POINT Biopharma and Athebio Announce Partnership to Develop Designed Ankyrin Repeat Protein Targeted Radioligands

On September 18, 2023 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and Athebio AG ("Athebio"), an innovation leader in the discovery and design of designed ankyrin repeat proteins (DARPins), reported a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands ("Radio-DARPins") (Press release, Point Biopharma, SEP 18, 2023, View Source [SID1234635217]).

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!

DARPins are an attractive ligand class for cell-surface targets that could enable access to cell "surfaceome" targets beyond catalytic and ligand binding sites typically accessible to small molecules and peptides. DARPins combine the small molecule feature of rapid tumor penetration and clearance from the body, with the antibody-like ability of binding to a wider range of proteins and other cell surface targets. Their well-behaved and customizable formatting options, including stability at high concentrations and temperatures, are expected to facilitate rapid discovery, validation, and commercial scale manufacturing applicable to fast (212Pb) and slower (177Lu, 225Ac) decaying isotopes.

The collaboration gives POINT exclusive access to Athebio’s intellectual property and capabilities in DARPin development in the radioligand therapy field. Together, the parties will collaborate in discovery, candidate selection and preclinical development of Athebody DARPins for use as Radio-DARPin drug entities. POINT will be solely responsible for the clinical development and commercialization of Radio-DARPins translated from the discovery collaboration.

"The holy grail of radioligand development is the ability to engineer ligands that can precisely deliver radiation and also have physical properties that are resistant to radiolytic damage, enabling them to be manufactured at scale," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "DARPins represent a potential goldilocks opportunity in this regard, and could unlock new cell surface targets creating a new horizon for the development of novel targeted radioligand therapies. I am excited by this collaboration with Athebio, experts in DARPin technology, as it further expands our library of tools to engineer next-generation radioligands."

"We are very excited to join forces with POINT. POINT is uniquely positioned in the radiotherapy field and just as committed as we are to unlock the full potential of Athebody DARPins to develop radiopharmaceuticals for patients in need," said Patrik Forrer, one of the inventors of the DARPin technology and CEO and Chairman of Athebio. "The exceptional properties of our Athebody DARPins make them ideally suited for targeting radioisotopes. In particular their high stability should allow for simple conjugation to radioisotopes and their small size and high affinity binding with precise specificity should allow for superior targeting of tumors. The convergence of these attributes holds immense promise for pushing the boundaries of radiotherapy."

Terms were not disclosed.

Shifting the balance in cytokine therapeutics

On September 18, 2023 Werewolf therapeutics presented its corporate presentation (Presentation, Werewolf Therapeutics, SEP 18, 2023, View Source [SID1234635214]).

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!


TRACON Pharmaceuticals Announces ENVASARC Phase 2 Pivotal Trial Exceeded Futility Threshold at Final Interim Analysis and Will Continue as Planned

On September 18, 2023 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that the ENVASARC Phase 2 pivotal trial more than satisfied the futility threshold of 3 responses out of 46 based on the results of the second and final mandated independent data monitoring committee (IDMC) efficacy review, and the trial will continue as planned (Press release, Tracon Pharmaceuticals, SEP 18, 2023, View Source [SID1234635213]).

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!

The IDMC reviewed interim safety and efficacy data from 46 patients enrolled into cohort C of treatment with single agent envafolimab who completed two on-treatment scans (a minimum of 12 weeks of efficacy evaluations). The objective response rate (ORR) in the initial 46 patients treated with single agent envafolimab was 13% by investigator review and 8.7% by blinded independent central review (BICR). The ORR assessed by BICR, all of which were confirmed responses, more than satisfied the prespecified futility rule and envafolimab monotherapy was generally well tolerated. Median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint.

"Envafolimab continues to demonstrate durable single agent activity and has been generally well tolerated," said James Freddo, M.D., TRACON’s Chief Medical Officer. "Our goal is the demonstration of nine objective responses by BICR in the 80 patient cohort of single agent envafolimab treatment."

"We continue to believe that these data position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS based on the ORR and tolerability data to date," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer.

The trial has enrolled more than 60 of the planned 80 patients and full accrual of the ENVASARC pivotal trial is expected in the fourth quarter of this year with final data anticipated in mid-2024.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. ENVASARC is enrolling patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

SELLAS Life Sciences to Participate in the Cantor Fitzgerald Global Healthcare Conference

On September 18, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, and members of the SELLAS management team will participate in a panel presentation and one-on-one investor meetings at the Cantor Fitzgerald Global Healthcare Conference, taking place in New York, NY, from September 26-28, 2023 (Press release, Sellas Life Sciences, SEP 18, 2023, View Source [SID1234635211]).

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!

Format: Panel presentation and one-on-one investor meetings
Date: Wednesday, September 27, 2023
Time: 9:10 a.m. EDT

For more information about the conference, please refer to the conference website or contact your Cantor Fitzgerald representative directly.

NuCana Announces Presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023

On September 18, 2023 NuCana plc (NASDAQ: NCNA) reported four presentations at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2023 being held October 11-15, 2023 in Boston, Massachusetts (Press release, Nucana BioPharmaceuticals, SEP 18, 2023, View Source [SID1234635209]).

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!

The details of NuCana’s presentations at the meeting are as follows:

Abstract title: NUC-3373 in combination with irinotecan (NUFIRI) or oxaliplatin (NUFOX) and bevacizumab for second-line treatment of patients with advanced colorectal cancer (NuTide:302)
Poster number: B048
Session: Poster Session B
Session date and time: Friday, October 13 from 12:30pm-4:00pm
Presenting Author: Dr. Khurum Khan

Abstract title: Phase II study of NUC-3373, leucovorin, irinotecan (NUFIRI) + bevacizumab vs FOLFIRI + bevacizumab for the second-line treatment of patients with advanced/metastatic colorectal cancer (NuTide:323)
Poster number: B049
Session: Poster Session B
Date and time: Friday, October 13 from 12:30pm-4:00pm
Presenting Author: Professor Richard Wilson

Abstract title: Phase Ib/II open label, multi-arm, parallel cohort dose finding and expansion study of NUC-3373 in combination with pembrolizumab in patients with advanced solid tumors or docetaxel in patients with lung cancer (NuTide:303)
Poster number: C029
Session: Poster Session C
Session date and time: Saturday, October 14 from 12:30pm-4:00pm
Presenting Author: Professor Richard Wilson

Abstract title: NUC-7738 in combination with pembrolizumab in patients with metastatic melanoma: Phase 2 results from the NuTide:701 study
Poster number: C032
Session: Poster Session C
Session date and time: Saturday, October 14 from 12:30pm-4:00pm
Presenting Author: Professor Sarah Blagden