On April 2, 2024 Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, reported the acquisition of Modulus Therapeutics’ cell therapy platform assets, including their chimeric antigen receptor (CAR) and switch receptor libraries (Press release, Ginkgo Bioworks, APR 2, 2024, View Source [SID1234641713]).

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Modulus Therapeutics is a cell engineering company focused on the design of next-generation cell therapies for autoimmune diseases. In contrast to legacy cell therapy design, the company uses a combinatorial approach to build and screen cell therapy components that work in concert with one another to yield novel cell behaviors.

Modulus has used its platform to develop and screen libraries of novel NK-specific and T-cell specific CAR and switch receptor designs, which enable improved control and performance of immune cell-based therapies. This technology has the potential to improve the safety and efficacy of cell therapies by allowing for more precise control over activation and targeting. Modulus’ CAR-NK and CAR-T components are designed to enhance proliferation and cytotoxicity, even in inhospitable cellular environments, providing a deeper and more durable response against target cells.

Modulus’ assets complement Ginkgo’s extensive cell therapy capabilities. With this addition, Ginkgo looks forward to supporting its customers who are improving the performance of T-cell and NK-cell based CAR therapies to treat solid tumors, autoimmune, and other diseases.

Jason Kelly, CEO and co-founder of Ginkgo Bioworks: "Modulus Therapeutics has built an array of incredible cell therapy assets that we are excited to add into the significant cell therapy capabilities Ginkgo has developed to date. Modulus’ CAR and switch receptor designs and libraries seamlessly integrate into our existing infrastructure and offerings. We are excited to put these new assets to work for our customers and contribute to the transformative advancements in CAR and cell therapies."

Max Darnell, CEO and co-founder of Modulus Therapeutics: "At Modulus, we have always been motivated by enhancing access to cutting-edge cell therapy innovation. We’re very pleased that Ginkgo Bioworks shares this commitment and can leverage our technology to help transform oncology and autoimmune cell therapies. We are thrilled to contribute our innovative designs to the Ginkgo ecosystem, and look forward to seeing these tools deployed across a range of Ginkgo-partnered programs."

Ginkgo’s platform works to enable its partners to sample CAR domains with a variety of functional roles and structural positions, sourced from diverse immune cell types. This approach to cell therapy discovery allows partners to thoroughly sample the breadth of therapeutic activities a CAR can produce. Last year, Ginkgo entered a partnership with the Wisconsin Alumni Research Foundation (WARF) to discover and develop next-generation CAR-T cell therapies. Ginkgo also presented new data on its high throughput pooled screening method to discover novel CAR-T designs for solid tumors at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in 2022, as well as data on its high-throughput screening platform for chimeric antigen receptor (CAR) libraries at the 26th American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting in 2023. The poster highlighted Ginkgo’s Foundry-enabled methods for large-scale, combinatorial library design and screening of CAR domains for improved persistence. Ginkgo expects Modulus’ cell therapy assets to help Ginkgo continue to strengthen its CAR-T research & development offerings.

On April 2, 2024 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that on March 6, 2024, the European Patent Office (EPO) issued EP patent 3,823,617 (‘617 patent) covering the pharmaceutical composition of matter for the company’s lead compound, LNS8801 (Press release, Linnaeus Therapeutics, APR 2, 2024, View Source [SID1234641712]).

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Linnaeus’s patent disclosure is directed toward the pharmaceutical composition of matter of LNS8801 and embodies (1) an enantiomerically purified compound SRR G-1, or a derivative thereof, including specific crystal forms, salts, and co-crystals, that modulates G protein-coupled estrogen receptor activity; (2) pharmaceutical and cosmetic compositions comprising an enantiomerically purified SRR G-1, or a derivative thereof; and (3) methods of treating or preventing disease states and conditions and cosmetic conditions mediated through these receptors and related methods thereof in humans and animals.

"We are extremely pleased that the EPO has issued this composition of matter patent," commented Patrick Mooney, MD, CEO of Linnaeus. "We are thrilled to have these issued claims in both the US and Europe, and we believe that they will provide critical market protection for LNS8801 into the 2040s. As we continue to collect very promising data from our clinical trials with LNS8001, we will continue to prosecute the claims in this patent worldwide."

Linnaeus is currently conducting an open-label phase 1/2 study assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced cancer, including cutaneous melanoma.

Based on promising data from the phase 1/2 study, Linnaeus plans to initiate a potentially pivotal, randomized controlled trial in patients with metastatic cutaneous melanoma who have had confirmed progression on immune checkpoint inhibitors. The study will enroll 135 patients who will be selected based on a predictive biomarker and then randomized to receive LNS8801 alone, LNS8801 and pembrolizumab, or physician’s choice therapy. Key endpoints will include an analysis of progression-free survival and overall survival between the treatment groups. Over 25 comprehensive cancer centers in the United States are eager to participate in this study.

About LNS8801

LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and durable clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified.

About Metastatic Cutaneous Melanoma
Although there has been progress in the treatment of metastatic cutaneous melanoma, most patients will progress on standard-of-care therapies and need further treatment. According to the American Cancer Society, almost 8000 patients die each year in the United States, highlighting the need for safe and effective therapies in the treatment-refractory setting.

On April 2, 2024 GC Cell, a fully integrated cell therapy pioneer reported poster presentations from studies of its preclinical study of GL205 (GCC2005), a CD5 CAR-NK targeting malignant T-cell lymphoma, and real-world data for the anticancer immunotherapy drug ‘Immuncell-LC’ at the AACR (Free AACR Whitepaper) Annual Meeting 2024 that will take place in San Diego, California, on April 5-10 (Press release, GC Cell, APR 2, 2024, View Source [SID1234641711]).

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"We are looking forward to sharing data that GL205 (GCC2005) effectively targets CD5 in malignant T-cell lymphomas, suggesting it as a new treatment option for patients with limited choices from current approved therapies. Presenting at AACR (Free AACR Whitepaper) offers a significant opportunity to globally disseminate our research findings, creating anticipation for the forthcoming clinical trials of GL205 (GCC2005) slated for IND submission this year." said Sungyong Won, CSO of GC Cell.

Details for the AACR (Free AACR Whitepaper) 2024 abstracts are as follows:

Poster Presentation Details

Title: Superior anti-tumor activity of GL205, an allogeneic anti-CD5 CAR-NK for treating T-cell malignancies
Authors: Miyoung Jung, Seung Min Kim, Eunsol Lee, Hyunseung Sun, Jaeyoung Yoo, Subin An, Jiyoung Park, MiAe Han, Yusun Kim, Sunglim Cho, Bokyung Min
Session Title: CAR-NK, NK Engagers, and NK Modulators
Session Date and Time: Monday, April 8, 2024 9:00 am PT – 12:40 pm PT
Location: Poster Section 2
Poster Board Number: 7
Published Abstract Number: 1324

Title: A retrospective analysis of the clinical characteristics of metastastic solid cancer patients with cytokine-induced killer cells combined immune checkpoint inhibitor immunotherapy
Lead Author: Jong Gwon Choi, Division of Oncology and Hematology, Konyang University Hospital, Daejeon, Korea
Session Title: Adoptive Cellular Therapy 1
Session Date and Time: Monday, April 8, 2024 1:30 pm PT – 5:00 pm PT
Location: Poster Section 39
Poster Board Number: 1
Published Abstract Number: 3595

About Immuncell-LC

Immuncell-LC is the only commercially available adoptive cell therapy treatment of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events.

On April 2, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-Oncology company, reported that its CF33-hNIS (VAXINIA) technology has been selected for a short oral presentation during the Basic Science Research Seminar Abstract Session at 12:15 pm on Thursday April 18th at the 2024 Cholangiocarcinoma Foundation Annual Conference (Press release, Imugene, APR 2, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/aac555dc-2479-31cc-7372-6973c7c0c6c8/Imugene_to_present_at_2024_Cholangiocarcinoma_Conference.01.pdf [SID1234641709]). Imugene will also be presenting a poster during the poster session.

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The abstract, titled ‘CF33-hNIS, a novel oncolytic virus for the treatment of cholangiocarcinoma and biliary tract malignancies,’ concludes that CF33-hNIS monotherapy may be an effective and safe treatment option for GI malignancies, including cholangiocarcinoma, a rare disease with an unmet medical need.

The Cholangiocarcinoma Foundation Annual Conference is dedicated to advancing the understanding and treatment of cholangiocarcinoma (bile duct cancer). The 2024 edition, marking the 11th annual conference, is scheduled for 17-19 April 2024 at the Salt Palace Convention Center in Salt Lake City, Utah. This conference brings together a wide array of participants, including medical professionals, researchers, patients, and caregivers, creating a unique platform for sharing the latest advancements in research, clinical trials, and patient care.

Cholangiocarcinoma is a rare and aggressive form of cancer that occurs in the bile ducts, which are the slender tubes that carry the digestive fluid bile from the liver to the small intestine. Early detection is challenging, and because of its aggressiveness, the prognosis for cholangiocarcinoma can be poor, making research and advancements in treatment essential.

On April 2, 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 an abstract regarding results of a clinical trial of MN-166 (ibudilast) in glioblastoma (GBM) has been selected for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (2024 ASCO (Free ASCO Whitepaper)) Annual Meeting to be held May 31 – June 4, 2024 in Chicago (Press release, MediciNova, APR 2, 2024, View Source [SID1234641708]). The oral presentation will be presented by one of the investigators of this clinical trial, Gilbert Youssef, M.D., Attending Physician at Harvard Medical School, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women’s Hospital.

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The presentation details are as follows:

Abstract Number: 2106

Title: Phase 1b/2a study evaluating the combination of MN-166 (ibudilast) and temozolomide in patients with newly diagnosed and recurrent glioblastoma (GBM)

Session Title: Rapid Oral Abstract – Central Nervous System Tumors
Session Date: June 2, 2024
Session Time: 11:30 AM – 1:00 PM

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).