On January 5, 2022 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs and AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company ("AVEO") , reported that they have entered into a clinical trial collaboration and supply agreement to evaluate NKT2152, NiKang’s small molecule that inhibits hypoxia inducible factor 2α (HIF2α), in combination with FOTIVDA (tivozanib), AVEO’s oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), which is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies (Press release, AVEO, JAN 5, 2022, View Source [SID1234598202]). The phase 2 clinical trial will evaluate the safety and efficacy of the combination of NKT2152 and tivozanib in clear cell RCC (ccRCC) patients who have not responded to or relapsed from prior therapies (R/R RCC). Under the terms of the agreement, NiKang will sponsor the trial and AVEO will co- fund the trial. Both companies will provide its respective drugs at no cost. The two companies will form a Joint Development Committee to oversee this collaboration.

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!

"Preclinical and early clinical data have demonstrated enhanced anti-tumor activity by the combination of HIF2α and VEGFR inhibition. Given tivozanib’s established excellent clinical profile, we are excited to work with AVEO to explore such opportunity," said Zhenhai Gao, Ph.D., Co-founder, President and Chief Executive Officer of NiKang. "We look forward to collaborating with our partners to further advance NKT2152 into its next stage of development as part of our combination strategy. This clinical collaboration with AVEO is an excellent example of pooling expertise and resources together to maximize the potential of both NKT2152 and tivozanib in helping R/R ccRCC patients."

"This collaboration with NiKang, will play an important role in the advancement of both the tivozanib and NKT2152 programs," said Michael Bailey, President and Chief Executive Officer of AVEO. "The tivozanib and NKT2152 combination will build on the activity seen with VEGFR TKIs and HIF2α agents in ccRCC. We believe the best-in-class qualities of these two compounds provide a unique combination of efficacy and tolerability for patients with R/R ccRCC as a doublet or, potentially in the future, as part of a triple combination."

The phase 2 clinical trial is expected to commence in 2022.

About NKT2152

NKT2152 is a small molecule that inhibits HIF2α. It is currently in a phase 1/2 dose escalation and expansion trial (NCT05119335). This trial is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in patients with advanced ccRCC. Once an appropriate dose is identified, combination studies including NKT2152 will commence.

On January 5, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported its participation in upcoming investor and healthcare conferences to be held in January 2022 (Press release, Genprex, JAN 5, 2022, https://www.genprex.com/news/genprex-to-participate-in-january-investor-and-healthcare-conferences-to-highlight-companys-gene-therapies-in-cancer-and-diabetes/ [SID1234598219]). Genprex’s President and Chief Executive Officer, Rodney Varner, and the Company’s Chief Medical Officer, Mark Berger, MD will lead the Company’s presentations.

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!

Details on Genprex’s participation in January conferences include:

Event: HC Wainwright BIOCONNECT 2022 Virtual Conference

Conference Dates: January 10-13, 2022

Presentation Time: Available on-demand beginning January 10 at 7 a.m. EST

Presenters: Rodney Varner, President and Chief Executive Officer and Mark Berger, MD, Chief Medical Officer

Conference Registration: https://bit.ly/3lMBq6G

Webcast Link: https://bit.ly/3q5EewX

Event: Biotech Showcase 2022

Conference Dates: January 10-13, 2022

Presentation Time: Available on-demand beginning January 10

Presenter: Rodney Varner, President and Chief Executive Officer

Conference Registration: https://bit.ly/3y80EB5

Event: Precision: Lung Cancer World R&D Virtual Summit

Conference Dates: January 25-26

Presentation Date: Tuesday, January 25

Presenters: Mark Berger, MD, Chief Medical Officer

Conference Registration: https://bit.ly/3pxW1wg

Event: CEO Roadshow

Presentation Date: Wednesday, January 26

Presentation Time: 11 a.m. EST

Presenters: Rodney Varner, President and Chief Executive Officer

Location: Virtual Webinar

Conference Registration: https://bit.ly/3IxMrSY

At these virtual events, Mr. Varner and Dr. Berger will either be available to participate in virtual one-on-one meetings with registered participants or will be available for questions following the Company presentation. If available, a recording of these presentations will be available for replay on Genprex’s website for a period of time.

On January 5, 2022 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal") and Saol Therapeutics, a private specialty pharmaceutical company ("Saol"), reported a definitive agreement under which Amneal will acquire Saol’s Baclofen franchise, including Lioresal and LYVISPAHTM as well as a pipeline product under development (Press release, Amneal Pharmaceuticals, JAN 5, 2022, View Source [SID1234598270]). The acquisition expands Amneal’s commercial institutional and specialty portfolio in neurology while adding commercial infrastructure in advance of its entry into the biosimilar institutional market. The transaction is expected to be accretive to Amneal’s adjusted EBITDA and adjusted earnings per share results for 2022.

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!

Lioresal is an intrathecal baclofen product delivered through an implantable intrathecal pump for use in the management of severe spasticity of cerebral or spinal origin for the institutional market. It has approximately $25 million in annual net revenue. LYVISPAHTM is a baclofen oral granules (5, 10 and 20 mg) specialty product recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of spasticity. The product is expected to launch in 2022 leveraging Amneal’s neurology commercial team. Together, Amneal expects these two products to generate between $40 and $50 million in combined annual net revenues by 2025.

As part of the transaction, Amneal is adding Saol’s experienced institutional commercial team for Lioresal that can be utilized to support future product launches, including three oncology biosimilar products, filgrastim (biosimilar for Neupogen), pegfilgrastim (biosimilar for Neulasta) and bevacizumab (biosimilar for Avastin). Amneal expects to launch all three biosimilars in 2022, subject to approval by FDA.

"This acquisition is highly aligned with Amneal’s long-term growth strategy adding to our specialty and biosimilars businesses. In specialty, we see LYVISPAHTM fitting well with our neurology portfolio and pipeline. In addition, Lioresal is a durable product with a long-established presence in the institutional market that we look to leverage as we prepare to commercialize our biosimilars in 2022 and beyond," said Chirag and Chintu Patel, Co-Chief Executive Officers.

"For over 5 years, the Saol team has worked to reinvigorate the Lioresal brand and develop new treatment options, like LYVISPAHTM, for patients struggling with spasticity. We are excited to see these products find their new home at Amneal along with many of our team members that have been critical to our success," said David Penake, CEO of Saol Therapeutics.

Baclofen is a skeletal muscle relaxant used to treat muscle spasms caused by spinal cord injury, multiple sclerosis, and other conditions. It was first approved by the FDA in 1977. Important Safety Information includes a boxed warning on abrupt discontinuation, which can result in sequalae and in rare cases, has advanced to multiple organ-system failure and death. Reported adverse drug reaction includes convulsion, hypotension, hypotonia, somnolence, dizziness, nausea and headache. Animal data indicates it may cause fetal harm.

See Package Insert (PI) for full prescribing information including boxed warning and complete safety information:

Lioresal: View Source

LYVISPAHTM: View Source

Terms of the Transaction

Under the terms of the transaction, Amneal will pay approximately $83.5 million of cash at close, and certain royalties (low double-digits) based on annual net sales for certain acquired products. The transaction will be financed with cash on hand and is expected to close in the first quarter of 2022, subject to the satisfaction of customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.

Advisors

Morgan Lewis & Bockius LLP served as legal counsel to Amneal. SVB Leerink served as exclusive financial advisor and Mayer Brown LLP served as legal counsel to Saol Therapeutics.

On January 5, 2022 Adlai Nortye Ltd. ("Adlai Nortye"), a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, reported that the first patient was dosed in the Phase I clinical trial in the U.S. to evaluate the safety, tolerability, PK and preliminary efficacy of the orally available, small-molecule PD-L1 inhibitor AN4005 in patients with advanced tumors (Press release, Adlai Nortye Biopharma, JAN 5, 2022, View Source [SID1234598290]).

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!

"Adlai Nortye aspires to develop differentiated cancer immunotherapy medicines for global markets. The Company’s "cocktail" therapy strategy represents the third wave of immuno-oncology therapy, featuring the combination of an immune checkpoint inhibitor with two or more additional cancer therapies. The Company expects it to achieve synergistic and calibrated anti-cancer effects with a significant higher overall response rates than present combination therapies. As a potential first-in-class, orally available, small-molecule PD-L1 inhibitor, AN4005 has exhibited excellent in vitro and in vivo activities, favorable safety profile, as well as the ability to promote adaptive immune response for antitumor efficacy in preclinical studies, and the Company believes that it has the potential to serve as a backbone drug in the emerging next wave of cocktail immuno-oncology therapies, opening a new avenue for tumor immunotherapy based on the PD-1/PD-L1 signaling pathway," said Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye, and Chief Executive Officer of Adlai Nortye USA.

About AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction. In nonclinical studies, AN4005 has demonstrated significant pharmacological activity, target engagement and acceptable safety profiles, which support the clinical development as a potential therapy for advanced malignancies. In pharmacology studies, AN4005 was shown to functionally overcome the inhibition derived from PD-1/L1 interaction in reporter- and human PBMC (hPBMC)-based cellular assays. Small molecule PD-(L)1 inhibitors are expected to provide several benefits over mAbs, such as, allowing for oral administration, lower production costs, improved tumor penetration, and lack of immunogenicity.

On January 5, 2022 Shattuck Labs, Inc. (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported that company management will participate in two virtual investor conferences in January 2022 (Press release, Shattuck Labs, JAN 5, 2022, View Source [SID1234598308]).

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!

Presentation Details

Conference: H.C. Wainwright BioConnect 2022 Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: January 10, 2022
Time: 7:00 a.m. EST

Conference: 40th Annual J.P. Morgan Healthcare Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: January 13, 2022
Time: 11:15 a.m. EST

A live webcast of both presentations will be available on the Events & Presentations section of the Company’s website. A replay of the webcasts will be archived for up to 90 days following the presentation date.