On June 5, 2022 Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported results of Cadonilimab (PD-1/CTLA-4 Bispecific, AK104) combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer (R/M CC) (Press release, Akeso Biopharma, JUN 5, 2022, View Source [SID1234615588]). The findings were reported in an oral presentation at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.

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Summary of the clinical results:

At dose of 10mg/kg, regardless of CPS status, Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab, the objective response rate (ORR) was 79.3%; in CPS≥1 and CPS<1 population, ORR was 82.4% and 75.0%, respectively. Progression-free survival (PFS) or overall survival (OS) data is not mature by the cut-off date.
Among all evaluable patients treated with the 10 mg/kg dose, 41.4% of the patients were PD-L1-negative patients (CPS<1)
The incidence of ≥3 grade TRAE of the trial was 60.0%.
As of April 18, 2022, the study evaluated the safety of all patients and the efficacy of patients who received at least one tumor evaluation. The results of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab continued the excellent performance of Cadonilimab monotherapy for second-or third-line R/M CC and demonstrating a promising therapeutic solution for all patients with advanced cervical cancer.

Based on the excellent efficacy and safety results of phase II study, Akeso is conducting a phase III study of Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M cervical cancer. In September 2021, Akeso submitted NDA in China for Cadonilimab for the treatment of second-or third-line R/M CC under priority review. In addition, a phase III study of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is also ongoing.

Related Study

FDA has approved Pembrolizumab plus chemotherapy +/- bevacizumab for first-line treatment of persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test (KEYNOTE-826 study). According to the KEYNOTE-826 study, in the Pembrolizumab arm, ORR was 65.9% in the all-comer population and 68.1% in the CPS≥1 population, the percentage of patients with CPS <1 was 11.4%, the incidence of ≥3 grade TRAE was 68.4%. In the placebo arm (placebo plus chemotherapy +/- bevacizumab), ORR was 50.2% in the CPS≥1 population.[1][2]

Reference

[1] Colombo N, Dubot C, Lorusso D, et al; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435.

[2] Disclaimer: the study mentioned above is for reference only. It doesn’t necessarily represent the latest clinical study ongoing for the same indication, and it is not a head-to-head study derived from Cadonilimab clinical trial.

On June 5, 2022 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that yesterday on June 4, 2022, in the Industry Expert Theater during the ASCO (Free ASCO Whitepaper) 2022 conference, Dr. Marnix Bosch made a presentation discussing the Company’s DCVax-L technology for personalized dendritic cell vaccines, the Sawston, UK facility, the manufacturing technology, the development of automation, and preparations for manufacturing scale-up (Press release, Northwest Biotherapeutics, JUN 5, 2022, View Source [SID1234615587]). In addition, a video presentation about the DCVax-L clinical program was screened in the Company’s exhibit booth in the ASCO (Free ASCO Whitepaper) Exhibit Hall.

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These presentations are now available online at View Source

The Industry Expert Theater is not an official event of the ASCO (Free ASCO Whitepaper) Annual Meeting. It is not sponsored, endorsed or accredited by ASCO (Free ASCO Whitepaper), CancerLinq, or Conquer Cancer the ASCO (Free ASCO Whitepaper) Foundation. It is not CME-accredited.

On June 5, 2022 Creatv Bio, Division of Creatv MicroTech, Inc., reported the release of an abstract featuring the results of its LifeTracDx blood test for predicting response of metastatic breast cancer (mBC) to new lines of therapy following a single cycle of therapy induction (Press release, Creatv Bio, JUN 5, 2022, View Source [SID1234615586]). The results will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting June 3-7, 2022, one of the most influential oncology events in the world for presenting new cutting-edge advances in cancer science that will shape the future of cancer treatment.

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Creatv Bio’s poster presents data showing that analysis of circulating stromal cells and circulating tumor cells from the blood of mBC patients undergoing therapy can predict tumor responsiveness to a new line of therapy within a single cycle of treatment, regardless of disease subtype or drug classification, including the cancer vaccine, Bria-IMTTM, developed by BriaCell Therapeutics Corp. (NASDAQ: BCTX) (TSX: BCT).

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 5th, 2022, 8:00AM-11:00AM
Poster Title: Tracking Changes in Circulating Stromal Cells and Circulating Tumor Cells Predicts Responsiveness of New Line Induction in Metastatic Breast Cancer after 1 Cycle of Therapy
Poster Location: Poster number: 48; Abstract number: 3056

Daniel L. Adams, Creatv Bio Director of Clinical R&D, stated, "We are excited for the opportunity to present these results to the leaders in oncology and hope this study leads to larger interventional trials that one day will help all cancer patients. LifeTracDx ‘s ability to rapidly identify MBC patients responding to a new therapeutic regimen after only one cycle of treatment could eventually be used to rapidly assess and alter patient’s therapy in real time, leading to improved patient outcomes."

"We are looking forward to continuing our work with the experts at Creatv Bio as we advance the clinical development of our novel cellular immunotherapy for advanced breast cancer," stated Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell. "We are hopeful that the technology will allow us to better identify breast cancer patients most likely to benefit from novel therapies."

On June 5, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported a collaboration with Arvinas, Inc., to develop FoundationOneLiquid CDx as a companion diagnostic for use with Arvinas’ bavdegalutamide (ARV-110), an investigational novel PROTAC protein degrader targeting the androgen receptor (AR) (Press release, Foundation Medicine, JUN 5, 2022, View Source [SID1234615583]). Arvinas’ bavdegalutamide is being developed for the potential treatment of men with metastatic castration resistant prostate cancer (mCRPC) who have progressed on existing therapies.

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Arvinas is a clinical-stage biotechnology company and a pioneer in the rapidly growing field of targeted protein degradation. Arvinas’ proprietary PROTAC targeted protein degraders, or proteolysis-targeting chimeras, work by harnessing the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. AR activity is a key driver of prostate cancer, which makes the ability to regulate AR signaling an important factor in controlling disease progression.

"We look forward to collaborating with Foundation Medicine to develop a companion diagnostic aimed at improving patient access," said Ron Peck, M.D., chief medical officer at Arvinas. "Foundation Medicine’s deep understanding of cancer genomics, scalable solutions, and regulatory expertise makes them an ideal partner for us as we develop bavdegalutamide as a potential new therapy for men with prostate cancer."

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOneCDx and FoundationOneLiquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies.

"We are proud to serve as an end-to-end partner for Arvinas as they pioneer this new approach to treat cancer," said Sanket Agrawal, chief biopharma business officer, Foundation Medicine. "Bringing our capabilities to this emerging area of biotechnology sets us on an exciting path to deepen our collective understanding of cancer biology and deliver more novel treatment options to patients now and in the future."

Foundation Medicine is an essential partner for biopharma organizations navigating the complexity of cancer care and research. This latest collaboration adds to its more than 65 global biopharma and biotechnology partnerships aimed at getting targeted cancer treatments to patients faster.

About FoundationOneCDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

On June 5, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that results from a Phase 1 dose escalation monotherapy trial with CYT-0851 in a poster titled "Phase 1 Results of CYT-0851 in Patients with Advanced Solid and Hematologic Cancers" (Abstract: 3084, Poster: 76) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois (Press release, Cyteir Therapeutics, JUN 5, 2022, View Source [SID1234615582]).

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"Data presented today from the Phase 1 dose escalation study with CYT-0851 show that the drug has performed well in advanced, relapsed and/or refractory cancer patients: it has desirable pharmacologic properties with an estimated half-life of three days, dose proportional exposure, and a dose dependent, predictable, and favorable safety profile. In addition, anti-tumor activity was observed with disease stabilization and responses in patients with solid tumors and hematologic malignancies, supporting the advancement of CYT-0851, as a potentially first-in-class drug, into Phase 2 expansion cohorts as a monotherapy and Phase 1 in combination with standard of care treatment regimens," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "The Cyteir team continues to execute on the clinical development of CYT-0851 and we look forward to sharing data in the second half of 2022."

Phase 1 Dose Escalation Results

The primary objectives of the Phase 1 dose escalation trial with CYT-0851 were to determine the recommended Phase 2 dose, determine the maximum tolerated dose (MTD) and to evaluate safety and tolerability. Key secondary objectives include determination of the pharmacokinetic parameters, optimal dosing regimen and preliminary anti-tumor activity. As of the April 13, 2022 data cutoff, 80 patients were enrolled across twelve dose-escalation cohorts from 30 mg to 1200 mg total daily dose. Eighty patients were evaluable for safety and 65 patients were evaluable for efficacy.

The maximum tolerated dose was determined to be 600 mg once a day for both solid tumors and hematologic malignancies. The recommended Phase 2 dose is 400 mg once a day, a convenient and commercially attractive schedule.

Key Findings

In solid tumors:

Forty-five patients were response evaluable and one unconfirmed partial response (PR) was achieved in a patient with soft-tissue sarcoma who was treated for almost 11 months
Nineteen patients (42%) had stable disease and twelve patients (27%) had a decrease in target lesion size for an overall disease control rate of 44%
Stable disease (42%) was seen in patients with soft-tissue sarcoma, head and neck squamous cell, pancreatic, ovarian, and breast cancers
In hematologic cancers:

Eighteen patients with non-Hodgkin lymphoma were response evaluable
Responses were seen in patients with follicular lymphoma (1 complete response (CR) and 1 PR) and diffuse large B-cell lymphoma (1 PR)
Three patients with follicular lymphoma, one patient with diffuse large B-cell lymphoma and one patient with hairy-cell leukemia achieved stable disease
Patients responding to CYT-0851 exhibited a durable clinical benefit as evidenced by the more than 18 months of treatment in the patient with follicular lymphoma who achieved a CR
Safety:

To date, CYT-0851 has exhibited a generally well tolerated safety profile with 42% of patients reporting no treatment related adverse events (TRAEs)
At the recommended Phase 2 dose or below, no patient discontinued therapy for TRAEs
The most common TRAEs were fatigue (18%), alopecia (14%), nausea (11%), hyperuricemia (10%), constipation (8%) and anemia (8%)
The dose limiting toxicity was reversible metabolic acidosis, consistent with the mechanism of action of the drug
"The Phase 1 data for monotherapy CYT-0851 has demonstrated promising clinical activity with a manageable safety profile across a wide array of cancers in a heavily pretreated patient population," said Dr. Ryan C. Lynch, Assistant Professor at the Fred Hutchinson Cancer Center and first author of the study. "The broad activity coupled with the mechanistic understanding that CYT-0851 is impacting cancer cell metabolism creates a promising therapeutic approach for use in a wide range of cancers."

CYT-0851 Mechanism of Action Insights Have Potential to Expand into Additional Tumor Types

Based on new molecular, bioinformatic, and biochemical characterization research that has been done at Cyteir to elucidate the mechanism of action of CYT-0851, management believes that the observed effects of CYT-0851 on the viability of cancer cells are due to inhibition of monocarboxylate transporter (MCT) activity and the subsequent disruption of lactate transport. Monocarboxylate transporters are essential proteins in cancer metabolism making MCTs an attractive target for cancer therapy. This new understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types.

Data from the Ongoing Phase 2 Monotherapy Expansion Cohorts and Phase 1 Combination Study Expected in 2H 2022

Cyteir continues to make progress advancing CYT-0851 in monotherapy and combination clinical studies. Enrollment is ongoing in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. Completion of enrollment in stage 1 of this study is expected before the end of 2022. Enrollment is also ongoing in a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: (1) rituximab plus bendamustine; (2) gemcitabine; and (3) capecitabine, in both hematologic malignancies and solid tumors. Initial safety data from this combination study is expected before the end of 2022.