On December 14, 2021 Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, reported it has acquired substantially all assets of Labtech Diagnostics, an independent clinical diagnostic laboratory provider serving physicians and patients primarily in South and North Carolina, Georgia and Florida (Press release, Quest Diagnostics, DEC 14, 2021, View Source [SID1234597183]).

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With the acquisition, Quest broadens access to diagnostic innovation and insights empowering better health for more communities in the Southeast. The Labtech laboratory in Anderson joins the national network of Quest Diagnostics laboratories, making it the first full-service laboratory owned by Quest in South Carolina. The acquisition will also enable more physicians in the state to access diagnostic services directly from Quest through its Cleveland HeartLab cardiometabolic center of excellence and other laboratories in Atlanta, Tampa and Greensboro, North Carolina.

"Our acquisition of Labtech Diagnostics delivers on our Accelerate growth strategy in the Southeast and vision of a healthier world," said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. "Establishing a laboratory in South Carolina will enable us to provide diagnostic insights empowering affordable care to more patients and providers while building on our growth aims in the region."

On December 14, 2021 Gretel.ai reported a collaboration with Illumina, Inc. (NASDAQ: ILMN), the global leader in DNA sequencing and array-based technologies, to create privacy-protected, synthetic genomic data that can be accessed by medical researchers anywhere (Press release, Illumina, DEC 14, 2021, View Source [SID1234597167]). This announcement includes the release of a successful study the partnership conducted, which proves the viability of significant new use cases for synthetic data in genomics and related fields including medical diagnosis, biotechnology, forensic biology, virology, and biological systematics. Beyond healthcare and life sciences, synthetic data has already proven effective in privacy-related use cases in other industries, such as finance and gaming, to help augment small data collections and balance biased datasets.

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This strategic partnership will provide healthcare and life science practitioners access to highly statistically accurate, artificial versions of complex genomic datasets that align with GDPR, CCPA, and other major privacy laws. By using synthetic data, researchers can gain access to datasets immediately and avoid lengthy approval processes by institutional review boards (IRBs) that can take anywhere from 6 months to a year today. "We’re thrilled to show what the highest quality synthetic data available can enable when combined with the groundbreaking genomic work of Illumina’s team," said Ali Golshan, co-founder and CEO of Gretel.

This privacy-preserving method of sharing sensitive data will also allow a much more accelerated and collaborative approach to next-generation DNA sequencing analysis — leading to the discovery of new drugs, insights into genetic disorders, and disease detection and treatments, which could be used for variants of COVID-19, for example. "This work will inspire new medical discoveries and breakthroughs, and has the potential to help save millions of lives as well as improve the quality of life for generations to come," said Alex Watson, co-founder and lead Gretel researcher on the partnership study.

On December 14, 2021 Kenox Pharmaceuticals Inc, a privately owned pharmaceutical company focused on respiratory drug products, reported that it has submitted Type B Pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its lead program KNX018, a novel inhaled drug-device combination product as an adjunct sensitizer for radiation therapy in Non-Small-Cell Lung Carcinoma (NSCLC) patients in October 2021 and received a positive response supporting the planned CMC, non-clinical and clinical development strategy (Press release, Kenox Pharmaceuticals, DEC 14, 2021, View Source;a-novel-inhaled-drug-device-combination-product-as-an-adjunct-sensitizer-for-radiation-therapy-in-nsclc-patie-301443308.html [SID1234597166]).

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Kenox Pharmaceuticals Inc plans to submit an Investigative New Drug Application (IND) to FDA in 2022

Lung cancer is the leading cause of cancer deaths globally, about 1.8 million people die as a result of the disease each year. NSCLC is the most prevalent type, accounting for approximately 85% of all lung cancers. Depending on the stage, radiation therapy in combination with chemotherapy and PD-1 is often the treatment of choice. KNX018 is being developed to act as a sensitizer to facilitate the combination therapy to obtain more favorable therapeutic outcomes.

"We are extremely pleased and appreciate FDA for thoughtful feedback, which provides a path forward for KNX018; a first-of its kind adjuvant therapy in NSCLC patients. We will continue to work with the agency to ensure all CMC and clinical requirements are fulfilled for a successful filing and approval of NDA. I’m grateful and tremendously proud of my team for the hard work, dedication, and creativity in advancing this program" said Dr. Sitaram Velaga, CEO and President of Kenox Pharmaceuticals.

On December 14, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported interim data from an ongoing clinical trial (NCT03934814) of lemzoparlimab in combination with rituximab (Rituxan) in heavily treated patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL), at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, I-Mab Biopharma, DEC 14, 2021, View Source [SID1234597164]).

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Lemzoparlimab is a novel CD47 antibody that blocks CD47 and SIRPα interaction through a epitope designed to confer red blood cell (RBC) sparing properties. In all clinical trials conducted so far, lemzoparlimab is administered without a priming dose.

"Lemzoparlimab’s initial results show it appears to be safe and well-tolerated in combination with rituximab without the need of a priming dose," said Amitkumar Mehta, MD, Associate Professor and Director of the Lymphoma Program at the University of Alabama at Birmingham and O’Neal Comprehensive Cancer Center at UAB. "This data support further evaluation of lemzoparlimab in combination with rituximab, which is currently ongoing in study in patients with r/r DLBCL and indolent lymphoma."

The preliminary data was generated from nine patients with relapsed and refractory NHL who received at least two prior lines of therapies, with a median of four lines. Lemzoparlimab was safe and well-tolerated at doses of 20 mg/kg and 30 mg/kg weekly, without a priming dose. The maximum tolerated dose (MTD) was not reached. Most treatment-related adverse events (TRAE) were manageable infusion-related reactions (n=4). Among seven efficacy-evaluable patients, four achieved complete response (CR) [1 transformed FL-DLBCL +3 FL], one partial response (PR) of FL were observed (ORR=71%); two reported stable disease (SD); and the disease control rate (DCR) is 100%. Tumor shrinkage was observed in all evaluable patients. The median time to response was 50 days and response lasted from 61 to 236 days. A high level (80% and 90%) of intra-tumoral distribution measured by IHC of tumor biopsy was reached at 20 mg/kg and 30mg/kg weekly.

"We’re encouraged by the interim results reported today. The clinical data of lemzoparlimab further builds our confidence for an innovative therapy that utilizes macrophages against tumors, said Dr. Joan Shen, Chief Executive Officer of I-Mab. "It is very exciting that lemzoparlimab is bringing new hopes to our patients, and we are accelerating its clinical development through international multi-center trials in the U.S. and China."

The ongoing study with 30 mg/kg lemzoparlimab weekly combined with rituximab is being expanded to enroll more patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) or indolent lymphoma.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

Multiple clinical studies are ongoing in both the U.S. and China to explore indications in treating both hematologic maliglencies and solid tumors. Lemzoparlimab is being studied in patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors in the U.S. and China. Combined clinical results from these studies will potentially support registrational trials later in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

On December 14, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that new data for the treatment of relapsed or refractory(r/r) PTCL patients with COPIKTRA were presented at the 63rd annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia (Press release, Secura Bio, DEC 14, 2021, View Source [SID1234597159]).

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Jonathan Brammer M.D. of The Ohio State University James Comprehensive Cancer Center presented the interim analysis of the phase 2 PRIMO trial of r/r PTCL patients treated with single-agent COPIKTRA 75mg BID for the first two months followed by 25mg BID until progression or unacceptable toxicity. 78 of a planned 125 patients were included in this analysis with a minimum follow-up of 6 months. The trial is ongoing, with completion expected in 2022.

The interim results include an ORR by IRC assessment of 50% (39/78 pts) and a CR of 32.1% (25/78) with a median duration of response of 233 days (range, 1-420+). Patients had a median of 3 (range, 1-7) prior therapeutic regimens and included the following PTCL subtypes: PTCL NOS (53.8%), ALCL (14.1%), AITL (26.0%) and Other (0.5%). 18% of patients remain on therapy, 47.4% discontinued due to PD, 6.4% discontinued for stem cell transplant, and 19.2% discontinued due to unacceptable toxicity.

Overall, the safety profile was consistent with previous studies; in this analysis the most frequent > Grade 3 adverse events seen were neutropenia (38.5%), ALT/AST increased (24.4%/ 21.8%), rash (7.7%), lymphocyte count decreased (7.7%), and sepsis (6.4%). ALT and/or AST elevations were the most common AEs leading to treatment discontinuations (N=12, 15.4%).

"Patients with r/r PTCL usually relapse quickly and have limited treatment options, and the data from the PRIMO trial show very promising activity and even a remarkable number of complete responses. Importantly, these responses are better than current standard of care options" said Dr. Brammer.

"We are encouraged to see such robust responses in a significant number of patients who are suffering with these aggressive forms of lymphoma" said David Cohan M.D., Chief Medical Officer at Secura Bio. "We will continue to develop COPIKTRA for the treatment of the r/r population, and we have also expanded our clinical research program to include earlier lines of therapy for various T-cell lymphomas."

The original abstract published for ASH (Free ASH Whitepaper) can be viewed by clicking HERE.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track designation in the United States. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full prescribing information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.