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.

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!

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.

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]).

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!

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]

On January 12, 2022 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it has expanded its collaboration agreement with the Developmental Therapeutics Branch (DTB) of the National Cancer Institute (NCI) of the National Institutes of Health (Press release, Lantern Pharma, JAN 12, 2022, View Source [SID1234598628]). The expansion of this collaboration comes after identifying several gene signatures that predict a potential response of a patient’s tumor to Lantern’s drug candidates, LP-184 and LP-284. LP-184 is being pursued as a new therapy across a range of genetically defined solid tumors, including pancreatic cancer and GBM (Glioblastoma Multiforme). LP-184 was presented as a novel agent effective in GBM at SNO (Society of Neuro-Oncology) in November of 2021. LP-284 is being developed as a new therapy for certain leukemias and lymphomas as presented for the first time in December at the 2021 ASH (Free ASH Whitepaper) Annual Meeting.

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!

"This expanded collaboration with the NCI is further evidence of the power of combining multiomic data with our A.I. platform, RADR, to accelerate the cost-effective and biomarker guided development of targeted oncology therapies," stated Dr. Kishor Bhatia, Chief Scientific Officer of Lantern Pharma. "We look forward to publishing our first in human Phase 1 results in peer-reviewed publications and bringing our potential cancer therapies to patients through the power of A.I. and data."

The first phase of the collaboration with the DTB Genomics and Pharmacology Facility at NCI successfully identified biomarker correlations from multiomic NCI datasets that will be used to guide the accelerated development of Lantern’s drug candidates. The biomarker correlations are being used for LP-184 and LP-284 to: 1) uncover insights into the mechanisms of action 2) develop a signature predicting the response of a tumor, 3) prioritize the sub-types of cancer most likely to respond in a manner that would improve the current standard of care and, 4) generate data and models to guide the selection of other approved drugs that can be used in combination with LP-184 and LP-284.

The second phase of the collaboration will leverage the data and functionality provided by NCI’s complementary CellMiner and CellMinerCDB platforms to examine additional multiomic data for more accurate and powerful drug response correlation. This phase will also include data from Project Achilles at the Broad Institute, which is integrated into the CellMiner platform, to compare how Lantern’s complete drug candidate portfolio compares with other anti-cancer drugs under specific genetic and molecular conditions. The additional data and expanded analytic toolbox, including epigenetic, proteomic and microRNA data types, will enable Lantern to further refine multiomic signatures predictive of drug efficacy into a curated list of candidate biomarkers. These biomarkers can be utilized in gene editing and CRISPR technology studies to derisk development decisions and validate additional therapeutic strategies. Lantern will be using this rigorous approach to guide future development initiatives for itself and for potential development and commercial partners.

"The data generated from this collaboration will further advance and scale the capabilities of the RADR A.I. platform for potentially breakthrough drug discovery and development," stated Panna Sharma, CEO of Lantern Pharma. "The new data will drive insights and drug-candidate innovations and also lead to additional biopharma collaboration and partnership opportunities."

Lantern and the NCI expect to publish the research results of this collaboration in peer-reviewed journals. Early data indicates the uniqueness of the correlation of LP-184 with PTGR1 expression compared to other therapeutic agents in the database. Gene correlation comparisons between LP-184 and other DNA targeting agents support LP-184’s potential as a more effective drug candidate in tumors that show resistance to other DNA targeting agents, including synthetic lethal agents.

The data types in the NCI datasets included, DNA mutation, mRNA/ miRNA expression, DNA methylation, DNA copy number and protein data. This data was then used to characterize Lantern’s pipeline of drug candidate and their bioactivity profiles through NCI’s CellMiner platform. These multiomic analyses have provided deeper insights into the mechanism of action, efficacy profile and optimal cancer indications for Lantern’s pipeline of drug candidates in preclinical and clinical development. This analysis has aided in the accelerated development of the DNA damaging agents LP-184 and LP-284. Initial work helped identify several hundred genes whose transcript levels significantly correlated both positively and negatively with pan-cancer sensitivity to LP-184. Additional correlations were found for LP-284 that aided in targeting subsets of blood cancer indications. The expression of PTGR1, which was among the strongest correlations, reinforced a critical component underlying LP-184 sensitivity and was further validated in vitro and in vivo across several tumors.

Several negatively correlated genes confirmed the enhanced LP-184 sensitivity in tumors that harbor compromised DNA repair pathways. For example, the negative correlation of LP-184 sensitivity with methylation of MGMT substantiate the potential for higher sensitivity of LP-184’s efficacy in MGMT methylated tumors – an important therapeutic refractory feature in glioblastomas. The availability of multiomic data such as methylation data and protein data continue to support areas of applicability of such correlations.

LP-184 is being developed for multiple targeted oncology indications. Lantern Pharma intends to further advancing LP-184 as a new, potent treatment option in genetically defined subsets of patient populations in areas of high unmet clinical need, including pancreatic cancers, GBM, and other cancers that are DNA damage repair deficient. The U.S. Food and Drug Administration (FDA) granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer and GBM and other malignant gliomas in August 2021. LP-284 is expected to be developed for multiple hematological indications, including several rare sub-types of leukemia and lymphoma.

On January 12, 2022 Targovax ASA (OSE: TRVX) a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that Innovation Norway has awarded Targovax an NOK 8.2m grant to accelerate product development activities related to the company’s TG mutant RAS vaccine program and planned clinical trials (Press release, Targovax, JAN 12, 2022, View Source [SID1234598627]).

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!

Awarded by: Innovation Norway
Granted amount: NOK 8.2m
Time frame: 2022-2024

Kristin Willoch Haugen, Director of Innovation Norway Oslo Viken, commented: "Through this project Targovax and their partners aim to solve an important part of the great, international societal challenge that cancer represents. Innovation Norway has awarded a significant grant to reduce the development risk in the project, which we believe has a high level of innovation and a great potential for value creation in Norway. The Research Council of Norway has also contributed with funding to this exciting project. "

Dr. Erik Digman Wiklund, CEO of Targovax, added: "We are very pleased to be awarded yet another prestigious grant towards our mutant RAS vaccines, this time from Innovation Norway. Targovax’s TG program is set up to develop innovative novel immunotherapies that target critical mutations in KRAS, a key driver of around 30% of all cancers. With the support from Innovation Norway, we have now secured a total of up to NOK 18m in grant funding, which will allow us to move the TG program forward faster and more broadly, and thus bring benefit to a patient group with poor prognosis and few available treatment options."

On January 12, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported a first patient dosed in the VITALIZE Phase 2B clinical trial (Press release, IMV, JAN 12, 2022, View Source [SID1234598626]). VITALIZE will further evaluate the clinical benefit of IMV’s lead compound, maveropepimut-S (MVP-S), in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL). The contribution of low dose cyclophosphamide (CPA) as an immune modulator will also be evaluated in this trial.

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 VITALIZE study represents a critical step in advancing MVP-S toward registration," said Jeremy Graff, PhD, Chief Scientific Officer at IMV. "We believe this study should help affirm and extend our understanding of the clinical benefit previously seen in r/r DLBCL patients in the SPiReL trial and may support the use of PD-L1 as a biomarker for MVP-S in combination with KEYTRUDA. Importantly, this is an open label study, so we expect to review early data in the summer 2022."

In December 2020, results of the SPiReL study were presented at the ASH (Free ASH Whitepaper) annual meeting. In his presentation, Dr. Neil Berinstein, Principal Investigator of the SPiReL study and hematologist at Sunnybrook Health Sciences Center, describes that MVP-S in combination with KEYTRUDA induced durable clinical benefit and grade 1 or 2 adverse events. PD-L1+ patients demonstrated an objective response rate (ORR) of 75%.

About the VITALIZE Study

The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess MVP-S in combination with KEYTRUDA with or without CPA. Across the arms of this study, the combination will be evaluated in up to 150 subjects with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.

The primary endpoint is Objective Response Rate (ORR), centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (PR+CR) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression. Exploratory endpoints include cell mediated immune response, tumor immune cell infiltration, and biomarker analysis.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.