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.

On April 3, 2024 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, is scheduled to present at the following virtual investor conferences (Press release, Geron, APR 3, 2024, View Source [SID1234641740]):

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23rd Annual Needham Virtual Healthcare Conference

Wednesday, April 10th at 10:15 a.m. ET (Fireside Chat)

Stifel’s 2024 Virtual Targeted Oncology Days

Wednesday, April 17th at 11:30 a.m. ET (Corporate Presentation)
A webcast of each fireside chat and corporate presentation will be available through the Investor Relations section of the Company’s website under Events. An archive of the webcast will be available on the Company’s website for 30 days.

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 3, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical company investigating REM-001 in an NIH-sponsored and funded open label study in cutaneous metastatic breast cancer, and TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that they have entered into a definitive agreement for an all-stock transaction forming a company with expertise and resources to advance a risk diversified late-stage oncology pipeline (Press release, Kintara Therapeutics, APR 3, 2024, View Source [SID1234641741]). The combined company will focus on advancing TuHURA’s personalized cancer vaccine(s) and first-in-class bi-functional ADCS, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name "TuHURA Biosciences, Inc." and to trade on The Nasdaq Capital Market ("Nasdaq") under the ticker "HURA". The transaction is expected to close in the third quarter of 2024.

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Robert E. Hoffman, Kintara’s President and Chief Executive Officer, commented, "Following a thorough review and evaluation of opportunities to rebuild value for Kintara shareholders, we believe merging with TuHURA, a Phase 3 immuno-oncology company focused in two compelling areas of research, represents the best path forward for our stockholders and has the potential to deliver near and long-term value. Our board believes that the combined company will be well-positioned to develop powerful new therapies with the potential to overcome resistance to current immunotherapies, an area of significant unmet need."

TuHURA’s technologies are being developed to overcome primary and acquired resistance– two major obstacles to cancer immunotherapy’s ability to treat and cure cancer.

Immune Fx (IFx) Personalized Cancer Vaccines Harnessing the Power of the Innate Immune Response: TuHURA’s IFx technology utilizes a proprietary plasmid DNA ("pDNA") or messenger RNA ("mRNA") which, when introduced into a tumor cell, results in the expression of a highly immunogenic bacterial protein (emm55) on the surface of the tumor cell. TuHURA’s lead program, IFx-2.0, is designed to harness the power of the patient’s innate immune response, which has evolved over time to detect foreign pathogens like bacterial proteins. By making the surface of a tumor look like a bacterium, IFx-2.0 is designed to use the tumor itself as the source of foreign tumor neoantigens to prime and initiate an innate immune response against the tumor, thereby restoring the cancer immunity cycle and allowing checkpoint inhibitors like Keytruda to work where they previously failed to work.

IFx-2.0 expects to be entering a Phase 3 trial as adjunctive therapy with the checkpoint inhibitor Keytruda, to improve tumor response rate when compared to Keytruda alone in the first line treatment of patients with advanced or metastatic Merkel cell carcinoma. This single, placebo-controlled registration directed trial is expected to be conducted under the FDA’s Accelerated Approval Pathway and is expected to begin enrollment in 2H-2024. The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint like Overall Response Rate.

Bi-Functional Antibody Drug Conjugates ("ADCs"): Targeting Myeloid Derived Suppressor Cells ("MDSCs") to Modulate Their Immunosuppressive Effects on the Tumor Microenvironment: Leveraging its proprietary Delta receptor technology, TuHURA is developing first-in-class bi-functional ADCs that target MDSCs, which are cells that are responsible for creating an immunologic sanctuary for the tumor through their immunosuppressing effects on the tumor microenvironment ("TME"). The TME is the tissue surrounding a tumor, and MDSCs are cells that are characterized by the ability to suppress both innate and adaptive immune responses and are generally believed to be responsible for T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. Utilizing its bi-functional ADCs to inhibit the immune suppressing effects of MDSCs, while localizing an immune checkpoint inhibitor or T cell activator in the TME, TuHURA believes it may be able to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies, allowing them to continue working while potentially reducing off-tumor severe side effects resulting from checkpoint released indiscriminate T cell toxicity to normal tissues.
"With IFx-2.0 readying to enter a single Phase 3 registration trial, we believe this is the optimal time for TuHURA to transition from a private company to a public company. This proposed merger with Kintara lets us achieve that goal while combining the resources of the two companies. Coupled with a $31 million subscribed financing by TuHURA in connection with the merger agreement, and which is expected to fund the combined company’s operations and development programs through late 2025, we believe this merger will also allow our combined company the flexibility to focus our resources and efforts on advancing IFx-2.0 to market and our other drug candidates toward human clinical trials," said Dr. James Bianco, President and Chief Executive Officer of TuHURA. "This transaction with Kintara serves as a significant next step in our continued commitment to patients to develop novel therapies to overcome the major obstacles that limit the effectiveness of immunotherapies to treat and cure cancer."

About the Proposed Transaction, Management & Organization

Under the terms of the merger agreement, subject to stockholder approval, on a pro forma basis, post-merger Kintara equityholders are expected to collectively own up to approximately 2.85%, or approximately 5.45% including the shares underlying the contingent value rights (CVR) to be received by certain of Kintara’s equityholders as described below, of the common stock of post-merger combined company on a pro forma fully diluted basis. TuHURA equityholders are expected to collectively own approximately 97.15%, or 94.55% assuming the distribution of the CVR shares, of the common stock of combined company on a pro forma fully diluted basis.

Pre-merger Kintara common stockholders, certain warrant holders and certain preferred stockholders of record of Kintara will receive a CVR, entitling the holder to receive shares of Kintara common stock to be issued upon achievement of the CVR milestone. The Kintara CVR shares will be issued and distributed once 10 patients are enrolled and tracked in a study to determine whether a lower dose of REM-001 elicits a treatment effect similar to that seen in prior REM-001 studies. Once completed, the company will seek to out-license or identify an acquirer for the technology.

The merger agreement has been approved by the boards of directors of both companies and is subject to stockholder approval of both companies and other customary closing conditions. The proposed merger is expected to close in the third quarter of 2024.

Following the merger, the combined company will be headquartered in Tampa, Florida, and the executive officers are expected to be James Bianco, MD as President and Chief Executive Officer, and Dan Dearborn, CPA as Chief Financial Officer. The merger agreement provides that the board of directors of the combined company will be composed of five members, with four members initially designated by TuHURA and one member initially designated by Kintara.

Lucid Capital Markets, LLC is acting as the exclusive financial advisor and Lowenstein Sandler LLP is acting as legal counsel to Kintara. H.C. Wainwright & Co. is acting as the exclusive financial advisor and Foley & Lardner LLP is acting as legal counsel to TuHURA.

Conference Call & Webcast Details

The companies plan to hold a joint conference call and webcast today, April 3, 2024 at 8:30 AM ET to discuss the Merger details.

Interested participants and investors may access the conference call and webcast via the Investors section of the Kintara website at www.kintara.com and on TuHURA’s website, tuhurabio.com. A webcast replay will be available following the live event and will be accessible for 90 days.

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).