On June 14, 2022 CDx Diagnostics, Inc. reported that it has signed an agreement with laboratory benefits management provider Avalon Healthcare Solutions, Inc. of Tampa, Fla (Press release, CDx Diagnostics, JUN 14, 2022, View Source [SID1234615974]). The agreement means that CDx will be an in-network specialty anatomic pathology laboratory of Avalon client BlueCross BlueShield of South Carolina, and builds on Avalon’s positive medical policy for CDx’s proprietary diagnostic platform, WATS3D.

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Short for wide-area transepithelial sampling with three-dimensional analysis, WATS3D utilizes enhanced tissue acquisition, 3D imaging with AI-powered analysis, and expert pathologists to reliably detect Barrett’s esophagus (BE) and esophageal dysplasia. Effectively immediately, the agreement makes WATS3D available to the 565,000 members of BCBS of South Carolina with all commercial and Medicare Advantage plans.

"At CDx, we’re driven to empower physicians to preempt esophageal cancer and improve patient lives," said Bill Huffnagle, CEO of CDx Diagnostics. "This new agreement with Avalon brings modern, proven diagnostic technology to more than half a million more members. We will work together to bring this potentially lifesaving technology to additional payors and the members they serve."

WATS3D technology helps clinicians overcome the limitations associated with traditional upper endoscopy screening and surveillance methods, by combining a specially designed brush, unique 3D imaging powered by AI, and a team of trained GI pathologists. In large multicenter clinical studies, WATS3D has been found to significantly increase the detection rate of BE and esophageal dysplasia, both treatable precursors to esophageal cancer, one of the fastest growing and most fatal cancers in the United States.

On June 14, 2022 Spirea Limited, a Cambridge company created to advance a new generation of antibody drug conjugate (ADC) therapeutics, reported that it has secured funding of £2.4 million with investments from high-profile UK and US investors (Press release, Spirea, JUN 14, 2022, View Source [SID1234615973]). Spirea will use the funds to initiate its pipeline of superior and differentiated ADCs in the treatment of solid tumours where there is a high unmet need.

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ADCs combine the cell killing activity of a cytotoxic drug with the cancer targeting capability of a monoclonal antibody. Although the ADC concept has been exemplified with approved products, many ADC programmes have failed to progress through clinical development because of dose-limiting toxicities, restricted efficacy, and limitations in the range of treatable cancers.

Spirea’s technology allows more cytotoxic drug to be attached to the targeting antibody (a higher drug-to-antibody ratio) which means more drug is delivered to the cancer cell. This allows for the development of stable and tailored ADCs incorporating a variety of drug payloads at varying levels of potency and different modes-of-action. This will result in cancer therapeutics with significantly better efficacy and safety profiles.

Dr Myriam Ouberai, Chief Executive Officer at Spirea, commented: "We welcome our new investors and thank our existing investors for their continuing confidence in Spirea. With our novel approach to building ADC therapeutics, we aim to radically improve the treatment options for patients with hard-to-treat cancers. Having shown the flexibility and strength of our technology, we look forward to the next exciting stage in the development of Spirea’s ADC pipeline and to building significant strategic partnerships."

Dr Christine Martin, Head of Seed Funds at Cambridge Enterprise, said: "This is an exciting time for Spirea and we are pleased to be supporting them with this further investment. Spirea’s innovative antibody drug conjugate technology is highly differentiated, and we believe it holds great value and potential to lead developments in the field of cancer therapeutics."

Dr Jonathan Milner, Founder of Abcam and CEO of Meltwind Advisory, said: "Spirea has overcome many of the hurdles commonly associated with antibody drug conjugate therapeutics. By developing a highly customisable platform where drug payloads and targets can be altered as needed, the Company is revealing the true potential of ADCs as a cancer cell specific, highly effective therapeutic option for a wide range of cancers."

Spirea, a spin-out from the University of Cambridge, has previously received investment from IP Group, Cambridge Enterprise, Start Codon, Jonathan Milner, o2h Ventures and Syndicate Room, and is supported by a number of successful, high-profile board members from the life sciences.

On June 14, 2022 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Dr. Reddy’s Sorafenib Tablets, USP, 200 mg, a therapeutic generic equivalent of Nexavar (sorafenib) Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUN 14, 2022, View Source [SID1234615972]).

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"We are pleased to launch this important generic product, illustrating our continued commitment to bring affordable generic medicines to market for patients," says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories Inc.

Dr. Reddy’s Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.

Please click here: View Source to see the full prescribing information.

Nexavar is a trademark of Bayer HealthCare Pharmaceuticals Inc.

RDY-0522-415

On June 14, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase biology platform, reported that new findings from its platform will be presented in a poster today at the Keystone Symposia Tissue Fibrosis and Repair: Mechanisms, Human Disease and Therapeutics in Keystone, CO (Press release, aTyr Pharma, JUN 14, 2022, View Source [SID1234615971]).

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The poster presents findings from aTyr’s innovative tRNA synthetase platform, whereby selected fragments of Alanyl-tRNA Synthetase (AARS) and Aspartyl-tRNA Synthetase (DARS) were found to bind to the surface of specific human cell types via novel binding partners. Additionally, the target receptor of the fragment AARS-1 was identified as fibroblast growth factor receptor 4 (FGFR4), indicating that AARS-1 may have therapeutic potential in fibrosis, inflammation and cancer. Moreover, the methods utilized in the study can be further employed to identify and validate new molecular targets from aTyr’s tRNA synthetase platform.

Details of the poster presentation appear below. The poster will be available on the aTyr website once presented.

Title: Identification of key extracellular binding proteins implicate role in inflammation and fibrosis for alanyl- and aspartyl-tRNA synthetases
Authors: Ryan A. Adams, Tarsis F. Brust, Yeeting E. Chong, Ann L. Menefee, Andrew Imfeld, Michaela Ferrer, Zachary Fogassy, Alison G. Barber, Suzanne Paz, Leslie A. Nangle. aTyr Pharma, San Diego.
Poster Number: 2022
Poster Session: Poster Session 2
Date: Tuesday, June 14, 2022

"We are very pleased that our novel approach to drug discovery has yielded the identification of a receptor target for yet another tRNA synthetase from our platform," said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr. "The target receptor identified for the fragment AARS-1, FGFR4, is involved in many cellular processes including cell proliferation, differentiation and tissue repair. FGFR4 is known to play a role in diseases related to inflammation and fibrosis, including conditions where unchecked fibrosis can precede the development of certain cancers. We look forward to further interrogating the interaction between AARS-1 and FGFR4 and the implications for disease in order to explore this synthetase fragment as a potential pipeline candidate.

On June 10, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s lead product candidate, PRP, targets solid tumors, which accounts for 80 – 90% of cancer cases, according to the National Cancer Institute (Press release, Propanc, JUN 14, 2022, View Source [SID1234615970]). Chief Scientific Officer and Co-Founder, Dr Julian Kenyon MD, MB, ChB, is leading research into a novel approach to prevent recurrence and metastasis from solid tumors using pancreatic proenzymes that target and eradicate cancer stem cells (CSCs), which are a small subpopulation of cells within tumors capable of self-renewal, differentiation and tumorigenicity when transplanted into an animal host. CSCs is the mechanism by which cancer is able to return and spread, even post standard treatments.

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Dr Kenyon explains that metastasis occurs because a program inside the cell, called the Epithelial-Mesenchymal Transition (EMT) is activated. The EMT is a biological process associated with wound healing and embryogenesis, but when associated with cancer, causes epithelial (organ originating) cancer cells to become invasive and stem cell like, features which then allow CSCs to spread and metastasize. PRP reverses the transition to a CSC and as such, reduces the metastatic potential of the tumor cells. Furthermore, traditional cancer therapies act on replicating cells, but not CSCs, so they rebuild the tumor mass and can migrate to start a new tumor in another organ. PRP stops CSCs so that a tumor loses the ability to generate new cells and the tumor disappears without the option to form a metastatic tumor elsewhere.

Dr Kenyon believes that PRP will be most effective against tumors which consist of a high percentage of CSCs, therefore less differentiated, more aggressive tumors which spread rapidly and often leads to a poor prognosis for the patient. These tumors are often a largely underserved patient population. Also, the EMT process which leads to cells transitioning to a mesenchymal (skeletal) state, implies that sarcomas, which is a cancer that originates in supportive and connective tissues such as bones, tendons, cartilage, muscle and fat, which are mesenchymal, could also be treated with PRP. Generally occurring in young adults, the most common sarcoma often develops as a painful mass on the bone. Sarcomas are particularly challenging tumors for which there are no effective treatments other than surgery in early stages. According to Dr Kenyon, these highly mesenchymal tumors would be likely to respond to PRP. This would be a breakthrough in the treatment of these types of tumors.

Dr Kenyon said, "Based on the mode of action, PRP targets 80 to 90% of all cancers, which is highly significant. Furthermore, sarcomas are a largely underserved patient treatment population with a poor prognosis for sufferers. I have reviewed early 19th century published clinical cases, when enzyme therapy was first proposed, including a 23 y/o female, with a large fibrosarcoma of the tongue, who was successfully treated, despite 3 unsuccessful surgeries due to recurrence. Over 100 years later, we have been able to elucidate a mechanism of action which explains why, and which tumors to target. Our scientific research over the last 15 years gives me great confidence about the potential of PRP as a breakthrough therapy for the treatment of metastatic cancer, which I believe will be tremendously impactful for humankind."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.