On October 27, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that it has raised $310 million in growth capital (Press release, Caris Life Sciences, OCT 27, 2020, View Source [SID1234569172]).

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The financing includes $235 million in equity financing co-led by Highland Capital Management and Coatue, with participation from funds and accounts advised by T. Rowe Price Associates, Inc., OrbiMed, Millennium Management, Neuberger Berman, ClearBridge Investments, First Light Asset Management and other undisclosed investors.

The Company also raised $75 million in debt from Sixth Street as an extension to the $150 million in structured debt financing Sixth Street invested in September 2018. Sixth Street also participated in the equity round. Following the conclusion of this financing, Vijay Mohan, Co-founding Partner at Sixth Street, has been appointed to the board of directors.

Caris will dedicate the new capital to fund its continued growth in precision medicine to reinvent cancer care, accelerate innovative product development and pursue new initiatives in both the clinical trial and biopharmaceutical markets.

"Caris puts the patient at the center of everything we do, and focuses on fulfilling the promise of improving patient outcomes across all cancer types worldwide. As tumor profiling becomes standard practice, it’s important that we continue to grow rapidly as we maintain our leadership position," said David D. Halbert, Chairman and CEO of Caris Life Sciences. "We continue to advance our market-leading tumor profiling platform, clinical trial delivery service, grow our clinical and R&D laboratory facilities, expand our biopharmaceutical partnerships and further expand our investments in AI-powered innovation with our Precision Oncology Alliance collaborators. We are thrilled that our new partners share our vision to be the industry-leader in the precision medicine space."

"This financing represents the first significant external equity investment in Caris. We are tremendously proud to partner with a diverse and high-quality syndicate of leading investors with deep domain knowledge in healthcare and technology," said Brian J. Brille, Vice Chairman of Caris Life Sciences.

"We’ve reached an inflection point in the ability to use precision medicine to guide treatment decisions for cancer patients. Caris has built the leading clinically-focused comprehensive tumor profiling platform, providing the broadest coverage of actionable biomarkers, unparalleled physician support, and proprietary molecular signature analytics that will continue to enhance the utility of its testing platform for clinicians," said Nate Burns, Portfolio Manager and Head of Healthcare at Highland Capital Management. "The Company is also leveraging its unique multi-omics capabilities and extensive patient outcomes database to pursue compelling new pipeline opportunities including high-sensitivity liquid biopsy diagnostics and novel drug-target identification partnerships. We look forward to working with Caris and are excited about the tremendous growth opportunity ahead."

"By growing its platform, increasing its research and testing capacity, and strengthening its client partnerships, Caris has steadily advanced its position as the leading tumor profiling company," said Vijay Mohan, Co-founding Partner at Sixth Street. "We are proud to continue to support Mr. Halbert, Mr. Brille and the entire Caris team on their mission to help physicians and cancer patients make more personalized and precise treatment decisions. We look forward to our board engagement as Caris keeps leading as an innovator in precision medicine."

On October 27, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the presentation of new research data further supporting PVRIG as a potentially promising target for cancer immunotherapy (Press release, Compugen, OCT 27, 2020, View Source [SID1234569169]). These data suggest that PVRIG inhibition may enhance T cell priming and infiltration into tumors and provide further evidence supporting the potential advantages of targeting PVRIG alone and in combination with TIGIT and PD-1 inhibitors, in tumors for which current checkpoint blockers have not proven successful. The new findings are delivered in a presentation at the 2020 TIGIT Therapies Digital Summit today, October 27, 2020, at 11:00 AM EDT.

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"There is a growing appreciation for the potential role of stem-like memory T cells, known as TSCM, in cancer biology, as these cells can self-renew and differentiate into effector cells that mediate direct anti-tumor effects. While recent evidence suggests that TSCM cells express TIGIT and PD-1, our work now shows that they also express PVRIG. Furthermore, our data show that PVRIG’s ligand, PVRL2, is expressed in both dendritic cells and tertiary lymphoid structures, as well as in PD-L1low less inflamed tumors," said Eran Ophir, Ph.D., Vice President of Research and Drug Discovery at Compugen. "These new data suggest that PVRIG may be involved in the inhibition of T cell proliferation, activation and infiltration into tumors and that its blockade by COM701, our first-in-class PVRIG inhibitor, may enhance T cell proliferation and infiltration into tumors through the modulation of these important cell populations, even in tumors in which current checkpoint blockers have not proven successful."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added, "We are excited to share this new data showing that PVRIG and PVRL2 are expressed in three cell types, TSCM cells, dendritic cells and tertiary lymphoid structures, all of which have been shown to be important in clinical response to checkpoint inhibitors. These data reinforce our view that PVRIG plays a significant role within the DNAM axis in triggering an immune response in the tumor microenvironment. As such, targeting the PVRIG pathway has the potential to provide new treatment options, as monotherapy or in combination with other immune checkpoints, for both inflamed and less inflamed tumors. Additionally, the co-expression of PVRIG, TIGIT and PD-1 on TSCM cells and their ligands on activated dendritic cells further substantiates our hypothesis that the simultaneous triple blockade of these pathways has the potential to expand the reach of cancer immunotherapies to new patient populations and cancer indications currently unresponsive or refractory to existing treatments."

Key new findings presented by Dr. Ophir in the presentation titled, "Rationalizing Combination Strategies to Maximize Clinical Response as Novel ICI Therapies Emerge," include:

PVRIG is expressed on stem-like memory T cells (TSCM), the cells that give rise to differentiated cytotoxic effector T cells, mediating direct anti-tumor effects in the tumor microenvironment.
PVRL2 and PVR, the ligands for PVRIG and TIGIT, respectively, are expressed in both PD-L1low and PD-L1high tumor types.
PVRL2 has abundant expression across various dendritic cell (DC) types; PVRL2, PVR and PD-L1 are expressed by activated DCs which are associated with efficient T cell activation.
PVRL2 is expressed in tertiary lymphoid structures, structures in the tumor bed where local T cell priming occurs and which have been shown to be linked to positive response to immunotherapy.
Cumulatively, the data presented suggest that COM701 blockade could potentially mediate an interaction between DCs & TSCM cells in the tumor bed and lymphoid organs. This potential mechanism could lead to increase T cell priming and infiltration into less inflamed tumors.

On October 27, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported the first patient has been dosed in the Phase 2 expansion portion of the study evaluating DSP-7888, an investigational immunotherapeutic cancer vaccine that targets Wilms Tumor 1 (WT1), in combination with checkpoint inhibitor pembrolizumab, in patients with platinum-resistant ovarian cancer (PROC) (Press release, Sumitomo Dainippon Pharma, OCT 27, 2020, View Source [SID1234569167]).

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The Phase 1b/2 open-label, multicenter study consists of two parts. The Phase 1b portion evaluated the safety and tolerability of the combination of DSP-7888 with a PD-1 checkpoint inhibitor in adult patients with solid tumors. Based on the known high prevalence of WT1 in ovarian cancer and the findings from the Phase 1b portion of this study, the Phase 2 part will evaluate the antitumor activity of DSP-7888 in combination with pembrolizumab in patients with PROC.

"Patients with platinum-resistant ovarian cancer have a high unmet need with limited treatment options; therefore, we are excited to advance the study of DSP-7888 plus pembrolizumab and evaluate its role and potential benefits," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "Furthermore, we look forward to better understanding how these combined mechanisms may be able to sensitize this patient population to immunomodulators and improve clinical benefits."

The primary objective for the Phase 2 portion of the study is to evaluate the preliminary antitumor activity of DSP-7888 in combination with pembrolizumab in terms of the objective response rate (ORR) in patients with PROC. Secondary objectives of the Phase 2 portion of the study are to evaluate the preliminary clinical activity of DSP-7888 in combination with pembrolizumab in terms of duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), 6-month PFS rate and overall survival (OS) in this patient population. Additional secondary objectives of the Phase 2 portion of the study include evaluating ORR, DCR and PFS per iRECIST of DSP-7888 administered in combination with pembrolizumab in patients with PROC. Exploratory objectives of the Phase 2 portion of the study include determining the progression-free survival ratio (PFSr) as an evaluation of treatment benefit of DSP-7888 administered with pembrolizumab.

Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States.1 Patients with ovarian cancer who relapse within six months of completing first-line therapy are classified as being "platinum resistant" and typically have low response rates to subsequent chemotherapy, with a median survival under a year.2 Therefore, more efficient treatment methods are warranted to improve the survival of patients with ovarian cancer. In addition, the majority of ovarian cancer patients with serous histology are positive with WT1 in their tumors.3

The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03311334).

About DSP-7888 (ombipepimut-S*)

DSP-7888 is an investigational immunotherapeutic cancer vaccine containing two peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.4

DSP-7888 is currently being investigated in combination with bevacizumab in a Phase 2 trial in patients with recurrent or progressive glioblastoma (NCT03149003) and in a Phase 1/2 trial in combination with nivolumab or pembrolizumab in patients with advanced solid tumors (NCT03311334). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer.

*Adegramotide/nelatimotide is also assigned as the international nonproprietary name (INN).

On October 27, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the Company will present the latest preclinical data from its C5aR program, TJ210 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 – 14, 2020 (Press release, I-Mab Biopharma, OCT 27, 2020, View Source [SID1234569165]). The preclinical data will provide a rationale for the use of TJ210 as a monotherapy or in combination with immune checkpoint inhibitors such as anti PD-1 therapies as anti-tumor agent.

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Complement component fragment 5a receptor (C5aR1, CD88) is a G-protein coupled receptor (GPCR) and is being investigated as a potential new drug target in the field of immuno-oncology. C5a is produced in the tumoral microenvironment which acts as a chemoattractant to recruit through one of its receptors namely C5aR1 pro-tumor cells such as myeloid derived suppressive cells (MDSCs), neutrophils and M2 macrophages to the tumor site to suppress the human immune system attacking on the cancer and accelerate tumor progression.

TJ210 is an anti-C5aR monoclonal antibody in-licensed from MorphoSys, designed to bind to a unique epitope on C5aR1, thereby aimed to block the recruitment of pro-tumor cells into the tumor microenvironment.

Details of the oral presentation are as follows:

Title

TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy

Abstract #

607

Presenting Author

Jane Meng, PhD, I-Mab Biopharma

Presentation Time

11:30 am – 11:45 am (EST), Thursday, November 12

Visit SITC (Free SITC Whitepaper) website for more abstract information.

About TJ210/MOR210

TJ210/MOR210 is a novel human antibody directed against C5aR derived from MorphoSys’s HuCAL Platinum technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function and enabling immune cells to attack the tumor.

HuCAL and HuCAL Platinum are registered trademarks of MorphoSys AG.

On October 27, 2020 Celsius Holdings, Inc., (Nasdaq: CELH), maker of the leading global fitness drink, CELSIUS, reported that it will release financial results for the third quarter ended September 30, 2020 on Thursday, November 12, 2020, before the market open (Press release, Celsius Therapeutics, OCT 27, 2020, View Source [SID1234569164]). Management will then host a conference call that same day at 10:00 a.m. Eastern Time to discuss the results with the investment community.

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To participate in the conference call, please call one of the following telephone numbers at least 10 minutes before the start of the call:

The conference may also be accessed by going to: View Source;passcode=13668240&h=true&info=company&r=true&B=6, for the live audio webcast of the call, which will subsequently be available for replay.