On January 8, 2020 KDx Diagnostics, Inc. (KDx), reported that the Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its URO17 Bladder Cancer Recurrence Test (Press release, KDx Diagnostics, JAN 8, 2020, View Source [SID1234552887]). This revolutionary new test exploits a novel cancer marker that could dramatically improve the accuracy and sensitivity of non-invasive bladder cancer testing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bladder cancer is the 6th most common cancer in the US, and 81,000 people are newly diagnosed with the disease annually. Moreover, bladder cancer has a relatively high recurrence rate and is one of the most expensive patients to treat, in part because patients must be regularly monitored for recurrence.

KDx has published data (Babu et al., 2018) showing the URO17 test exhibited 100% sensitivity and 96% specificity in detecting recurrent bladder cancer from urine samples. While this was an initial study, these rates are among the best ever reported for a non-invasive test.

"The FDA’s designation of Breakthrough Device for our URO17 test validates our excitement about the potential of our test to improve bladder cancer treatment with attendant major impact in the marketplace for bladder cancer diagnostics. Breakthrough Device designation significantly enhances our ability to conduct the necessary clinical trials for approval and expedites the review process. We look forward to working closely with the FDA during this next exciting phase of product development," said Nam W. Kim, Ph.D., KDx’ Co-Founder and CEO.

On January 8, 2020 Nurix Therapeutics, Inc., a company developing targeted protein modulation drugs reported that CEO Arthur Sands will present at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 8:30 a.m. PST in San Francisco (Press release, Nurix Therapeutics, JAN 8, 2020, View Source [SID1234552853]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 8, 2020 Veracyte (Nasdaq: VCYT) reported a multi-year partnership with Acerta Pharma, the hematology research and development arm of AstraZeneca (LSE/STO/NYSE: AZN), to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics (Press release, Veracyte, JAN 8, 2020, View Source [SID1234552870]). Financial and other terms of the collaboration were not disclosed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to partner with Acerta Pharma and AstraZeneca, global leaders whose innovative medicines are benefitting millions of patients worldwide"

The agreement marks Veracyte’s first biopharmaceutical partnership since the company announced its acquisition of the exclusive diagnostics rights to the NanoString nCounter platform and genomic tests in breast cancer and lymphoma on December 3, 2019. That transaction positions Veracyte to expand globally using a distributed platform and comprehensive menu of advanced genomic tests.

"We are excited to partner with Acerta Pharma and AstraZeneca, global leaders whose innovative medicines are benefitting millions of patients worldwide," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "This collaboration reflects the significant value we can bring to biopharmaceutical companies through our expanding global footprint, as well as our ability to potentially inform diagnosis and treatment decisions in new oncology indications."

On January 8, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses and cancer vaccines to target hard-to-treat solid tumors, reported that it has entered into an exclusive option agreement with IOVaxis Therapeutics of Nantong, China, for clinical development and licensing of the Targovax mutant RAS vaccines TG01 and TG02 in China, Hong Kong, Macau and Singapore (Press release, Targovax, JAN 8, 2020, View Source [SID1234552888]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IOVaxis, a spin-off from ImmuOn Therapeutics, has secured an exclusive option to develop and license the TG01 and TG02 mutant RAS neoantigen vaccines in the above mentioned territories. The option can be exercised into an exclusive license by the earlier of i) the first regulatory approval to start a clinical trial in the territory, or ii) one year from the effective date of the Option Agreement. IOVaxis will pay Targovax USD 250.000 for this exclusive option. The milestone payment for the exercise of the option to license TG01/02 is USD 3 million.

Under the Option Agreement, IOVaxis and Targovax will jointly define a development plan in the territory, and IOVaxis will be responsible for all local regulatory filings and be the sponsor of clinical trials. The full License Agreement remains to be finalized, but the parties have pre-agreed the key commercial and operational terms in the Option Agreement. If exercised, the total potential development and commercial milestones for the TG01/02 license may reach up to USD 100 million, plus tiered royalties on net sales up to mid double digits.

On January 8, 2020 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, and Daewoong Pharmaceutical Co. Ltd., (KSX: 069620), a leading Korean pharmaceutical company, reported that they have agreed to establish a joint venture in South Korea, and to enter a collaboration and license agreement for the joint venture to develop the next generation of cell and gene therapies incorporating Affimer proteins to enhance the immune-modulatory effects (Press release, Avacta, JAN 8, 2020, View Source [SID1234612389]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mesenchymal stem cells (MSCs) are promising agents for the treatment of autoimmune and inflammatory diseases. The joint venture will develop a new class of MSCs that are primed to produce Affimer proteins, which are designed to enhance the immune-modulatory effect when administered to patients, by reducing inflammatory or autoimmune responses.

Daewoong will provide the joint venture with access to its proprietary technology for generating allogeneic MSCs from a single donor to treat a large number of patients. This proprietary technology facilitates developing cell therapies as "off-the-shelf" products.

Avacta will develop Affimer proteins against several undisclosed targets which will be transferred to the joint venture to be incorporated into MSCs. The resulting engineered MSCs will have broad ranging therapeutic utility, depending on the Affimer proteins’ intended therapeutic purposes.

Avacta’s research and development costs will be fully covered by the joint venture and Avacta retains the rights to commercialise the Affimer proteins outside of the field of cell therapies. Avacta’s shareholding in the joint venture is 45% with Daewoong holding 55%, and the joint venture will be operationally managed by Seng-ho Jeon, CEO of Daewoong, with a Board composed of representatives of both Avacta (Alastair Smith, CEO and Matthew Vincent, VP Business Development and Strategy) and Daewoong.

"Our partnership reinforces the shared vision of both companies to design the next level of treatment paradigm, and to open up a new horizon in immunotherapeutic strategies", said Seng-ho Jeon. "This innovative collaboration will deliver invaluable synergy and lead to new solutions with the potential to transform patients’ lives."

"We are very excited to establish the joint venture with Daewoong, a world-class partner, combining our powerful Affimer platform with MSCs to develop breakthrough medicines targeting immune-mediated diseases", said Dr Alastair Smith, CEO of Avacta. "Affimer proteins have the potential to selectively modulate signalling pathways in inflammatory diseases in order to reduce the aberrant immune response occurring in those tissues, as well as positively impacting tissue regenerative pathways meant to repair and restore normal function to the affected tissues. We look forward to working closely with the Daewoong team to advance these promising therapeutics, and get them to the patients who need them."