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Medigene Reports Financial Results and Corporate Update for Q3 2023

On October 25, 2023 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results and provided a corporate update for the third quarter of 2023 (Press release, MediGene, OCT 25, 2023, View Source [SID1234636349]). The Company’s Quarterly Statement Q3 2023 is available on Medigene’s website: View Source

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"In the past quarter, we continued to successfully execute our corporate strategy and deliver on our commitments. We have further progressed our lead candidate, MDG1015 with our IND / CTA enabling work and also expanded our pipeline into neoantigens with the annoucement of the lead for MDG2011, which targets KRAS G12V A*11, and the first pre-clinical data presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October. Here, MDG2011 showed significantly enhanced anti-tumor activity and tumor killing of our optimal affinity T cell receptor (TCR) when combined with the PD1-41BB costimulatory switch protein," said Selwyn Ho, Chief Executive Officer at Medigene.

"On our End-to-End Platform, we expanded the license for our PD1-41BB and CD40L-CD28 costimulatory switch proteins to include uses in additional cell types and in Chimeric Antigen Receptor T cell (CAR-T) therapies. Backed by a growing T cell receptor engineered T cell (TCR-T) therapy pipeline, additional armoring, enhancement and optimization technologies, as well as a solid IP-portfolio, we are advancing towards our ambition of developing first-in-class / best-in-class TCR-T therapies for patients suffering from solid tumors. We are confident that by fully leveraging the capabilities of our End-to-End Platform, we will deliver significant value to patients and shareholders."

Financial and Corporate Highlights:

The financial performance in the third quarter of 2023 was in line with the Executive Management Board’s expectations. Revenues in the third quarter 2023 amounted to EUR 1.6 million compared to EUR 1.4 million in the previous year period (9-month period 2023: EUR 4.6 million), primarily from the partnership with BioNTech. Reflecting our commitment towards advancing and expanding the pipeline, R&D expenses for the quarter were EUR 3.2 million compared to EUR 3.3 million in the prior year period (9-month period 2023: EUR 8.4 million).
The Executive Management Board, therefore, maintains its guidance for the fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Accordingly, the Executive Management Board expects revenue in 2023 to be between EUR 5 and 7 million. The Company expects R&D costs ranging from EUR 13 to 16 million. As of September 30, 2023, cash and cash equivalents and time deposits amounted to EUR 21.2 million (December 31, 2022: EUR 33.2 million). Based on current planning, the Company is financed until the fourth quarter of 2024.
In September, the Company’s partner 2seventy bio, together with JW Therapeutics, has announced the acceleration of their T cell-based immunotherapy projects in Greater China. Specifically, the program containing Medigene’s MAGE-A4-targeted TCR is on track to initiate an investigator-initiated study in China by the end of 2023.
Due to the prolonged funding and development pause by Hongsheng Sciences of the partnered program that included Medigene’s NY-ESO-1-targeted TCR, the parties have mutually agreed to terminate the partnership agreement as it relates to the NY-ESO-1 asset in Q3 2023. The return of this asset to Medigene allows Medigene to find a new strategic development partner in Asia, but now for our first-in-class MDG1015 program containing the Company’s optimal affinity NY-ESO-1-targeted TCR.

Research & Development Highlights:

In August, Medigene announced the expansion of the intellectual property (IP) license for its PD1-41BB and CD40L-CD28 costimulatory switch proteins, enabling their application to additional cell types and for use in Chimeric Antigen Receptor T cell (CAR-T) therapies.
In September, the Company was granted a patent by the European Patent Office protecting its PD1-41BB costimulatory switch protein technology. The patent complements the PD1-41BB IP-portfolio with similar patents already granted in the United States, China and Japan.
In September, Medigene delivered on its commitment to select a lead candidate for the second TCR-T therapy program in solid tumors, MDG2011, targeting KRAS (Kirsten rat sarcoma viral oncogene homologue) G12V with HLA-A*11 (HLA, human leukocyte antigen) and being developed in combination with Medigene’s PD1-41BB costimulatory switch protein Medigene’s End-to-End Platform has successfully generated not one but three KRAS G12V-HLA-A*11-directed TCRs, of which the Company has prioritized one as the lead to move forward to the pre-clinical stage for the MDG2011 program.
Subsequent to the quarter, first pre-clinical data on MDG2011 was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 held in Madrid in October 2023. The pre-clinical data presented showed significantly enhanced T cell activity and tumor killing when combining the PD1-41BB costimulatory switch protein with recombinant TCRs not only when directed at the cancer-testis antigen NY-ESO-1/LAGE-1a (MDG1015), but also, presented for the first time, against the neoantigen mutant KRAS G12V.
Describing in detail our End-to-end Platform approach, the paper Evolution by Innovation as a Driving Force to Improve TCR-T Therapies, by Dolores J. Schendel, was published in Frontiers in Oncology, section Molecular and Cellular Oncology in September 2023.

Latest study demonstrates high efficacy in curing invasive non-melanoma skin cancer

On October 26, 2023 Oncobeta reported results from a recently completed study show topical rhenium-188 skin cancer therapy to be a highly effective option for treating non-melanoma skin cancer (NMSC) of up to 3 mm thickness (Press release, OncoBeta, OCT 25, 2023, View Source [SID1234636348]).

NMSCs are the most common cancers seen in the European population and their incidence are rising all over the world,2,3 with 7.7 million cases reported globally in 2017.4 In Australia, 2 in 3 people will be diagnosed with skin cancer in their lifetime and this is likely to increase as the population ages.5

Typically, treatment options for NMSCs include surgery, radiation, and cryotherapy. Surgical intervention is currently the most common treatment for invasive tumors, but it can lead to unfavorable cosmetic outcomes for some presentations.6

A team of researchers in Germany, led by dermatologist Professor Julia Tietze, and funded by OncoBeta GmbH, Germany, investigated the efficacy and safety of topical rhenium-188 ionizing radiation therapy for the treatment of invasive NMSC.

Research lead, Professor Tietze from the University Medical Center, Rostock says, "The study found rhenium skin cancer therapy to be a highly effective treatment for NMSCs, in particular, the cosmetic outcomes on the head and face. The overall conclusion is, while surgery is the gold standard therapy for NMSCs, rhenium skin cancer therapy may be suitable for large tumors, and tumors located on sensitive areas such as nose, ear, or lips; or where surgery would be challenging."

The study involved 22 patients with 40 histologically confirmed NMSCs (57.5% basal cell carcinomas (BCCs), 12.5% cutaneous squamous cell carcinomas (cSCCs), 30% Bowen’s disease lesions). Following the rhenium-188 single-session treatment, the response rate, adverse events, and cosmetic outcomes were assessed at 14 days, 4 months, and 12 months.

The key findings included:

Response rate at 12 months was 97.5% with 95.0% complete responses (clinically or histologically proven).
No adverse events reported during the application of rhenium-188.
Most patients (62.5%) did not experience an adverse event during the trial period.
Most adverse events were reported at 14 days post-treatment, with 20% of lesions itching, 12.5% were painful (mostly minor pain) and 7.5% had a burning sensation.
The majority of treated lesions were not reported to be painful.
At 4 months:
Most lesions (35/40) were clinically healed.
One lesion that only partly responded to treatment and was found to be outside the study inclusion criteria (being 3.8 mm thick).
Beneficially, the size of that tumor was decreased by 75% which meant a reduced surgical procedure.
At 12 months:
Only 3/39 lesions remained potentially suspect, with one confirmed as a newly developed Bowen’s disease.
41% of lesions were graded as either cosmetically superior to the expected result after surgery and/or as barely detectable.
51% of lesions were graded as comparable to successful surgery and/or as detectable but aesthetically appealing, even though 49% of the lesions showed hypopigmentation.
"Surgery for the removal of NMCSs has a high clearance rate of 95% after 5 years, however depending on the size and localization of the lesion, treatment may be painful and it may also lead to disfigurement. This study shows the efficacy of rhenium skin cancer therapy demonstrating a 97.5% response rate with 37 of the 39 lesions showing complete response at 12 months," adds Professor Tietze.

The full report and results of the study have been published in the Journal Clinical Nuclear Medicine – available to healthcare professionals via this link: https://bit.ly/Tietze2023

Study Design and Ethics Approval
Patients were eligible if they had a histologically confirmed BCC or cSCC with an area of <5 cm2 and thickness <3 mm, they were least 18 years of age and were not suitable or not willing to undergo surgery due to comorbidities, specific anatomic location or unsuccessful previous surgical procedures. Exclusion criteria included known primary melanoma near the treatment area, they were undergoing treatment for non-resectable or metastatic melanoma (including BRAF- or MEK-Kinase inhibition), they had significant impaired blood circulation in the treatment area or if they were pregnant. Patients were treated once with 188Re resin with a targeted dose of 50 Gy. The response rate (RR), adverse events (AEs) and cosmetic outcome were assessed at 14 days, 4- and 12-months post-treatment.

All procedures performed in this study were in accordance with the 1964 Helsinki declaration and its later amendments. The study was approved by the local Ethical Committee (A2020-0178). Patients signed written informed consent to participate.

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.3 The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.7

The Rhenium-SCT is a painless*, single session†, non-invasive‡ therapy that provides aesthetic results, even in cases otherwise considered difficult to treat8-10 The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs. The Rhenium-SCT is a precise, personalised8,11 therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient’s skin and the application is safe and simple for the applying physician. Most cases of NMSCs (basal cell carcinoma, squamous cell carcinoma, Bowen’s disease, and Queyrate Erythroplasia) can be treated using the Rhenium-SCT in one single session.8-10† Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.

Good Safety Profile and Antitumor Activity: Oral Presentation of Mabwell’s 9MW2821 at 2023 ESMO

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]).

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.

Medivir to report new and updated data from ongoing phase 2a HCC study as part of its Q3 report on Friday

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.

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.

LEADING RESEARCH INSTITUTES TO PRESENT NEW DATA USING LUNAPHORE’S COMET™ TECHNOLOGY AT THE SOCIETY FOR IMMUNOTHERAPY OF CANCER (SITC) 38th ANNUAL MEETING

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.

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.