On April 03, 2024 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported it has closed a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management (Press release, Obsidian Therapeutics, APR 3, 2024, View Source [SID1234641757]). Additional new investors participating in the financing include Foresite Capital, Janus Henderson Investors, Novo Holdings A/S, Paradigm BioCapital, RTW Investments, funds and accounts advised by T. Rowe Price Associates, Inc., and Woodline Partners LP. Existing investors Atlas Venture, Blue Owl Healthcare Opportunities, Bristol Myers Squibb, Deep Track Capital, Logos Capital, RA Capital Management, TCGX, Samsara BioCapital and Surveyor Capital (a Citadel company) also participated in the financing.

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Proceeds from the financing will advance Obsidian’s lead engineered tumor-infiltrating lymphocyte (TIL) program, OBX-115, in its ongoing trials for patients with melanoma and non-small cell lung cancer (NSCLC). The Company is focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.

The Company also announced the appointment of Ray Camahort, Ph.D., Partner in the Venture Investments group at Novo Holdings US, to its Board of Directors. "Obsidian’s engineered TIL cell therapy is highly differentiated and has the potential to bring transformational efficacy to patients with solid tumors," said Dr. Camahort. "We look forward to supporting Obsidian’s team on their journey to bring OBX-115 to additional patients."

"Wellington is excited to be supporting Obsidian through its next phase of growth, as the Company continues demonstrating the potential of OBX-115 to address the unmet need of patients with immune checkpoint inhibitor-resistant advanced or metastatic melanoma. The Company has been generating momentum with its novel cytoDRiVE technology and advancing OBX-115 into late-stage clinical trials," commented Irina Margine, Ph.D., Biotech Sector Lead at Wellington Management.

"The strong demand and support from this syndicate of premier investors is a testament to the promise of OBX-115 for patients with treatment-resistant advanced melanoma," said Madan Jagasia, M.D., M.S., Chief Executive Officer of Obsidian. "This financing provides funding through key clinical readouts in melanoma and is the catalyst to continue expanding OBX-115 into NSCLC, where there is significant potential and high unmet need."

About OBX-115

Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. OBX-115 is being investigated in two ongoing and enrolling clinical trials in advanced or metastatic melanoma and NSCLC (NCT05470283 and NCT06060613).

On April 03, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present data from nine studies highlighting advances in methylation-based epigenomic analysis for precision oncology at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 5-10 in San Diego (Press release, Guardant Health, APR 3, 2024, View Source [SID1234641756]).

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Multiple poster sessions will report on the utility of using the Guardant Infinity platform across the continuum of cancer care, ranging from predictive histologic subtyping of tumors to cardiac adverse event prediction. Data will also be presented demonstrating strong performance of Guardant Reveal for minimal residual disease (MRD) detection in breast cancer, allowing quantification of ctDNA even in early-stage disease without the need for a tissue specimen.

"We look forward to sharing new data at AACR (Free AACR Whitepaper), in particular studies demonstrating the potential for epigenomic analysis using the Guardant Infinity platform to advance cancer research," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "These presentations illustrate how epigenomics can unlock the mechanisms of cancer cell regulation that are invisible to genomic testing, allowing us to expand patient eligibility for clinical trials and contributing to targeted therapy development and better-informed patient care."

The Guardant Infinity smart liquid biopsy platform used in many of the studies combines genomic and epigenomic profiling to deliver multidimensional insights that allow researchers and clinicians to characterize and quantify cancer—in areas such as tumor heterogeneity, disease progression and treatment response. The epigenomic insights enable more personalized treatment strategies by increasing accuracy in minimal residual disease detection and monitoring through enhanced ctDNA detection and quantification, and by identifying new patients or predicting response to therapy through novel epigenomic biomarkers.

Full List of Guardant Health Presentations

Poster

Title

Product

Sunday, April 7 | 1:30 – 5:00 pm

406/6

Characterization of whole genome duplication in a genomic cohort of over 14000 cell free DNA samples

GuardantOMNI

969/10

Tumor-agnostic ctDNA monitoring in patients with metastatic HR+/HER2- breast cancer receiving first-line CDK4/6 inhibitor and endocrine therapy

Guardant Infinity

Monday, April 8 | 9:00 am – 12:30 pm

2390/5

Longitudinal assessment of circulating tumor DNA in patients with advanced colorectal cancer: A proposed general statistical framework and visualization tool

GuardantINFORM

2420/16

Evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker utilizing a tissue-free epigenomic assay in early-stage triple negative breast cancer (TNBC)

Guardant Reveal

2490/7

Quantification of tumor fraction and outcomes association in a real-world non-small cell lung cancer (NSCLC) cohort using a tissue agnostic epigenomic circulating tumor DNA (ctDNA) assay

Guardant Infinity

Monday, April 8 | 1:30 – 5:00 pm

3499/21

Non-small cell lung cancer (NSCLC) histology classification using DNA methylation data captured from liquid biopsies

Guardant Infinity

3399/1

Prediction of cardiac adverse events (AE) in trastuzumab treated breast cancer patients (pts) via a comprehensive genomic and DNA methylation blood based assay

Guardant Infinity

3670/15

Reducing the patient burden for ctDNA biomarkers: Advancing small volume home-based collection technologies

Guardant360

Monday, April 8 | 3:05 – 3:20 pm Minisymposium – Oral Presentation

3888

TOP1 mutations mediate cross resistance to ADCs in metastatic breast cancer

GuardantOMNI

The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting can be found at the AACR (Free AACR Whitepaper) website here.

For more information and updates from the meeting, follow Guardant Health on LinkedIn, X (Twitter) and Facebook or visit AACR (Free AACR Whitepaper) booth #3545.

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."

Post this
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.

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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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.