On January 19, 2021 BioEclipse Therapeutics (BioEclipse), a private clinical-stage biopharmaceutical company with a proprietary platform for developing next-generation cancer immunotherapies, reported the initiation of patient enrollment at the HonorHealth Research Institute in Scottsdale, Ariz. for a Phase 1 dose-escalation trial to treat refractory solid tumors (Press release, BioEclipse Therapeutics, JAN 19, 2021, View Source;utm_medium=rss&utm_campaign=bioeclipse-initiates-enrollment-in-phase-1-dose-escalation-clinical-trial-for-crx100-at-honorhealth-research-institute [SID1234575165]). The trial marks the first-in-human study of CRX100, an intravenously delivered agent designed to target and destroy multiple cancer types and address disease recurrence.

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"We are excited to be working with HonorHealth as we advance CRX100 into the clinic, an event that marks a major milestone for our company," stated Pamela Contag, Ph.D., President and CEO of BioEclipse. "CRX100 is a single therapeutic designed to attack multiple characteristics of numerous cancer types. With this new approach, BioEclipse is poised to address the substantial and growing unmet need for treatment options for solid tumors and metastatic disease considered by many to be untreatable."

This open-label, Phase 1 dose-escalation study is to determine the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in up to 24 participants ­18 years or older with advanced solid tumors that do not respond to standard of care. The trial specifically targets six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer. Each patient will receive up to two doses of CRX100. As secondary endpoints, the trial will also investigate the effect CRX100 has on a participant’s tumor progression and overall immune response.

More information about this study and general information about participating in clinical trials can be found at ClinicalTrials.gov.

BioEclipse is currently focused on the treatment of recurring cancers with a unique multi-mechanistic approach that could address cancers believed to be untreatable. Developed with technology exclusively licensed from Stanford University, CRX100 combines activated immune cells, known as cytokine-induced killer (CIK) cells, with an oncolytic virus. When the two components were combined in preclinical animal models, they worked together to attack the cancer.

"We are excited to begin working with BioEclipse to evaluate CRX100 for the first time in human study participants, given the urgent need for better cancer therapies, especially for patients with cancers that do not respond to standard treatments," said Jasgit Sachdev, M.D., Director, Breast and Gynecological Early Phase Clinical Trials at HonorHealth Research Institute, and a Principal Investigator for this study. "Refractory disease is challenging to treat. Data from preclinical models assessing the treatment approached used by CRX100 suggest the potential to address several types of cancer and bring hope to patients with otherwise poor prognosis."

On January 19, 2021 Servier reported that Group revenue for the 2019/20 financial year amounted to €4.7 billion, an increase of 1.6% at real exchange rates, compared with the previous financial year (Press release, Servier, JAN 19, 2021, View Source;utm_medium=rss&utm_campaign=servier-presents-its-2019-20-annual-results-its-rd-strategy-and-pipeline [SID1234575049]). Revenue from brand-name medicines represents 70% of the Group revenue, and generics 30%. This progression is mainly due to the increase in the volume of brand-name medicine sales (+2.9% in boxes distributed compared with the previous financial year) and a good performance in oncology.

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"During the Covid-19 global health crisis, Servier was able to adapt to maintain the production and distribution of its medicines so that they remain available to patients, while ensuring the health and safety of its employees. Results for the 2019/20 financial year are in line with our objectives […]," comments Pascal Lemaire, Executive Vice President Finance at Servier.

The conference was also the opportunity to present Servier’s strategic objectives: "The Group has set ambitious objectives for 2025 that aim to improve its current performance in order to develop new medicines to the benefit of patients," states Olivier Laureau, President of Servier. "This is why we accelerate the Group’s global transformation dynamic, across all its business segments. This, in order to be ever more committed to therapeutic progress and to guarantee our sustainability and our independence."

Claude Bertrand, Executive Vice President, R&D, highlighted the transformation of R&D activities, recently initiated in order to foster innovation and meet the Group’s 2025 strategic objectives, in particular that of launching a new molecular entity every three year: "[…] An initial action plan has been deployed within R&D. This plan focuses on de novo innovation, which consists of accelerating the discovery and development of new medicines to meet therapeutic needs in oncology, neurology, and immuno-inflammation. It is also based on innovation linked to medicine life-cycle management, through incremental research, particularly for medicines in the cardio-metabolic field. This transformation project is based on the commitment and adaptability demonstrated by all our teams since the beginning of the health crisis."

On January 19, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the Company will present data in the form of six poster presentations at the Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), being held virtually February 8-12, 2021 (Press release, Atara Biotherapeutics, JAN 19, 2021, View Source [SID1234574481]).

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Among the data being presented is a poster describing key characteristics of tabelecleucel (tab-cel) that help elucidate the product’s proposed mechanism of action (MOA) and a poster presenting an innovative assay to detect and quantify non-engineered allogeneic T cell therapies such as ATA188.

Details of the 2021 TCT Meeting Posters
All posters will be available for viewing at the start of the meeting on Monday, February 8, 2021

Title: Comprehensive activation profiling of tabelecleucel, an off-the-shelf, allogeneic EBV-specific T cell therapy
Poster #: 206

Title: A sensitive and precise universal surveillance solution for pharmacokinetic monitoring of off-the-shelf cell therapies (in collaboration with CareDx)
Poster #: 204

Title: Clinical experience of tabelecleucel in patients with EBV+ primary (PID) or acquired immunodeficiency (AID) associated lymphoproliferative disease (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 219

Title: Clinical experience of tabelecleucel in patients with life-threatening complications of Epstein–Barr virus viremia (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 233

Title: A multicenter, multicohort, open-label, single arm per cohort, Phase II study to assess the efficacy and safety of tabelecleucel in patients with EBV-associated diseases using an adaptive two-stage study design (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 532

Title: ATA3219: A potent next-generation allogeneic off-the-shelf CD19 CAR-T therapy without the need for gene editing (encore from ASH (Free ASH Whitepaper) 2020)
Poster #: 203

On January 19, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR) ("TCR2" or the "Company"), a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported that it has commenced an underwritten public offering of $125,000,000 of shares of its common stock (Press release, TCR2 Therapeutics, JAN 19, 2021, View Source [SID1234574206]). TCR2 also intends to grant the underwriters a 30-day option to purchase up to an additional $18,750,000 of shares of common stock. All of the shares in the proposed offering are to be sold by TCR2. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Goldman Sachs & Co. LLC, Jefferies, Piper Sandler and BMO Capital Markets are acting as joint book-running managers for the offering.

TCR2 intends to use the net proceeds of the offering to advance its clinical and earlier stage programs and for research and development, working capital and general corporate purposes.

The securities described may be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-236965), including a base prospectus that was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on April 28, 2020. The proposed offering will be made only by means of a prospectus. A preliminary prospectus supplement and a final prospectus supplement relating to, and describing the terms of, this offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus may also be obtained from: Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by phone at (877) 821-7388, or by email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by email at [email protected], or by phone at (800) 747-3924; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by email at [email protected], or by phone at (800) 414-3627.

On January 19, 2021 Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, reported an agreement on a Phase 1b clinical trial with City of Hope, a world-renowned independent cancer research and treatment center (Press release, Lixte Biotechnology, JAN 19, 2021, View Source [SID1234574205]). The trial will assess the combination of Lixte’s first-in-class protein phosphatase inhibitor LB-100 with a standard regimen for untreated, extensive stage-disease small cell lung cancer (ED-SCLC).

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LB-100 will be given in combination with carboplatin, etoposide and atezolizumab, an FDA approved but marginally effective regimen, in previously untreated ED-SCLC. The dose of LB-100 will be escalated with fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (RP2D). Patient entry will then be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm its safety and to look for objective evidence of potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free-survival and overall survival.

John S. Kovach, M.D., Lixte founder and chief executive officer, said "Small cell lung cancer (SCLC) comprises approximately 15% of all lung cancers worldwide with about 30,000 new cases annually in the US. Although this very aggressive neuroendocrine tumor is much more sensitive to cytotoxic chemotherapy and radiation than the most common type of lung cancer, SCLC patients soon relapse after treatment and have a dismal prognosis. Recently, the addition of an immune blocker, atezolizumab, to carboplatin plus etoposide showed the first significant but modest improvement in median progression free survival from 4.3 to 5.2 months, and in median overall survival from 10.3 to 12.3 months."

Kovach continued, "In animal models, LB-100 significantly enhances the antitumor activity of cytotoxic chemotherapy in general, and in particular, the combination of carboplatin and etoposide against SCLC cells without enhancing toxicity. Mice models may not be predictive for humans, but if the extensive preclinical data showing LB-100 increases the effectiveness of chemotherapy applies to patients, we should see clear evidence of therapeutic benefit even in this early trial."

Ravi Salgia, M.D., Ph.D., the trial’s principal investigator and City of Hope’s Arthur & Rosalie Kaplan Chair in Medical Oncology, said, "City of Hope is in constant pursuit of more effective therapies for its cancer patients, and this therapeutic combination could be one for patients with small cell lung cancer, which is currently difficult to treat, particularly after a patient has relapsed. We look forward to working with Lixte on this important trial that we hope will make more therapeutic options available for patients with small cell lung cancer."