Sutro Biopharma Named Best New Drug Developer at the 7th Annual World ADC

On September 21, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company reported that it has been recognized as Best New Drug Developer at the World ADC Digital Awards, held during the World ADC Digital Event (Press release, Sutro Biopharma, SEP 21, 2020, View Source [SID1234565458]).

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"We are honored to receive the World ADC Best New Drug Developer Award," said Bill Newell, Sutro’s Chief Executive Officer. "The award recognizes our three innovative clinical development candidate ADCs. STRO-001 and STRO-002 are currently in Phase 1 clinical studies and CC-99712 is under investigation in a Phase 1b/2 clinical trial by our partner Bristol Myers Squibb. We are encouraged by our emerging and promising clinical data and the patient benefit that these product candidates may offer."

Our unique, rapid and precise protein engineering technology is focused on the design and manufacture of homogeneous potential best-in-class oncology therapeutics. In addition to the three clinical candidates, two more are projected to enter the clinic in 2021. "The presentation of this award to Sutro is particularly pleasing given that it represents recognition by some of the most talented professionals in the biopharmaceutical industry. It is a tribute to the innovation, commitment and contributions of our talented Sutro team," said Dr. Trevor Hallam, Sutro’s Chief Scientific Officer.

The World ADC Awards showcases companies, teams and individuals in the industry, across 9 categories, at the forefront of cancer research today. Finalists and winners were shortlisted from over 1,000 votes cast and each submission was evaluated by a panel of seven judges.

ESSA Pharma to Participate in Oppenheimer Fall Healthcare Life Science & MedTech Summit

On September 21, 2020 ESSA Pharma Inc. (Nasdaq: EPIX) (TSX-V: EPI; ) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer reported the Company will be presenting at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22nd at 11:40am Eastern (Press release, ESSA, SEP 21, 2020, View Source;medtech-summit-301134423.html [SID1234565457])

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Dr. David. R. Parkinson, Chief Executive Officer, will present a corporate overview of the Company’s business. Dr. Parkinson along with ESSA’s Chief Operating Officer, Peter Virsik, and Chief Financial Officer, David S. Wood will be available for one-on-one meetings.

The presentations will be webcast live and can be accessed through the Investor Relations page at www.essapharma.com. A replay of the presentations will be available on the Company’s website for 90 days.

Tuesday September 22, 2020

Presentation Date: Tuesday September 22, 2020
Presentation Time: 8:40am Pacific / 11:40am Eastern

I-Mab Announces China NMPA Clearance for Phase 1 Clinical Trial of Lemzoparlimab in Relapsed or Refractory Advanced Lymphoma

On September 21, 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 Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for lemzoparlimab (also known as TJC4) to initiate a phase 1 clinical trial in patients with relapsed or refractory advanced lymphoma (CXSL2000206) as part of an ongoing IMCT being conducted also in the U.S. Additionally, a phase 1/2a clinical trial in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in China (CXSL1900039; NCT04202003;) is currently underway with clinical results expected in early 2021 (Press release, I-Mab Biopharma, SEP 21, 2020, View Source [SID1234565456]).

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Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.

The preliminary results of the recent phase 1 clinical trial in the U.S. have shown differentiation of lemzoparlimab in terms of safety and pharmacokinetics profiles in cancer patients. Lemzoparlimab was well tolerated as a single agent at a dose up to 30 mg/kg/week without introducing any priming dose strategy. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year. At the same time, combination therapy of lemzoparlimab with pembrolizumab in patients with solid tumors and classical Hodgkin’s lymphoma are also ongoing in the U.S.

"We strongly believe that lemzoparlimab has the potential to make a significant difference in the treatment of multiple cancers, particularly hematologic malignancies in China," said Dr. Joan Shen, CEO of I-Mab. "We look forward to accelerating this program through close collaboration between the U.S. and China teams and delivering a potentially life-changing medicine to patients in need."

Earlier this month, I-Mab entered into a global strategic partnership with AbbVie to develop and commercialize lemzoparlimab. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumor and with Rituxan for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML in China.

Biocept Announces that Highmark Has Made a Positive Coverage Determination on Target Selector™ Liquid Biopsy

On September 21, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular technologies designed to provide physicians with clinically actionable information to improve the outcomes of patients with cancer, reported that Highmark, America’s fourth largest Blue Cross Blue Shield affiliate, has made a positive coverage determination that Biocept’s Target Selector liquid biopsy assay has been accepted for medical coverage for use in the diagnosis and treatment of patients with non-small cell lung cancer (NSCLC) (Press release, Biocept, SEP 21, 2020, View Source [SID1234565455]). The coverage determination follows two years of evaluation performed by the Allegheny Health Network Cancer Institute of Biocept’s liquid biopsy assay to more rapidly assess the molecular status of patients with NSCLC, enabling oncologists to select the most appropriate therapy while also reducing the overall cost of care.

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Highmark’s coverage determination includes testing with Biocept’s assay in health insurances across the insurer’s footprint, which includes Pennsylvania, Delaware and West Virginia, where it serves 5.6 million members. The evaluation was managed by Highmark Health’s VITAL Innovation Platform, which facilitates real-world testing of early-stage health innovations, producing evidence related to patient experience, care, and cost outcomes to support potential adoption within Highmark Health, as well as acceleration into the broader healthcare community. Highmark will be the first insurer in its footprint to provide coverage of the test. In addition, Allegheny Health Network is the first health system to offer the testing in Highmark’s footprint, with others to follow.

"The diagnosis, treatment and care of patients with cancer is among Highmark Health’s top priorities and a focus of the VITAL Innovation Platform," said Anil C. Singh, MD, Allegheny Health Network (AHN) System Director of Pulmonary/Critical Care/Allergy-Immunology and Sleep Medicine, and medical advisor to VITAL. "VITAL’s evaluation clearly demonstrates the value of using Biocept’s liquid biopsy test in making informed, first-line therapy decisions for patients with non-small cell lung cancer. Additionally, using a simple blood sample reduced the number of invasive tissue biopsies, which can be challenging in patients with advanced NSCLC."

The Biocept Target Selector platform was used to molecularly profile the liquid biopsies of newly diagnosed, treatment-naïve advanced NSCLC patients, as well as NSCLC patients who were progressing after initial therapy. These patients also received tissue biopsy as part of the evaluation.

"This project directly supports Highmark’s and AHN’s mission to provide members and patients with access to the best care that is available, freeing them to be their best," said Gene G. Finley, MD, deputy director of Allegheny Health Network Medical Oncology and lead investigator on the project. "In order to realize the full potential of targeted therapies, oncologists require timely and accurate molecular characterization of a patient’s cancer for selection of the best possible therapy. Our study indicated that results of Biocept’s liquid biopsy provided clinicians with accurate knowledge about their patients’ disease, allowing us to implement more effective and better targeted treatment strategies. This improves the patient experience and lowers healthcare costs."

"The positive results from our collaboration under the VITAL program further solidifies Biocept’s role as a leader in the liquid biopsy field and represents an important movement towards improving care for cancer patients," said Michael Nall, Biocept’s president and chief executive officer. "After several years of participating in the VITAL program, the fact that Highmark has made a positive coverage determination is a testament to the value we bring to patients with cancer and to the healthcare system."

Lung cancer is the leading cause of cancer death in the United States. The American Cancer Society estimates that approximately 135,720 Americans will die from lung cancer in 2020. The five-year survival rate for advanced NSCLC is less than 10%. However, 17–27% of NSCLC patients harbor molecular alterations that can be treated with specific FDA-approved targeted therapies.

Despite the advances of targeted therapies, a large percentage of patients may not undergo molecular profiling due to a number of practical constraints. Chief among these is the availability of tissue for molecular testing. Lung cancers are often difficult to biopsy because of their location within what is often diseased lung tissue of elderly patients. Needle biopsy is the most common technique but often does not yield enough tissue for molecular testing. Performing a second biopsy is a way of remedying this situation, but these procedures can add to risk and cost, making liquid biopsy (peripheral blood) a more feasible specimen type.

Harbour BioMed Announces Two China NMPA Clearances for Clinical Trials for Phase I & Combination Therapy of Next Generation Anti-CTLA-4 Antibody for Treatment of Solid Tumors

On September 21, 2020 Harbour BioMed (HBM), a global, clinical-stage, innovative biopharmaceutical company reported approval of two Investigational New Drug (IND) applications by the China National Medical Products Administration (NMPA) of its next-generation fully human anti-CTLA-4 antibody (HBM4003) (Press release, Harbour BioMed, SEP 21, 2020, View Source;combination-therapy-of-next-generation-anti-ctla-4-antibody-for-treatment-of-solid-tumors-301134611.html [SID1234565454]). These approvals for mono- and combination therapy with toripalimab (TUOYI, PD-1, Junshi Biosciences) for the treatment of patients with advanced solid tumors, closely follow HBM’s ongoing Ph. 1 trial in Australia (Nov 2019), and U.S. Food and Drug Administration (FDA) approval its IND application.

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CTLA-4 is one of the major negative regulators of T cell immune activation. First-generation anti-CTLA-4 antibodies are immune checkpoint inhibitors that enhance T cell activity, improving anti-tumor immune response. Despite demonstrated efficacy of anti-CTLA 4 antibodies in cancer immunotherapy, their safety profiles have always hindered their potential applications as mono- or combination therapies.

HBM4003 is the first of several fully human mAbs generated using its proprietary heavy chain only antibody (HCAb) technology. It targets CTLA-4 and enhances the elimination of tumor infiltrating regulatory T cells (Treg) by enhancing the antibody dependent cellular cytotoxicity (ADCC), consequently improving the body’s immune response against tumor cells to treat multiple refractory or recurrent tumors. Improved anti-tumor efficacy, tolerance of HBM4003 and synergistic efficacy with combination of anti-PD-1 antibody were demonstrated in a series of preclinical animal efficacy and toxicology studies, which showed the great potential of HBM4003 as both mono- and combination therapy with other immune-oncology drugs in clinic.

Junshi Biosciences’ toripalimab (TUOYI) is the first commercialized domestically-developed anti-PD-1 mAb approved for unresectable or metastatic melanoma for those who have previously failed systemic treatments. So far, more than 30 clinical studies of toripalimab covering more than ten indications have been carried out in China, the United States and other countries. Recently, toripalimab has achieved Breakthrough Therapy designation (BTD) and 3 Orphan Drug designations (ODD) from the US FDA.

HBM will evaluate the safety, tolerability, pharmacokinetic characteristics, and anti-tumor activity in patients with advanced solid tumors, in both mono- and combination therapy setting in melanoma and other solid tumors in China and around the world to establish HBM4003 as the leading next-generation IO therapy.

"This is a significant milestone for HBM and our growing portfolio of innovative molecules starting with HBM4003, which is the first of our HCAb molecules to be tested in the clinics. The preclinical and clinical results so far have been encouraging and with these approvals, we aim to expand the use of HBM4003 in Chinese patients and in combination therapy." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "These studies are part of our global development program, where we believe HBM4003 will potentially provide better treatment opportunities for patients suffering from malignant tumors across the world." he added.