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Kintara Announces Grant from Luxembourg National Research Fund and Cancer Foundation Luxembourg to Support VAL-083’s Mechanism of Action Research in Glioblastoma

On January 12, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that a multiyear research grant from Luxembourg National Research Fund (FNR) and Cancer Foundation Luxembourg has been awarded to Doctor Anna Golebiewska Ph.D., co-leading the NORLUX Neuro-Oncology laboratory with Professor Simone Niclou at the Luxembourg Institute of Health (Press release, Kintara Therapeutics, JAN 12, 2022, View Source [SID1234598633]). The FNR is the main funder of research activities in Luxembourg. The Cancer Foundation Luxembourg is dedicated to patient support and oncology research by providing information to the cancer patient community on preventing, screening and living with the disease. The two organizations jointly fund outstanding projects in the cancer research field. The grant is intended to support Dr. Golebiewska’s research on the mechanism of action for VAL-083’s utility to treat glioblastoma (GBM). Trained as a cellular and molecular biologist, Dr. Golebiewska has been engaged in brain tumor research primarily focused on the biology of GBM with a special interest in tumor heterogeneity, plasticity, and tumor microenvironment.

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Along with co-investigator Dr. Petr Nazarov, Ph.D., Dr. Golebiewska’s research project is titled "Deconvolution of heterogeneity in the Glioblastoma cellular ecosystem for understanding treatment resistance and improving patient stratification (DIOMEDES)," and is based on complementary expertise in GBM biology and computational methods for the deconvolution of the complex biological systems associated with the disease. By combining state-of-the art preclinical models, transcriptomic analyses at the single and bulk cell level, and powerful deconvolution methods, the researchers aim to unravel mechanisms that shape treatment resistance in GBM. They will assess transcriptomic changes upon treatment with Temozolomide (TMZ) and VAL-083 in their GBM patient-derived orthotopic xenografts (PDOXs). Direct treatment of PDOXs will allow for the investigation of transcriptomic transitions towards resistant states at the moment of treatment. This research may lead to improved stratification of patients for personalized therapies.

"The recognition and financial support from this esteemed organization to support VAL-083’s research in Dr. Golebiewska’s laboratory is extremely exciting as it will provide important data to optimize the clinical use of this first-in-class small molecule chemotherapeutic," said Dennis Brown, Ph. D., Kintara’s Chief Scientific Officer. "The findings from this research will help elucidate potential therapeutic targets for innovative combination treatment strategies that involve VAL-083 and importantly, further advance the opportunity to increase therapeutic precision when treating GBM patients."

The DIOMEDES project in addition to Kintara’s other scientific collaborations with investigators at M.D. Anderson Cancer Center, University of California San Francisco, and the University of British Columbia, have helped to refine the understanding of VAL-083’s therapeutic potential as a treatment for multiple oncology indications including platinum resistant ovarian cancer, pediatric cancers such as DIPG and Ewings sarcoma, as well as GBM where the utility of the current standard of care (TMZ) is very limited.

KemPharm to Host Investor Conference Call Detailing Plans for Pipeline Expansion

On January 12, 2022 KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that the Company will host a conference call and live audio webcast on Wednesday, January 19, 2022, at 4:30 p.m. ET, to discuss the Company’s strategy for advancing and expanding its development pipeline. During the call, senior management will provide guidance regarding KemPharm’s future clinical development priorities.

Conference Call Information:

Telephone Access: To access the conference call telephonically, interested participants and investors will be required to register via the following online form: View Source

Once registered, all individuals will be provided with participant dial-in numbers, a passcode and a registrant ID, which can then be used to access the conference call.

Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.

Webcast Access: The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 5:30 p.m. ET, on January 19, 2022.

Crinetics Pharmaceuticals?to Present Corporate and Clinical Update at 40th Annual J.P. Morgan Healthcare Conference?

On January 12, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that Scott Struthers, Ph.D., founder & CEO of Crinetics, will provide a company update at the 40th annual J.P. Morgan Healthcare Conference today, Wednesday, January 12th at 4:30 PM Eastern Time / 1:30 PM Pacific Time (Press release, Crinetics Pharmaceuticals, JAN 12, 2022, View Source [SID1234598631]). A live audio webcast of Dr. Struthers’ presentation may be accessed on the Events page of the company’s website.

During his presentation, Dr. Struthers will discuss Crinetics’ key priorities and anticipated milestones for 2022. These include:

Continued progress in the two ongoing Phase 3 PATHFNDR trials of paltusotine in acromegaly. Both trials remain on track and topline data is expected in 2023.
The initiation of patient dosing in a Phase 2 trial of paltusotine in patients with carcinoid syndrome associated with neuroendocrine tumors (NETs), which is expected in 2022.
Reporting Phase 1 multiple ascending dose (MAD) data for CRN04894, an investigational, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist being developed for the treatment of Cushing’s disease and congenital adrenal hyperplasia, which is expected in 1Q 2022.
The initiation of a Phase 2 trial of CRN04894, which is expected in 2H 2022.
Reporting Phase 1 MAD data for CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist being developed for the treatment of congenital hyperinsulinism, which is expected in 1Q 2022.
The initiation of a Phase 2 trial of CRN04777, which is expected in 2H 2022.
The initiation of IND-enabling studies for a parathyroid receptor type-1 (PTHR1) antagonist, which is expected in 2022. Target indications for this program potentially include hyperparathyroidism and humoral hypercalcemia of malignancy.
"2021 was a transformational year for Crinetics as we achieved a number of important milestones that diversified our clinical pipeline and highlighted the strength of our drug discovery capabilities," stated Dr. Struthers. "We advanced paltusotine into a registrational Phase 3 program and reported Phase 1 clinical proof-of-concept data for both CRN04894 and CRN04777. Each of these data announcements provided additional validation for our drug development roadmap, which aims for early de-risking through animal and healthy volunteer studies leveraging well-established endocrine biomarkers. Looking ahead, we will continue to follow this plan as we work to advance our PTHR1 antagonist program and expand our pipeline. With a talented drug discovery and development team, a steady cadence of catalysts ahead of us, and a strong balance sheet, we believe we are well positioned for sustained success."

QUEST DIAGNOSTICS ANNOUNCES PRELIMINARY FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

On January 12, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that preliminary financial results for the fourth quarter and full year 2021 (Press release, Quest Diagnostics, JAN 12, 2022, View Source [SID1234598630]). Fourth quarter 2021 results reflect higher than expected demand for COVID-19 testing services, while base testing volumes remained steady and consistent with the company’s latest outlook shared on October 21, 2021. The company is scheduled to present virtually today at the 40th Annual J.P. Morgan Healthcare Conference.

Preliminary Fourth Quarter 2021 Results

The company expects fourth quarter 2021 reported revenue to be approximately $2.74 billion, a decrease of 9% compared to $3.00 billion in 2020.

Total volume, measured by the number of requisitions, increased approximately 1.3% in the fourth quarter of 2021 versus the prior year. Total base testing volumes (excluding COVID-19 testing) increased approximately 10% compared to the company’s fourth quarter of 2019, which represents a pre-pandemic baseline. COVID-19 testing volumes in the fourth quarter, which included approximately 7.9 million molecular tests and 0.7 million serology tests, declined compared to the prior year.

The company expects reported diluted earnings per share ("EPS") for the fourth quarter 2021 to be $3.12 compared to $4.21 in 2020. Adjusted diluted EPS for the fourth quarter 2021 is expected to be $3.33, compared to $4.48 in the fourth quarter of 2020.

Preliminary Full Year 2021 Results

The company expects full year 2021 reported revenue to be approximately $10.79 billion, an increase of 14% compared to $9.44 billion in 2020.

The company expects reported diluted EPS for the full year 2021 to be $15.55 compared to $10.47 in 2020. Adjusted diluted EPS for the full year 2021 is expected to be $14.24, compared to $11.18 in 2020.

The full year 2021 results are expected to exceed the company’s latest outlook shared on October 21, 2021. The full year performance reflects an increase in COVID-19 testing services and a steady recovery in the company’s base testing volumes throughout 2021.

Actual results for the fourth quarter and full year ended December 31, 2021 may differ from those indicated as a result of financial closing procedures, final adjustments and other developments that may arise between the date of this announcement and when results for the fourth quarter and full year ended December 31, 2021 are finalized, as well as other risks and uncertainties.

Updated Expectations for 2022

At its Investor Day in March 2021, the company shared a baseline view for 2022, including revenue of at least $8.5 billion and adjusted diluted EPS near the upper end of $7.40 to $8.00. The company reaffirmed this view on its third quarter 2021 earnings call on October 21, 2021.

The company now believes that it will exceed adjusted diluted EPS of $8.00 in 2022, driven by: higher than anticipated current demand for COVID-19 testing services; expected growth in the base business; and the recently announced one-year delay of PAMA cuts; partially offset by inflation, higher labor costs, and investments to accelerate growth. The company will provide a detailed 2022 outlook when it reports fourth quarter and full year 2021 results on Thursday, February 3, 2022.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, a gain on remeasurement of an equity interest, a gain on sale of an ownership interest in a joint venture, gains associated with changes in the carrying value of our strategic investments, costs associated with donations, contributions, and other financial support through Quest for Health Equity, the company’s initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

We are unable to reconcile our preliminary 2022 outlook for adjusted diluted EPS at this time because we cannot, without unreasonable efforts, estimate the impact of the adjustments to our diluted GAAP EPS to provide a reconciliation to adjusted diluted EPS.

HUTCHMED Receives Breakthrough Therapy Designation in China for HMPL-523 for Treatment of Primary Immune Thrombocytopenia

On January 12, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that the Center for Drug Evaluation of China’s National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation ("BTD") to HMPL-523, a novel, investigational spleen tyrosine kinase ("Syk") inhibitor, for the treatment of chronic adult primary immune thrombocytopenia ("ITP") patients who have received at least one prior therapy (Press release, Hutchison China MediTech, JAN 12, 2022, View Source [SID1234598629]).

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

Christian Hogg, Chief Executive Officer of HUTCHMED, said, "ITP is an autoimmune bleeding disorder that can often be serious and can have a significant, multifaceted impact on patients’ health and quality of life. The granting of BTD to HMPL-523 in ITP highlights the unmet need in this treatment setting and the promising clinical value of this novel oral Syk inhibitor. With this designation, we are hopeful that can accelerate the development of HMPL-523 in China."

The BTD is supported by the encouraging results from the Phase Ib study of HMPL-523, which were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The data also supported the initiation of a Phase III trial, ESLIM-01, in China of HMPL-523 in adult patients with ITP in October 2021. Approximately 180 patients are expected to be enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635.

About HMPL-523
HMPL-523 is a novel, investigational, selective small molecule inhibitor for oral administration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.

HUTCHMED currently retains all rights to HMPL-523 worldwide. The ESLIM-01 Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in treating adult patients with primary ITP, an autoimmune disorder that can lead to increased risk of bleeding. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635. HMPL-523 is also being studied in indolent non-Hodgkin’s lymphoma and multiple subtypes of B-cell malignancies in China (NCT02857998), the U.S. and Europe (NCT03779113).

About ITP and Syk
ITP is an autoimmune disorder characterized by immunologic destruction of platelets and decreased platelet production. Patients with ITP exhibit symptoms of petechiae, purpura, and gastrointestinal and/or urinary mucosal tract bleeding.[1] ITP is also associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life, across domains of emotional, functional and reproductive health, and work or social life.[2][3][4][5][6] The incidence of primary ITP in adults is estimated to be 3.3 per 100,000 adults per year with a prevalence of 9.5 per 100,000 adults.[7]

Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treatments are infrequently curative. Despite the availability of several treatments with differing mechanisms of action, chronicity of disease continues to be a problem. Many patients develop resistance to treatment and thereby are prone to relapse.[8] Thus, there remains a significant population of patients who have limited sensitivity to currently available agents and are in need of new treatments.

As platelet destruction in ITP is mediated by Syk-dependent phagocytosis of FcγR-bound platelets, Syk inhibition represents a promising approach to the management of ITP.[9]