On May 31, 2023 RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported that the first patient has been dosed in the Phase 3 trial of RYZ101 in patients with SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior Lutetium-177 labelled somatostatin analogue therapy (Press release, RayzeBio, MAY 31, 2023, View Source [SID1234632315]).

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"Patients with GEP-NETs have very limited options upon progression after Lutetium-177 labelled somatostatin analogue therapy," said Dr. Thomas Hope, M.D., Vice Chair of Clinical Operations and Strategy in the Department of Radiology. "With existing results using Actinium-225 DOTATATE suggesting clinical benefit, we are excited to be moving this therapy forward in the ACTION-1 study."

The Phase 3 trial is a global study and expected to enroll 210 patients, randomized 1:1 between RYZ101 and investigator’s choice of standard of care (SOC), which includes everolimus, sunitinib, or high-dose long-acting SSAs. The primary endpoint for the trial is progression free survival (PFS). Patients randomized to SOC are allowed to crossover to RYZ101 upon disease progression.

"We are very encouraged by the continued interest in and potential of RYZ101. I look forward to working with the GEP-NET community to advance RYZ101 in this important therapeutic indication. RYZ101 was well tolerated in the Phase 1b trial and we look forward to providing updates on efficacy from the Phase 1b trial even as we continue to enroll patients in the Phase 3 trial," said Susan Moran, M.D., M.S.C.E., Chief Medical Officer of RayzeBio.

About gastroenteropancreatic neuroendocrine tumors

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare tumors with an incidence of approximately 18,000 patients annually in the United States. Many GEP-NETs follow an indolent disease course and thus the prevalence of patients with GEP-NETs in the United States is several fold that of the incidence. The prognosis for patients with GEP-NET tumors depends on tumor grade and other histopathologic characteristics. Approximately 80% of GEP-NETs express the somatostatin receptor type 2 (SSTR2). Lutathera is a targeted radiopharmaceutical therapy comprised of a somatostatin analog peptide labeled with the beta-emitting radioisotope Lutetium-177 (Lu177), which received regulatory approval for treatment of adult patients with SSTR+ GEP-NETs in Europe and the United States in 2017 and 2018, respectively. However, most patients who receive Lu177-based somatostatin therapies eventually experience tumor progression and have limited subsequent treatment options.

About RYZ101

RYZ101 is an investigational targeted radiopharmaceutical therapy, designed to deliver a highly potent radioisotope, Actinium-225 (Ac225), to tumors expressing SSTR2. RYZ101 is being evaluated in clinical studies for patients with SSTR+ GEP-NETs who have previously been treated with Lu177-based somatostatin therapies and also in patients with newly diagnosed extensive stage small cell lung cancer. Details of the studies can be found at View Source and View Source

Ac225 for the study was provided by multiple sources including the U.S. Department of Energy Isotope Program.

On May 31, 2023 Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, reported a poster presentation at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting on the miLung small RNA blood test for early-stage lung cancer detection (Press release, Hummingbird Diagnostics, MAY 31, 2023, View Source [SID1234632314]).

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Details of the poster presentation are as follows:

Title: Early detection of lung cancer using small RNAs
Presenting Author: Bruno Steinkraus, PhD, Chief Scientific Officer of Hummingbird Diagnostics
Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Abstract: #3035
Poster Board: #233
Location: Hall A
Date/Time: June 3, 2023 from 8:00 AM – 11:00 AM CDT

On May 31, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the company and its research collaborators will present data from 17 studies that highlight the contribution of Guardant blood tests and real-world data to advances in precision oncology and cancer screening at the 2023 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6 in Chicago (Press release, Guardant Health, MAY 31, 2023, View Source [SID1234632313]).

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Data being presented from multiple studies demonstrate the utility of Guardant Health’s portfolio of cancer tests to help healthcare professionals optimize care for patients at all stages of the disease—from detecting early-stage cancers to identifying the presence of residual disease and delivering insights that inform treatment to improve outcomes.

"We look forward to sharing new data at ASCO (Free ASCO Whitepaper) that demonstrate scientific and clinical advances across the entire continuum of cancer care," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "In particular, research demonstrating the tremendous potential of epigenomic analysis through our new Guardant Infinity platform shows how gaining deeper insights into the tumor microenvironment can help us identify new potential biomarker targets for therapy and predictive markers for treatment resistance."

Featured presentations include:

Guardant Health will present a session highlighting the performance of the Guardant Infinity platform in the detection of homologous recombination deficiency (HRD) status in patients with breast cancer. With HRD prediction, the platform provides a comprehensive, minimally invasive solution for PARPi and DNA damage treatment selection and longitudinal monitoring, and an exploratory platform for investigating epigenetic signals that may underpin resistance. (Abstract 556, Sunday, June 4, 8-11am, Hall A)
Guardant Health collaborators will present a session on the ESR1 mutational landscape and the impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer. The study demonstrates that plasma-based genotyping can detect ESR1 mutations that qualify patients to receive FDA-approved SERD therapy, including repeat testing over time even when an ESR1 mutation was not present in a past sample. The study also explores additional co-mutations ascertained through broad genomic liquid profiling and their impact on patient survival. (Abstract 1074, Sunday, June 4, 8-11am, Hall A)
Guardant Health collaborators will present results from HERALD/EPOC1806, a multicenter, investigator-initiated phase 2 trial of T-DXd for patients with HER2 (ERBB2)-amplified advanced solid tumors identified in cfDNA by Guardant360 (G360) as a part of the Nationwide Cancer Genome Screening Project (GOZILA study) in Japan. Results indicate that T-DXd achieved a high objective response rate and durable response with a manageable safety profile in patients with advanced solid tumors and HER2 amplification detected in cfDNA. (Abstract 3014, Saturday, June 3, 1:15–2:45pm, Grand Ballroom S100bc)
Complete list of Guardant Health and collaborator presentations at ASCO (Free ASCO Whitepaper)

Abstract

Poster

Title (Hall A unless otherwise noted)

Product

Saturday, June 3 | 8:00 am – 11:00 am

3030

228

Changes in ctDNA levels as an early indicator of outcomes in advanced NSCLC treated with TKI: Initial findings from a retrospective aggregate analysis of 8 clinical trials

Guardant360

3053

251

cfDNA NGS detection of fusions acquired as mechanisms of resistance in the post-EGFR setting across multiple solid tumors

Guardant360

3102

300

Efficacy and safety of futibatinib for refractory advanced solid malignancies with FGFR alterations identified in circulating tumor DNA: TiFFANY, A GOZILA-affiliated Trial

Guardant360

2561

403

Clinical outcomes of immune checkpoint inhibitor treatment in patients with classic cold tumors identified to have a high tumor mutational burden via ctDNA

Guardant360

3049

247

ctDNA-based genomic landscape analysis to evaluate molecular brake and gatekeeper mutations in FGFR2 alterations

GuardantINFORM

Saturday, June 3 | 1:15 pm – 4:15 pm

3014

212

Tissue-agnostic efficacy of trastuzumab deruxtecan (T-DXd) in advanced solid tumors with HER2 amplification identified by plasma cell-free DNA (cfDNA) testing: Results from a phase 2 basket trial (HERALD/EPOC1806) (Note: Location is Grand Ballroom S100bc)

Guardant360

TPS6654

145b

Understanding patient acceptance and compliance of a blood-based colorectal cancer screening test

Shield

Sunday, June 4 | 8:00 am – 11:00 am

556

386

Detection of homologous recombination deficiency (HRD) using a novel genomic and epigenomic liquid biopsy assay in patients with breast cancer

Guardant Infinity

9133

121

Investigating racial inequities of circulating tumor DNA (ctDNA) use in patients with non-small cell lung cancer: A real world analysis

Guardant360

1074

295

ESR1 mutational landscape and impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer

Guardant360

1081

302

Real-world outcomes of patients with advanced breast cancer with and without resistance alterations detected in cell-free circulating tumor DNA prior to CDK4/6 inhibitor plus endocrine therapy treatment

GuardantINFORM

9029

17

Impact of EML4-ALK fusion variant and co-occurring TP53 mutation on treatment duration of first-line next-generation ALK TKIs in ALK fusion+ NSCLC

GuardantINFORM

Monday, June 5 | 8:00 am – 11:00 am

3540

240

Does serial circulating tumor DNA (ctDNA) monitoring identify additional acquired actionable alterations in metastatic colorectal cancer (mCRC)?

Guardant360

TPS3625

324b

Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA)

Guardant Reveal

3567

267

Reversion of RAS mutations in metastatic colorectal cancer in the CCTG CO.26 clinical trial

GuardantOMNI

TPS3626

325a

The Ohio State University Guardant Shield Colorectal Cancer Screening Project

Shield

Monday, June 5 | 1:15 pm – 4:15 pm

TPS1610

203a

Screening for high frequency malignant disease (SHIELD)

Shield (Next Generation)

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

For more information and updates from the meeting, follow Guardant Health on LinkedIn and Twitter or visit ASCO (Free ASCO Whitepaper) booth #19119.

On May 31, 2023 LTZ Therapeutics – an immunotherapy-focused biotech company – reported it has raised over $10 million in pre-A+ financing led by Qiming Venture Partners, with co-investor participation from Shunwei Capital, Lihehongxin Venture Capital Partnership and K2 Venture Partners (Press release, LTZ Therapeutics, MAY 31, 2023, View Source [SID1234632312]). The closing of this round brings LTZ’s total funding to approximately $30 million since the company was founded in 2022. The proceeds from this round of funding will be used to continue establishing the company’s platform and pipeline and building LTZ’s global operations team.

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"LTZ has made significant progress, both scientifically and operationally, since it was established last year," said Robert Li, Ph.D., Co-Founder and CEO of LTZ. "We plan to capitalize on our progress by advancing the company’s lead molecule to its first in-human clinical trial in early 2024, completing preclinical validation work of our Innate Engager Platform and continuing to advance other molecules in the company’s portfolio and build our global team. Furthermore, we’re grateful for our scientific team and advisory board as well as the support from our syndicate of investors who acknowledge the exceptional value of our platform and pipeline."

With the addition of three new members, there is now a total of six scientific board members. Joining Sarah Hymowitz, Ph.D.; Greg Cosma, Ph.D. and Lukas Amler, Ph.D., new members include Lillian L Siu, M.D.; Stephen Beers, Ph.D. and Hiroyoshi Nishikawa, M.D., Ph.D.

"LTZ’s strategy to develop a novel Innate Engager Platform for both hematological malignancy and solid tumors as well as its preclinical validation work of selected constructs is extremely promising. This approach could have profound impact on the future of immunotherapy development in China and globally," said Kan Chen, Ph.D., Partner at Qiming Venture Partners.

Additionally, external research collaborations with top-tier cancer hospitals have also been established to support the company’s reverse translational studies – to better understand the cancer biology and immunology in tumor microenvironment.

"The LTZ team is taking a next-generation immunotherapy approach in treating cancer and autoimmune diseases, where there’s a high unmet need," said Rui Li, Partner at Shunwei Capital. "We’re excited about LTZ’s strong leadership and look forward to supporting the company as they develop novel therapies that have the potential to positively impact human health."

About the Science

LTZ is focused on leveraging the power of innate immunity (e.g., macrophages) and elimination of immunosuppression (e.g.,T regulatory cells, cancer-associated fibroblasts) as these areas have been shown to offer tremendous potential for developing innovative and effective therapies. Specifically, LTZ is developing its own novel Innate Engager Platform to effectively activate macrophages in addition to natural killing (NK) cells as effectors to deliver direct anti-tumor and anti-immunosuppressive cell killing as well as promote inflammation in the tumor microenvironment – indirectly resulting in activated adaptive immunity and long-term memory.

On May 31, 2023 Alpha Cancer Technologies Inc. (ACT), a biopharmaceutical company focused on developing and commercializing targeted immuno-oncology and immunomodulation therapies based on its proprietary recombinant human Alpha Fetoprotein (AFP) platform, reported details from the company’s abstract published as part of the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alpha Cancer Technologies, MAY 31, 2023, View Source [SID1234632311]). The ASCO (Free ASCO Whitepaper) meeting will take place in Chicago from June 2-6, 2023.

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"ACT continues to build upon the body of evidence supporting our novel approach of targeting alpha fetoprotein receptors for the treatment of cancer using our truly next-generation ADC technology," said Dr. Igor Sherman, CEO of ACT. "By selectively targeting cancer cells and myeloid derived suppressor cells we can deliver toxins directly to the tumor, leading to enhanced therapeutic efficacy while mitigating many of the side effects associated with traditional ADC treatments. Now across multiple tumor models, we have observed high activity in treatment groups including statistically significant dose-dependent reduction in tumor volume and increased survival. With robust preclinical data demonstrating both safety and efficacy, we look forward to taking ACT-903 into the clinic next year."

The abstract, entitled "Efficacy and safety study of a novel Alpha-fetoprotein (AFP)-Maytansine conjugate in an ovarian xenograft model" was selected by the ASCO (Free ASCO Whitepaper) Scientific Program Committee for publication in the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, a supplement to the Journal of Clinical Oncology. The research used an ovarian xenograft model compared to control with four dosing regimens of the AFP-maytansine conjugate, ACT-903. Tumor growth, survival, and clinical observations were assessed 62 days following implantation. Separately, organoids were cultured from primary reprogrammed tumor cells from two different patients with high-grade serous ovarian carcinoma and treated with ACT-903 to observe cytotoxicity.

The results in the ovarian xenograft models, consistent with prior research conducted by ACT using colorectal xenograft models, show a statistically significant dose-dependent reduction in tumor volume (p<0.001) and increase in survival (p<0.002) in all treatment groups when compared to the control group. All mice survived to the end of the study (day 62) in Groups 1, 3, and 4, and 6 out of 10 mice survived in the lowest dose group. In the control group, all animals were dead by day 38 due to excessive tumor burden. In the highest dose group, 100% of the mice had complete tumor regression with no regrowth at the end of the study. No signs of toxicity were observed in any treatment group. In the two ovarian organoids, ACT-903 demonstrated a cytotoxic effect over 72 hours similar to that of other known anti-cancer agents, such as paclitaxel and cisplatin.

The results from this study demonstrating the safety and efficacy of ACT-903 in ovarian xenograft models and the cytotoxicity observed in patient-derived cancer organoids support advancement of ACT-903 into clinical studies. ACT plans to submit an Investigational New Drug (IND) application for ACT-903 in 2024.