On January 16, 2024 Chengdu Chipscreen NewWay Biosciences Co., Ltd. (NewWay) reported that on January 5, 2024, the dosing of the first patient for a phase I clinical trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001, at Sun Yat-Sen University Cancer Center in China, the trial-leading institution (Press release, Shenzhen Chipscreen Biosciences, JAN 16, 2024, View Source [SID1234639275]). The trial is a multi-center, non-randomized, open-label, multi-dose phase I clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors.

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NWY001 is world’s first PD-1/CD40 bispecific antibody entering clinical study. Mechanistically, the bsAb targets two targets synergistically and can activate the CD40 pathway in a PD-1 dependent manner, reducing the potential toxicity commonly associated with CD40 agonistic monoclonal antibody (mAb). It is expected that this bsAb can transform "cold" tumors into "hot" tumors, thereby increasing cancer patients’ sensitivity to PD-(L)1 immune checkpoint inhibitors, especially PD-(L)1 antibody resistant cancer patients.

Dr. Bin Liu, Scientific Director of Chipscreen NewWay, said:

"Dosing of the first patient marks a significant milestone for the clinical development of NWY001. Its unique mechanism is expected to circumvent the ineffectiveness or toxicity caused by PD-(L)1 immune checkpoint inhibitor monotherapy, CD40 agonists, or their combination therapy, therefore benefiting more cancer patients. We thank the experts at Sun Yat-Sen University Cancer Center for their great support, the clinical and related teams at Chipscreen for their efforts, and the patients enrolled in this NWY001 clinical trial and their families."

February 27th, 2023 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd., has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences, a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences", SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 (NWY001) in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).

On January 16, 2024 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the first commercial use of HEPZATO KIT for the treatment of metastatic uveal melanoma (mUM) (Press release, Delcath Systems, JAN 16, 2024, https://delcathsystemsinc.gcs-web.com/news-releases/news-release-details/delcath-systems-announces-us-launch-and-first-commercial [SID1234639256]).

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The procedure took place at Moffitt Cancer Center in Tampa, Florida by Dr. Jonathan S. Zager, M.D., Chief Academic Officer; Senior Member, Department of Cutaneous, Oncology; Director of Regional Therapies, Moffitt Cancer Center. Dr. Zager was the global Lead Investigator for the FOCUS Phase 3 trial.

"The fact that patients with difficult to treat metastatic uveal melanoma with limited treatment options now have another alternative is truly remarkable and exciting. There has been a large unmet need for liver directed therapy options to treat this patient population and we intend to incorporate this as standard of care for appropriate patients," said Dr. Zager. Dr. Zager enrolled and treated the first and last patients on the FOCUS Phase 3 trial and the team at Moffitt has performed the procedure over 200 times to date.

The company is working with numerous other leading cancer centers across the U.S. which have indicated interest in HEPZATO KIT to ensure patients nationwide have access to this important treatment. In conjunction with the first commercial treatment, Delcath also launched websites relating to the HEPZATO KIT, including HEPZATO KIT, HEPZATO KIT REMS, and HEPZATO KIT Access, to support the commercial launch.

"The first commercial procedure utilizing HEPZATO KIT in the U.S. is a significant milestone for Delcath and patients suffering from metastatic uveal melanoma. We are proud to continue our relationship with Dr. Zager and the team at Moffitt Cancer Center to bring this unique treatment to appropriate patients in need. I want to thank all the collaborators and patients who participated in the long but necessary process to bring HEPZATO KIT to market," said Gerard Michel, Delcath’s Chief Executive Officer.

About HEPZATO KIT

HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by FDA, is a combination drug/device product which administers HEPZATO (melphalan) directly to the liver through the HDS, which permits higher drug exposure in target tissues while limiting systemic toxicity.

HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

HEPZATO KIT Important Safety Information
Patients eligible for HEPZATO KIT should NOT have any of the following medical conditions:

Active intracranial metastases or brain lesions with a propensity to bleed
Liver failure, portal hypertension, or known varices at risk for bleeding
Surgery or medical treatment of the liver in the previous 4 weeks
Active cardiac conditions including unstable or severe angina or myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease
History of allergies or known hypersensitivity to melphalan or a component or material utilized within the HEPZATO KIT including natural rubber latex, heparin, and severe hypersensitivity to iodinated contrast not controlled by antihistamines and steroids
Most common adverse reactions or laboratory abnormalities occurring with HEPZATO KIT treatment are thrombocytopenia, fatigue, anemia, nausea, musculoskeletal pain, leukopenia, abdominal pain, neutropenia, vomiting, increased alanine aminotransferase, prolonged activated partial thromboplastin time, increased alkaline phosphatase, increased aspartate aminotransferase and dyspnea.

Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of HEPZATO. HEPZATO KIT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS. Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Additional cycles of HEPZATO KIT therapy will be delayed until blood counts have improved.

Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.

On January 16, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported that Roche received European Commission (EC) marketing authorization of Tecentriq SC (atezolizumab) co-formulated with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20 (Press release, Halozyme, JAN 16, 2024, View Source [SID1234639276]). The approval applies to all approved indications of Tecentriq IV and represents the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous injection.

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Tecentriq SC reduces treatment time to approximately 7 minutes, compared to an IV infusion which can take approximately 30 to 60 minutes. In addition, it may be administered by a healthcare professional outside of the hospital, in a community care setting or at home, depending on national regulations and health systems.

"As the first subcutaneous PD-(L)1 cancer immunotherapy in Europe, Tecentriq SC can provide a new treatment option that can enhance the treatment experience for patients and caregivers while freeing up resources in constrained healthcare systems," said Dr. Helen Torley, president and chief executive officer of Halozyme.

The EC approval follows pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The study found 90% of healthcare professionals agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation.

On January 16, 2024 Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), reported that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed notification for testing a pre-GMP drug candidate with the CIVO platform (Press release, Presage Biosciences, JAN 16, 2024, View Source [SID1234639277]). The drug candidate, PBA-0405, is owned by Poland-based biopharmaceutical company, Pure Biologics, and represents the earliest stage material to date that will be evaluated in patients in a CIVO Phase 0 clinical trial. PBA-0405 is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.

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"We are very excited by this first opportunity to evaluate pre-GMP material in partnership with Pure Biologics," said Patrick Gray, PhD, Presage CEO. "This is a tremendous step forward for both Presage and overall drug development. We continue to push the bounds on finding alternatives to using preclinical models that fail to capture the effects of novel agents in the intact TME."

"The Pure Biologics team is incredibly proud of this momentous achievement," said Dr. Filip Jelen, Pure Biologics Co-Founder and President of the Management Board." "Our partnership with Presage was key in achieving this milestone and we eagerly await the first insights into drug efficacy and impact on the tumor microenvironment."

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.

On January 15, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually (Press release, Eisai, JAN 15, 2024, View Source [SID1234639236]). First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20. Eisai will also present research results in renal cell carcinoma (RCC) during the 2024 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (#GU24), which is taking place from January 25-27.

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Key Data from Eisai’s Pipeline and Portfolio to be Presented at ASCO (Free ASCO Whitepaper) GI 2024

Notable findings from Eisai’s pipeline include results from a single-arm Phase 2 trial evaluating tasurgratinib (formerly E7090) as a treatment for patients with fibroblast growth factor receptor 2 (FGFR2) gene fusion positive cholangiocarcinoma (NCT04238715(New Window); Abstract: #471). Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3. An analysis of tumor biomarkers in patients with advanced HCC from a Phase 1b study of E7386*1, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in combination with lenvatinib, will also be presented (NCT04008797(New Window); Abstract: #535).

Additional data from the LEAP (LEnvatinib And Pembrolizumab) clinical program include longer term efficacy and safety results from the Phase 3 LEAP-002 trial, which evaluated lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus pembrolizumab (KEYTRUDA*2), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, versus lenvatinib monotherapy as a first-line treatment for patients with unresectable HCC (NCT03713593(New Window); Abstract: #482).

The list of notable ASCO (Free ASCO Whitepaper) GI 2024 presentations is included below. These abstracts will be made available via the ASCO (Free ASCO Whitepaper) website on Tuesday, January 16, 2024, at 2:00 PM PST.

ASCO GI 2024
Cancer Type Study/Compound Abstract Title Abstract Type & Details
(Pacific Standard Time)
Pipeline
Gastrointestinal Cancer E7090 Pivotal single-arm, phase 2 trial of tasurgratinib for patients with fibroblast growth factor receptor-2 gene fusion-positive cholangiocarcinoma
Poster Session
Abstract #471
January 19, 2024
12:30-2:00 PM

E7386 Analysis of tumor biomarkers in patients with advanced hepatocellular carcinoma from a phase 1b study of E7386, a CREB-binding protein/β-catenin interaction inhibitor, in combination with lenvatinib
Poster Session
Abstract #535
January 19, 2024
12:30-2:00 PM

Lenvatinib Plus Pembrolizumab
Gastrointestinal Cancer LEAP-002 Lenvatinib plus pembrolizumab versus lenvatinib alone as first-line therapy for advanced hepatocellular carcinoma: longer-term efficacy and safety results from the phase 3 LEAP-002 study
Poster Session
Abstract #482
January 19, 2024
12:30-2:00 PM

　

Key Data from Eisai’s Pipeline and Portfolio to be Presented at ASCO (Free ASCO Whitepaper) GU 2024

Subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib plus pembrolizumab versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (aRCC), will be featured in a rapid oral abstract session (NCT02811861(New Window); Abstract: #364) and a network meta-analysis to assess the efficacy of lenvatinib plus pembrolizumab compared with other first-line treatment options for patients with aRCC will also be presented in a poster session (Abstract: #482). Extended follow-up results from the Phase 2 KEYNOTE-B61 trial evaluating the combination as a first-line treatment for patients with non-clear cell RCC will be shared in a poster presentation (NCT04704219(New Window); Abstract: #2) by Merck & Co., Inc., Rahway, NJ, USA. Finally, a poster featuring real-world evidence on the use of lenvatinib plus everolimus in previously treated patients with aRCC (Abstract: #437) will also be presented.

The list of notable ASCO (Free ASCO Whitepaper) GU 2024 presentations is included below. These abstracts will be made available via the ASCO (Free ASCO Whitepaper) website on Monday, January 22, 2024, at 2:00 PM PST.

ASCO GU 2024
Cancer Type Study/Compound Abstract Title Abstract Type & Details
(Pacific Standard Time)
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR Subgroup analyses of efficacy outcomes by baseline tumor size in the phase 3, open‐label CLEAR trial
Rapid Oral Abstract Session
Abstract #364
January 27, 2024
1:00-2:15 PM

Network Meta-Analysis Network meta-analysis to assess comparative efficacy of lenvatinib plus pembrolizumab compared with other first-line treatments for management of advanced renal cell carcinoma
Poster Session
Abstract #482
January 27, 2024
7:00 AM

KEYNOTE-B61 First-line pembrolizumab plus lenvatinib for non-clear cell renal carcinomas: Extended follow-up of the Phase 2 KEYNOTE-B61 Study
(Presented by Merck & Co., Inc., Rahway, NJ, USA)
Poster Session
Abstract #2
January 27, 2024
7:00 AM

Lenvatinib Plus Everolimus
Genitourinary Cancer Real World Evidence Lenvatinib plus everolimus in patients with pre-treated advanced renal cell carcinoma: Real world evidence
Poster Session
Abstract #437
January 27, 2024
7:00AM

　

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, pembrolizumab. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.

This release discusses investigational compounds and investigational uses for Food and Drug Administration (FDA)-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.