On March 1, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the Company has entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical Co., Ltd. ("AstraZeneca Pharmaceutical" or the "Promoter"), pursuant to which Junshi Biosciences will grant AstraZeneca Pharmaceutical the exclusive promotion right of toripalimab in mainland China for the urothelial carcinoma indications to be approved subsequently for marketing and the exclusive promotion right for all indications approved and to be approved in non-core areas (Press release, Shanghai Junshi Bioscience, MAR 1, 2021, View Source [SID1234575836]). Junshi Biosciences will continue to be responsible for the promotion of other indications approved and to be approved excluding urothelial carcinoma indications in core areas.

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This strong alliance between the two companies will help promote local high-quality innovative drugs to benefit more Chinese patients. Junshi Biosciences and AstraZeneca will continue to explore overseas business collaboration including the emerging markets and actively explore the possibility of expanding the depth and breadth of future collaborations.

"We are delighted to work with AstraZeneca in the commercialization of Toripalimab in China," said Dr. Ning Li, CEO of Junshi Biosciences. "We are confident that by leveraging the extensive networks AstraZeneca has established over the years, and especially by utilizing its ability to promote in the county-level markets, this innovative drug with excellent performance in efficacy and safety will achieve greater success in the Chinese market and will enable more patients to receive timely and effective treatment. Under the guidance of the company’s ‘In China, For Global’ strategy, we also look forward to more in-depth collaborations with AstraZeneca in a wider range of fields in order to provide better and more affordable treatment options to patients in China and all over the world."

About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On 17 December 2018, Toripalimab obtained a conditional approval from the the National Medical Products Administration ("NMPA") for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designations from the NMPA in July 2020. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration ("FDA") for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA application of Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

On March 1, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer (Press release, Athenex, MAR 1, 2021, View Source [SID1234575854]). The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

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In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.

The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR). The Agency stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.

The agency recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The Agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA.

Athenex plans to request a meeting with the FDA to discuss the Agency’s response, engage in a dialogue on the design and scope of a clinical trial to address the FDA’s requirements and align on the next steps required to obtain approval.

"Our clinical and regulatory teams are disappointed by the complete response letter," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "We plan to work with the Agency to resolve the issues raised in the CRL and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancer."

Dr. Johnson Lau, Chief Executive Officer of Athenex, added, "We remain committed to the breast cancer community and will explore the best path forward to obtain regulatory approval. In the interim, we will identify and undertake the appropriate internal organizational adjustments accordingly."

Webcast and Conference Call

Athenex will host a webcast and conference call today Monday, March 1, 2021, at 8 a.m. ET to discuss this regulatory update for oral paclitaxel, as well as the company’s fourth quarter and full year 2020 financial results. The live call may be access by dialing (877) 407 – 0784 (domestic) or (201) 689-8560 (international) fifteen minutes before the conference call begins and reference the passcode 13715950. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

On March 1, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, reported the publication of the results of both pivotal studies for PyL, an investigational PET imaging agent that targets prostate-specific membrane antigen (PSMA) (Press release, Lantheus Medical Imaging, MAR 1, 2021, View Source [SID1234575870]). The OSPREY Phase 2/3 trial results have been published online in the Journal of Urology and the CONDOR Phase 3 trial results have been published in the online version of Clinical Cancer Research.

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"The limitations of conventional imaging modalities for prostate cancer create a need for targeted imaging in the initial assessment of high-risk patients as well as in men with early biochemically relapsed disease," said Michael J. Morris, M.D., Prostate Cancer Section Head, Genitourinary Medical Oncology Service, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the CONDOR manuscript and senior author on the OSPREY manuscript. "The OSPREY trial data highlighted the high positive predictive value, negative predictive value and specificity of PyL in staging high-risk patients. The CONDOR trial demonstrates its high positive predictive value to accurately locate and identify recurrent cancer early and non-invasively. Assuming FDA approval, physicians will be able to use this clinically meaningful information to identify disease, guide treatment plans, and improve disease management."

Mary Anne Heino, President and Chief Executive Officer of Lantheus added, "We believe these data demonstrate PyL’s clinical benefit and are honored to have our studies published in such well-respected peer-reviewed journals. The results of the OSPREY and CONDOR trials are part of our NDA that is currently under priority review at the FDA for marketing authorization in the United States. We believe PyL has the potential to play an important role in transforming the management of men with high-risk, recurrent or metastatic prostate cancer."

Kenneth J. Pienta, M.D., Director of Research at the James Buchanan Brady Urological Institute and Professor of Urology at Johns Hopkins University School of Medicine, was the lead author of the OSPREY manuscript. The OSPREY publication in the Journal of Urology may be found online here.

Michael J. Morris, M.D., Prostate Cancer Section Head of the Genitourinary Medical Oncology Service and Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center. Was the lead author of the CONDOR manuscript. The CONDOR publication in Clinical Cancer Research may be found online here.

OSPREY Phase 2/3 Trial
The OSPREY trial was designed to assess the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A) and confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). The primary endpoints for the trial were sensitivity and specificity of PyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A. A key secondary endpoint of the trial was the sensitivity of PyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B.

In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. PyL showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% meeting the specificity but not the pre-established sensitivity co-primary endpoint. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

Safety results showed PyL was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%), and fatigue (1.3%).

CONDOR Phase 3 Trial
The CONDOR trial was designed to assess the diagnostic performance and clinical utility of PyL in men with biochemically recurrent prostate cancer and uninformative standard imaging. The primary endpoint in the trial was the Correct Localization Rate (CLR) of PyL. CLR is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard. The composite truth is comprised of, in descending priority, histopathology, subsequent correlative imaging findings, or PSA response following radiation therapy. The key secondary endpoint in the trial was the percent of subjects with a change in intended prostate cancer treatment due to PyL imaging results.

The CONDOR trial achieved its primary endpoint, with a CLR of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). In the key secondary endpoint, 63.9% of patients had a change in intended prostate cancer treatment following review of PyL imaging results. The most frequent changes in intended prostate cancer treatment plans included changing salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage curative local therapy and planned treatment to observation.

Safety results showed PyL was well tolerated. The most frequent adverse event reported was headache, which was reported in four patients (1.9% of the trial population). There was one serious adverse event of hypersensitivity reported as related to the study drug.

About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, 248,530 new cases of prostate cancer will be diagnosed, and 34,130 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.1

About PyL
PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer both localized as well as metastatic to lymph nodes, bone and soft tissue to detect and localize recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus submitted a new drug application (NDA) for PyL which was accepted and granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021.

On March 1, 2021 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, and Mount Sinai Health System, one of the world’s leading academic health systems, reported a new research collaboration for the development of clinical strategies for Allocetra with checkpoint inhibitors (Press release, Enlivex Therapeutics, MAR 1, 2021, View Source [SID1234575892]). Allocetra is a macrophage-reprogramming immunotherapy product candidate currently in clinical development by Enlivex for the potential treatment of life-threatening immune-mediated diseases.

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Under the strategic collaboration agreement, the parties have agreed to develop and execute a pre-clinical program to investigate the potential synergies between Allocetra and commercially approved checkpoint inhibitor therapies for select solid cancers.

Carlos Cordon-Cardo, M.D., Ph.D., Irene Heinz Given and John LaPorte Given Professor and Chair of the Lillian and Henry M. Stratton-Hans Popper Department of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai, commented, "We are impressed with the data supporting the immunotherapeutic effects of Allocetra in preclinical cancer models. The scientific rationale supporting AllocetraTM-checkpoint inhibitor combination therapies is intriguing, as preclinical studies suggest Allocetra may reverse the immunosuppressive tumor microenvironments that often hamper checkpoint inhibitors by reprogramming anti-tumor macrophages to their homeostatic state. We look forward to the further development of Allocetra-checkpoint inhibitor combination therapies through this newly formed collaboration."

A pioneer of the oncologic molecular pathology discipline, Dr. Cordon-Cardo has helped establish a deeper understanding of the mechanisms of human cancers and new targets for cancer diagnosis and therapeutics, enhancing the vision of personalized medicine. Dr. Cordon-Cardo is one of the "Highly Cited Authors" by the Institute of Scientific Information, one of the "Highly Influential Biomedical Researchers" (one of the top 400 over 15,153,100 author identifiers) by the European Society for Clinical Investigation; and one of the top "List of 500 Most Highly Cited Researchers Worldwide," Google Scholar, Citations 101,185; h-index 158; i10-index 521 (Google Scholar-2020). Dr. Cordon-Cardo is the recipient of numerous honors and awards, including "Roll of Honour" of the International Union Against Cancer; Gold Medal of the Swedish Society of Physicians; Distinguished Alumnus Award, Weill-Cornell Graduate School of Medical Science, Cornell University; Fellow, Royal Society of Medicine.

Dror Mevorach, M.D., Chief Medical Officer of Enlivex, commented, "We are excited to collaborate with the distinguished research and clinical teams at Mount Sinai. Allocetra may have a rebalancing effect on the typically immunosuppressive tumor microenvironment, potentially by facilitating the conversion of pro-tumor macrophage populations to anti-tumor populations. Together, we plan to investigate the potential of AllocetraTM to synergistically combine with commercially available checkpoint inhibitors for the treatment of solid tumors."

Oren Hershkovitz, Ph.D., CEO of Enlivex, stated, "The researchers and clinicians at Mount Sinai are world-class and ideal partners as we work toward the realization of Allocetra’s potential. We are pleased with the decision of Mount Sinai to formulate a strategic collaboration with Enlivex for the development of Allocetra as a potentially key component of combination therapies for solid tumors."

Allocetra is currently in clinical development for acute life-threatening immune-mediated diseases such as sepsis and COVID-19. Enlivex recently reported positive top-line results in 21 patients from Phase Ib and Phase II investigator-initiated trials in COVID-19 patients in severe/critical condition. The Company has also previously reported positive results from a Phase Ib investigator-initiated trial in 10 sepsis patients and plans to initiate a controlled, randomized, Phase IIb study in sepsis during the first quarter of 2021.

On March 1, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that it will present at the Cowen 41st Annual Health Care Conference being held virtually from March 1-4, 2021 (Press release, Cue Biopharma, MAR 1, 2021, https://cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-present-cowen-41st-annual-health-care-conference [SID1234608285]).

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At the conference, Cue Biopharma will provide an overview highlighting recent developments of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform, its expanding pipeline and anticipated milestones. The presentation will also include an update on the Company’s ongoing Phase 1 monotherapy dose escalation trial of CUE-101 as well as its combination trial of CUE-101 with KEYTRUDA (pembrolizumab) as first-line treatment for HPV+ recurrent/metastatic head and neck cancer.

Presentation Details

Date and Time: Thursday, March 4, 2021 at 9:10 a.m. EST
Webcast Link: https://wsw.com/webcast/cowen81/cue/1782129
A live and archived webcast of the presentation will be available in the Investors & Media section of the Company’s website at www.cuebiopharma.com. The presentation will be archived for 30 days.