On June 2, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, the Prostate Cancer Clinical Trial Consortium (PCCTC) and Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19, reported a strategic collaboration to guide more precise treatment decisions for patients with advanced prostate cancer (Press release, Caris Life Sciences, JUN 2, 2022, View Source [SID1234615480]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The vast majority of men with prostate cancer do not have their tumors molecularly profiled, in part because of the limited targeted therapy options available for this disease," said Brian Lamon, Ph.D., Chief Business Officer at Caris Life Sciences. "We are very pleased to partner with the PCCTC to leverage our industry-leading precision medicine technologies and maximize the potential of molecular learnings from Sorrento’s Maverick trial to positively impact the future of cancer treatments and drive better outcomes for patients with prostate cancer."

The PCCTC was formed to address critically unmet needs in prostate cancer, with a mission to design, implement and complete early-phase process driven clinical trials and translate scientific discoveries to improved standards of care. The Phase 2 Maverick trial

(ClinicalTrials.gov Identifier: NCT05361915) is sponsored by Sorrento and managed by the PCCTC. Utilizing Caris’ unique MI Profile, PCCTC investigators will profile whole exome DNA, whole transcriptome RNA, and proteins from samples collected from participants enrolled in the trial, creating a molecular blueprint to better understand mechanisms of response and resistance following therapy.

Maverick investigator Rana R. McKay, M.D. of the University of California San Diego (UCSD) noted, "This study is the first biomarker clinical trial for patients with the HSD3B1 adrenal-permissive genotype in men with metastatic castration resistant prostate. A growing wave of data demonstrates that such patients exhibit resistance to hormonal treatment. This study tests the efficacy and safety of avibertinib plus abiraterone in this vulnerable patient population." UCSD is one of 67 member sites of the Caris Precision Oncology Alliance, a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research.

"We are excited to partner with Caris and utilize their next generation sequencing platform and data analytics capabilities to evaluate treatment response and resistance patterns in this study," added Jake Vinson, Chief Executive Officer at the PCCTC. "Through this collaboration, we hope to gain knowledge to better guide treatment options for future clinical trial participants, and ultimately all patients with prostate cancer."

Since the launch of its molecular profiling service in 2009, Caris has amassed molecular data on more than 378,000 patients and real-world clinical outcomes on more than 275,000 patients. Caris has the most advanced sequencing laboratories in the world, which allows the company to perform whole exome DNA sequencing and whole transcriptome RNA sequencing on every patient. Caris’ data-driven, molecular insights are changing the landscape of precision medicine with actionable insights from retrospective, epidemiologic and real-time molecular data to enhance research and commercial activities.

On June 2, 2022 Sihuan Pharma and CTTQ-Akeso (Shanghai) Biomed reported that it will cooperate to test Sihuan’s AXL inhibitor paired with CTTQ-Akeso’s anti-PD-1 in patients with solid tumors (Press release, Sihuan Pharmaceutical, JUN 2, 2022, View Source [SID1234615498]). Xuanzhu Biopharm, the novel drug subsidiary of Sihuan, has already been approved to start China trials of its AXL inhibitor in advanced solid tumors and hematological malignancies. CTTQ-Akeso was approved to launch its PD-1 (penpulimab), a product co-developed by Sino Bio and Akeso, as a third-line therapy for Hodgkin’s lymphoma. The companies plan to test the combination in patients with non-small cell lung cancer

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On June 2, 2022 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of stem cell-based delivery of oncolytic viruses, reported that Stephen Thesing, Chief Business Officer, will present a company overview at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 2:00 p.m. ET (Press release, Calidi Biotherapeutics, JUN 2, 2022, View Source [SID1234615413]). The conference will be taking place June 8-10, 2022 in New York City.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On June 2, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported the important and growing role of precision medicine and is working to ensure more people have access to targeted and personalized treatments (Press release, LabCorp, JUN 2, 2022, View Source [SID1234615429]). As part of this effort, the company is announcing a new sponsored testing program aimed at helping advanced non-small cell lung (NSCLC) cancer patients and their physicians make informed treatment and care management decisions through comprehensive genomic insights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The new program is sponsored by Eli Lilly and Company, a global health care leader dedicated to developing and delivering innovative new medicines to make a meaningful difference in the lives of cancer patients. The program will use Labcorp’s OmniSeq INSIGHTSM test, a pan-cancer, tissue-based sequencing test, to provide comprehensive genomic and immune profiling for cases that meet eligibility criteria. The program is designed to increase awareness of and provide enhanced access to more comprehensive testing options for eligible NSCLC patients in order to encompass all indicated guideline-directed genes and biomarkers.

"Comprehensive genomic and immune profiling allows for a much more extensive investigation into biomarkers that can lead to more effective treatment options, access to new clinical trials, and better patient outcomes," said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp. "With OmniSeq INSIGHT testing, people across the country living with lung cancer may be able to receive therapies or be informed of clinical trials that otherwise may not have been available because their specific biomarkers or gene mutations were not found in a single gene test. By equipping oncologists, health care systems and pharmaceutical developers with data-driven insights we are bringing the promise of precision medicine within reach for all."

Comprehensive genomic profiling (CGP) allows physicians to test for all actionable biomarkers that may be present in patients with NSCLC, rather than one or a few biomarkers that can be found using single gene testing. Comprehensive immune profiling tests for immune-related genes to provide novel, differentiating insights into the tumor microenvironment by testing for immune-related genes. These insights help identify potential immunotherapy eligibility. Test results from both genomic and immune profiling are used to help inform oncologists of the most appropriate targeted therapy for their patients.

"Comprehensive genomic profiling helps identify treatment options for patients to better inform targeted therapy selection," said Anthony (Nino) Sireci, M.D., vice president clinical biomarker and diagnostics development, Loxo Oncology at Lilly. "Our collaboration with Labcorp in their efforts to deliver OmniSeq INSIGHT tests to more patients further demonstrates the value of precision medicine and our commitment to making a difference."

Labcorp Oncology is committed to pioneering scientific breakthroughs that make a difference in cancer care through investments in innovative programs such as OmniSeq INSIGHT. OmniSeq INSIGHT is a pan-cancer, solid tumor test that combines two different treatment paradigms—genomic and immune profiling. The test enhances the characterization of the unique genomic biomarkers in a patient’s tumor enabling clinicians to make more informed decisions about personalized treatment approaches that can be more effective and may have fewer side effects, in addition to identifying clinical trials for which patients may be eligible.

On June 2, 2022 Immunicom, Inc., a privately held clinical-stage biotechnology company with a transformative immuno-oncology platform, reported data from its ongoing clinical investigation [NCT04004910] at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Immunicom, JUN 2, 2022, View Source [SID1234615463]). The trial data, detailed by principal investigator Prof. Piotr Wysocki, show that the Company’s Immunopheresis LW-02 Column is a safe, promising immunotherapy that helps spur upregulation of a patient’s TNF-α pathway—an endogenous cytokine broadly recognized for its anticancer characteristics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

As part of Immunicom’s ongoing clinical study, 28 patients with advanced triple negative breast cancer (TNBC) underwent 862 LW-02 Column Immunopheresis procedures. 10 patients received Immunopheresis LW-02 Column as a monotherapy, and 18 patients received it in addition to various chemotherapy regimens. As reflected in the trial data, subtractive therapy with the LW-02 Colum as a monotherapy or adjunct to chemotherapy is safe and achieves effective depletion of soluble TNF-α receptors from plasma. It was also noted that no serious device-related adverse events related to the LW-02 Column have been reported in the trial.

Therapy with the LW-02 Column was performed three times a week for at least 16 weeks by processing two plasma volumes via apheresis per treatment. After 30 minutes of therapy, the mean capture efficiencies for sTNF-R1 and sTNF-R2—the proteins shed by tumors that suppress endogenous TNF-α—were 95.2% and 79.6%, respectively. The LW-02 Column was also found to be highly selective in removing sTNF-R1 and sTNR-R2 from total plasma proteins. The mean total amount of sTNF-R1 & sTNF-R2 that leeched from the LW-02 Column was 109 ng per apheresis session, many orders of magnitude lower than TNF-α concentrations known to trigger clinically meaningful effects.

Commenting on the trial data presentation, Immunicom Chief Clinical Officer Dr. Victoria Manax revealed, "LW-02 Column Immunopheresis data suggest that removing these factors is an increasingly promising modality for cancer patients. The ASCO (Free ASCO Whitepaper) abstract highlights both the LW-02 column’s efficacy and safety profile. Coupled with our AACR (Free AACR Whitepaper) presentation last month, which shared results of the ongoing clinical benefit to patients, even patients with advanced stage cancers, we continue to find evidence that this is an exciting new option in immuno-oncology."

Through the Company’s three ongoing global clinical trials, Immunicom continues to evaluate the safety and efficacy of LW-02 Column Immunopheresis for advanced TNBC as well as other solid tumor types. You can learn more about Immunopheresis and TNBC in Immunicom’s ASCO (Free ASCO Whitepaper) 2022 Abstract presentation.

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom employs a proprietary, high-affinity, molecular capture-ligand binding matrix within the LW-02 Column to remove specific cytokine receptors, soluble TNF-Receptors 1 and 2 (sTNFR-1/2), that are shed by cancer cells into the extracellular tumor microenvironment. sTNF-Rs serve as decoys, binding to tumor necrosis factor alpha (TNF-α) before it can bind to its membrane-embedded sTNF-R receptors to trigger several cell death pathways. The selective removal of decoy sTNF-Rs by the LW-02 Column allows the patient’s immune system to identify and aggressively attack the cancer.

Immunopheresis, like dialysis, is a subtractive therapy that occurs outside the body, in contrast to conventional drugs and biologics that are infused into the patient. Immunopheresis is thus intended to be much better tolerated than chemo- and immunotherapies, allowing for its use as an adjunct with these therapies, possibly in lower doses to reduce their toxicity.