On June 5, 2024 Genmab A/S (Nasdaq: GMAB) reported that its Chief Financial Officer Anthony Pagano and Chief Operating Officer Anthony Mancini will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, Florida 9:20 AM EDT (3:20 PM CEST) on June 10, 2024 (Press release, Genmab, JUN 5, 2024, View Source [SID1234644122]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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On June 5, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported the grant of European Patent No. 4269578, covering the ENHANZE rHuPH20 product obtained from Halozyme’s ENHANZE manufacturing methods that the Company provides to its current and future licensees (Press release, Halozyme, JUN 5, 2024, View Source [SID1234644144]). The new patent is licensed under all of Halozyme’s ENHANZE licenses. It will be validated in 37 European countries and expires on March 6, 2029.

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"This new European patent for ENHANZE further strengthens our robust patent estate and extends the durability of our portfolio," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are pleased to be able to maintain the original royalty rate for DARZALEX SC in Europe through March 2029 based on this new patent."

Under the terms of Halozyme’s ENHANZE license with Janssen, the newly granted patent prevents the reduction in the royalty rate on sales of DARZALEX SC in the European countries where it is validated until the patent expires. The new patent is not expected to have any impact to royalties under other ENHANZE licenses with an issued or pending collaboration patent, as current royalty rates for these licenses are already expected to extend beyond expiration of the new patent.

Webcast and Conference Call

Halozyme will discuss the new European patent and provide an update to its 2024 financial guidance and 5-year financial outlook on a conference call tomorrow, Thursday, June 6 at 5:30am PT/8:30am ET. The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the completion of the call. To access the webcast and presentation, please visit ir.halozyme.com.

The call may also be accessed with the dial-in information below:

Participant Toll-Free Number: 888-632-3384
Participant Direct/International Number: 785-424-1794
Conference ID: HALO0624

On June 5, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, reported that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY) (Press release, I-Mab Biopharma, JUN 5, 2024, View Source [SID1234644123]). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb’s immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

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Under the terms of the agreement, the study will be a multi-national Phase 1 study conducted by I-Mab. Bristol Myers Squibb will supply nivolumab. Nivolumab is an immune checkpoint inhibitor that is designed to block the PD-L1 protein on cancer cells from binding to PD-1, enhancing T-cell function and resulting in improved anti-tumor responses.

"We are pleased to enter into this clinical collaboration agreement with Bristol Myers Squibb as we embark on the next stage of givastomig’s development to explore the significant promise of this bispecific antibody in a triple-therapy regimen," said Raj Kannan, CEO of I-Mab. "The study builds on the encouraging single-agent activity and safety we have observed with givastomig as presented at ESMO (Free ESMO Whitepaper) 2023. We remain optimistic that givastomig in combination with nivolumab and chemotherapy will drive potent anti-tumor activity in specific tumors, and we look forward to accelerating progress in the clinic."

About Givastomig

Givastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. Givastomig uniquely binds to tumor cells expressing various levels of CLDN18.2, including gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T-cells at the tumor site through 4-1BB. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Developed through a collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

On June 5, 2024 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis in various cancers including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, melanoma, and ovarian cancer (Press release, MediciNova, JUN 5, 2024, https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-mn-31 [SID1234644145]).

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Once issued, this patent is expected to expire no earlier than July 2042. The allowed claims cover the use of MN-166 (ibudilast) in combination with one or more additional therapies including chemotherapy, immunotherapy, radiotherapy, photodynamic therapy, epigenetic therapy, and liver-directed therapy and others. The allowed claims specifically cover the use of MN-166 (ibudilast) for preventing, ameliorating, or minimizing metastasis of various cancers including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, melanoma, or ovarian cancer. The allowed claims cover oral administration, a wide range of doses, a range of different dosing frequencies, and a range of different treatment periods.

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "Cancer metastasis is often the major driver of cancer-related deaths rather than the primary cancer. Recently we were granted a patent *1 to cover preventing metastasis of uveal melanoma. We are delighted to see our growing intellectual property patent portfolio and value of MN-166 (ibudilast) increase with the addition of patents covering the prevention of metastasis of various solid tumors."

*1: MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Prevention of Metastasis of Eye Cancer
https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-mn-30

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

On June 5, 2024 Domain Therapeutics ("Domain" or "the Company"), a global clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptor (GPCR) driven immuno-resistance, reported the publication of three international PCT patent applications (Press release, Domain Therapeutics, JUN 5, 2024, View Source [SID1234644168]).

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Expanding geographic protection of Domain’s best-in-class CCR8 asset with three new patents
These patents will significantly strengthen the Company’s intellectual property protection for its series of tumor–infiltrating regulatory T cells (Tregs) depleting antibody-dependent cell-mediated cytotoxicity/ phagocytosis (ADCC/ADCP) anti-CCR8 antibodies, including DT-7012, a novel drug candidate with best-in-class potential compared to other clinical-stage CCR8 antibodies. Currently in the pre-IND stage of development, DT-7012 is set to commence Phase I clinical trials in early 2025.

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "These three new patents are pivotal to our strategy, enhancing our robust patent estate and expanding our reach across diverse market opportunities. They underscore the broad international application of our Treg depleting ADCC/ADCP anti-CCR8 antibodies, particularly for our lead anti-CCR8 candidate DT-7012. They also reinforce Domain’s position as an industry leader in GPCR-mediated immunotherapies. Notably, this timely publication of PCT patent applications aligns with our accelerated and broadened research and development efforts in immuno-oncology."

Improving clinical outcomes in cancer patients via strategic depletion of T regulatory cells in the tumor microenvironment
CCR8 is a GPCR target specifically expressed by tumor infiltrating Tregs, major immunosuppressive cells responsible for the failure of several therapeutics in the clinic, which makes this target highly strategic for the development of efficient novel immunotherapies.