WINNIPEG, MB, Nov. 27, 2020 /CNW/ - Lakeview Hotel Investment Corp. (TSXV: LHIC) (the "Corporation" or "Lakeview") announced today that it will not be able to meet the filing date of November 30, 2020, as provided in National Instrument 51-102 – Continuous Disclosure Requirements, for filing of the following continuous disclosure documents: (i) interim financial statements for the 3-month period ended November 30, 2020; (ii) management's discussion & analysis for the 3-month period ended November 30, 2020 and (iii) certification of filings under section 5.1 of Regulation 52-109 – Certification of Disclosure in Issuers' Annual and Annual Filings (collectively, the "Interim Filings").
The default is due to the outbreak of the novel coronavirus ("COVID-19"), which had a negative impact on Lakeview's business and administrative operations.
Accordingly, the Corporation has applied to The Manitoba Securities Commission (the "MSC") for a Management Cease Trade Order that will prohibit the Chief Executive Officer and the Chief Financial Officer of Lakeview from trading in the securities of the Corporation until such time as the Interim Filings have been filed. The MSC has yet to make a decision on the aforementioned application. The MSC may grant the application and issue the Management Cease Trade Order or it may impose an Issuer Cease Trade Order if the Interim Filings are not filed in a timely fashion.
During the period of default and until filing of the Interim Filings, the Corporation intends to satisfy the provisions of the alternative information guidelines as required by National Policy 12-203 – Management Cease Trade Orders.
The Corporation's management and other insiders are subject to a trading blackout reflecting the principles contained in section 9 of National Policy 11-207 – Failure-to-File Cease Trade Orders and Revocations in Multiple Jurisdictions until the Interim Filings have been completed.
Lakeview plans to complete the Interim Filings on or before December 17, 2020.
Other than disclosed in the Corporation's press releases, there have been no material business developments since September 30, 2020, when the Corporation filed its interim financial statements for the 3-month period ended September 30, 2020.
About the Corporation
Lakeview Hotel Investment Corp is listed on the TSX Venture Exchange under the symbol "LHR". Lakeview Hotel Investment Corp receives income from ownership, management and licensing of hotel properties.
Neither the TSX Venture Exchange nor its Regulation Service Provider (as the term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Lakeview Hotel Investment Corp
NEW YORK, July 24, 2020 /PRNewswire/ -- On the heels of launching their online COVID-19 Resource Center, Jumo Health, the global provider of age appropriate health care resources, has donated a supply of its COVID-19 related resources to hundreds of hospitals whose service areas cover nearly 159 million people. This service has been provided at no cost to the hospitals in partnership with The Hibbert Group.
Using the most recent guidance from the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO), Jumo Health's team of medical researchers, writers, and animators created culturally sensitive print and digital resources to provide information on this specific coronavirus, how to protect yourself and the community to stop the spread, and more.
"We are honored to assist Jumo Health in their efforts to educate people on COVID-19 and other chronic illnesses. We join them in expressing our gratitude to the frontline workers dedicated to fighting this unprecedented pandemic," said Tim Moonan, CEO of The Hibbert Group.
Raising Health Literacy to Alleviate Fear of the UnknownNearly 90% of the population is health illiterate which includes not having access to information that can promote better health outcomes. Building on its commitment to provide patient friendly, evidence based information that addresses the fundamental issues of health literacy - including age, education attainment, and cultural bias - Jumo Health published a suite of highly visual COVID-19 resources that enable patients and caregivers to make informed decisions and act upon physicians' instructions.
"The unfortunate reality is that the COVID-19 pandemic has exacerbated a chronic issue that has plagued the US and world countries for decades and this disparity in health literacy has proven to cripple communities and stifle economies. Thanks to our friends at The Hibbert Group, we are able to work together to ensure access to education at the point of care is available to allow frontline workers to focus on what they do best - administering care," shared Kevin Aniskovich, Jumo Health President and CEO.
To access the COVID-19 Resource Center online, please visit www.JumoHealth.com/covid-19. For more information on how we are here to help you and our community, email firstname.lastname@example.org.
About The Hibbert Group The Hibbert Group is a full service provider of Integrated Marketing Solutions, including International Fulfillment, Database & MCM, and Professional Services.
About Jumo HealthJumo Health develops age appropriate, educational resources for patients and their care circle for use throughout their medical journey.
By working with providers, manufacturers, and advocacy groups, we ensure our resources are available at the moment of diagnosis, during a treatment regimen, or while participating in a clinical trial. With the belief that an informed patient is a compliant patient, Jumo Health designs practical solutions using popular mediums. With experience providing resources to more than 70 countries in 80 languages, covering more than 200 topics, our mixed media solutions range from comic books to animated videos, are evidence based and peer reviewed, and pay careful attention to health literacy and reading comprehension barriers.
View original content:https://www.prnewswire.com/news-releases/jumo-health-assists-hospitals-to-combat-covid-19-with-educational-resources-at-no-cost-301099706.html
SOURCE Jumo Health
RARITAN, N.J., Dec. 5, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today initial data for the Phase 1 first-in-human dose escalation study of talquetamab (JNJ-64407564) for the treatment of relapsed or refractory multiple myeloma (NCT03399799). Talquetamab is a first-in-class, and the only investigational bispecific antibody that targets both GPRC5D, a novel multiple myeloma target, and CD3 on T-cells. Initial results for both the subcutaneous (SC) and intravenous (IV) formulations show encouraging clinical activity against the GPRC5D target, which is highly expressed on multiple myeloma cells and associated with poor prognostic factors.1,2,3 At the SC recommended Phase 2 dose (RP2D), the overall response rate (ORR) was 69 percent (9/13) and 39 percent achieved a very good partial response (VGPR) or better. The data will be featured during the American Society of Hematology (ASH) 2020 Annual Meeting as an oral presentation on Saturday, December 5 at 5:00 p.m. ET (Abstract #290).
"There is a pressing need for continued innovation of multiple myeloma treatments – particularly for patients who have relapsed on other therapies – and the results presented today for talquetamab are encouraging," said Ajai Chari, M.D., Professor of Medicine, the Director of Clinical Research in the Multiple Myeloma Program, and the Associate Director of Clinical Research, Mount Sinai Cancer Clinical Trials Office. "The Phase 1 overall response rate and safety profile support further study of talquetamab in monotherapy and in combination approaches for patients with few options for treatment."
Investigators identified the RP2D of 405 µg/kg SC and concluded subcutaneous treatment may provide an opportunity for less frequent dosing than the intravenous formulation. A response was observed in 6/9 triple-class refractory patients and 2/2 penta-drug refractory patients. Pharmacokinetic results indicate target exposure levels at the RP2D. At the RP2D of 405 µg/kg SC, pharmacodynamic data demonstrate consistent T-cell activation, cytokine production and redistribution.
Patients received talquetamab at doses of 1–180 µg/kg with IV administration and 5–800 µg/kg for the SC formulation. Results from the Phase 1 study showed responses in patients who were treated with talquetamab across dose groups; median time to first confirmed response across all doses was one month (range, 0.2–3).4
The Phase 1 study enrolled patients (n=157) with multiple myeloma who had progressed on, or could not tolerate, any available established therapies. Patients had received a median of six prior lines of treatment (range, 2-20); 87 percent were refractory to the last line of therapy, 82 percent were triple-class refractory, and 33 percent were penta-drug refractory to two or more immunomodulatory agents, two or more PIs, and an anti-CD38 therapy. The study is conducted in two parts: dose escalation (part 1) and dose expansion (part 2).4
In the Phase 1 study, adverse events (AEs) at the RP2D which occurred with a Grade 3 frequency of ≥25 percent among the SC cohort were neutropenia (42 percent). With SC dosing, cytokine release syndrome (CRS) was observed in 64 percent of patients and was low-grade with no Grade 3 or greater CRS events at the RP2D. CRS occurred at a median of two days after dosing, and median duration of CRS was also two days. The incidence of neurotoxicity was five percent at the RP2D, with no patients experiencing Grade 3 or greater events with SC dosing.4
"GPRC5D is a novel target in the treatment of multiple myeloma and, as a bispecific antibody that engages T-cells by also targeting CD3, talquetamab is emerging as a potential therapeutic option for heavily pretreated patients," said Yusri Elsayed, M.D., MHSc., Ph.D., Vice President, Global Head, Hematologic Malignancies, Janssen Research & Development, LLC. "Based on the preliminary efficacy, safety, pharmacokinetic and pharmacodynamic data presented today, we are committed to fully exploring the promise of talquetamab in multiple myeloma."
About TalquetamabTalquetamab is a first-in-class investigational bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, the T-cell receptor.4 CD3 is involved in activating T-cells and GPRC5D is highly expressed on multiple myeloma cells.4,5,6 Results from preclinical studies in mouse models demonstrate that talquetamab induces T-cell-mediated killing of GPRC5D-expressing multiple myeloma cells through the recruitment and activation of CD3-positive T-cells and inhibits tumor formation and growth.6
Talquetamab is currently being evaluated in a Phase 1/2 clinical study for the treatment of relapsed or refractory multiple myeloma and is also being explored in combination studies. The development of the antibody followed Janssen Biotech, Inc.'s licensing agreement with Genmab for use of its DuoBody® technology platform.*
*DuoBody® is a registered trademark of Genmab A/S.
About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.7,8 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that more than 32,000 people will be diagnosed and close to 13,000 will die from the disease in the U.S.9 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.10
About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Smith Sci Transl Med 11(485):eaau7746.2 Pillarisetti Blood 135(15):1232.3 Atamaniuk Eur J Clin Invest 42(9):953. CD3, cluster of differentiation 3; MGUS, monoclonal gammopathy of undetermined significance; SMM, smoldering multiple myeloma.4 Chari A et al. A Phase 1, First-in-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D (GPRC5D) x CD3 Bispecific Antibody, in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM).: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408718/. Accessed November 20205 Labrijn AF et al. Proc Natl Acad Sci USA. 2013;110:5145.6 Cohen, Y., et al. Hematology. 2013 Nov; 18(6):348-51.7 Kumar SK, et al. Leukemia. 2012 Jan; 26(1):149-57.8 American Cancer Society. "What Is Multiple Myeloma?." Available at: https://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed November 2020.9 American Cancer Society: Cancer Facts & Statistics. American Cancer Society | Cancer Facts & Statistics. https://cancerstatisticscenter.cancer.org/#!/cancer-site/Myeloma. Accessed November 2020. 10 American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed January 2020.
Media Contacts:Brian KenneyPhone: +1 215-620-0111
Satu GlawePhone: +49 172-294-6264
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U.S. Medical Inquiries:+1 800-526-7736
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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson