median age of diagnosis around 18 months[3].

Neuroblastoma is a serious condition that can be life-threatening to pediatric patients. Patients diagnosed as low-risk usually have a good prognosis. However, those diagnosed with high-risk disease are difficult to cure, with a large proportion of these patients eventually experiencing disease recurrence. Despite intense multimodal treatments, patients with high-risk neuroblastoma have a poor prognosis with an Event-Free Survival (EFS) of less than 50%. Patients with relapsed or refractory neuroblastoma are extremely difficult to cure, and there is no standard treatment for these patients.

Being developed by Ascentage Pharma, alrizomadlin is an orally administered, selective, small-molecule inhibitor of the MDM2 protein. Alrizomadlin has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. In earlier studies, APG-115 as a single agent has shown antitumor activity in in vitro and in vivo models of neuroblastoma, demonstrating a mechanism of action that supports the clinical development of the drug candidate in patients with neuroblastoma.

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said, "In addition to the benefits provided by the ODD, the RPD designation offers sponsors the additional incentive of priority review status for their future marketing applications, encourages the drug development for the treatment of rare pediatric diseases. Alrizomadlin is a key drug candidate in our apoptosis-targeted pipeline. It has already been granted six ODDs, one Fast Track Designation (FTD), and two RPDs by the US FDA, thus signifies this asset’s clinical potential. This RPD will qualify this program for a PRV, which should help us better communicate with the FDA to hopefully accelerate the clinical development of alrizomadlin. We will initiate the clinical study in neuroblastoma as soon as possible in order to develop a new treatment option for those pediatric patients in need."

References

American Cancer Society. Cancer Facts & Figures 2014. Atlanta, Ga: American Cancer
Ward E, DeSantis C, et al. Childhood and adolescent cancer statistics, 2014. CA Cancer J Clin. Mar-Apr 2014;64(2):83-103.
Shohet J, Foster J. Neuroblastoma. BMJ. 2017 May 3;357:j1863.