On November 21, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. González Convention Center in San Antonio, Texas from December 6 – 10, 2022 (Press release, Oncolytics Biotech, NOV 21, 2022, View Source [SID1234624267]).

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One poster will feature interim results from a bridging clinical trial being conducted by Oncolytics’ partner, Adlai Nortye, to evaluate pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. The second poster, in collaboration with SOLTI-Innovative Cancer Research, will include data from the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.

Additional details on the upcoming posters and corresponding abstracts are shown below. Full texts of the abstracts are available on the SABCS website here.

Results published in the SABCS abstract indicate that pelareorep in combination with paclitaxel was safe, well tolerated, and showed anti-tumor activity in Adlai Nortye’s single-arm bridging clinical trial in Chinese patients with advanced or metastatic HR+/HER2- breast cancer. As of the abstract’s data cut-off date (June 2, 2022), ten patients had been treated in the trial, with four achieving a partial response (two confirmed, two unconfirmed) and five showing stable disease (SD). Eight of the nine patients achieving a partial response (PR) or SD remained on study and continued to receive treatment as of the cut-off date. Updated and additional data from the trial will be presented in the poster corresponding to the abstract in accordance with the SABCS embargo policies.

The bridging trial is designed to accelerate Adlai Nortye’s development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics’ North American metastatic breast cancer trials, IND-213 and BRACELET-1. Results from IND-213 showed a statistically significant near doubling of median overall survival in HR+/HER2- breast cancer patients treated with pelareorep plus paclitaxel compared to those treated with paclitaxel monotherapy. BRACELET-1 remains ongoing, with a readout on overall response rate, progression-free survival, and evolving overall survival data from the randomized phase 2 trial expected in the first half of 2023.

Described in this abstract are the results of gene expression analyses from cohorts 1 and 2 of AWARE-1, a collaborative window-of-opportunity study in patients with early-stage breast cancer that was conducted by Oncolytics Biotech and SOLTI-Innovative Cancer Research. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with the HR+/HER2- breast cancer subtype who were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 checkpoint inhibitor atezolizumab. Results published in the abstract showed that the studied combinations altered tumor microenvironments to induce and enhance anti-tumor immunity. Additional details on the analyses and results described in the abstract will be provided during the SABCS poster presentation in accordance with symposium embargo policies.

About Adlai Nortye
Adlai Nortye is a clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies, with its R&D centers in both China and the U.S. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with seven drug candidates in development, including (i) Buparlisib (AN2025), which was in a global Phase III clinical trial in combination with paclitaxel for the treatment of patients with recurrent or metastatic HNSCC after anti-PD-1 treatment; (ii) Palupiprant (AN0025), an oral EP4 antagonist which is undergoing Phase Ib trial in combination with Keytruda in patients with multiple solid tumors; and (iii) AN4005, an oral small molecule PD-L1 inhibitor which was currently in Phase Ia trial. Adlai Nortye is also conducting a Phase I clinical trial in collaboration with Roche to evaluate the triple combination of AN2025, AN0025 and atezolizumab (PD-L1 inhibitor) for a variety of PIK3CA mutant solid tumors in the U.S. In addition, Adlai Nortye owns the exclusive rights to Pelareorep (AN1004) in greater China, Singapore, and South Korea, and is conducting a bridging trial in China to assess the safety and tolerability of AN1004 in combination with paclitaxel for the Chinese patient population with metastatic HR+/HER2- breast cancer.

Adlai Nortye has assembled an experienced management team, built its proprietary immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: www.adlainortye.com.

About AWARE-1
AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

On November 21, 2022 Vivesto AB ("Vivesto" or the "Company") reported that the Board of Directors of the Company has appointed Erik Kinnman as CEO of the Company (Press release, Vivesto, NOV 21, 2022, View Source [SID1234624266]). Erik Kinnman will assume the position as CEO no later than 20 May 2023.

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Erik Kinnman is a physician, Ph.D., with specialist training in neurology and pain management, a Doctor of Medicine and an associate professor at Karolinska Institutet, and holds an Executive MBA from the Stockholm School of Economics. Erik has 25 years of experience from senior positions within Life Science and is currently a Board member of Stayble Therapeutics and Immune System Regulation and the CEO of Sprint Bioscience. He has previously been the CEO of Abliva AB (formerly Neurovive) and has held senior positions at AstraZeneca and Sobi, among others, and worked as a financial analyst at Danske Bank. Erik does not own any shares or share-related instruments in Vivesto.

Peter Zonabend, Chairman of the Board of Vivesto, says: "Erik has a robust industry experience and high academic competence. Erik has also, for many years held senior positions in listed Life Science companies, which has given him the expertise to lead Vivesto. The Board is therefore very pleased that Erik is joining us, and we look forward to the future with confidence."

On November 21, 2022 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy (Press release, AbbVie, NOV 21, 2022, View Source [SID1234624265]).

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The application is supported by previously announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-center Phase 1/2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL).

"We are committed to the research and development of innovative therapies to provide important treatment options for people living with blood cancer such as large B-cell lymphoma, which has limited treatment options in the relapsed/refractory setting," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. "This milestone signals an early step in our hope to develop a core therapy for people living with B-cell malignancies."

Additionally, the European Medicines Agency recently validated a Marketing Authorization Application for epcoritamab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – a major subtype of LBCL – after two or more lines of systemic therapy.

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes an ongoing Phase 3, open-label, randomized clinical trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL (NCT: 04628494) and a Phase 3, open-label clinical trial evaluating epcoritamab in combination in patients with relapsed/refractory follicular lymphoma (NCT: 05409066).

About Large B-Cell Lymphoma (LBCL)
LBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell.1 There are an estimated 150,000 new LBCL cases each year globally.1 LBCL includes DLBCL, which is the most common type of NHL worldwide and accounts for approximately 30 percent of all NHL cases.1

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab including a Phase 1 first-in-human, dose escalation part; a Phase 2 expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including LBCL and DLBCL. Data from the dose escalation part of the study, which determined the recommended Phase 2 dose, were published in The Lancet in 2021. In the Phase 2 expansion part, additional patients are treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-cell NHLs who had limited therapeutic options.

The primary endpoint of the Phase 2 expansion part was overall response rate as assessed by an Independent Review Committee. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T-cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells, and induces T-cell mediated killing of CD20+ cells.2 CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.3,4 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit View Source and our Blood Cancer Press Kit page.

On November 21, 2022 Chimeric Therapeutics (ASX: CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, reported that it has entered into an exclusive license agreement with Case Western Reserve University (CWRU) for the CORE-NK platform, invented by Dr David Wald (Press release, Chimeric Therapeutics, NOV 21, 2022, View Source [SID1234624264]).

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The CORE-NK platform uses a novel, proprietary genetically-modified feeder cell line to activate and expand universal off-the-shelf allogeneic NK cell products derived from healthy donors. The expanded CORE-NK cells exhibit enhanced cytotoxicity, metabolism, and expression of activating receptors compared to fresh, activated NK cells.

Under the agreement, Chimeric gains exclusive global rights to the CORE-NK platform for oncology, where Chimeric and CWRU are currently advancing multiple product candidates in Dr Wald’s laboratory under the recently announced Sponsored Research Agreement. Chimeric also receives exclusive global rights to the CORE-NK platform for immune disorders and viral infectious diseases.

"We are excited to continue building on our collaboration with CWRU with the definitive license agreement for the CORE-NK platform," said Jennifer Chow, CEO and Managing Director of Chimeric. "This transaction builds significant value for Chimeric, first by bringing a highly promising and clinically de-risked asset with CHM 0201 fully into our portfolio, and second by establishing the foundation for a suite of next-generation genetically modified NK cell products."

Chimeric’s NK cell therapy portfolio foundational asset, CHM 0201 was studied in a phase 1 clinical trial at University Hospitals Seidman Cancer Center in Ohio. Clinical results published earlier this year in the journal Transplantation and Cellular Therapy demonstrated safety with no GvHD (Graft versus host disease), NK cell persistence for at least 28 days, and encouraging For personal use only early activity signals, particularly in blood cancers where all patients achieved disease control and one patient achieved a complete response that was sustained for over 15 months at time of study publication.

Chimeric’s exclusive global license from CWRU covers patent rights, knowhow, and biological materials for the NKF feeder cell line and CORE-NK manufacturing process in the fields of use, including access to regulatory documents for the first-in-human Phase 1 trial of CHM 0201. Upfront fees associated with the license agreement will be funded entirely from existing cash reserves. The agreement also includes industry standard development milestones, patent costs, maintenance fees, and royalties on commercial net sales.

Dr Wald is an Associate Professor, Department of Pathology, School of Medicine, CWRU, a member of the Immune Oncology Program, Case Comprehensive Cancer Center, and the Associate Director for Basic Research, University Hospitals, Wesley Center for Immunotherapy.

Chimeric previously announced its exclusive option agreement with CWRU in November 2021 and exercise of the exclusive option in May 2022.

On November 21, 2022 Cambrex, a leading global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services across the entire drug lifecycle, reported that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers (Press release, Cambrex, NOV 21, 2022, View Source [SID1234624263]).

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Snapdragon specializes in active pharmaceutical ingredient (API) batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon’s 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff.

"The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility," said Tom Loewald, CEO of Cambrex. "With R&D and manufacturing capabilities in the heart of Boston’s biopharma hub, Snapdragon will continue to focus on solving their customers’ most difficult process development challenges."

"We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex’s larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers."

Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company’s capacity for supplying clinical intermediates and drug substances.

The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex’s second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing.