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Adcendo ApS Announces Option License Agreement with Duality Biologics to Enhance Optionality to Further Expand First-in-Class ADC Pipeline

On May 30, 2023 Adcendo ApS ("Adcendo"), a biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, reported the expansion of its current collaboration with Duality Biologics ("Duality"), a clinical-stage biotech company focusing on the discovery and development of next generation antibody-drug conjugate therapeutics (Press release, ADCendo, MAY 30, 2023, View Source [SID1234632234]).

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In January 2023, Adcendo announced an agreement to license Duality’s proprietary, industry leading DITAC (Duality Immune Toxin Antibody Conjugates) linker-payload platform for its lead uPARAP-ADC program in mesenchymal cancers. Under the new MTA and Option License Agreement, Adcendo has the opportunity to nominate ADCs against two novel ADC targets.

The new agreement further broadens and expands the existing collaboration between Adcendo and Duality. Based on the agreement, new targets will be evaluated under MTA with Duality’s linker-payload platform, designed to generate ADCs with superior safety profiles, sustainable payload delivery and release in tumors, and efficient bystander killing of antigen low and negative cells. Following evaluation, Adcendo has the option to gain access to Duality’s next generation ADC platform.

Michael Pehl, Chief Executive Officer of Adcendo, said "We are delighted to deepen our strategic collaboration with Duality, allowing us to progress with our aim to develop highly differentiated novel ADCs for the therapy of hard-to-treat cancers. Duality’s unique and clinically validated DITAC platform is becoming a cornerstone as we further build on our novel pipeline and continue on our way to becoming a leader in the field of ADC cancer therapy."

John Zhu, Chief Executive Officer of Duality Biologics, said "Duality is dedicated to becoming a leading next-generation ADC company. We are very glad to expand our collaboration with Adcendo on breakthrough ADC medicines and apply our platform. We believe the collaboration reflects the mutual recognition of each party’s unique strengths in ADC discovery and development and look forward to supporting the development of innovative ADC drugs."

Lunit and the Japan National Cancer Center Hospital East Partner in AI Pathology to Advance Precision Oncology

On May 30, 2023 Lunit (KRX:328130.KQ), a global provider of AI-powered cancer diagnostic solutions, reported collaboration with the National Cancer Center Hospital East (NCCHE) to evaluate and validate its AI pathology solution for tissue data analysis (Press release, National Cancer Center of Japan, MAY 30, 2023, View Source [SID1234632233]).

This partnership aims to leverage the capabilities of Lunit SCOPE, an AI-biomarker platform, in analyzing Immunohistochemistry and H&E tissue slide data from various clinical trials, including NCCHE’s molecular profiling projects such as SCRUM-Japan MONSTAR-SCREEN. The primary objective is to assess AI’s ability to accurately read known biomarkers such as HER2 and PD-L1, as well as to evaluate the performance of emerging biomarkers like immune phenotype, as read by Lunit SCOPE IO, in predicting clinical outcomes in multiple treatment settings.

"Our collaborative research using Lunit’s outstanding AI analysis technology has demonstrated that in addition to assisting in pathological diagnosis, a single slide can predict a response based on biological mechanisms. Working with Lunit and the SCRUM project will bring a new approach to cancer treatment," said the principal investigator of SCRUM-Japan MONSTAR-SCREEN project, Dr. Takayuki Yoshino of the National Cancer Center Hospital East (Kashiwa City, Chiba Prefecture). "We are pleased to collaborate with Lunit and look forward to working towards our goal of leading to further personalized medicine for cancer patients around the world."

This collaboration’s first set of findings will be unveiled at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The finding includes the analysis of AI-assessed tumor-infiltrating lymphocyte (TIL) density in the tumor microenvironment of microsatellite stable (MSS) locally advanced rectal cancer (LARC) samples. The study shows a strong correlation between changes in TIL density during preoperative chemoradiotherapy (CRT) and pathologic complete response (pCR) rate of MSS LARC patients. This finding underscores the potential of tumor microenvironment (TME) analysis by Lunit SCOPE IO to predict favorable outcomes.

Lunit and NCCHE remain committed to conducting studies to further validate the findings and to explore AI analysis in additional treatment settings. Additional results and validations from ongoing studies will be shared at future congresses, ensuring transparency and driving further AI-powered tissue data analysis advancements.

"We are delighted to partner with the National Cancer Center Hospital East in the validation of our Lunit SCOPE suite, marking a significant step towards advancing precision oncology and improving optimized patient treatment," said Brandon Suh, CEO of Lunit. "Through this collaboration, we aim to unlock the full potential of Lunit SCOPE to provide an accurate and efficient analysis of tissue slide data. Our goal is to equip clinicians and researchers with powerful tools that can transform oncology practices, drive more informed clinical decision-making and ultimately improve patient outcomes."

DEBIOPHARM LAUNCHES PHASE 1 RESEARCH IN SMALL CELL LUNG CANCER WITH WEE1 INHIBITOR DEBIO 0123 TO OUTSMART DDR IN SMALL CELL LUNG CANCER

On May 30, 2023 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported the first patient dosed in its open-label, multicenter, Phase 1 study evaluating Debio 0123, an oral, potent, highly selective and brain penetrant WEE1 inhibitor, in combination with carboplatin and etoposide in patients with recurrent or progressive SCLC following standard platinum-based chemotherapy (Press release, Debiopharm, MAY 30, 2023, View Source [SID1234632232]). This Phase 1 study, NCT05815160 (Debio 0123-SCLC-104), comprises two parts, namely a dose escalation phase to identify the recommended dose and an expansion phase, to characterize the safety, tolerability, and initial signal of antitumoral activity of Debio 0123 in combination with carboplatin and etoposide in this patient population.

SCLC is a highly aggressive, hard-to-treat cancer with poor prognosis, representing 15% of all lung cancers. It is characterized by an extraordinarily high proliferative rate, leading to early metastasis, most of which are already present at the time of diagnosis.1 Moreover, SCLC carries a massive variety of structural mutations and cell populations inside the tumor.1 This diversity in cell populations is known to play a critical role in tumor evolution, metastasis, and acquired resistance to available therapies. In the attempt to find new therapies, targeting the DDR pathway has shown great promise when combined with DNA-damaging agents such as carboplatin and etoposide.

The Debio 0123 program originates from a growing awareness of DDR inhibition in fighting life-threatening cancers. Optimizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123. With the fruition of these factors, Debio 0123 could become the first choice WEE1 inhibitor.

"Small cell lung cancer is the most aggressive type of lung cancer, and frequently presents with metastatic disease. Despite initial responses to front-line therapy these are typically transient, and survival at 5 years is infrequent. With this program we hope to show that Debio 0123 combined with one of the current standard of care treatments may extend the lives of recurrent small cell lung cancer patients." Dr. Luis Paz-Ares Rodríguez, Coordinating Investigator.

"This combination might succeed in strategically enhancing antitumoral activity and delay the resistance to carboplatin and etoposide combination in patients with recurrent SCLC." expressed Dr. Esteban Rodrigo Imedio, Senior Medical Director, Oncology Research & Development, Debiopharm.

About Small Cell Lung Cancer (SCLC)

Lung cancer is the leading cause of cancer mortality worldwide with a yearly estimate of 250,000 new cases and 200,000 deaths globally.1 SCLC is most prevalent in men over 70 years of age, however the proportion of cases of women has risen over the past 50 years due to a popularization of tobacco consumption.1 SCLC, an aggressive high-grade malignant epithelial tumor, is deadly, highly metastatic, and highly mutagenic.1 Because of these traits and despite 30 years of clinical trials designed to improve therapies for SCLC, the outcomes for this disease still remain poor with a median overall survival from diagnosis of up to 13 months in patients receiving standard of care.2

About Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently in research for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.

About DNA-Damage Repair (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells use their hyperactive DDR response to divide and grow uncontrollably, which promotes cancer expansion. Inhibition of DDR, particularly in combination with other anticancer agents, induces an overall arrest in the uncontrollable cancer cell cycle. This ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm’s WEE1 and USP1 inhibitors, are being tested in clinical and preclinical studies.

Carisma Therapeutics to Present at Upcoming Healthcare Industry Conferences in June 2023

On May 30, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the Company will present at several healthcare industry conferences in June 2023 (Press release, Carisma Therapeutics, MAY 30, 2023, View Source [SID1234632230]). These conferences include:

2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Yara Abdou, MD, will present trials in progress poster during the meeting:
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
Saturday, June 3, 2023, at 8:00 am CT
Chicago, Illinois

2023 Fierce Biotech Next Gen Virtual Event

Michael Klichinsky, Pharm.D., Ph.D., Co-Founder & Chief Scientific Officer will give a presentation on Carisma’s revolutionary CAR-M approach.
Tuesday, June 13, 2023 at 10:00 am ET
Virtual
Register to view webcast here.

CHI’s Immuno-Oncology Summit Europe

Tom Wilton, Chief Business Officer, will give a presentation titled "CAR-M: Driving Anti-Tumor Immunity with Chimeric Antigen Receptor Macrophages."
Wednesday, June 21, 2023, at 5:10 pm BST
London, United Kingdom

The Cell and Gene Therapy Conference

Michael Klichinsky, Pharm.D., Ph.D., Co-Founder & Chief Scientific Officer will give a presentation titled "Development of CAR macrophages – a novel approach for solid tumor immunotherapy."
Saturday, June 24, 2023 at 2:30 pm ET
King of Prussia, Pennsylvania
A replay of webcasts, when available, will be posted and archived at Carisma’s Investor Events webpage for a limited time following the event.

Ascentage Pharma’s Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

On May 30, 2023 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has recommended olverembatinib (HQP1351), Ascentage Pharma’s lead novel drug candidate, for a Breakthrough Therapy Designation (BTD) for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment (Press release, Ascentage Pharma, MAY 30, 2023, View Source [SID1234632229]).

This marks the second BTD granted to olverembatinib by the CDE, with the first one granted in March 2021 for the treatment of patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). A New Drug Application (NDA) for this indication was accepted by the NMPA in July 2022 and subsequently granted a BTD that will support a full approval of olverembatinib. To date, olverembatinib has been granted two Priority Review Designations that underscored the drug’s promising therapeutic utility.

BTDs are commonly granted to innovative drugs and modified novel drugs that are intended for the prevention or treatment of serious life-threatening diseases and/or conditions that severely impact the quality of life for which there is no existing treatment or where sufficient evidence indicates advantages over currently available treatment options. Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress. Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA). In conclusion, granting of BTDs effectively accelerates development and review of innovative drugs and modified novel drugs presenting significant clinical value or addressing urgent unmet clinical needs.

GIST is a type of malignancy that arises in mesenchymal tissues of the gastrointestinal tract, and most patients with GIST harbor KIT or PDGFRA mutations. The introduction of TKIs has significantly improved the prognosis of these patients. However, patients with SHD-deficient GIST, a rare subtype of GIST, still have considerable unmet medical needs. It is known to the research community that patients with SDH-deficient GIST are commonly insensitive to existing TKIs. Although patients with early-stage localized disease can benefit from surgical treatment, most of them eventually experience relapse[1]-[5]. At present, there is no standard of care for patients with relapsed or advanced SDH-deficient GIST, whose 5-year event-free survival (EFS) is only 24%[1]-[5].

Olverembatinib, a third-generation TKI being jointly commercialized in China by Ascentage Pharma and Innovent Biologics, is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation. While being clinically developed and adopted for the treatment of hematologic malignancies, olverembatinib also showed potent antitumor activity against GIST in preclinical models and early clinical studies, including particularly promising efficacy in patients with SDH-deficient GIST. Results from an ongoing Phase Ib/II study of olverembatinib in China showed an impressive clinical benefit rate (CBR) of 93.8% in patients with this subtype of GIST[6]. Based on these promising results, the study was selected for presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for two consecutive years. (Olverembatinib is an investigational drug that has not been approved for any indication in the US.)

"We are highly appreciative of the regulator’s recognition of olverembatinib’s clinical potential," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "This BTD indicates olverembatinib’s promising therapeutic utility in SDH-deficient GIST, marking a major milestone in its clinical development for nonhematologic indications. Moving forward, we will maintain close contact with the CDE to expedite the clinical development program in China and allow patients to benefit from this novel therapeutic as soon as possible."