On April 3, 2024 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will participate in the following upcoming investor conferences in April (Press release, Compugen, APR 3, 2024, View Source [SID1234641754]):

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23rd Annual Needham Virtual Healthcare Conference
Date: Wednesday, April 10, 2024, at 8:00 AM ET
Location: Virtual
Format: Presentation

Canaccord Genuity Horizons in Oncology Virtual Conference
Date: Monday, April 15, 2024, at 9:00 AM ET
Location: Virtual
Format: Panel: Novel Immune Checkpoints – There’s more than one way to stimulate a T-cell

Live webcast of the presentation and a replay will be available on the Investor Relations section of Compugen’s website at www.cgen.com. Live webcast of the panel and a replay will be available by contacting your representative at Canaccord Genuity.

On April 3, 2024 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported it will be exhibiting at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, 2024, held in San Diego, California, at the San Diego Convention Center from April 5 to 10 (Press release, Senhwa Biosciences, APR 3, 2024, View Source [SID1234641753]).

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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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The AACR (Free AACR Whitepaper) Annual is one of the biggest and most important events in cancer research, and brings together clinicians, researchers, industry, policymakers, and patient organizations. Senhwa will display a booth for the first time at the conference (Booths: Ground Level #1454, open from April 7-10), showcasing the innovative mechanisms and clinical results of the company’s two new drugs, Pidnarulex (CX-5461) and Silmitasertib (CX-4945) in treating various cancers and the combination with PARP inhibitors and IO therapeutics. The team is very excited to meet its research and medical partners, make new connections, and get updated with the latest advancements in cancer research.

Aside from the booth, the Company will host a dinner reception at the Hilton San Diego Bayfront. Those partner physicians who have worked closely on clinical trials in the United States, Canada, Australia, Taiwan are invited and this event aims to explore more potential collaboration opportunities. a

At the same time, the Senhwa AACR (Free AACR Whitepaper) team is led by CEO, Jin-Ding Huang Ph. D and also includes Ms. Joanne Lo, director of business development, Ms. Mermay Chen, director of strategy and Tzu-I Chao, director of drug development and other managers from the US subsidiary. The company’s major focus is engaging with academic and industry researchers as well as with clinicians in person, and explore more opportunities, which may include cooperation in clinical trials, licensing agreements, introducing late-stage or marketed novel drugs to expand the company’s current product line.

If you are attending this year’s AACR (Free AACR Whitepaper) and wish to learn more about how we can support your research or enroll in our clinical network program, visit us at Booth #1454 or get in touch with our team to schedule your meeting.

See you in San Diego!

About Silmitasertib
Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered with its oral formulation. Silmitasertib is currently under development through several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I and one Phase I/II study of Silmitasertib in oncology, as well as two Phase II trials in infectious diseases, have been completed.

The US FDA has granted Silmitasertib Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.

On April 3, 2024 Reaction Biology ("Reaction" or the "Company"), an industry-leading provider of drug discovery and development services, reported that it will feature its recently launched HotSpot ATP-Max KinomeScreen at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, held April 7-10, 2024, in San Diego, California (Press release, REACTION BIOLOGY, APR 3, 2024, View Source [SID1234641752]).

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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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"ATP-Max KinomeScreen represents our commitment to innovation in kinase testing and further cements Reaction Biology as the leader in kinase innovation for more than 20 years," said Haiching Ma, Ph.D., Chief Scientific Officer of Reaction Biology. "We are now delivering the highest level of sensitivity at 1mM ATP testing on the industry’s largest portfolio of kinase targets using the gold standard filter binding radiometric assay. At AACR (Free AACR Whitepaper) 2024, we are excited to showcase how this advancement will provide customers with even more physiologically relevant data to help identify more potent and specific kinase inhibitors as they advance their discovery programs."

In addition, the Company will present fifteen abstracts highlighting data from its broad end-to-end oncology platform, with products and services ranging from protein production to in vivo services. For additional information on the data to be presented, please visit Reaction’s website.

"We provide biopharmaceutical companies with a comprehensive and robust end-to-end oncology platform," said John H. Johnson, Chief Executive Officer of Reaction Biology. "We maintain more than 2,000 targets across our portfolio of biochemical assays, a wide variety of cell-based assays, including target engagement and 2D/3D cell panel screening, and biophysical assays including SPR. Within our offering, we also have a unique portfolio of in vivo models, including one of the broadest collections of syngeneic tumor models used in conjunction with our in vitro and in vivo immuno-oncology applications, along with InVEST, which is our in vitro safety screening service. Through the work of our highly qualified team of scientists within our state-of-the-art laboratories, we proudly deliver high integrity data with passionate service to help our customers more effectively discover and develop innovative medicines."

New data will be presented on the Company’s innovative assay technologies, preclinical profiling models and proprietary screening platforms. The full range of data to be presented at AACR (Free AACR Whitepaper) include:

Relevance of substrate selection for the results of biochemical WEE1 in-vitro kinase activity inhibition assays
(Sunday, April 7, 2024, 1:30 – 5:30 PM; Poster Section 26, Poster Board Number: 25, Permanent Abstract Number: 648)
Comprehensive 27-marker standard panel for immune monitoring of pre-clinical tumor mouse models using spectral analyzer technology
(Sunday, April 7, 2024, 1:30 – 5:30 PM; Poster Section 3, Poster Board Number: 27, Permanent Abstract Number: 91)
Screening the entire kinase-directed, FDA-approved pharmacopeia against the largest collection of wild-type and mutant kinases reveals many opportunities for drug repurposing and targeted therapy
(Sunday, April 7, 2024, 1:30 – 5:30 PM; Poster Section 39, Poster Board Number: 6, Permanent Abstract Number: 938)
The in vivo Hollow Fiber model is a valuable tool in drug development of selective Kras inhibitors
(Monday, April 8, 2024, 1:30 – 5:00 PM; Poster Section 22, Poster Board Number: 12, Permanent Abstract Number: 3164)
Comparison of MB-49_luc bladder carcinoma cell clones in the orthotopic superficial bladder tumor model in C57BL/6 female mice
(Monday, April 8, 2024, 1:30 – 5:00 PM; Poster Section 10, Poster Board Number: 3, Permanent Abstract Number: 2816)
Biochemical and cell-based assay platforms for development of RAF inhibitors against human cancers
(Tuesday, April 9, 2024, 9:00 AM – 12:30 PM; Poster Section 28, Poster Board Number: 24, Permanent Abstract Number: 4704)
Development and evaluation of a high-throughput method for rapid detection of surface antigen expression in fixed cells
(Tuesday, April 9, 2024, 9:00 AM – 12:30 PM; Poster Section 44, Poster Board Number: 30, Permanent Abstract Number: 5157). These data are in collaboration with 4HF Biotec GmbH.
Potency and selectivity of ERBB2-targeting antibody drug conjugates in vitro
(Tuesday, April 9, 2024, 9:00 AM – 12:30 PM; Poster Section 29, Poster Board Number: 1, Permanent Abstract Number: 4708). These data are in collaboration with 4HF Biotec GmbH.
Development of biochemical screening assays to facilitate drug discovery in RNA m6A modification regulators
(Tuesday, April 9, 2024, 9:00 AM – 12:30 PM; Poster Section 17, Poster Board Number: 21, Permanent Abstract Number: 4417)
Donor-dependent anti-tumoral efficacy of human CD19 CAR T cells in a leukemic xenograft mouse mode
(Tuesday, April 9, 2024, 9:00 AM – 12:30 PM; Poster Section 2, Poster Board Number: 29, Permanent Abstract Number: 4020)
Cell-based PROTAC screening for cancer drug discovery
(Tuesday, April 9, 2024, 1:30 PM – 5:00 PM; Poster Section 30, Poster Board Number: 8, Permanent Abstract Number: 6049)
In vitro cytotoxicity assays to support CAR T cell evaluation against solid tumors
(Tuesday, April 9, 2024, 1:30 PM – 5:00 PM; Poster Section 1, Poster Board Number: 17, Permanent Abstract Number: 5242)
Selectivity profiling of small molecule kinesin inhibitors using microplate-based ATPase activity assay
(Tuesday, April 9, 2024, 1:30 PM – 5:00 PM; Poster Section 18, Poster Board Number: 23, Permanent Abstract Number: 5723)
Paradoxical activation of kinases occurs directly with ATP-competitive kinase inhibitors and is observable biochemically at physiologically relevant drug concentrations
(Tuesday, April 9, 2024, 1:30 PM – 5:00 PM; Poster Section 46, Poster Board Number: 6, Permanent Abstract Number: 6489)
Modulation of human macrophage differentiation, phenotype and function in vitro as a strategy to characterize novel tumor microenvironment modulators
(Tuesday, April 9, 2024, 1:30 PM – 5:00 PM; Poster Section 47, Poster Board Number: 23, Permanent Abstract Number: 6538)
Copies of the poster presentations will be available at Reaction Biology’s booth (#141) during Exhibit Hall hours from April 7-10, 2024.

On April 3, 2024 Ractigen Therapeutics, a pioneer in small activating RNA (saRNA) therapeutics, reported a major milestone with the first patient dosed in its First-in-human phase I clinical trial for RAG-01 conducted in collaboration with GenesisCare, Australia’s leading provider of cancer care services (Press release, Ractigen, APR 3, 2024, View Source [SID1234641751]). This marks a significant advancement in the fight against non-muscle invasive bladder cancer (NMIBC).

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RAG-01 is a groundbreaking saRNA medication designed to combat bladder cancer by targeting and activating the p21 tumor suppressor gene in NMIBC. The trial is an open-label, multi-center study designed to assess RAG-01’s safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy in NMIBC patients who have failed Bacillus Calmette-Guérin (BCG) therapy. Preclinical data indicates that RAG-01 effectively inhibits bladder cancer tumor growth in animal models and has shown a favorable safety profile.

Dr. Long-Cheng Li, Founder and CEO of Ractigen Therapeutics, stated, "The successful administration of RAG-01 to the first patient underscores Ractigen’s robust clinical translation capabilities, signifying an important milestone in our quest to develop innovative treatments for NMIBC patients and to prove the effectiveness of the saRNA platform in real-world applications."

About RAG-01: RAG-01 stands as a pioneering saRNA candidate from Ractigen Therapeutics, engineered to target and activate the tumor suppressor gene p21 via the RNAa mechanism which was discovered by the founding team of Ractigen Therapeutics. The drug, delivered through intravesical instillation using Ractigen’s proprietary LiCOTM delivery technology, has shown significant tumor suppression in mouse orthotopic bladder cancer models. Its development marks a significant stride in RNAa based therapies, addressing the unmet needs of NMIBC patients.

About NMIBC: NMIBC represents 50-80% of all bladder cancer cases. Despite standard treatments like transurethral resection of bladder tumor (TURBT) followed by intravesical BCG or chemotherapy, recurrence rates remain high, estimated at 50-70% within the first five years. RAG-01’s development is a significant step towards addressing this substantial unmet need in bladder cancer therapy.

About LiCOTM: LiCOTM, Ractigen’s proprietary extra-hepatic delivery system, enables the delivery of duplex RNA into a variety of tissues and organs which are harf to reach by conventional approach. It supports multiple administration routes, including subcutaneous, intravenous, intravesical, and intravitreal, providing profound and durable activity. Its versatility and effectiveness have been validated in many preclinical studies, marking it as a cornerstone in Ractigen’s therapeutic arsenal.

About RNAa: Pioneered by Dr. Long-Cheng Li and his team, RNAa is a clinically validated platform technology. It employs saRNA to target gene regulatory domains, activating gene expression and restoring therapeutic protein levels. This technology has vast potential for developing therapeutic drugs across various diseases, especially where traditional methods fall short, including cancer, genetic disorders, chronic diseases, and metabolic and cerebrovascular disorders.

On April 3, 2024 Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the first patient has been dosed in the REJOICE-Ovarian01 Phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer (Press release, Merck & Co, APR 3, 2024, View Source [SID1234641750]). The Phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the Phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy.

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Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck.

Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens.1 The median overall survival for advanced ovarian cancer following recurrence is approximately two years, with a five-year survival rate of less than 30%.2,3 Up to 85% of advanced ovarian tumors have overexpression of CDH6, which is associated with poor prognosis.4,5

The initiation of REJOICE-Ovarian01 is based on results from an ongoing Phase 1 trial of raludotatug deruxtecan presented at the European Society for Medical Oncology Congress 2023 with a subgroup analysis presented at the Society for Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer.

"Raludotatug deruxtecan has shown promising activity in a Phase 1 trial of patients with advanced ovarian cancer," said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo. "The REJOICE-Ovarian01 trial, which is our first trial initiation for raludotatug deruxtecan in collaboration with Merck, will evaluate the efficacy of this CDH6 directed DXd antibody-drug conjugate versus investigator’s choice of chemotherapy in patients with platinum-resistant ovarian cancer."

"The prognosis for the majority of patients diagnosed with advanced ovarian cancer is bleak, with a low five-year survival rate, underscoring the critical need for the development of innovative and effective therapies," said Marjorie Green, MD, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. "We look forward to working with our colleagues at Daiichi Sankyo to further evaluate the potential of raludotatug deruxtecan to provide a new treatment option for patients with platinum-resistant ovarian cancer."

About the REJOICE-Ovarian01 trial

REJOICE-Ovarian01 is a global, multicenter, randomized, open-label Phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant, high-grade ovarian cancer, including primary peritoneal or fallopian tube cancer, who received at least one and no more than three prior systemic lines of anticancer therapy, including prior treatment with mirvetuximab soravtansine for those with documented high-folate receptor alpha expression.

The Phase 2 part of REJOICE-Ovarian01 will assess the safety and tolerability of three doses of raludotatug deruxtecan (4.8 mg/kg, 5.6 mg/kg, or 6.4 mg/kg) to identify the recommended dose for the Phase 3 part of the trial. The primary endpoint of the Phase 2 part of the trial is objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary endpoints include ORR as assessed by investigator, duration of response (DoR), progression free survival (PFS) and disease control rate (DCR) – all assessed by both BICR and investigator – and overall survival (OS).

The Phase 3 part of REJOICE-Ovarian01 will assess the efficacy and safety of raludotatug deruxtecan at the selected dose compared to investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan). The dual primary endpoints of the Phase 3 part of the trial are ORR and PFS as assessed by BICR. Secondary endpoints include PFS and ORR as assessed by investigator, DoR and DCR as assessed by both BICR and investigator, and OS. Pharmacokinetic and biomarker endpoints also will be assessed in both parts of the trial.

The trial is expected to enroll approximately 650 patients across Asia, Europe, North America and South America. For more information, please visit ClinicalTrials.gov.

About ovarian cancer

More than 324,000 women were diagnosed with ovarian cancer worldwide in 2022.6,7 Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens.1 The median overall survival for advanced ovarian cancer following recurrence is approximately two years, with a five-year survival rate of less than 30%.2,3 For patients that develop resistance to platinum-based chemotherapy, treatment options are limited.8

The introduction of targeted therapies has expanded treatment options and improved survival outcomes for some patients with ovarian cancer, but additional options are needed for patients with tumors that progress on available medicines.9

About CDH6

CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, including ovarian tumors.4 An estimated 65% to 85% of patients with ovarian cancer have tumors that express CDH6, which is associated with poor prognosis.4,5 There is currently no CDH6 directed therapy approved for treatment of any cancer.

About raludotatug deruxtecan

Raludotatug deruxtecan (R-DXd) is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

In addition to the REJOICE-Ovarian01 trial, raludotatug deruxtecan is being evaluated in a Phase 1 trial in advanced ovarian cancer as part of a strategic collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN.

About the Daiichi Sankyo and Merck collaboration

Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

About the DXd ADC portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

Designed using Daiichi Sankyo’s proprietary DXd ADC Technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.