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.

On November 21, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that VIRALEZE nasal spray has now launched online in Hong Kong and Macau, with launch in leading pharmacies to occur this week (Press release, Starpharma, NOV 21, 2022, View Source;mc_cid=d97ae29cc2&mc_eid=bf52dd3418 [SID1234624261]). This announcement follows the recently signed distribution agreement with Hengan Pharmacare Company Limited, a subsidiary of Hengan Group (HKSE:1044.HK) (see company announcement dated 21 October 2022).

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For the Hong Kong and Macau markets, VIRALEZE will carry Hengan’s local brand which is also used for their COVID-19 related products, such as face masks and rapid antigen tests. The product will be supported with extensive traditional and digital marketing activities by Hengan Group.

Hengan Pharmacare Company Limited Managing Director Ms. Wong Pui Wai, Nancy commented, "We are excited to launch VIRALEZE in Hong Kong and Macau, bringing this innovative product to consumers."

Dr Jackie Fairley, Starpharma CEO, said "We are delighted to see our new partner, Hengan Group, launch VIRALEZE in Hong Kong and Macau so quickly and through leading pharmacies and online channels."

On November 21, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product for identification and treatment of metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Clarity Pharmaceuticals, NOV 21, 2022, View Source [SID1234624260]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "This trial with SAR-Bombesin marks our third therapy program, and sixth program overall, in the Targeted Copper Theranostic pipeline that is progressing through clinical trials in the US. Receiving clearance from the FDA is yet another significant milestone for the Company as it continues to showcase the capabilities of Clarity’s small but high performing team in developing next-generation theranostics from the benchtop, through preclinical studies and into clinical trials in the largest pharmaceutical market in the world. This is Clarity’s fifth IND, highlighting our strategy of developing radiopharmaceuticals for the very large US market."

This IND gives Clarity clearance to proceed with a US-based Phase I/IIa 64Cu/67Cu SAR-Bombesin theranostic trial for identification and treatment of mCRPC that is expressing the Gastrin-Releasing Peptide receptor (GRPr).

COMBAT (Copper-67 SAR Bombesin in metastatic castrate resistant prostate cancer) is a dose escalation study with a cohort expansion. The aim for the study is to determine the safety and efficacy of 67Cu-SAR-Bombesin in participants with GRPr-expressing mCRPC in patients who are ineligible for therapy with 177Lu-PSMA-617.

Approximately 25% of mCRPC patients have low or no uptake of a PSMA-targeting tracer.1 These patients are therefore unlikely to show uptake of PSMA-targeted products, such as 68Ga-PSMA-11 for imaging or 177Lu-PSMA-617 for therapy, and currently have few radiopharmaceutical treatment options available to them. Given prostate cancer is one of the largest indications in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product targets the GRP receptor found on prostate and many other cancers. As such, the SAR-Bombesin could offer valuable imaging and therapeutic options for not only PSMA negative patients, but also the large number of patients that have the target receptor on their cancers.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We look forward to further progressing the development of SAR-Bombesin as a theranostic under this trial, as well as a stand-alone diagnostic agent under the SABRE and BOP clinical trials that are currently progressing in the US and Australia respectively. The diagnostic SAR-Bombesin product has already shown utility in improving the management of disease for PSMA-negative prostate cancer patients and, given the mounting clinical and preclinical data to date, we believe that it has potential to provide this large patient population with more accurate and precise detection and treatment of disease. SAR-Bombesin is a pan-cancer product, and the open IND offers exciting opportunities for exploring new theranostic indications with this versatile product as Clarity pursues our ultimate goal of improving treatment outcomes for children and adults with cancer."

Clarity’s Prostate Cancer clinical trial program overview

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)2-6. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide7. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease8.