Nimble Therapeutics Expands its Drug Discovery Capabilities to Advance Pipeline to the Clinic

On April 03, 2024 Nimble Therapeutics reported the opening of a second R&D site in Philadelphia, PA (Press release, Nimble Therapeutics, APR 3, 2024, View Source [SID1234641755]). The new site, located in B+Labs, a hub for scientific innovation in University City Philadelphia, will focus on progressing Nimble’s growing pipeline of orally-delivered peptide therapeutics into clinical development. The Philadelphia site will synergize with activities at Nimble’s main R&D site in Madison, WI, which is focused on leveraging its proprietary platform to optimize oral peptide therapeutics at unprecedented scale and speed.

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"This is a reflection of the growing maturity of our internal pipeline of orally-delivered peptide therapeutics, and the need to build additional capabilities as we progress candidates into the clinic."

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In addition to the new site, Nimble also announced the appointment of two senior leaders to spearhead the drug discovery efforts and catalyze the build out of the Philadelphia site and team. Shelley Allen will join as Head of Drug Discovery and will lead the advanced optimization and characterization of clinical candidate peptides and their progression into the clinic. Munir Mosaheb will join as Head of Biology and will lead the pharmacological, immunological and translational aspects of Nimble’s drug discovery programs.

Shelley has over 25 years of experience in the discovery and development of high-impact medicines. She joined Nimble from Think Bioscience where she was VP, Medicinal Chemistry, and responsible for establishing drug discovery teams and capabilities to develop their internal programs. Previously, Shelley spent 22 years with Array Biopharma / Pfizer in roles of increasing responsibility, contributing to the discovery of several clinical candidates including oncology therapeutics Vitrakvi and Tukysa. As director of medicinal chemistry at Pfizer, she led teams and programs from lead discovery to IND in the kinase space. Shelley began her career at Rhone-Poulenc Rorer after completing undergraduate studies at DeMontfort University of Leicester. She has published > 40 scientific papers and patents and is active in the American Chemical Society community.

Munir has over 15 years of experience in developing and applying novel immunological insights in academic and biotech settings. Most recently Munir was the Head of Translational Biology and Immunology at Senda Biosciences (now Sail Biomedicines), where he built a Translational Biology team and led platform and program development, and IND-enabling preclinical data generation. Prior to Senda, Munir received broad training across diverse aspects of immunology. He explored molecular vaccinology during his time at Merck & Co. and the Wetzler lab at BU, studied T cell biology while at the Flavell lab at Yale, and immuno-oncology and cell trafficking as a post-doctoral fellow in the von Andrian lab at Harvard.

"We are pleased to open our second R&D site in the Philadelphia area," said Jigar Patel, founder & CEO of Nimble Therapeutics. "This is a reflection of the growing maturity of our internal pipeline of orally-delivered peptide therapeutics, and the need to build additional capabilities as we progress candidates into the clinic."

"I’m thrilled to have Shelley and Munir join us at this exciting stage in the journey of Nimble," said Pete Gough, CSO of Nimble Therapeutics. "They both bring a wealth of experience in the key areas of immunology, drug discovery and pre-clinical development and will be instrumental in building and leading the teams that will take our programs into the clinic."

"As a medicinal chemist of 25 years, I am incredibly impressed by the power and unprecedented speed of the Nimble platform to identify and optimize oral therapeutic peptides. I’m very much looking forward to partnering with our team in Madison to deliver a robust pipeline of clinical candidates to patients," said Shelley.

"Despite the progress we’ve made with parenteral biological therapies for the treatment of immune-mediated diseases over the past couple of decades, patients want oral medicines. Because of our platform, Nimble is uniquely placed to become a leader in developing oral peptide therapeutics as next-generation treatments for these patients and I’m excited to be part of the team to help this vision become reality," said Munir.

Compugen to Participate in Two Upcoming Investor Conferences

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.

AACR 2024 Annual Meeting-Visit Senhwa Biosciences Exhibit Booth

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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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.

Reaction Biology Launches Innovative Offering Within Its Kinase Testing Platform and Presents New Data at the American Association for Cancer Research (AACR) Annual Meeting 2024

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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"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.

Ractigen Announces First Patient Dosed in the Phase I Clinical Trial of RAG-01 for NMIBC

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.