On March 23, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and a live audio webcast on Wednesday, March 30th, 2022, at 8:00 a.m. EDT, to report fourth quarter and full year 2021 financial results and provide business updates (Press release, BiomX, MAR 23, 2022, View Source [SID1234610762]). To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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On March 23, 2022 Novocure (NASDAQ: NVCR) reported the results of a pre-specified interim analysis for the phase 3 pivotal INNOVATE-3 study evaluating the safety and efficacy of Tumor Treating Fields (TTFields) together with paclitaxel for the treatment of patients with platinum-resistant ovarian cancer (Press release, NovoCure, MAR 23, 2022, View Source [SID1234610761]).

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An independent data monitoring committee (DMC) reviewed the safety data for all platinum-resistant ovarian cancer patients enrolled on the trial. In addition, an analysis of overall survival was performed on the first 540 patients randomized. The interim analysis did not indicate a need to increase the sample size and the DMC recommended that the study should continue to final analysis as planned.

"Completion of the DMC interim analysis represents the next milestone in our journey to address the significant unmet need for patients diagnosed with platinum-resistant ovarian cancer," said Dr. Ely Benaim, Novocure’s Chief Medical Officer. "I would like to thank our investigators and collaborators, ENGOT and The GOG Foundation, as well as our patients for their passion and bravery. We look forward to reviewing final data next year."

The INNOVATE-3 study is designed to evaluate the safety and effectiveness of TTFields together with paclitaxel in patients with platinum-resistant ovarian cancer. There remains a significant unmet need for treatments for platinum-resistant ovarian cancer, for which approximately 16,000 patients are diagnosed each year in the U.S. The primary endpoint of INNOVATE-3 is overall survival. Secondary endpoints include progression-free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life. The study accrued 540 patients as of October 2021 and data will be reviewed in 2023, following an 18 month follow-up period.

The European Network for Gynaecological Oncological Trial groups ("ENGOT") and The GOG Foundation, Inc. ("GOG"), third-party clinical trial networks, are collaborating with Novocure on the trial. Both ENGOT and GOG were involved in the development and facilitation of the trial at leading cancer centers in Europe and the United States.

About Ovarian Cancer
In the U.S., ovarian cancer ranks fifth in cancer deaths among women, with approximately 24,000 women diagnosed each year. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old.

Physicians use different combinations of surgery and pharmacological therapies to treat ovarian cancer, depending on the stage of the disease. Surgery is usually used in early stages of the disease and is usually combined with chemotherapy, including paclitaxel and platinum-based chemotherapy. Unfortunately, the majority of patients are diagnosed at an advanced stage when the cancer has spread outside of the ovaries to include regional tissue involvement and/or metastases. Platinum-based chemotherapy remains part of the standard of care in advanced ovarian cancer, but most patients with advanced ovarian cancer will have tumor progression or, more commonly, recurrence. Almost all patients with recurrent disease ultimately develop platinum resistance, and the prognosis for this population remains poor.

About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 22,000 patients have been treated with TTFields therapy.

On March 23, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its President and Chief Executive Officer, Rodney Varner, will provide an overview of the Company’s gene therapies for cancer and diabetes to investors at the 2022 BIO Europe Spring Investor Conference (Press release, Genprex, MAR 23, 2022, View Source [SID1234610760]).

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Conference Details:

Event: BIO Europe Spring Investor Conference
Conference Dates: March 28-31, 2022
Presentation Time: Available on-demand throughout duration of the conference
Presenter: Rodney Varner, President and Chief Executive Officer
Conference Registration: https://bit.ly/3hNGjcW

At the event, Mr. Varner will be available to participate in virtual one-on-one meetings with registered participants. A recording of this presentation will be available for replay on Genprex’s website for a period of time.

On March 23, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that it has launched Lucid Test Centers in three new metropolitan areas—Seattle, Washington, Portland, Oregon, and Boise, Idaho. Patients in these cities with chronic heartburn, also known as gastroesophageal reflux disease ("GERD"), and an order from their own physician or from a telemedicine physician provided to them after self-referral, can now undergo a brief, non-invasive, office-based test to detect esophageal precancer before it progresses to deadly esophageal cancer (Press release, Lucid Diagnostics, MAR 23, 2022, View Source [SID1234610759]). The test centers are staffed with Lucid-employed nurse practitioners who use Lucid’s EsoCheck Cell Collection Device ("EsoCheck") to collect surface esophageal cells which are sent for Lucid’s EsoGuard DNA Esophageal Test ("EsoGuard"). Lucid believes EsoGuard and EsoCheck constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths, through the early detection of esophageal precancer in at-risk GERD patients.

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"This launch represents another important milestone for Lucid and our EsoGuard commercialization efforts"

"This launch represents another important milestone for Lucid and our EsoGuard commercialization efforts," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "We now have completed the first stage of our Lucid Test Center program, an important pillar of our growth strategy—with test centers in seven metropolitan areas in the Southwest and Pacific Northwest".

"Our experience since the launch of our first test center in Phoenix, approximately six months ago, has validated our commercial strategy, which places a strong emphasis on driving primary care physician (PCP) orders for EsoGuard testing at Lucid Test Centers. During this period, we have honed our sales processes and training programs to drive this strategy. We are well positioned to proceed to the next stage of our Lucid Test Center program, with accelerated expansion into larger states across the nation. We have built a robust compliance program which allows us to proceed with this expansion, including in states with more complex laboratory regulations," Dr. Aklog added.

The new Lucid Test Centers operate in leased medical office suites located in Seattle, Washington, Portland, Oregon, and Boise, Idaho. Each test center is staffed by an EsoCheck-trained nurse practitioner and medical assistant employed by Lucid. Lucid estimates that a single nurse practitioner can perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office leases costs with only a few tests per week. Each test center will initially be supported with two highly experienced sales representatives targeting PCPs. The test centers will also support Lucid’s EsoGuard Telemedicine Program, operated in partnership with independent third-party telemedicine provider, UpScript, to accommodate EsoGuard self-referrals.

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On March 23, 2022 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported an overview of its innovative pipeline with a focus on five mid- to late-stage assets with first-in-class and/or best-in-class potential at its R&D Update Call (Press release, Merck KGaA, MAR 23, 2022, View Source [SID1234610758]).

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"At Merck KGaA, Darmstadt, Germany we are working to translate our extensive expertise and deep knowledge in key tumors and neurological and immunological diseases with a goal to change treatment paradigms and improve patient outcomes," said Danny Bar-Zohar, Global Head of Development for the Healthcare business of Merck KGaA, Darmstadt, Germany. "With evobrutinib, xevinapant, and berzosertib, we have the opportunity to be not only first-in-class, but potential game-changers in how we treat MS, head & neck cancer and small cell lung cancer going forward."

Advancing Assets with Transformational Potential

Evobrutinib (BTK inhibitor) – A pioneering development program with a new mechanism of action (MoA) for the treatment of patients with relapsing multiple sclerosis (RMS) that has the potential to change the standard of care.

Oral, central nervous system (CNS)-penetrant, covalent Bruton’s tyrosine kinase inhibitor (BTKi) in development for RMS.
MoA combines potent B-cell inhibition to target acute inflammation (associated with relapses) with a central effect on microglia that aims to reduce chronic inflammation (associated with disease progression).
Comprehensive Phase II clinical data support best-in-class potential.
Evobrutinib is the first BTKi to have completed enrollment of the Phase III clinical trial program for relapsing multiple sclerosis, with data readout expected in Q4 2023.
Xevinapant (IAP antagonist) – As a potent oral antagonist of Inhibitor of Apoptosis Proteins (IAP) and the only IAP antagonist in late-stage development, xevinapant builds on our market-leading expertise in squamous cell carcinoma of the head and neck (SCCHN), aimed at maximizing the chances of a cure in locally advanced disease setting.

Ongoing Phase III TrilynX study for previously untreated unresectable locally advanced (LA) SCCHN in combination with platinum-based chemoradiotherapy.
Second global Phase III study to be initiated in the first half of 2022 to evaluate xevinapant in patients with cisplatin-ineligible LA SCCHN.
5-year update of OS data from Phase II study anticipated in 2022.
First launch expected in 2025.
Berzosertib (ATR inhibitor) – The lead candidate in our DNA Damage Response (DDR) inhibitor portfolio and the first ATR inhibitor with positive randomized clinical trial in any tumor type, seeks to exploit the synergistic effect of combining ATR inhibition with topoisomerase I inhibitors

Multiple mid-stage clinical trials in small cell lung cancer (SCLC) build on positive Phase II study results, with the goal of establishing a new standard of care in second-line SCLC.
Study planned for indication expansion in ovarian cancer and potentially in refractory GI cancers.
M1231 (MUC1/EGFR bi-specific ADC) – The first bi-specific ADC (antibody-drug conjugate) from our pipeline that aims to optimize targeting of cancer cells and overcome remaining safety limitations of conventional ADCs.

M1231 delivers a cytotoxic payload to tumor cells expressing both MUC1 and EGFR and has a highly controlled drug-antibody ratio, which is anticipated to increase tumor specificity, selectivity, and efficacy.
Phase I clinical study to characterize the safety and preliminary activity is well underway, and efficacy expansions into late-stage non-small cell lung cancer and esophageal squamous cell carcinoma are expected to begin in 2022.
Enpatoran (TLR7/8 inhibitor) – Oral therapy that aims to overcome limitations of available lupus therapies by providing selective inhibition of lupus-relevant disease drivers, which may increase efficacy while preserving immunity against infections.

Highly specific potential first-in-class immune modulator blocking the activation of Toll-like receptor (TLR)7 and TLR8, known to be activated in lupus.
Initiation of Phase II studies in systemic lupus erythematosus (SLE) / cutaneous lupus erythematosus (CLE) in the first half of 2022.
Advancing the broader pipeline and portfolio

Merck KGaA, Darmstadt, Germany will initiate 11 new studies in 2022 across the early- and late-stage pipeline, including a Phase III confirmatory study with tepotinib in EGFRm MET amplification in NSCLC, five proof-of-concept studies including trials of M1774, an oral ATR inhibitor being evaluated as both a monotherapy and in combination with PARP inhibitors; the JAVELIN Bladder Medley umbrella study in the first-line urothelial carcinoma, combining avelumab with novel investigational agents including our anti-TIGIT M6223 and Nektar Therapeutics’ interleukin-15 (IL-15) receptor agonist, NKTR-255, in the maintenance setting; two first-in-human studies involving M9140, a next-generation ADC based on an internally developed linker-payload technology; and M1069, our dual adenosine receptor antagonist.

"Our rapidly progressing pipeline of in-house–discovered and partnered assets with first-in-class potential demonstrate the deep expertise and collaborative mindset of our R&D organization," said Joern-Peter Halle, Global Head of Research for the Healthcare business of Merck KGaA, Darmstadt, Germany. "We expect exciting new entries and substantial advances of our early- and late-stage pipeline in the next few years."

To access the presentation and a recording, please visit the Company’s website at View Source

Merck KGaA, Darmstadt, Germany’s Commitment to Cancer

Merck KGaA, Darmstadt, Germany is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at View Source

Merck KGaA, Darmstadt, Germany in Neurology and Immunology

Merck KGaA, Darmstadt, Germany has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS – Rebif (interferon beta-1a) and MAVENCLAD (cladribine tablets). Merck KGaA, Darmstadt, Germany aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to KGaA, Darmstadt, Germany`s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have the potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE).

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