OSE Immunotherapeutics Announces Latest Preclinical Efficacy Data on its Anti-IL-7 Receptor Antagonist OSE-127 in Acute Lymphoblastic Leukemia at the 2022 American Society of Hematology (ASH) Annual Meeting

On December 12, 2022 OSE Immunotherapeutics reported the latest preclinical data on the use of its anti-IL-7 receptor (IL-7R) antagonist OSE-127 for the treatment of B- and T-Cell Acute Lymphoblastic Leukemia (B- and T-ALL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (1) on December 11, 2022 (New Orleans, Louisiana) (Press release, OSE Immunotherapeutics, DEC 12, 2022, View Source [SID1234646949]). This oral presentation has received the meritbased "Abstract Achievement Award" from the peer-review committee.

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The preclinical data on OSE-127 presented at ASH (Free ASH Whitepaper) was generated from a collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany). This collaboration is using patient-derived samples and in-vivo xenograft models to evaluate the therapeutic potential of anti-IL-7R antagonist OSE-127 in targeting and blocking the high and dysregulated IL-7R-expression observed in 84% of B- or T-Acute Lymphoblastic Leukemia (ALL) patients.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to share our collaborative research on OSE-127 in B-ALL and T-ALL with the international scientific hematology research community. By targeting the oncogenic IL-7 pathway and simultaneously triggering leukemia clearance through macrophage-driven phagocytosis, OSE-127 demonstrated great therapeutic potential in both B-ALL and T-ALL patient-derived xenograft experiments to address a significant unmet need for a wide spectrum of leukemia subtypes".

Pr. Denis Schewe (Head of the Pediatrics Department, Otto-von-Guericke-University, Magdeburg and formerly from the University Medical Center Schleswig-Holstein of Kiel) and Dr. Lennart Lenk (Department of Pediatrics I, Christian-Albrechts University Kiel and University Medical Center Schleswig-Holstein, Kiel), leading the research program in collaboration with OSE Immunotherapeutics, state: "Treatment options for T-ALL remain very limited and there is an urgent need for novel immunotherapy approaches to reduce toxicity and to target relapsed or refractory disease in ALL patients. Due to its dual mode of action comprising both antibody-dependent cellular phagocytosis induction and IL-7R-pathway blockade, OSE-127 may represent a promising novel immunotherapy option for ALL patients, including cases with dysregulated IL-7R signaling, particularly in combination with standard of care polychemotherapy. When translated into the clinic, OSE-127 could significantly improve ALL-therapy and the outcome of relapsed/refractory disease."

The 2022 ASH (Free ASH Whitepaper) presentation, entitled "The IL7R-Antagonist OSE-127 Blocks Acute Lymphoblastic Leukemia Development Via a Dual Mode of Action" (2) , reported on the preclinical efficacy of OSE-127 in ALL and on the mechanism of action underlying its anti-leukemic efficacy:

• In a large prospective ALL patient cohort, IL-7R positivity was detected in more than 84% of cases.

• Mechanistically, OSE-127 efficiently targeted leukemic cells not only via its IL-7R antagonist activity but also through macrophage-mediated antibody dependent phagocytosis (ADCP).

• In vivo efficacy of OSE-127 treatment correlated with IL-7R expression levels on patient leukemic cells, independently of IL-7R pathway activity, highlighting IL-7R as a potential predictive biomarker for OSE-127 efficacy in ALL.

• High preclinical efficacy has been observed both in minimal residual disease (MRD) as well as in overt-leukemia patient derived xenograft (PDX) models.

• OSE-127 demonstrated preclinical in vivo efficacy as monotherapy in 96% of tested B- and T-ALL Patient Derived Xenografts (PDXs), including samples from relapse and refractory patients.

• Standard of Care (SOC) poly-chemotherapy synergized with OSE-127 treatment, resulting in increased survival in overt-
leukemia settings, with clearance of the disease in 56% of SOC + OSE127 treated cases.

Additional patent applications were filed in 2021 and 2022 to strengthen the global intellectual property of OSE-127 by covering the use of anti-IL-7R antagonist antibodies with macrophageredirected phagocytic activity for the targeted treatment of IL-7R-positive cancers.

Oncopeptides presents new scientific data at the Annual American Society of Hematology Meeting ASH

On December 12, 2022 Oncopeptides, a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that the company presents new scientific data including one clinical abstract and three preclinical research posters at the Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, ASH (Free ASH Whitepaper), in New Orleans, Louisiana, USA, on December 10-13 (Press release, Oncopeptides, DEC 12, 2022, View Source [SID1234646786]). The clinical abstract evaluated patients with multiple myeloma who were refractory to prior alkylators in the phase 3 OCEAN study. Data shows that melflufen is a safe and effective therapy in patients who are alkylator refractory, regardless of whether they received a prior autologous stem cell transplant or not.
The preclinical posters are based on the Company´s proprietary technology platforms for Peptide Drug Conjugate, PDC, and for NK-cell engagers, "Small Polypeptide based Killer Engagers", SPiKE and have been materialized through partnerships with leading research institutions in Finland, Norway, and Sweden.

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"We are very pleased to present preclinical data for OPDC3, next generation drug candidate from our PDC-platform, which has demonstrated significant activity in various hematological malignancies,"says Klaas Bakker, MD, PhD, Head of R&D and Chief Medical Officer. "Notably, for the first time we are also able to present preclinical data from our affibody-based NK-cell engager, that has strong potential to selectively activate NK-cells in multiple myeloma and other potential hematological malignancies."

Below is a brief description of the abstracts that have been accepted by the American Society of Hematology (ASH) (Free ASH Whitepaper). The abstracts are available at:
View Source

Scientific abstracts First author Publication Disposition
OCEAN (OP-103) Melflufen/dexamethasone compared with pomalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma – Subgroup analysis in patients refractory to prior alkylators F Schjesvold 5776 Abstract only
Potential role of NK cells and ABCB9 gene in melflufen resistance in multiple myeloma P. Sergeev 2673 Poster
The novel peptide drug conjugate OPDC3 is highly effective in different hematological malignancies J.J. Miettinen 4799 Poster
Affibody-based BCMA x CD-16 dual engagers for activation of NK-cells towards multiple myeloma K.A. Giang 4800 Poster

Polymed Biotech completed a new round of financing joint by Shaanxi Junying Jiacheng Pharmaceutical Industry Development Fund for developing PROTAC drugs

On December 12, 2022, Hangzhou Polymed Biopharmaceuticals Co., Ltd. (Hangzhou Polymed Biopharmaceuticals, hereinafter referred to as "Polymed") reported that it has received the funds from Shaanxi Junying Jiacheng Pharmaceutical Industry Development Fund Management Co., Ltd. (hereinafter referred to as "Shaanxi Junying Jiacheng Fund"), thus completing the new round of investment together with Cybernaut Investment and ZJKF Capital Management Co. , Ltd (ZJKF Capital) (Press release, Polymed Biopharmaceuticals, DEC 12, 2022, View Source [SID1234630626]). The funds obtained from this round of financing will be used to support the IND submission and clinical trial planning of the company’s two preclinical candidate compounds (PCCs).

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Based in Hangzhou with offices in Shanghai an Boston, Polymed is focused on discovery and development of novel drugs for high unmet medical need in cancer and autoimmune disease. Polymed’s differentiated discovery platform is designed to tackle "undruggable" drug targets using bifunctional molecules especially PRTOACs. The core leadership team of Polymed consists of three experts with more than 20 years of experience working in top international pharmaceutical companies such as Novartis and Pfizer for new drug research and development. Polymed has established a rich product pipeline on PROTAC and small molecule inhibitors.

The company has also made a major breakthrough of bifunctional small molecule inhibitors. At present, a candidate compound with unique inhibition profile and excellent pharmaceutical properties has been established, and CMC work has been initiated. The new round of funding will enable the advancement of the preclinical program to the clinic, aiming at advancement of the lead programs to preclinical proof of concept and further development of the platform.

Dr. Jason Shaoyun Xiang, founder and CEO of Polymed, believes that the development of new PROTAC drugs is a disruptive technological innovation, and its potential impact may be comparable to that of therapeutic antibodies two decades ago and mRNA vaccines today, bringing about a wave of novel therapeutics. This disruptive technological breakthrough will undoubtedly bring great benefits to patients, and reward those visionary supporters. Dr. Xiang sincerely thanks the team of Saizhibole, Kefa and Matrix Partners for their firm trust in and support to Polymed. Polymed will make full use of its team experience and international advantages to rapidly advance the research and development progress of various projects, and strive to develop more efficacious therapeutics for patients as soon as possible.

Dr. Jia Guo, Managing Director of Shaanxi Junying Jiacheng Fund, said that PROTAC technology has once again illuminated the bright moment of small molecule drugs, making it possible to develop therapeutics for "undruggable targets". Under the leadership of Dr. Jason Shaoyun Xiang, Polymed has built a dual technology platform of PROTAC and multifunctional molecules, developed a rich product pipeline, and obtained remarkable experimental data that may foretell its therapeutic value in clinical trials. Polymed is a rare innovative company in China that is comparable to the international peers, and we look forward to more research progress of Polymed to benefit patients as soon as possible.

Starton Therapeutics’ STAR-LLD Continuous Delivery Shows Superior Tumor Reduction and Progression Free Survival (PFS) Compared to Pulsatile Lenalidomide Treatment in Lenalidomide-Resistant Model

On December 12, 2022 Starton Therapeutics Inc., (the "Company") a clinical stage biotechnology company announced today results from a 28-day efficacy study of STAR-LLD continuous subcutaneous (SC) infusion versus intraperitoneal (IP) lenalidomide in immunomodulatory drug (IMiD)-resistant RPMI CB.17 SCID mice (Press release, Starton Therapeutics, DEC 12, 2022, View Source [SID1234627699]). In this preclinical study: continuous delivery of lenalidomide resulted in significant improvements (p<0.05) in the mean time to treatment failure (TTF) in the 216 mcg/day (42 days) and 288 mcg/day (43 days) groups compared to both vehicle and IP arms.

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Mean tumor volume at the end of the 27 day cycle was ~40% greater in the vehicle and IP-treated animals (1096 an 1042 mm3) compared to continuous doses of 144 mcg/day (742 mm3), 216 mcg/day (707 mm3), and 288 mcg/day (702 mm3). These differences were significant (p<0.05).

"We conducted this study to further analyze our hypothesis that changing the pharmacokinetic profile of lenalidomide may result in clinically superior pharmacodynamic outcomes," said Jamie Oliver, the Company’s Chief Medical Officer. "We are encouraged by these results and believe STAR-LLD has the potential to provide a significant benefit to patients with multiple myeloma, lymphomas, and CLL."

Five groups of animals (n=10 per group) were implanted with RPMI 8226 cells. Overall tolerability was not different between the groups, including variability in body weight which was acceptable across all treatment groups in both studies. In lenalidomide-resistant tumors there was no significant difference in mean TTF between vehicle and IP lenalidomide treated animals.

These data suggest that changing the delivery of lenalidomide to a continuous subcutaneous infusion improves tumor control and tumor volume in lenalidomide resistant tumors.

The Company previously announced an upcoming Phase 1b/2 clinical study in multiple myeloma and is currently targeting enrollment at US sites in the first quarter of 2023.

Update on Acclaim-1 Phase 1 dose escalation cohort study

On December 12, 2022, Genprex reported the Safety Review Committee for the Acclaim-1 Phase 1/2 clinical trial that uses a combination of Genprex, Inc.’s REQORSA and AstraZeneca PLC’s Tagrisso in patients with late-stage non-small cell lung cancer that has activating epidermal growth factor receptor (EGFR") mutations and progression after treatment with Tagrisso, approved escalating the dose in the Phase 1 dose escalation portion of the study from 0.09 mg/kg in the second cohort of patients to 0.12 mg/kg in the third and final cohort of patients (Press release, Genprex, DEC 12, 2022, View Source [SID1234625401]).

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