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4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby)

On February 29, 2024 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 has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by the EMA as sufficient for examination (Press release, 4SC, MAR 1, 2024, https://www.pressetext.com/news/20240301006 [SID1234640681]).

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In September 2023, the Company announced data from its RESMAIN study on resminostat (Kinselby) that showed:

A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group

Side effects of resminostat were mainly mild to moderate, manageable and reversible.
Jason Loveridge, Ph.D., CEO of 4SC, commented: "The team has worked hard to successfully file the Marketing Authorisation Application for resminostat in CTCL ahead of schedule. This represents a significant step forward for 4SC and a great achievement for our team as it further de-risks our resminostat program and will assist our ongoing efforts to bring this important treatment to patients suffering with this disease, commercialise the asset and create value for shareholders."

Taiho Pharma Enters Exclusive License Agreement with Haihe Biopharma for Gumarontinib (SCC244), an Agent for Non-Small Cell Lung Cancer

On February 29, 2024 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho") and Haihe Biopharma Co., Ltd. (hereinafter "Haihe") reported that two companies have entered into an exclusive license agreement regarding the development, manufacturing and commercialization of gumarontinib (development code : SCC244), agent for non-small cell lung cancer, which application for marketing authorization has been submitted and is currently being reviewed in Japan by Haihe Biopharma K. K., fully owned affiliate of Haihe (Press release, Taiho, MAR 1, 2024, View Source [SID1234640679]).

Under the license agreement, Taiho will obtain exclusive rights in Japan, Asia (excluding China) and Oceania to develop, manufacture and commercialize, gumarontinib, Haihe will receive an upfront payment, development and sales milestones, and royalty based on sales revenue from Taiho.

Gumarontinib is an oral, small molecule MET inhibitor discovered by Haihe. In September 2023, Haihe Biopharma K. K., submitted new drug application of gumarontinib in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations as possible indications. Gumarontinib has been approved in China in March 2023 by NMPA (National Medical Products Administration) for the treatment of non-small cell lung cancer (NSCLC) with METex14.

"We are pleased to announce that we will be entering into a partnership withHaihe on gumarontinib, a new treatment option for the patients with non-small cell lung cancer. We will be preparing for the successful launch of gumarontinib with Haihe to contribute to the patients and healthcare professionals." stated Masayuki Kobayashi, President and Representative Director of Taiho.

"We are pleased to announce that we are entering into partnership with Taiho, one of the leading companies of oncology in Japan. We hope our collaboration shall be able to provide a promising treatment option for the patients with nonsmall cell lung cancer." stated Ruiping Dong, M.D., Ph.D., Chief Executive Officer of Haihe.

Taiho and Haihe through its alliance, will make every effort to deliver gumarontinib to patients and healthcare professionals as soon as possible.

About NSCLC with METex14 Skipping Mutations

Primary lung cancer is the malignant tumor with one of the highest morbidity and mortality. Globally, the number of new patients with lung cancer is estimated to be 2.2 million/year and the number of deaths to be 1.79 million/year (2020)1). In Japan, the number of new patients with lung cancer is more than 120,000/year (2019) and the number of deaths is over 70,000. /year (2020) 2). The proportion of non-small cell lung cancer among lung cancer patients in Japan is 88%, and the frequency of mesenchymal epithelial transforming factor (MET) gene exon 14 skipping mutation is about 3% 3). Thus, in Japan, the number of patients eligible for treatment with this drug is estimated to be around 3,000/year.

PharmAbcine Announces Japan Patent Registration for PMC-403

On February 29, 2024 PharmAbcine, Inc. ("PharmAbcine" or the "Company") (KOSDAQ: 208340), a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, reported the registration of Japan patent for its candidate drug, PMC-403, marking the third patent registration following Russia and Singapore (Press release, PharmAbcine, FEB 29, 2024, View Source;bmode=view&idx=18233718&t=board [SID1234649175]).

PMC-403 is a novel first-in-class therapeutic antibody candidate with a unique mechanism of activating TIE2 receptors in endothelial cells. PMC-403 normalizes pathological leaky blood vessels by activating TIE2 receptors in endothelial cells. Through TIE2 activation, PMC-403 inhibits VEGFR-2 phosphorylation and maintains intercellular adhesion factors, thereby inhibiting vascular leakage caused by neovascularization.

The registered patent pertains to PMC-403’s TIE2-binding antibody compositions. Patent registrations are currently underway in countries including the United States, Europe, China, and Korea. The Company anticipates that the registrations in Japan, Russia and Singapore will positively impact registrations in other countries.

A representative from PharmAbcine stated, "Through the ongoing clinical trial, we expect to strengthen the exclusive rights of PMC-403 in major countries." They added, "Along with patent acquisition, we are eager to maximize the therapeutic potential of PMC-403 in various vessel-related diseases such as cancer, age-related macular degeneration, diabetic retinopathy, kidney disease, and many others."

With a mechanism distinct from currently available therapies, PMC-403 is undergoing Phase 1 clinical trial targeting patients with neovascular age-related macular degeneration in Korea. The evaluation of efficacy and safety in the third dosing group (3mg) is ongoing, following confirmation of safety in the second dosing group (2mg). After this is complete, both the last single-dose group (4mg) and the first multiple-dose group (MAD 3mg) will proceed simultaneously.

Neobe Therapeutics raises over $2m for synthetic biology enabled tumour microenvironment remodelling

On February 29, 2024 Neobe Therapeutics, a pioneering synthetic biology startup at the forefront of immuno-oncology innovation, reported the successful closure of a $2.34M financing round (Press release, Neobe Therapeutics, FEB 29, 2024, View Source [SID1234646112]).

This significant financial milestone was achieved with the support of new investors Pioneer Group* (lead) and 2048 Ventures, alongside existing backers Deep Science Ventures*, Cancer Research Horizons*, and Discovery Park Ventures. Additionally. Additionally, the round received a non-dilutive grant award from Innovate UK’s Cancer Therapeutics fund through the Investor Partnership programme.

Neobe has built a synthetic biology platform to engineer safe microbial strains to disrupt the microenvironment of solid tumours, without affecting healthy tissues. These programmable microscopic trojan horses enable immunotherapy responses by breaking down barriers to immune infiltration locally. Since its inception Neobe has successfully engineered two differentiated proprietary products aimed at enabling immunotherapy efficacy in patients with colorectal, pancreatic and breast cancer, with demonstrated pre-clinical efficacy.

Neobe was founded by Pedro Correa de Sampaio and Annelise Soulier in 2021, from a venture creation alliance between Deep Science Ventures and Cancer Research Horizons established to help founder-type scientists build high-impact ventures in oncology, using DSV’s proven approach to ideation-based innovation. Neobe was created specifically to address the key issue of existing barriers created by the local microenvironment of solid tumours which prevent the infiltration of cancer reactive immune cells. This "immune exclusion" is a key contributing factor in why about 80% of patients with solid tumours still do not respond to life changing immunotherapies.

"We are immensely grateful for the continued backing of our existing investors and thrilled to have Pioneer Group and 2048 Ventures join Neobe’s journey", said Pedro Correa de Sampaio, CEO and co-founder of Neobe. "The trust and support of all our investors as well as Innovate UK truly validates our innovative approach, harnessing synthetic biology to build safer and more effective strategies to enable therapeutic efficacy in cancer patients. Our mission continues to be to transform cancer treatment through engineered live biotherapeutics, and with this support, we are one step closer to making that a reality."

""Supporting Neobe in addressing previously untreatable cancers is truly exciting. Their pioneering approach holds immense promise in broadening access to immunotherapies, potentially transforming treatment and importantly preserving life for many patients. We’re honoured to welcome Neobe to our portfolio and recognise the pivotal role they play in advancing this vital mission of making cancer treatment more accessible." " — Imelda Juniarsih, Investment Director at Pioneer Group

"At 2048 Ventures, we look to invest in platform plays that solve huge healthcare challenges. Neobe’s stromal remodeling microbes represent the best application of a synbio platform, which is using biology to engineer life-saving therapies for cancer patients. We are excited to partner with Neobe and join their mission in unlocking immunooncology treatments for all patients."— Julie Wolf, 2048 Ventures

Neobe is on a mission to unlock the full potential of immuno-oncology therapeutics," said Tony Hickson, Chief Business Officer at Cancer Research Horizons. "Since its inception from one of our venture creation programmes, we have been impressed by the entrepreneurial activities of the Neobe team. We are excited to continue to work with Neobe’s innovative team to support the company’s next phase of growth and realize its full potential to deliver much needed therapeutic solutions for patients."

TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav® to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

On February 29, 2024 TriSalus Life Sciences Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported the publication in Current Medical Research and Opinion a manuscript detailing a real-world study of the use of the pressure-enabled drug delivery (PEDD) method with the TriNav device for trans-arterial chemoembolization (TACE) and trans-arterial radioembolization (TARE) in patients with hepatocellular carcinoma (HCC) and liver metastases (Press release, TriSalus Life Sciences, FEB 29, 2024, View Source [SID1234640689]).

The data presented in this study captured real-world safety and clinical outcomes data for TriNav in its launch phase (2020-2022) utilizing a large, 300 million patient dataset covering 98% of US payers. These data provide valuable insights into the important benefits of this technology that would otherwise take many years to accumulate through alternative approaches using clinical trials. Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden. The study also revealed that:

In TACE procedures, interventional radiologists could deliver significantly more chemotherapeutic to the tumor when using TriNav vs. the amount delivered using standard catheters, a critical treatment goal.
In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
TriNav HCC patients were more likely to have a post-procedure liver transplant in a matched cohort comparison.
TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
TriNav TARE patients with liver metastases had lower rates of post-procedure fatigue vs. non-TriNav patients.
These study data clearly demonstrate that TriNav is preferentially selected to treat patients with a higher burden of disease than patients treated with standard catheters, yet these patients show similar results post-treatment compared to patients with a lower disease burden. TriNav patients showed impressive trends toward better outcomes in matched cohort comparisons, including an increased rate of liver transplants. The results also demonstrate how real-world data complement traditional clinical trials to provide a more robust and timely understanding of the benefits realized by patients. TriSalus is committed to updating this data set continuously and affirming the benefit TriNav and the PEDD approach bring to patients, providers, and payers.

"Analyses of real-world data are critical to obtaining a holistic understanding of the benefits of treatment with TriNav. The ability of the PEDD method to impact more complex patients when compared to standard-of-care drug delivery systems is potentially game-changing and brings us closer to addressing the limitations of current treatment options for HCC and other liver cancer patients," said Mary Szela, Chief Executive Officer of TriSalus. "This important, peer-reviewed, real-world study speaks to our commitment to improve patient care and outcomes. These data, together with the recent, new Centers for Medicare and Medicaid (CMS) Healthcare Common Procedure Coding System (HCPCS) code effective as of this year, are a testament to TriNav’s continued emergence as a potentially best-in-class and cost-effective drug delivery method for patients with liver and pancreatic tumors."

"These new population-based findings resonate well with previously published clinical studies that indicate PEDD improves therapeutic uptake, accuracy of therapeutic delivery, and clinical outcomes in liver cancer patients. The ability of the TriNav’s SmartValve to favorably modulate drug delivery pressure and flow within target blood vessels gives liver cancer patients, even those with major medical co-morbidities and large tumor burdens, the opportunity to achieve better outcomes," said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus. "This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems."

About the TriNav Infusion System

TriNav is a flexible, ultra-thin therapy delivery system with SmartValve technology, a self-expanding, nonocclusive one-way dynamic microvalve that opens and closes in synchrony with the patient’s heart to modulate pressure and flow. This system uses the Pressure-Enabled Drug Delivery approach and has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures. For more information, please visit www.trinavinfusion.com.