On December 9, 2020 Incyte (Nasdaq:INCY) reported that it will present at the 39th Annual J. P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 7:30 a.m. EST (Press release, Incyte, DEC 9, 2020, View Source [SID1234572509]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

On December 9, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, and WuXi Biologics (2269.HK), a global company with leading open-access biologics technology platforms, reported an expansion of their existing strategic relationship under which the parties will discover anti-CD39 antibodies using WuXi Bio’s proprietary technology (Press release, Arcus Biosciences, DEC 9, 2020, View Source [SID1234572544]). This CD39 collaboration represents the fourth antibody development program on which the two companies have joined forces. Arcus was granted exclusive worldwide rights to anti-CD39 antibodies discovered under the collaboration and will be responsible for all further development and commercialization activities of such anti-CD39 antibodies.

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The ATP-adenosine axis is believed to play a critical role in maintaining an immunosuppressed tumor microenvironment. Inhibition of one or more of the key nodes (CD39, CD73, or adenosine A2a and A2b receptors) along this axis aims to reduce the formation or activity of the highly immunosuppressive adenosine. A potential additional benefit of CD39 inhibition, aside from blocking an important source of adenosine, is the increase in intra-tumoral ATP, an important molecule for the recruitment and activation of dendritic cells. Preclinical experiments indicate that the combination of CD39 inhibition with either CD73 or adenosine receptor inhibition provides robust inhibition of this axis and increased anti-tumor immunity.

"WuXi Biologics is a global leader in the development and manufacture of therapeutic antibodies. Our relationship with WuXi Biologics started in 2017 with a clinic-ready anti-PD1 antibody, zimberelimab, which possesses molecular properties similar to those of marketed anti-PD1 therapies and has shown impressive clinical anti-tumor activity," said Juan Jaen, Ph.D., president and head of research at Arcus Biosciences. "Furthermore, WuXi Biologics has been an excellent manufacturing partner for our anti-TIGIT antibodies, domvanalimab (AB154) and AB308. We are excited to now extend our existing relationship with WuXi Biologics by combining core competencies to discover anti-CD39 antibodies that have the potential to synergize with adenosine-targeted molecules in our existing portfolio of clinical agents. This will allow us to continue to maintain our position as one of the industry’s leading companies in the targeting of the ATP-adenosine axis for the treatment of cancer."

"We’re thrilled to expand our strategic partnership with Arcus Biosciences to further enable this innovative company to bring new biologics solutions using WuXi Biologics’ proprietary integrated platforms. This partnership is a strong testament to our industry-leading capabilities and expertise," said Dr. Chris Chen, CEO of WuXi Biologics. "We’re committed to offering global open-access technology platforms with premier quality standards to support our global partners as they build their innovative ideas into transformative new treatments for patients worldwide."

Financial terms of the agreement were not disclosed, and the development of any anti-CD39 antibodies from the collaboration is not expected to materially impact Arcus’s financial position over the current cash runway.

On December 9, 2020 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology and neuroscience, reported the presentation of new preclinical data on its VISTA antagonist antibodies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Kineta, DEC 9, 2020, View Source;utm_medium=rss&utm_campaign=kineta-presents-new-preclinical-data-at-esmo-virtual-congress-2020-on-its-vista-antagonist-antibodies [SID1234572510]).

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Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented the new preclinical data on the company’s fully human anti-VISTA antibodies in a virtual poster presentation on December 9th, 2020. Key findings from the presentation include the following:

VISTA is highly expressed on myeloid cells granulocytes, NK and NKT cells
VISTA is also expressed at moderate levels on Treg CD4 and CD8 T cells, while CD4/CD69 activated T cells are high expressers
VISTA binds to the 5 putative receptors already identified at either neutral or acidic pH
Kineta’s anti-VISTA antibodies selectively inhibit these interactions with different potencies
"The results presented at ESMO (Free ESMO Whitepaper) further validate VISTA as a novel innate immune target with the potential to reprogram the tumor microenvironment and improve survival for patients with cancer." said Thierry Guillaudeux. "Kineta’s anti-VISTA antibodies demonstrate exceptional selectivity and potency. We have several outstanding antibodies from which to choose a lead candidate and initiate IND enabling studies in early 2021."

VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate antitumor immune function. Blocking VISTA activates an immune cell cascade that increases T cell effector functions to drive an efficient anti-tumor response. Preclinical studies have demonstrated that anti-VISTA antibodies mediate tumor growth inhibition when administered alone and display additive efficacy in combination with PD-(L)1 and CTLA-4 targeted therapy.

Presentation Details:

Poster Title: Highly Potent Fully Human Anti-VISTA Antibodies Efficiently Abrogate the Interaction of VISTA to its Different Putative Receptors at Different pH

Date/Time: December 9, 2020 from 9:00 AM to 8:00 PM Central European Time

Presenter: Thierry Guillaudeux, PhD

Click on the link below to take you to the Kineta website where you can view the presentation:

VISTA Publications – Kineta VISTA Poster Presentation at ESMO (Free ESMO Whitepaper) Virtual Congress 2020

On December 9, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX), the leading provider of innovative non-opioid pain management options, reported preliminary unaudited net product sales of EXPAREL (bupivacaine liposome injectable suspension) and iovera° of $38.1 million and $0.8 million, respectively, for the month of November 2020 (Press release, Pacira Pharmaceuticals, DEC 9, 2020, View Source [SID1234572526]).

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"We are pleased to report our sixth consecutive month of year-over-year growth for EXPAREL in the face of ongoing challenges from the COVID-19 pandemic. Sales for the final two days of November were meaningfully below the daily average for the month, which we believe to be attributable to the Thanksgiving holiday. Such anomalies aside, market indicators remain favorable as EXPAREL growth rates are significantly exceeding those of the elective surgery market versus pre-COVID baseline levels. This outperformance reflects the increasing use of EXPAREL within 23-hour sites of care and within non-elective procedures, such as cesarean section, oncology, and cardiovascular surgeries. We expect these favorable market dynamics to continue as we drive stronger growth in a post-pandemic world. EXPAREL not only helps enable the shifting of complex, painful procedures to outpatient settings but is well entrenched as the forerunner in opioid-sparing postsurgical pain management," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

The company’s 2020 product sales have been negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2020.

On December 9, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that efficacy results of neratinib in HER2-positive early stage breast cancer (eBC) from the Phase III ExteNET trial were presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place (Press release, Puma Biotechnology, DEC 9, 2020, View Source [SID1234572545]). The presentation entitled, "Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer: Final overall survival analysis from the randomized phase 3 ExteNET trial," is being presented at a Spotlight Poster Discussion Session by Frankie Ann Holmes, M.D., FACP, Texas Oncology Houston – US Oncology Research, an investigator of the trial. A copy of this poster presentation is available on the Puma website.

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ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive eBC patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. Patients were stratified by hormone receptor status and randomly assigned to one year of treatment with either oral neratinib 240 mg/day or placebo. The primary endpoint of the trial was invasive disease-free survival (iDFS). Secondary endpoints include overall survival and cumulative incidence of CNS metastases. A descriptive analysis that evaluated CNS disease free survival, which was defined as time from randomization to any CNS recurrence or death from any cause, was performed.

Within the European Union, neratinib is approved in patients with hormone receptor positive (HR+) breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen.

The endpoints were analyzed for three groups of clinical interest: (i) the intent to treat (ITT) population; (ii) patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen; and (iii) patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen and who did not achieve a pathological complete response (no pCR) after neoadjuvant treatment and therefore were at a high risk of disease recurrence. Results from the Phase III ExteNET trial were published in the October 5, 2020 issue of Clinical Breast Cancer. The manuscript is accessible online at View Source(20)30258-5/fulltext.

In the ITT population, 127 of 1420 patients (8.9%) in the neratinib group and 137 of 1420 patients (9.6%) in the placebo group died, as of the analysis cut-off date (July 2019). The estimated 8-year overall survival (OS) rates were 90.1% in the neratinib group and 90.2% in the placebo group (stratified HR 0.95; 95% confidence interval [CI] 0.75-1.21; p=0.69). The cumulative incidence of CNS metastases at 5 years was 1.3% (95% CI 0.8-2.1) in the neratinib arm and 1.8% (95% CI 1.2-2.7%) in the placebo arm, while the estimated CNS disease free survival at 5 years was 97.5% in the neratinib group and 96.4% in the placebo group (stratified HR 0.73; 95% CI 0.45-1.17).

In the HR+ /< 1 yr patient population, 53 of 670 patients (7.9%) in the neratinib group and 68 of 664 patients (10.2%) in the placebo group died. The estimated 8-year OS rates were 91.5% in the neratinib group and 89.4% in the placebo group, corresponding to a 2.1% absolute benefit (HR 0.79; 95% CI 0.55‒1.13). The cumulative incidence of CNS metastases at 5 years was 0.7% (95% CI 0.2-1.7) in the neratinib arm and 2.1% (95% CI 1.1-3.5) in the placebo arm, while the estimated CNS disease free survival at 5 years was 98.4% in the neratinib group and 95.7% in the placebo group (stratified HR 0.41; 95% CI 0.18-0.85).

In the HR+/ <1 yr, no pCR subgroup of patients (n=295), 8-year OS rates were 91.3% in the neratinib group and 82.2% in the placebo group, corresponding to a 9.1% absolute benefit (HR 0.47; 95% CI 0.23–0.92). In the HR+/ <1 yr, with a pCR (n=38), 8-year OS rates were 93.3% in the neratinib group and 73.7% in the placebo group, corresponding to a 19.6% absolute benefit (HR 0.40; 95% CI 0.06–1.88). The cumulative incidence of CNS metastases at 5 years was 0.8% (95% CI 0.1-4.0) in the neratinib arm and 3.6% (95% CI 1.3-7.8%) in the placebo arm, while the estimated CNS disease free survival at 5 years was 98.4% in the neratinib group and 92.0% in the placebo group (stratified HR 0.24; 95% CI 0.04-0.92).

Dr. Frankie Ann Holmes said, "These descriptive analyses in HR+ patients who received neratinib within one year of completing trastuzumab and did not achieve a pCR post neoadjuvant therapy suggest that neratinib may be associated with improved OS in this high-risk group (HR 0.47, absolute benefit 9.1%). Importantly, neratinib is the first HER2-directed agent to show a trend towards improved CNS outcomes in early stage HER2-positive breast cancer, with consistently fewer CNS events observed in the neratinib arm compared with placebo in all groups evaluated."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "Descriptive analyses suggest that neratinib may be associated with longer overall survival in subgroups of clinical interest and in the high-risk patient subgroup with residual disease after neoadjuvant therapy who are at a high risk of disease recurrence. Although there have been many new treatment options for patients with early stage HER2-positive breast cancer, the risk of disease recurrence and more specifically CNS recurrence remains significant and more must be done. These newly published data demonstrate that neratinib provides a clinically meaningful reduction in the risk of recurrence and CNS recurrence and provides a very important option for these high risk patients."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.