On January 7, 2025 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing the novel, selective AXL kinase inhibitor bemcentinib for lung cancer reported that the first patient has been included in a clinical trial sponsored by the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) (Press release, BerGenBio, JAN 7, 2025, View Source [SID1234649446]). The study is led by Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Associate Professor in the Division of Hematology and Oncology at UT Health San Antonio.

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"Dr. Taverna’s research has shown that AXL and JAK-STAT3 work in tandem to transmit signals promoting tumor growth and metastasis in advanced lung cancer. We are pleased to see this research advancing into clinical application and believe this study aligns closely with BerGenBio’s strategic focus on addressing the significant unmet needs of lung cancer patients, including first-line Non-Small Cell Lung Cancer patients with mutations in the STK11 gene," said Olav Hellebø, Chief Executive Officer of BerGenBio.

The trial is designed to study BerGenBio’s bemcentinib in combination with pacritinib, which is a JAK2 inhibitor indicated for treatment of the bone marrow disorder myelofibrosis in patients with platelet counts below 50 x 109/L. It works by blocking certain growth factors and cytokines. Pacritinib is marketed in the United States as VONJO and owned by Swedish Orphan Biovitrum AB (Sobi) (STO: SOBI), a specialized international biopharmaceutical company. Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase, a promising therapeutic target for serious diseases.

The study will include patients with lung adenocarcinoma, the most common type of lung cancer in the United States, accounting for approximately 40% of all lung cancers. The study is funded by a grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

On January 7, 2025 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported that it had submitted its responses to the Day-120 List of Questions from the European Medicines Agency (EMA) in December 2024 as planned, following 4SC’s initial Marketing Authorisation Application (MAA) filing for resminostat (Kinselby) in March 2024 (Press release, 4SC, JAN 7, 2025, View Source [SID1234649444]). The EMA has notified 4SC that examination of the Company’s MAA shall continue according to schedule.

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The Day-120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process for resminostat (Kinselby), an orally available treatment for Cutaneous T-cell Lymphoma (CTCL).

Subject to the EMA’s decision, marketing authorisation approval is expected around mid-2025. This filing moves resminostat (Kinselby) another step closer to market following Orphan Drug Designation from the EMA in 2023 and from the Swiss Agency for Therapeutic Products (SwissMedic) in September 2024.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "This filing marks a significant step forward for resminostat (Kinselby) as we progress ever closer to marketing authorisation approval, which is expected in mid-2025. We remain committed to bringing this much needed treatment to patients as soon as possible, and preparations for market launch are ongoing, as well as actively engaging with potential partners interested in commercializing the drug."

On January 7, 2025 Orion’s collaboration partner Bayer reported it has submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the oral androgen receptor inhibitor (ARi) darolutamide (Press release, Orion, JAN 7, 2025, View Source [SID1234649443]). Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The submission is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC.

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The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets around the world, including China. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world, including China. Darolutamide is developed jointly by Orion and Bayer.

On January 6, 2025 Marijuana, Inc. (OTCPINK: MAJI), dba Exousia Pro, Inc., reported it has acquired 100% of Exousia AI in a cash and stock transaction from Ludwig Enterprises, Inc (Press release, Exousia Pro, JAN 6, 2025, View Source [SID1234656255]). Exousia Pro will issue 47,000,000 million restricted shares of its Common stock to Ludwig Enterprises.

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The 47,000,000 shares being issued are restricted shares with certain lock-up features. The legend cannot be removed until six months AFTER Exousia Pro has completed its up-listing with NASDAQ or an equivalent exchange. The Company further agreed to assume liabilities under $75,000 and issued Ludwig a Note for $100,000.

Exousia AI is a leading USA-based biotechnology company in the field of Exosomes. The Company secured a worldwide license for its Exosome technology. The technology covers growing and extracting plant-based exosomes and loading them for use as a drug delivery system. The loading process can also be applied to human-derived exosomes. The acquisition includes an ongoing study on using Exosomes to treat Glioblastoma ("GBM"). The study is well underway, with very promising initial findings. Exousia AI is involved in other studies, including one study concluding in Italy. Exousia Pro will enter two additional studies covering dermatology and the dental market that are part of the acquisition.

Exousia Pro will manufacture and sell vials of wet exosomes or jars of dried exosomes to the nutraceutical and dermatology markets. The OTC exosome market, known as cosmeceuticals, is rapidly expanding due to consumer demand for antiaging and regenerative skincare solutions. A 30-day treatment for skin and hair sells for $400 a vial. Reports suggest a compound annual growth rate of 10%, growing from $310 million in 2025 to $633 million in 2033, for the exosomes skincare market; this is a global trend, with markets in North America, Europe, and Asia Pacific showing strong growth.

Exousia is in talks to license several other patents using Exosomes, which, once secured, will allow the Company to expand its oncology studies beyond GBM.

When Exousia Pro proves its technology enhances current chemotherapy drugs on the market, it can contact the drug manufacturers and license the tech for use in their drug therapy.

"The exosome market is in its infancy, but poised for explosive growth, as evidence by a surge of promising studies," said CEO of Marijuana Inc., Michael Sheikh. "Mounting research points to the vast therapeutic potential of exosomes, highlighting their capacity to precisely target diseases while minimizing side effects. Investors may not fully appreciate the dominance of monoclonal antibodies, which now lead the pharmaceutical market in revenue. This success stems from their ability to target diseased cells, often delivering therapeutic payloads directly where needed. Every major pharmaceutical company is actively developing monoclonal antibody drugs, driven by the universal desire for treatments that alleviate symptoms without causing new ones."

"Exosomes represent the next generation of targeted therapies, surpassing monoclonal antibodies in several key aspects. They offer significant cost advantages in production, the capacity to deliver larger and more complex payloads, including sensitive molecules like DNA, and a broader range of applications. Importantly, exosomes also mitigate the risk of off-target effects and immune reactions often associated with current monoclonal antibody treatments. This would be a key selling point in the event of licensing discussions. Exosomes embody an elegant evolution in biotechnology, and Exousia Pro is committed to spearheading their commercialization and therapeutic development."

On January 6, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that members from its executive leadership team will be attending and participating in investor, industry and business development meetings at the 43rd Annual J.P. Morgan Healthcare Conference, taking place Jan. 13-16, 2025 in San Francisco, California (Press release, Genprex, JAN 6, 2025, View Source [SID1234649484]).

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In attendance will be Ryan Confer, President, Chief Executive Officer and Chief Financial Officer; Mark Berger, MD, Chief Medical Officer; and Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. Throughout the duration of the conference, Genprex executives will be available to conduct one-on-one meetings with industry and investor groups to provide an overview of the Company’s gene therapies for cancer and diabetes.

For those interested in meeting Genprex management during the conference, please request a meeting through Investor Relations at [email protected].