On July 13, 2022 Myovant Sciences (NYSE: MYOV), reported it will host a webcast and conference call to discuss corporate updates and financial results for its first fiscal quarter, ended June 30, 2022 (Press release, Myovant Sciences, JUL 13, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-first-fiscal-quarter-2022-earnings [SID1234616641]). The webcast and conference call will be held at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time on July 27, 2022.

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Investors and the general public may access the live webcast here. The live webcast can also be accessed by visiting the company’s investor relations page of Myovant’s website at: https://investors.myovant.com/.

The webcast will be archived on the company website for approximately one year.

On July 13, 2022 Lucence reported that it will present new data at the upcoming IASLC 2022 World Conference on Lung Cancer on August 6-9, 2022, highlighting novel applications of its ultrasensitive amplicon-based next generation sequencing technology in the detection and treatment of lung cancer (Press release, Lucence, JUL 13, 2022, View Source [SID1234616658]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Liquid biopsy will continue to transform the way we diagnose, treat, and understand lung cancer," said Min-Han Tan, Founding CEO and Medical Director at Lucence. "Lucence is committed to leveraging our ultrasensitive amplicon-based liquid biopsy technology, AmpliMark, to harvest as much actionable molecular information to help patients at every stage of their journey."

Lucence recently announced the publication of a validation study for its flagship LiquidHALLMARK ctDNA Liquid Biopsy Assay. The study, published in PLOS ONE, establishes LiquidHALLMARK’s performance and identifies actionable biomarkers in 70% of lung cancer patients. In addition to showing high sensitivity of both LiquidHALLMARK and Lucence’s AmpliMark amplicon next-generation sequencing (NGS) platform, external validation with cobas EGFR Mutation Test v2 for lung cancer specimens demonstrated an overall concordance of 84.00% with a 100% concordance rate for EGFR variants above 0.4% VAF.

Abstracts to be presented in poster presentations at the conference build on Lucence’s continued innovation in liquid biopsy in the detection, treatment, and monitoring of lung cancer.

Sensitive Detection of Lung Cancer Using a Multiomic Plasma Cell-Free DNA Sequencing Assay, #2347

A novel combinatorial AmpliMARK-based test measuring ctDNA abundance, cfDNA fragmentation profiles, and cfDNA methylation demonstrated an overall sensitivity of 85% and specificity of 95% for the detection of lung cancer. 14.3% additional lung cancer cases were detected compared to ctDNA detection alone, demonstrating the utility of a multi-signal cfDNA approach for sensitive detection of lung cancer.

Retrospective Analysis of BRCA1/2 Alterations in Advanced NSCLC Using An Amplicon-based NGS Liquid Biopsy Assay, #2472

Lucence’s AmpliMark-powered LiquidHALLMARK assay detected pathogenic BRCA1/2 alterations in the plasma ctDNA of 6.7% (19/285) of metastatic NSCLC patients. BRCA-mutant NSCLC had more somatic mutations and higher plasma cfDNA concentrations compared to BRCA-wildtype NSCLC, highlighting BRCA as a potential biomarker for inclusion in lung liquid biopsy testing.

Peripheral T-Cell Receptor Repertoire Profiling in Non-small Cell Lung Cancer Using an Amplicon-Based Sequencing Assay, #2293

Characterization of NSCLC patient peripheral T-cell receptor repertoire (TCR) using Lucence’s AmpliMark platform shows differences in TCR repertoires by molecular subtypes of NSCLC and treatment status, suggesting that TCR-sequencing can complement plasma-based cfDNA sequencing in treatment selection and monitoring.

On July 13, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported plans to focus on its emerging pre-clinical and early clinical pipeline and to realign its capital resources to drive these efforts (Press release, CytomX Therapeutics, JUL 13, 2022, View Source [SID1234616642]).

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"With the Probody therapeutic platform, CytomX has pioneered a new and strategic field of biologics drug discovery and development. Our leadership position will continue as we incorporate learnings from our broad clinical experience and advance our next wave of innovative product candidates," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "In the context of the challenging current investment climate for biotechnology, we are making a series of changes to ensure CytomX remains well positioned for the future. We are restructuring the organization to focus on our earlier stage capabilities and programs, as well as our partnerships, leveraging our multi-modality Probody platform to accelerate the development of next-generation therapeutics to destroy cancer differently," continued Dr. McCarthy.

Business & Strategy Updates

Strategic realignment to accelerate early-stage pipeline development, including partnered programs, and extend cash runway:
The Company is restructuring its business to prioritize internal investments in its emerging pre-clinical and early clinical pipeline, resulting in a reduction to its workforce, primarily development and general and administrative staff, by approximately 40%.
These changes are expected to extend the Company’s cash runway into 2025.
CytomX is maintaining its robust research, translational, and early development organizations to support ongoing internal pipeline efforts with two Investigational New Drug Applications (INDs) planned for 2023.
CytomX remains committed to its current alliances with AbbVie, Amgen, Astellas, and Bristol Myers Squibb, which include the clinical-stage programs CX-2029, CX-904, and BMS-986249.
The Company will continue to emphasize future business development and new alliance formation as an integral part of its corporate strategy.
Dr. McCarthy continued, "This difficult decision to restructure CytomX regrettably leads to the departure of many valued team members who have been dedicated to our vision and mission and whose contributions have been critical to the Company’s success to date. On behalf of myself and the Board of Directors, we thank them for their efforts and wish everyone the very best in their future endeavors."

Overview of CytomX Pipeline of Conditionally Activated Product Candidates:
New Emerging INDs

Interferon alpha-2b (IFN alpha-2b) program – CX-801 is a wholly-owned IFN alpha-2b Probody. Based on preclinical activity and tolerability studies, CX-801 demonstrated a wide therapeutic index with an enhanced tolerability profile versus unmasked IFN, without compromising its potent antitumor effects. CX-801 has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. An IND submission is planned in 2023.
EpCAM-directed ADC program – CX-2051 is a wholly-owned conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. An IND submission is planned in 2023. CX-2043, CytomX’s DM21-conjugated EpCAM-directed ADC, is being deprioritized.
Current Clinical Programs

T-cell-engaging bispecific (TCB) EGFRxCD3 program – CX-904 is designed to target both the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells. CX-904 is currently in a Phase 1 dose-escalation study and is part of CytomX’s partnership with Amgen.
CD71-directed antibody-drug conjugate (ADC) program – CX-2029 has shown encouraging activity in patients with squamous non-small cell lung cancer in a Phase 2 expansion study. Enrollment in this cohort is complete and a data update is expected in the second half of 2022. CX-2029 is part of CytomX’s partnership with AbbVie.
Ipilimumab Probody program – BMS-986249 and BMS-986288 are Probody versions of the CTLA-4-targeting antibodies, ipilimumab and non-fucosylated ipilimumab, respectively – both being developed by Bristol Myers Squibb. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. BMS-986288 is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors.
CD166-directed ADC program – Praluzatamab ravtansine demonstrated single-agent activity in a Phase 2 study in heavily-pretreated patients with advanced hormone receptor-positive, HER2-non-amplified breast cancer. As announced on July 6, 2022, based on results of a three-arm Phase 2 study, CytomX is deprioritizing internal investment in this program and will be seeking a partnership to further advance the asset.
Anticipated Future Pipeline Milestones

2022

Data update for CX-2029 from the ongoing Phase 2 expansion study in patients with squamous non-small cell lung cancer
Updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer
2023 – second half

IND submissions for CX-801 and CX-2051
Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 6:00 pm ET (3:00 pm PT) to discuss these updates. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. A live webcast of the call can be accessed via the Events and Presentations page of CytomX’s website at View Source

On July 13, 2022 Endevica Bio, a company developing first-in-class peptide drug candidates with better safety and efficacy properties, reported the first patient in its Phase 1 study has been dosed with TCMCB07, the company’s melanocortin‐4 antagonist peptide candidate for the treatment of cachexia (Press release, Endevica Bio, JUL 13, 2022, View Source [SID1234616659]). The study will enroll up to 97 healthy volunteers to assess the safety of TCMCB07, with data expected in the first quarter of 2023.

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Cancer, renal failure and congestive heart failure can generate a high degree of cachexia, which can impact survival and quality of life. This Phase 1 study design in healthy volunteers allows Endevica to have flexibility in the number of indications it will study in its Phase 2 trial.

"This important milestone represents our commitment to rapidly develop TCMCB07, which could be one of the first pharmaceutical treatment interventions to meaningfully improve the effects of cachexia," said Russ Potterfield, CEO and Executive Chairman of Endevica. "If our previous animal results translate to positive human data, TCMCB07 would potentially have a strong impact on patients’ lives across multiple underlying conditions."

About Cachexia

Cachexia is a life-threatening aspect to many diseases. The symptoms of this disease include lack of appetite and a loss of muscle disproportionate to the reduction in caloric intake. People suffering from cachexia often have a more difficult time doing day-to-day tasks, fatigue, a reduced quality of life and reduced survival. In advanced cases, cachexia can lead to multi-organ failure due to high metabolic rate-induced apoptosis. According to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), cachexia is highly prevalent cross malignancies, impacting approximately half of patients with advanced cancer.

About TCMCB07

TCMCB07 is a melanocortin‐4 antagonist peptide candidate in clinical development for the treatment of cachexia. It is designed to be a first-in-class peptide drug with the ability to cross the blood-brain barrier and act on previously inaccessible target receptors to modulate the body’s behavioral and metabolic response to chronic illness. Pre-clinical animal trial results show significant lean muscle mass gain (e.g., a reversal of the cachectic condition) during the administration of the drug. The results have been synchronous across multiple cachexia-inducing insult classes.

On July 13, 2022 EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry with its Asian regional headquarters in Singapore and offices across Japan, China and other countries in the area, and Compai Pharma, an enterprising pharmaceutical company offering full-service commercialisation with offices in Singapore and Malaysia, reported a strategic partnership to expand service across the Asia Pacific region (Press release, EVERSANA, JUL 13, 2022, View Source [SID1234616608]).

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Together, EVERSANA and Compai Pharma will provide medical and commercial resources to healthcare partners to support full market implementation and development for life science and pharmaceutical companies ready to expand into these markets.

"As the needs of clients and their patients continue to grow, so too do our capabilities to scale delivery on a global level," said Jim Lang, CEO, EVERSANA. "The Asia Pacific region is one of the fastest-growing pharmaceutical markets in the world and requires regional expertise to increase patient access. Together with Compai Pharma, we’re now able to drive greater value and services for our clients to support their evolving commercialisation needs."

Capabilities available through the partnership include consulting, market access, medical awareness, education and communication, pharmacovigilance, marketing & sales excellence, as well as distribution and additional services.

"I am deeply honoured and excited to enter this partnership with such an esteemed company as EVERSANA," said Tim Cushway, Founder and Director at Compai Pharma. "Our mission is to work closely with healthcare practitioners across APAC to ensure needed medications and devices are available for patients while also becoming a trusted partner to provide education and updates on the latest in clinical developments. This goal is highly synergistic with EVERSANA’s global ambition."

The partnership with Compai builds on EVERSANA’s continued global growth, including recent expansion across the European Union and the United Kingdom. Additionally in June 2021, EVERSANA announced the growth of its medical communications and integrated compliance services across 18 European countries and in 10 local languages.