On October 25, 2023 Mabwell reported that ESMO (Free ESMO Whitepaper) Congress 2023 was held in Madrid, Spain from October 20-24, the preliminary results of the Phase I/II study of 9MW2821 (Nectin-4 targeting ADC) in patients with advanced solid tumors were reported by Dr. Jian Zhang of Fudan University Shanghai Cancer Center, on behalf of the research team. The results of the Phase III study of 8MW0511 were presented as a poster (Press release, Mabwell Biotech, OCT 25, 2023, View Source [SID1234636347]).

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9MW2821: Oral Presentation

Background

Nectin-4 is an adhesion molecule that highly expressed in variety of solid tumors including urothelial cancer and could be a potent therapeutic target. 9MW2821 is a monoclonal antibody-drug conjugate (ADC) that delivers monomethyl auristatin E to cells expressing Nectin-4. The study assessed its safety, tolerability and preliminary efficacy in patients with solid tumors.

Methods

9MW2821 was administered by intravenous infusion on days 1, 8 and 15 of each 28-day cycle. The study included dose escalation, dose expansion and cohort expansion period which included urothelial cancer (UC) and other Nectin-4 positive solid tumors. Primary objectives were assessment of safety and preliminary efficacy.

Results

As of April 27, 2023, 97 patients (including 39 UC patients and 29 cervical cancer patients) were enrolled with doses ranging from 0.33 to 1.5mg/kg. Median age was 57 years (range, 32-78). All patients have been treated with platinum-based chemotherapy and immune checkpoint inhibitors before enrollment.

Treatment related death was not observed. Only 1 dose limiting toxicity of grade 4 neutropenia lasted more than 5 days was observed at 1.5mg/kg group. Maximum tolerated dose was not yet reached.

Treatment related adverse events (TRAEs) of any grade occurred in 64.9% patients. The most common TRAEs were white blood cell (WBC) count decreased (36.1%), neutropenia (35.1%), nausea (22.7%), aspartate aminotransferase increased (22.7%), rash (19.6%), alopecia (19.6%), fatigue (18.6%), decreased appetite (18.6%), anemia (17.5%), vomiting (16.5%), peripheral sensory neuropathy (16.5%). Grade 3/4 TRAEs occurred in 35.1% patients. The most common grade 3/4 TRAEs were WBC count decreased (18.6%) and neutropenia (18.6%).

Among 39 subjects with solid tumor who treated with 9MW2821 at 1.25mg/kg or above and evaluable for tumor assessment, ORR and DCR was 38.5% and 84.6%, respectively. In 18 patients with UC who dosed at 1.25mg/kg and evaluable for tumor assessment, ORR and DCR was 55.6% and 94.4%, respectively. Objective responses were also observed in patients with breast cancer and cervical cancer.

Conclusion

9MW2821 showed manageable safety profile. Hematological toxicity, the most common adverse events associated with 9MW2821, were deemed to be manageable, tolerable and reversible.
In addition to urothelial cancer, 9MW2821 showed promising antitumor activity in multiple tumor types.
Enrollment continues to determine efficacy of 9MW2821 in certain solid tumors.
8MW0511: Poster

Phase III study of recombinant (yeast-secreted) human granulocyte-colony stimulation factor fusion protein 8MW0511 for injection reported at ESMO (Free ESMO Whitepaper) showed that 8MW0511 was clinically effective, non-inferior to the positive control. It is able to improve the incidence and duration of grade 4 neutropenia, with a significantly lower incidence and duration of grade 4 neutropenia observed at cycle 2-3 than in the positive control group. The overall safety profile is similar to that of the positive control group, which indicates manageable safety profile and good tolerance in humans.

On October 25, 2023 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the company plans to report new and updated data from its ongoing phase 2a study with the candidate drug fostrox in combination with Lenvima in advanced hepatocellular carcinoma (HCC) (Press release, Medivir, OCT 25, 2023, View Source [SID1234636346]). The data will focus on the 18 out of 21 total patients that have had a minimum follow-up of 12 weeks.

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The data update will be part of Medivir’s interim report for the third quarter on Friday, October 27, 2023, followed by a comprehensive update in a webcasted presentation with associated slide presentation at 14.00 CET the same day.

In the webcast, Medivir will provide further context about how these data increase the opportunity for fostrox + Lenvima to transform treatment of second line HCC, a population for whom there are no approved medical treatments post current standard of care. In addition, the company will outline how promising clinical benefit in a high unmet medical need second line HCC population, opens the possibility for a faster path to approval and its commercial opportunity.

The webcast will be hosted by Medivir’s CEO Jens Lindberg together with Magnus Christensen, CFO, Dr. Pia Baumann, CMO, and Fredrik Öberg, CSO, who are joined in the presentation by Dr. Jeff Evans, who is an investigator in the fostrox clinical development program and a member of Medivir’s Scientific Advisory Council. All presenters will be available to answer questions following the formal presentations.

To access the webcast and information about the teleconference, please click HERE!

The webcast will also be streamed via a link on the website: www.medivir.com/investors/calendar

The presentation will be available on Medivir’s website after the webcast.

On October 25, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Lunaphore, a Bio-Techne brand, will have its technologies featured in several presentations by prominent research centers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting, taking place in San Diego, November 1-5, 2023 (Press release, BioNTech, OCT 25, 2023, View Source [SID1234636345]). The recent studies will demonstrate the unmatched spatial biology capabilities of the company’s universal, end-to-end COMET product suite, addressing complex biological questions from various research areas. COMET is the only fully automated, high-throughput, hyperplex platform ensuring scalability and reproducibility without the need to conjugate primary antibodies, making panel design much more flexible and faster than any other hyperplex solution.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Lunaphore’s sponsored symposia will provide novel insights into the optimization of innovative anti-cancer therapy approaches for head and neck squamous cell carcinoma (HNSCC). Researchers from the collaborative research project between the Earle A. Chiles Research Institute a division of Providence Cancer Institute, and Lunaphore will present the results of a hyperplex-based characterization of the tumor microenvironment (TME) in response to combined immunotherapy and stereotactic ablative radiation therapy (iSABR) neoadjuvant treatment of HNSCC, facilitated by the COMET platform. The presentation will discuss strategies for rapid hyperplex sequential immunofluorescence (seqIF) panel development and optimization, as well as methodologies for high-throughput data analytics. The novel seqIF method allows an unprecedented analysis of the immune compartment and potentially increases the clinical success of such therapies.

Additionally, poster presentations will highlight how research institutes use their off-the-shelf antibodies on COMET to map immune and tumoral cells in lymphomas and various cancer tissues with the seqIF approach. Furthermore, a poster of industry partnership will demonstrate proof-of-concept COMET workflow for same-slide, fully automated multiomics analysis of the TME.

Lunaphore’s scientists will be available at booth #530 to provide live demonstrations of the COMET system and access to raw staining images of various cancer types.

Sponsored symposia details

Using hyperplex immunofluorescence to characterize the immune response to iSABR in head and neck cancer

Location: room 15AB

Date & Time: November 3, 2023 | 12:15 – 1:15 PM EST

Speakers:

Dr. Brian Piening, Earle A. Chiles Research Institute a division of Providence Cancer Institute, USA
Dr. Rom Leidner, Earle A. Chiles Research Institute a division of Providence Cancer Institute, USA
Dr. Marco Cassano, Lunaphore – a Bio-Techne brand, Switzerland
The symposia will take place during the lunch break. Lunaphore will provide lunch for the attendees.

Poster presentation details

Development and optimization of a broad hyperplex immunofluorescence assay for tumor immune microenvironment characterization
Poster number: 65
Date & Time: November 3, 2023 | 12:15 – 1:15 PM | 5:10 – 6:40 PM EST
Presenter: Racheli Ben-Shimol, B.Sc., Earle A. Chiles Research Institute a division of Providence Cancer Institute, USA

Automated hyperplex staining and imaging system on various cancer tissues using off-the-shelf antibodies
Poster number: 222D
Date & Time: November 4, 2023 | 11:55 AM-1:25 PM | 7:00 – 8:30 PM
Presenter: Ms. Li Yen Chong, Institute of Molecular Cell Biology (IMCB), Agency for Science, Technology and Research (A*STAR), Singapore

Immune landscape of adenoid cystic carcinoma using multiplex immunofluorescence and digital pathology
Poster number: 102
Date & Time: November 4, 2023 | 11:55 AM-1:25 PM
Presenter: Dr. Annie Li, Massachusetts General Hospital and Harvard Medical School, USA

Profiling cytokeratins in the tumor microenvironment using multiplex immunofluorescence
Poster number: 1475
Date & Time: November 3, 2023 | 12:00 – 1:30 PM | 5:10 – 6:40 PM
Presenter: Danielle Fails, Spatial Biology Manager, Fortis Life Sciences, USA

Adding space to TiME by sequential immunofluorescence: a new dimension for the spatial biomarkers painting in a clinical cohort of lymphoma case
Poster number: 107
Date & Time: November 3, 2023 | 1:30 PM | 5:10 – 6:40 PM
Presenter: Dr. Pedro Machado Almeida, Lunaphore – a Bio-Techne brand, Switzerland
Research conducted in collaboration with École Polytechnique Fédérale de Lausanne, Swiss Institute for Experimental Cancer Research.

Integration of RNA in situ hybridization and sequential immunofluorescence for same-slide fully automated multi-omics analysis of the tumor microenvironment
Poster number: 71
Date & Time: November 3, 2023 | 2:00 – 1:30 PM | 5:10 – 6:40 PM
Presenter: Dr. Alice Comberlato, Lunaphore – a Bio-Techne brand, Switzerland
Research conducted in collaboration with ACD – a Bio-Techne brand, USA.

The posters are available during the conference opening times of the given day. Presenters will hold the reception at the given time.

Learn more about the event and book a meeting with Lunaphore here.

On October 25, 2023 ReHeva Biosciences, a pioneering biopharmaceutical startup with the mission to help people live longer and healthier with cancer through naturally derived complex drugs, reported the successful completion of its Phase I Safety Trial for its novel drug, RH324 (Press release, ReHeva Biosciences, OCT 25, 2023, View Source [SID1234636344]). This achievement marks a significant milestone for the company and its mission of advancing cancer treatment options and underscores ReHeva’s commitment to revolutionizing patient care.

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The Phase I trial was conducted in collaboration with Case Comprehensive Cancer Center University Hospitals and Case Western Reserve University in Cleveland. It evaluated the safety and tolerability of escalating doses of RH324 in patients diagnosed with advanced non-small cell lung cancer (NSCLC) who have failed prior treatments.

"At ReHeva, we are driven by a steadfast belief that cancer treatment can be transformed to help patients live longer and healthier with cancer. The completion of our Phase I clinical trial represents a tremendous milestone toward realizing this vision," said Dr. Zeenia Kaul, CEO, Co-Founder, and Chief Scientific Officer of ReHeva Biosciences. "By maximizing the potential of plant-derived agents to target multiple tissues and mechanisms of action, we are advancing the narrative of cancer treatment."

Furthermore, ReHeva’s proprietary methods of drug preparation set it apart from its competitors.

Founded in 2016 by Dr. Kaul, ReHeva Biosciences draws upon more than two decades of pre-clinical research and development. The company’s commitment to scientific integrity is underscored by studies published in prestigious peer-reviewed journals, cementing its role as a leading force in oncology research.

Receiving the FDA Investigational New Drug allowance (IND) in 2018 paved the way for ReHeva’s Phase I Safety Study in advanced NSCLC patients designed to assess the safety and tolerability of RH324. This is an important step towards the goal of achieving an FDA approved indication for RH324 and its diverse and broad-spectrum potential benefits which empower the drug to effectively target various pathways implicated in cancer progression.

"Rigorous clinical trials evaluating naturally derived products created many of the treatments we use to fight cancer today," said Dr. Santosh Rao, Medical Oncologist and Director of Integrative Oncology at the University Hospitals, Cleveland.

Dr. Afshin Dowlati, Principal Investigator on ReHeva Study, Professor and Director of the Phase 1 Clinical Trials Program at University Hospitals Seidman Cancer Center added "Partnering with ReHeva Biosciences to evaluate the use of RH324 could provide patients with another treatment option for cancer with less toxicity."

Completion of the Phase 1 Safety and Tolerability trial means that future Phase 2 trials can address multiple cancer types. ReHeva Biosciences is looking forward to the RH324 clinical program.

The Power of Partnerships

One strategic partnership that is helping strengthen ReHeva Biosciences’ mission is a pioneering vertical farming company based in Hamilton, Ohio. Recognizing the need for consistent and large-scale production of the botanical raw material is central to their research, ReHeva’s collaboration with 80 Acres Farms bridges the gap between botanical drug manufacturing needs and scalable supply chain necessary for long term clinical development.

"To be successful, we need a consistent supply of high-quality botanical raw material," said Kaul. "That’s why we turned to one of the most exciting new developments in agriculture—controlled environment agriculture (CEA), which promises ingredients that are clean, dependable, and unaffected by weather and the seasons. After researching the CEA space, we recognized that 80 Acres Farms had the technology platform to deliver what we need."

Utilizing cutting-edge controlled-environment agriculture CEA technology, 80 Acres Farms cultivates crops indoors, free from pesticides, while meticulously controlling growth conditions such as light, humidity, nutrients, and water. This precision results in optimal plants for clinical use, forming a reliable supply chain for ReHeva’s groundbreaking research. This strategic partnership exemplifies ReHeva’s commitment to innovation, as both entities collaborate to pioneer next-generation agricultural tools and technologies.

"As indoor farmers, we’re invested in challenging conventional wisdom, when the data supports it," said Mike Zelkind, CEO and co-founder of 80 Acres Farms. "ReHeva is doing innovative work with plant-derived ingredients at the foundations of modern medicine. We can support that work by growing plants with pharmaceutical precision, year-round—enabling traceability, consistency, and scaling."

Partnerships play a critical role in ReHeva Biosciences work to leverage cutting-edge technology to explore the potential of botanical-based drugs in treating a range of conditions, including cancer. The company is currently exploring educational partnerships with universities including MD Anderson Cancer Center, The Ohio State University and Emory University. Through grants, ReHeva will be able to run additional clinical trials on other cancers to continue proving effectiveness and safety in treating this disease.

A testament to its groundbreaking endeavors, ReHeva Biosciences has garnered over $7 million in funding. To learn more about the transformative work at ReHeva Biosciences, visit ReHevaBiosciences.com.

About RH324

RH324 is an investigational new drug manufactured by ReHeva Biosciences. The botanical drug substance retains a "full spectrum" of the plant’s natural constituents: proteins, amino acids, various fatty acids, carbohydrates, and vitamins, minerals, and phytochemicals. RH324 is being developed in accordance with the FDA Guidance for Industry for Botanical Drug Products (Chemistry June 2004/revised Dec 2016).

On October 25, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that new pre-clinical data leveraging an mRNA platform to develop in-vivo chimeric antigen receptor macrophage ("CAR-M") will be presented as a late-breaking abstract (#LBA1514) at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting held from Wednesday, November 1, to Sunday, November 5, 2023, in San Diego, California (Press release, Carisma Therapeutics, OCT 25, 2023, View Source [SID1234636343]). Two posters highlighting next-generation enhancements to Carisma’s CAR-M platform, including a custom intronic shRNA approach and data on Engineered Microenvironment Converters (EM-C), will also be presented. Additionally, Carisma will share a trial-in-progress poster overviewing its Phase 1 first-in-human (FIH) study design of its lead program, CT-0508, sharing objectives and eligibility criteria.

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Carisma will participate in the virtual SITC (Free SITC Whitepaper) 2023 Annual Meeting Press Conference on Wednesday, November 1, 2023, from 12:00–1:30 pm PT.

"We are excited to present this pre-clinical data from our collaboration with Moderna for the first time," said Steven Kelly, President and Chief Executive Officer of Carisma. "Over the past year, we have leveraged the expertise of both companies to pioneer the development of in-vivo mRNA/LNP-based cell therapy. The study is exploring the potential for an off-the-shelf treatment approach to enhance therapeutic benefit for patients living with cancer."

Oral & Poster Presentations:

In vivo CAR-M: Redirecting endogenous myeloid cells with mRNA for cancer immunotherapy
Primary Author: Bindu Varghese, PhD
Presentation Type/#: Oral – 1514
Session Date/Time (PT): Friday, November 3, 2023, 11:30 am, Session 104: Late Breaking Abstract Session
CAR-Macrophages with custom intronic shRNA exhibit enhanced efficacy against solid tumors
Primary Author: Chris Sloas, PhD
Presentation Type/#: Poster – 307
Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
Engineered Microenvironment Converters (EM-C): Macrophages expressing synthetic cytokine receptors reverse immunosuppressive signals in solid tumors
Primary Author: Chris Sloas, PhD
Presentation Type/#: Poster – 389
Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
A Phase 1, First in Human (FIH) study of autologous macrophages engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants (pts) with HER2 overexpressing solid tumors
Primary Author: Kim Reiss, MD
Presentation Type/#: Poster – 635
Session Date/Time: Friday, November 3, 2023, 9:00 am – 7:00 pm
Presentation and posters will be available in the Journal for ImmunoTherapy of Cancer (JITC) supplement once published on Tuesday, October 31, 2023, at 9:00 am ET.

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) Penn Medicine’s Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.