On December 9, 2020 Boehringer Ingelheim reported the execution of the agreement on the acquisition of Labor Dr. Merk & Kollegen (Press release, Boehringer Ingelheim, DEC 9, 2020, View Source [SID1234572470]). The acquisition will enable Boehringer Ingelheim to further expand and accelerate its comprehensive program for the development of ATMP-based immuno-oncology therapies including the Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP) platform and cancer vaccines platforms. Labor Dr. Merk & Kollegen has outstanding experience in process development, manufacturing and analytical characterization in virology besides expertise in microbiology and cell culture. Labor Dr. Merk & Kollegen has already worked in close collaboration with Boehringer Ingelheim on viral-based therapy development since 2015.

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"The acquisition of Labor Dr. Merk & Kollegen is strengthening our promising pipeline with diverse potential first-in-class cancer immunology and cancer cell directed therapies for patients with hard-to-treat cancer," said Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "The trusting and highly effective collaboration between our scientists and the Labor Dr. Merk & Kollegen team has already contributed significantly to our progress in viral-based cancer therapies. We will welcome the Labor Dr. Merk & Kollegen team and look forward to jointly advancing our program in this area."

Boehringer Ingelheim is taking cancer on by strengthening its position in cancer immunology, with a focus on cancer vaccines, oncolytic viruses, T-cell engagers, stromal modulators and myeloid cell modulators by combining its world-class, in-house research and development with that of highly innovative external companies. The addition of Labor Dr. Merk & Kollegen’s site will enable Boehringer Ingelheim to further strengthen its oncolytic virus and cancer vaccine development capabilities and capacities by establishing an end-to-end fully integrated center of excellence for virus development and clinical manufacturing. It will add to a series of strategic acquisitions and collaborations over the past years, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are contributing assets that will be further developed at Labor Dr. Merk & Kollegen’s site.

Labor Dr. Merk & Kollegen is a privately-held company founded in 1971. It is headquartered in Ochsenhausen, Germany, close to Boehringer Ingelheim’s Biberach R&D site. As a center of excellence in virology, Labor Dr. Merk & Kollegen has a long track record in GLP and GMP certified biosafety testing. In recent years Labor Dr. Merk & Kollegen established its GMP-virus manufacturing facility. With around 130 highly qualified and specialized employees, the company has built considerable expertise in process development, manufacturing and analytical characterization of viral therapeutics and oncolytic viral therapeutics. Labor Dr. Merk & Kollegen will be integrated with all employees as a new unit into Boehringer Ingelheim’s Development organization and continue to operate at its Ochsenhausen site. A future expansion is planned.

"Following our successful strategic partnership, we are really excited to join forces with Boehringer Ingelheim," said Dr. Ingrid Rapp, CEO at Labor Dr. Merk & Kollegen. "Boehringer Ingelheim is a truly global pharmaceutical company with excellent R&D capacities. We look forward to taking our next development step in oncology as part of this outstanding team."

The companies did not disclose the financial terms of the deal. The transaction is subject to the approval of the competition authorities in Germany. Closing will follow thereafter.

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.