On February 25, 2021 Kezar Life Sciences, Inc. (Nasdaq:KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported its Chief Executive Officer, John Fowler, will participate in the "Autoimmune/Complement" panel discussion at the Cowen 41st Annual Virtual Health Care Conference on Wednesday, March 3, 2021 at 11:40am EST (Press release, Kezar Life Sciences, FEB 25, 2021, View Source [SID1234575689]). The panel discussion will be available to live conference attendees.

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On February 25, 2021 Harbour BioMed (HBM) (HKEX: 02142) reported that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for HBM4003, the next generation anti-CTLA-4 antibody in combination with PD-1 antibody/chemotherapy for the treatment of patients with advanced NSCLC and solid tumors (Press release, Harbour BioMed, FEB 25, 2021, View Source [SID1234575705]). This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with PD-1 antibody, with or without chemotherapy in patients with advanced NSCLC and other solid tumors. Professor Shun Lu, Chairman of Chinese Society of Lung Cancer in China Anti-Cancer Association, Chief Key Program Expert of Ministry of Science and Technology of the People´s Republic of China, Director of Oncology Department at Shanghai Chest Hospital, will be the leading PI of this study. HBM4003 has already received US FDA and China NMPA IND approvals of the mono therapy, as well as another combination therapy in China, and has completed patient dosing in several patients in its ongoing phase I study in Australia.

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"The NMPA’s IND approval of HBM4003 for clinical trial in lung cancer is a significant leap forward in our global development plans for HBM4003. It has already demonstrated encouraging safety and anti-tumor activity in patients in our ongoing trials," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "Across the world, lung cancer remains the leading cause of cancer incidence and mortality, with over 2 million new cases in 2020. There are over 1 million patients in China alone and we look forward to bringing this novel combination therapeutic to these patients soon."

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to CTLA-4High Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

On February 25, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update (Press release, Jounce Therapeutics, FEB 25, 2021, View Source [SID1234575592]).

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"2020 proved to be a year of important pipeline execution and corporate development at Jounce despite the challenges presented by the COVID-19 pandemic. As we enter 2021, we are strongly positioned to execute on our two proof of concept studies, INNATE and SELECT, and continue to advance our sustainable discovery pipeline. Our potential first-in-class programs and biomarker approaches are aimed at bringing meaningful clinical benefit to the growing population of PD-(L)1 inhibitor naïve and experienced patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The need for novel approaches targeting different immune cells in the tumor microenvironment highlights the importance of our translational science platform and our productive discovery engine. This approach has allowed us to generate multiple targets beyond T-cells, most notably our highest priority program, JTX-8064, targeting LILRB2, also known as ILT4. As we enter 2021, Jounce is poised to further our goal of bringing the right immunotherapies to the right patients."

Pipeline Update and Highlights:

JTX-8064 (LILRB2 / ILT4)

Initiated Phase 1 INNATE trial of JTX-8064: In January 2021, Jounce enrolled the first dose cohort in INNATE, a Phase 1 clinical trial of JTX-8064 alone and in combination with its PD-1 inhibitor, JTX-4014, or pembrolizumab. The trial is designed to progress quickly through dose escalation and demonstrate proof of concept in tumor specific expansion cohorts.

Presented JTX-8064 preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Annual Meeting: In November 2020 at SITC (Free SITC Whitepaper), Jounce presented preclinical data for JTX-8064 that informed the indication selection and biomarker strategies for JTX-8064 to maximize potential therapeutic benefit for patients with solid tumor malignancies.
Vopratelimab (ICOS) and JTX-4014 (PD-1)

Initiated enrollment in the Phase 2 SELECT trial of vopratelimab: In October 2020, Jounce initiated enrollment in the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014 versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker-selected, second line non-small cell lung cancer patients. COVID-19 related delays are currently impacting patient enrollment, and Jounce now anticipates reporting data from the SELECT trial in 2022.

Continued to advance JTX-4014 as a combination agent: JTX-4014 is a PD-1 inhibitor intended for combination with Jounce’s broad pipeline beginning with its two ongoing proof of concept studies, the INNATE trial and the SELECT trial. The SELECT trial will also provide additional important single agent data for JTX-4014 in a new biomarker selection paradigm..
JTX-1811 (CCR8)

Established exclusive license agreement with Gilead for the development and commercialization of JTX-1811: In October 2020, Jounce licensed to Gilead Sciences, Inc. ("Gilead") the worldwide rights to JTX-1811, a potential first-in-class antibody designed to bind to CCR8 and selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. Upon clearance of an investigational new drug application ("IND"), JTX-1811 will transition to Gilead for clinical development and potential commercialization. In addition to an $85.0 million upfront and a $35.0 million equity investment, Jounce has the potential to earn up to $685.0 million in milestones as well as royalties on worldwide sales. Jounce continues to progress JTX-1811 to IND clearance and remains on track for an IND filing in the first half of 2021.
Discovery Pipeline

Productive discovery engine with IND every 12 to 18 months: Jounce continues to invest in and advance its growing immuno-oncology pipeline. Its discovery engine is built upon the capability to thoroughly investigate different cell types in the tumor microenvironment, including T cells, myeloid cells and stromal cells.
Fourth Quarter and Full Year 2020 Financial Results:

Cash position: As of December 31, 2020, cash, cash equivalents and investments were $213.2 million, compared to $170.4 million as of December 31, 2019. The increase in cash, cash equivalents and investments was primarily due to receipt of $120.0 million in proceeds from the license and stock purchase agreements with Gilead and $14.5 million received during 2020 under Jounce’s at-the-market offering program ("ATM"), offset by operating expenses incurred during the year. In January 2021, the Company completed the sale of all available amounts under the existing ATM with the sale of 3,156,200 shares for net proceeds of $30.2 million.
License and collaboration revenue: $62.3 million of license and collaboration revenue was recognized during the fourth quarter of 2020. Jounce did not recognize any license and collaboration revenue for the same period in 2019. License and collaboration revenue was $62.3 million for the full year 2020, compared to $147.9 million for the full year 2019. Revenue recognized during 2020 was related to Jounce’s license agreement with Gilead. Revenue recognized during 2019 was comprised of $50.0 million of cash revenue related to Jounce’s JTX-8064 license agreement with Celgene and $97.9 million of non-cash revenue recognition related to the $225.0 million upfront payment received in July 2016 under the Celgene collaboration agreement.
Research and development expenses: Research and development expenses were $20.0 million for the fourth quarter of 2020, compared to $16.6 million for the same period in 2019. Research and development expenses were $78.7 million for the full year 2020, compared to $67.1 million for the full year 2019. The increase in research and development expenses for the full year 2020 was primarily due to $7.9 million of increased clinical and regulatory expense primarily attributable to the SELECT clinical trial, $3.2 million of increased manufacturing and IND-enabling expenses and $2.9 million of increased employee compensation costs. These increases were partially offset by $0.9 million and $0.8 million of decreased other research costs, primarily related to reduced travel, and lab consumable costs, respectively.
General and administrative expenses: General and administrative expenses were $6.9 million for both the fourth quarter of 2020 and 2019. General and administrative expenses were $28.8 million for the full year 2020, compared to $27.9 million for the full year 2019. The increase in general and administrative expenses for full year 2020 was primarily attributable to $1.5 million of increased employee compensation costs.
Net income (loss): Net income was $35.5 million for the fourth quarter of 2020, resulting in basic net income per share of $0.90 and diluted net income per share of $0.86. Net loss was $22.7 million for the same period in 2019, resulting in basic and diluted net loss per share of $0.68. Net loss was $43.8 million for the full year 2020, resulting in basic and diluted net loss per share of $1.24. Net income was $56.8 million for the full year 2019, resulting in basic net income per share of $1.72 and diluted net income per share of $1.66. Net loss for the full year 2020 was attributable to increased operating expenses, offset by $62.3 million of license revenue recognized under Jounce’s agreement with Gilead. Net income for the full year 2019 was primarily attributable to $147.9 million of revenue recognized under the Celgene license and collaboration agreements in the year.
Financial Guidance:

Based on its current operating and development plans, Jounce reiterates its financial guidance for 2021. Gross cash burn on operating expenses and capital expenditures for the full year 2021 is expected to be approximately $95.0 million to $110.0 million. Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the second quarter of 2023.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4698355. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On February 25, 2021 An Upstate Medical University assistant professor and researcher reported that it has been awarded a $1.1 million, four-year National Institutes of Health grant to study what makes tumor cells grow and spread throughout the body (Press release, SUNY Upstate, FEB 25, 2021, View Source [SID1234575630]).

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Dimitra Bourboulia, PhD, assistant professor of urology and biochemistry and molecular biology, is principal investigator of the awarded project, "Regulation of the Extracellular Hsp90 Chaperone Machinery." Bourboulia has been investigating for more than a decade the regulation and function of secreted proteolytic enzymes (MMPs), predominantly in tumors that invade through the surrounding tissue. Her latest NIH grant will fund how multiple regulators (activators and inhibitors) interact and signal outside the cell to tweak the activity of MMPs.

Normally, cells release proteins that function to build and maintain a healthy surrounding environment called the extracellular matrix (ECM). The ECM is a well-organized supporting 3D structure. In some diseases including neurodegenerative, cardiovascular and cancer, the ECM can be damaged because protein-degrading enzymes (MMPs) fail to perform their function in a normal way.

"This research essentially focuses on key secreted proteins and their binding partners that function as a team not inside, but outside the cell," Bourboulia said. "If we want to therapeutically target invasive tumors and limit their spread, we need to understand what makes this extracellular Hsp90 pro-invasive machinery so powerful. Unfortunately, we know how only very few components of this machinery.

Bourboulia said she hopes the research will help to better understand how key secreted factors such as Hsp90 chaperone and TIMP2 inhibitor coordinate their binding to one another and to MMP2 to regulate the process of invasion.

"Current therapeutics target one single factor," she said, noting that while medications are designed to work effectively against single proteins, their efficiency drops against those proteins that make complexes, such as the Hsp90:MMP2 complex. "We have proposed that unless we determine at the molecular level how these proteins interact, only then will we design an effective strategy to prevent specifically these undesirable complexes from happening."

The study has direct ties to many human cancers such as kidney, prostate, breast and lung with a focus on cases where aggressive tumors have metastasized or are spreading throughout the body.

Bourboulia, who has worked at Upstate since 2013, said she is lucky to work with a talented team at Upstate including graduate students and residents from the Urology Department – as well as external collaborators – on this project, which could lead to better treatments for aggressive cancers.

"Being integrated with clinical experts here at Upstate Urology is an effective way to translate our bench discoveries and observe their clinical impact," she said. In addition, she feels fortunate to receive the NIH grant despite the many challenges associated with the ongoing COVID-19 pandemic. "There are a limited number of scientists working in this particular field, so we are very fortunate that NIH finds it exciting."

Bourboulia is an expert in extracellular protein signaling and homeostasis. She serves as the assistant dean for UME and GME Research, and Director of the Office of Research for Medical students at Upstate. She participates as panel member at the CDMRP Kidney Cancer scientific peer review team, and as ad hoc reviewer for many high impact scientific journals. Because of her contribution in deciphering the function of extracellular Hsp90 in cancer, Bourboulia was presented with the 2020 Ritossa Early Career Award by the Cell Stress Society International.

On February 25, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help transform complex data into actionable insights, reported financial results for its fourth quarter and full year ended December 31, 2020 (Press release, NantHealth, FEB 25, 2021, View Source [SID1234575658]).

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"While managing our business through the challenges associated with COVID-19 for most of the past year, we advanced our goal of expanding and diversifying NantHealth’s software portfolio and services offerings with the acquisition of OpenNMS, continued to invest in our data solutions and AI capabilities, and delivered expanded capabilities on our NaviNet and Eviti SaaS products," said Ron Louks, Chief Operating Officer, NantHealth. "In addition, as part of our NantHealth Cares initiative, we supported healthcare providers and medical staff by offering, at no cost for the entire month of May, our NaviNet AllPayer platform to providers. I am pleased to report that even with a month of free access, AllPayer revenues grew in 2020 and added more than 1,500 providers to its network."

Software and Services Q4 Highlights:

Clinical Decision Support (Eviti):
Signed a renewal agreement with a Maryland-based health plan for an additional three years, and expanded products and services within the plan
Continued to expand Eviti Connect across the Medicaid population of a leading U.S. health insurance company. Of the 13 states originally announced, eight states have gone live through the fourth quarter of 2020
Launched Eviti Connect 8.2 which included:
Formulary Redirection ‒ a major expansion of our Treatment Warning and Deviation (TWAD) feature that allows redirection to preferred drugs. This new functionality scales the payer’s ability to enable formulary redirection resulting in significant savings in delivery of care
Smart Justifications ‒ uses Eviti proprietary algorithms to identify characteristics of cancer type and treatment goals that streamline workflow and result in faster time to treatment plan
Payer Engagement (NaviNet):
Signed a three-year renewal agreement for NaviNet Open with one of the nation’s leading Medicaid managed care organizations, strengthening a nearly 20-year partnership
Launched a collaboration with Sesame, Inc. that enables providers to utilize Sesame’s payment tools giving patients direct access to affordable, high-quality care while increasing practice revenue
Introduced new network analytics solutions focused on providing our health plan partners with actionable insights into their providers’ NaviNet activity:
Document Exchange Insights Reports ‒ provide information on utilization trends, reach into the provider network, and identify opportunities for targeted action to drive greater adoption
Advanced user behavior analytics and user engagement tools ‒ influence the NaviNet product roadmap and augment existing analysis available to our health plans and partners
Enhanced Open Authorizations to more seamlessly inform providers on where and how to request service approval from their patient’s health plan
Network Monitoring and Management (OpenNMS)

Deployed the OpenNMS flows and streaming analytics solution (300,000 flows per second) in production at a Fortune 500 energy company; decommissioning and replacing their existing solution
Released OpenNMS Horizon 27.0, which introduced digital experience monitoring for in depth monitoring of applications from the vantage point of individual end users and support for OpenConfig, a new industry standard that enables direct streaming of device telemetry data
Precision Medicine and Artificial Intelligence – Highlights:

In December, NantHealth presented significant treatment insights at the 2020 San Antonio Breast Cancer Symposium around the adoption of trastuzumab biosimilars in the treatment of HER2-positive breast cancer and the potential clinical and cost benefits of biosimilars. By examining Eviti data, the study identified an opportunity for payers to successfully redirect providers to biosimilars that offer high-value care at lower costs
In November, NantHealth and ImmunityBio announced the publication in Nature’s Scientific Reports of a study that revealed RNA sequencing is not only viable but may also provide significant clinical value in analyzing a cancer patient’s specific disease biology to enable an optimized treatment decision with a higher likelihood of success
In October, NantHealth, ImmunityBio and NantOmics presented results at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference on the use of deep-learning models in providing significant risk-assessment of survival in pancreatic cancer patients, holding promise as a prognostic technology
Business and Financial Highlights

For the 2020 fourth quarter:

Total net revenue was $18.6 million, up slightly from $18.6 million in the 2019 fourth quarter.
Gross profit increased to $11.4 million, or 61% of total net revenue, compared with $10.8 million, or 58% of total net revenue, for the prior year period.
Selling, general and administrative (SG&A) expenses declined to $11.7 million from $12.8 million in the 2019 fourth quarter, mainly driven by ongoing cost management efforts and efficiencies in overall processes.
Research and development (R&D) expenses increased to $4.8 million from $3.4 million mainly from the Company’s ongoing investments in expanding its data and AI capabilities.
Net loss from continuing operations attributable to NantHealth, net of tax, was $20.1 million, or $0.18 per share, which includes a noncash charge related to the Allscripts Bookings Commitment of $8.1 million. This compares with net loss from continuing operations attributable to NantHealth, net of tax, of $13.2 million, or $0.12 per share, for the 2019 fourth quarter.
On a non-GAAP basis, net loss from continuing operations attributable to NantHealth was $6.2 million, or $0.06 per share, compared with $5.7 million, or $0.05 per share, for the fourth quarter of last year.
For the 2020 full year:

Total net revenue was $73.2 million. This compares with total net revenue of $77.4 million for the 2019 full year, which included $2.9 million of home healthcare services revenue, a business the company divested in June 2019.
Gross profit increased to $43.9 million, or 60% of total net revenue, from $43.3 million, or 56% of total net revenue, for the prior year.
SG&A expense declined substantially to $48.5 million from $55.6 million in 2019, driven by the divestiture of the home healthcare services business, continued efforts to reduce costs and maximize existing resources. R&D expense increased to $17.3 million from $13.9 million in 2019 mainly from ongoing investments in data and AI capabilities.
Net loss from continuing operations attributable to NantHealth, net of tax, was $88.3 million, or $0.80 per share, which includes noncash charges related to the Allscripts Bookings Commitment of $11.2 million and the impairment of the Company’s equity method investment in NantOmics of $28.2 million. This compares with net loss from continuing operations attributable to NantHealth, net of tax, of $65.4 million, or $0.59 per share, for the 2019 full year.
On a non-GAAP basis, net loss from continuing operations attributable to NantHealth was $27.0 million, or $0.24 per share, down from $30.1 million, or $0.27 per share, for 2019.
At December 31, 2020, cash and cash equivalents totaled $22.8 million.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the fourth quarter and full year ended December 31, 2020. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 9786375. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.