On April 13, 2022 Turning Point Therapeutics, Inc. Presented the Corporate Presentation (Presentation, Turning Point Therapeutics, APR 13, 2022, View Source [SID1234612152]).

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On April 13, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Cancer Research UK recently completed patient enrollment in the ongoing Phase 1 clinical trial of VAC2, an allogeneic cancer vaccine product candidate, for the treatment of non-small cell lung cancer ("NSCLC") (Press release, Lineage Cell Therapeutics, APR 13, 2022, View Source [SID1234612151]). Under the terms of an existing agreement, Cancer Research UK will complete the ongoing clinical trial and Lineage has now assumed responsibility for further clinical development of the VAC2 product candidate and any future development opportunities derived from the VAC platform.

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"We are pleased that Cancer Research UK has successfully completed patient enrollment in the VAC2 Phase 1 clinical study and overcame substantial challenges stemming from the COVID pandemic. We look forward to initial clinical results from this study being available later this year," stated Brian M. Culley, Lineage CEO. "Clinical data previously collected by Cancer Research UK demonstrated peripheral immunogenicity in patients with NSCLC treated with VAC2, providing support to the underlying mechanism of using allogeneic dendritic cells to present tumor-associated antigens to the body’s immune system. Simultaneous with Cancer Research UK efforts to complete enrollment in the current study, the focus at Lineage has been on making improvements and modernizations to the VAC manufacturing process, an approach which we similarly employed in the development of OpRegen. We believe our focus on manufacturing will help prepare VAC2 for additional clinical trials and provide a competitive advantage for any future VAC programs which we advance, either alone or through alliances. With Cancer Research UK having completed enrollment of the current study, the team at Lineage also has begun work towards the submission of an Investigational New Drug Application for clinical testing of VAC2 in the U.S., which we anticipate submitting to the FDA later this year."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, added: "We are delighted to see that this innovative VAC2 program has reached such an important milestone in its development and are extremely proud to have played an important role in establishing its tolerability in lung cancer patients. We look forward to seeing Lineage advance VAC2 under their leadership in the future."

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that could be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with NSCLC in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

On April 13, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Wednesday, May 4, 2022, at 8:00 a.m. CDT to review third quarter fiscal 2022 financial results (Press release, Bio-Techne, APR 13, 2022, https://investors.bio-techne.com/news/detail/299/bio-techne-to-host-conference-call-on-may-4-2022-to-announce-third-quarter-2022-financial-results [SID1234612150]).

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A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13728915.

The replay will be available from 11:00 a.m. CDT on Wednesday, May 4, 2022, until 11:00 p.m. CDT on Saturday, June 4, 2022.

On April 13, 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the preclinical data of multi-specific antibody CS2006/NM21-1480 has been presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, CStone Pharmaceauticals, APR 13, 2022, View Source [SID1234612149]).

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Session: PO.IM02.09 – Therapeutic Antibodies 1
Date: April 12, 2022, 9:00 AM – 12:30 PM ET
Format: E-posters
Title: 2870/13-Dose selection investigations and combination strategies of NM21-1480, a PD-L1/4-1BB/HSA trispecific MATCH3 therapeutic clinical candidate
Presenter: Dr. Dan Snell

CS2006/NM21-1480 is a monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin (HSA). CS2006/NM21-1480 represents a leading class of broadly acting next-generation anti-PD-1/PD-L1 cancer immunotherapies and a new backbone molecule for tumor-specific combination therapies. CS2006/NM21-1480 is designed to bind to the immune co-stimulatory receptor 4-1BB and conditionally activate T cells only when engaging and blocking the checkpoint receptor ligand PD-L1 on the surface of tumor cells, potentially preventing the liver toxicities observed with previous anti-4-1BB agonistic antibodies.

Compared to other PD-L1/4-1BB bispecific antibody candidates, CS2006/NM21-1480’s unique monovalent structure and ultra-high-affinity PD-L1-binding are designed to tap the synergistic potential of tumor-localized modulation of PD-L1 and 4-1BB. Furthermore, half-life extension via the HSA-binding is designed to enable convenient dosing schedules for patients. CS2006/NM21-1480 is anticipated to be effective against tumors with a wide range of PD-L1 expression levels and may overcome primary and/or acquired resistance to anti-PD-1/PD-L1 therapies.

"The preclinical data of CS2006/NM21-1480 are encouraging and further demonstrate its potential to become a best-in-class anti-4-1BB agonist and next-generation immune checkpoint inhibitor. The bell-shape dose-response curve associated with this class of agents presents a unique challenge with dose-selection in the clinic. However, this concern seems to be alleviated by the fine affinity balance engineered in CS2006/NM21-1480 which allows optimal PD-L1 blockade and 4-1BB activation at the same time." Dr. Archie Tse, Chief Scientific Officer of CStone, said, "The first-in-human dose escalation study is ongoing in the United States, and patient enrollment has commenced in Taiwan, China. In addition, the investigational new drug application has been approved by the National Medical Products Administration of China and the clinical trial is underway. Moving forward, we will step up our efforts to drive research and development of CS2006/NM21-1480, and other pipeline assets to provide high-quality treatments for a wider range of cancer patients as soon as possible."

CS2006/NM21-1480 was discovered and engineered by Numab Therapeutics ("Numab"), CStone’s partner, using its proprietary λcap technology and MATCH platform. CStone and Numab signed an exclusive regional licensing agreement for the development and commercialization of the drug candidate. Pursuant to the terms of the licensing agreement, CStone will fund the research and development of CS2006/NM21-1480 up to completion of an initial Phase 1b clinical trial. In exchange, CStone obtains exclusive rights from Numab to develop and commercialize CS2006/NM21-1480 in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan), South Korea, and Singapore. Numab retains all CS2006/NM21-1480 rights for the rest of the world. Upon completion of CStone’s funding period, no further financial obligations will be owed by either party.

On April 13, 2022 Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) reported topline results from the first cohort of the EPCORE NHL-1 phase 1/2, clinical trial evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody (Press release, Genmab, APR 13, 2022, View Source [SID1234612148]). The study cohort includes 157 patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy, including 38.9 percent who received prior treatment with chimeric antigen receptor (CAR) T-cell therapy. Based on the topline results, the companies will engage global regulatory authorities to determine next steps.

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The topline results from this cohort demonstrated an overall response rate (ORR) of 63.1 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 49.7 percent, including 2.5 percent grade 3. The data will be submitted for presentation at a future medical meeting.

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration. The companies remain committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy, for a variety of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (NCT: 04628494).

"Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to sharing the findings at a future medical meeting."

LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL) – a cancer that develops in the lymphatic system – that affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally. LBCL includes DLBCL, which is the most common type of NHL worldwide and accounts for approximately 31 percent of all NHL cases.i,ii,iii,iv

"We aim to leverage AbbVie’s strong blood cancer expertise to further develop epcoritamab, alongside Genmab, for certain blood cancer patients who have limited treatment options," said Mohamed Zaki, M.D., Ph.D., Vice President and Head, Global Oncology Development, AbbVie.

About the EPCORE NHL-1 Trial

EPCORE NHL-1 an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of two parts: a phase 1 first-in-human, dose escalation part; and a phase 2 expansion part. The trial was designed to evaluate

Graphic

Genmab and AbbVie Announce Topline Results for Epcoritamab (DuoBody-CD3xCD20) From Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL)

subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL. The dose escalation findings, which determined the recommended phase 2 dose RP2D, were published in The Lancet in 2021. In the phase 2 expansion part, additional patients are being treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.

The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response (CR) rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were evaluated as secondary efficacy endpoints.

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 tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of lymphoma B cells.v CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.vi,vii Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.