On July 28, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the second quarter ended June 30, 2021, after the market close on Thursday, August 12, 2021, and will host a corporate update conference call at 4:30pm Eastern Time (Press release, CorMedix, JUL 28, 2021, View Source [SID1234585277]).

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On July 28, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the second quarter ended June 30, 2021 (Press release, Compugen, JUL 28, 2021, View Source [SID1234585276]).

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"Our continued execution in the clinic, which includes the recent initiation of three clinical studies, further strengthens Compugen’s leadership position in the DNAM axis space," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "These new studies expand our comprehensive evaluation of the DNAM axis and leave us uniquely positioned as the only company, in a clinical setting, evaluating anti-PVRIG, anti-TIGIT and anti-PD-1 combinations, which is our key differentiator in the TIGIT space. We expect the remainder of the year to include data readouts from our triple combination study in collaboration with Bristol Myers Squibb and COM902 monotherapy study, which we expect to expand the foundation of our clinical data generated to date."

Dr. Cohen-Dayag continued, "The updated data from our COM701 Phase 1 combination and monotherapy studies presented at ASCO (Free ASCO Whitepaper) support our continued excitement in our science and potential benefit it may bring to patients, showing durable responses and disease control in patients not eligible for or typically not responding to checkpoint inhibitors including those with prior progression. In addition, we shared our first preliminary pharmacodynamic biomarker data indicating that treatment with COM701 leads to immune activation and has the potential to drive anti-tumor activity in non-inflamed tumors as evidenced by activity in selected PD-L1 low, PVRL2 positive patients. Our combination strategy around our wholly owned assets targeting PVRIG and TIGIT give us a strong first mover advantage, and we look forward to continued progress through 2021 as we work to elucidate the potential of the DNAM axis pathways in immunotherapy."

Recent and Second Quarter 2021 Corporate Highlights

Presented updated data from the COM701 monotherapy and combination with Opdivo (nivolumab) studies at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting including:
– Durable responses beyond one year, including one complete response, in tumor types typically unresponsive to checkpoint inhibitors
– Preliminary biomarker data reveal immune activation evidenced by a trend of increased proliferation of peripheral immune cells and IFNγ. IFNγ increased with increasing doses of COM701, suggesting the observed activity is likely derived from the combination treatment and not Opdivo alone
– Preliminary anti-tumor activity in PD-L1 low, PVRL2 positive patients, with non-inflamed tumor microenvironment/immune desert phenotype
Dosed the first patient in the Phase 1b cohort expansion study of COM701 in combination with Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers
Dosed the first patient in the Phase 1 dual combination study of COM902 and COM701 in patients with advanced malignancies, the first clinical study of dual blockade of TIGIT and PVRIG independent of anti-PD-1
Dosed the first patient in the Phase 1/2 triple combination cohort expansion of COM701 with Opdivo and Bristol Myers Squibb’s anti-TIGIT antibody, BMS-986207
Presented research at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Targets for Cancer Immunotherapy: A Deep Dive Seminar Series, supporting PVRIG as a novel and differentiated checkpoint in the DNAM axis
Financial Results

R&D expenses for the second quarter ended June 30, 2021, were $6.8 million compared with $4.4 million for the comparable period in 2020. The increase in R&D expenses reflects the strong execution and expansion of the Phase 1 clinical programs.

General and administrative expenses for the second quarter ended June 30, 2021, were $2.7 million compared with $2.1 million for the comparable period in 2020. The increase in expenses is attributed mainly to corporate related expenses.

Net loss for the second quarter of 2021 was $9.5 million, or $0.11 per basic and diluted share, compared with a net loss of $6.2 million, or $0.08 per basic and diluted share, in the comparable period of 2020.

As of June 30, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $111 million, compared with approximately $124 million on December 31, 2020. The Company has no debt.

Conference Call and Webcast Information

The Company will hold a conference call today, July 28, 2021, at 8:30 AM ET to review its second quarter 2021 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On July 28, 2021 Cytocom Inc. ("Cytocom" or "Company"), a leading biopharmaceutical company creating next-generation therapies that focus on immune homeostasis, reported the completion of its merger with Cleveland BioLabs, Inc (Press release, Cleveland BioLabs, JUL 28, 2021, View Source [SID1234585275]). The all-stock transaction was first announced on October 19, 2020.

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Shares of the new Cytocom’s common stock will begin trading on Nasdaq under the ticker symbol "CBLI," at the opening bell on Wednesday, July 28, 2021.

As previously reported, the newly combined company will operate as "Cytocom, Inc." under the leadership of the existing Cytocom management team led by CEO Michael K. Handley. Mr. Handley now serves as the new company’s President and CEO.

"With the merger completed, we look forward to further advancing our late-stage clinical programs and expanding what we believe to be one of the largest toll-like receptor platforms in the industry," said Michael K. Handley. "This merger, coupled with our acquisition of ImQuest Life Sciences and the listing of the new Cytocom common shares on Nasdaq, represents a transformative growth opportunity and fits firmly with our goal of becoming a recognized leader in immune-modulating therapies targeting cancer, ARS, inflammatory and autoimmune diseases, and viruses, including COVID-19. Looking forward, we anticipate achieving multiple commercial, regulatory and clinical milestones over the next 12 to 18 months that should enable us to showcase the power of our drug development platform and further generate shareholder value."

McGuireWoods LLP represented Cleveland BioLabs and Troutman Pepper Hamilton Sanders LLP represented Cytocom in the merger.

On July 28, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company committed to bringing the promise of cell therapy to life for more patients, reported that it has entered into an exclusive licensing agreement with world renowned cell therapy centre, the University of Pennsylvania (Penn), for the first CDH17 CAR (chimeric antigen receptor) T cell therapy (Press release, Chimeric Therapeutics, JUL 28, 2021, View Source [SID1234585274]).

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The novel CDH17 CAR T cell therapy targets CDH17, an oncogenic factor associated with poor prognosis and metastasis in neuroendocrine tumors as well as the most common gastrointestinal tumors including colorectal cancer, pancreatic cancer and gastric cancer.

More than a decade of research and optimization has gone into development of the novel CDH17 CAR T cell therapy, developed by leading cellular immunotherapy scientist Xianxin Hua, MD, PhD, and his team. Dr Hua is a professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator.

"Chimeric is incredibly excited to bring the CDH17 CAR T cell therapy into our pipeline. Our focus is on developing cell therapies that have the potential to be curative for patients and we believe that this CDH17 CAR T cell therapy has that transformative potential. We are very much looking forward to working with Dr Hua and his team to bring this CAR T to the clinic as soon as possible," said Jennifer Chow, Chimeric COO.

The CDH17 CAR T cell therapy is a next or 3rd generation CAR T cell therapy that utilizes novel technology to specifically address the challenges of solid tumors. Preclinical studies of the CHIMERIC THERAPEUTICS LIMITED | 2 LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA CDH17 CAR T have demonstrated safety, with no toxicity to normal tissues, and promising efficacy with complete eradication of tumor cells and no relapse of the tumor.

"The preclinical studies indicate that our CDH17 CAR T marks the recognition of an entirely new class of solid tumor antigen targets, that are highly susceptible to CAR T attack on tumor cells yet masked from attack by the CAR T in normal tissues," said Dr Hua.

Development is currently underway for a phase 1 clinical trial that is planned to begin in 2022 at the University of Pennsylvania.

A three-year commitment for further research and development has been made to Dr Hua and Penn.

Under the terms of the license agreement, Chimeric Therapeutics acquires the exclusive rights to develop and commercialize the CDH17 CAR T cell therapy for which it has agreed to pay Penn license fees, development milestones and royalty payments based on commercial net sales. Upfront fees associated with the license agreement will be funded entirely from existing cash reserves.

The University of Pennsylvania is a globally recognized leader in cellular immunotherapy and widely known for being home to the 1st FDA approved CAR T therapy.

The Chimeric team will be leveraging its unique cell therapy expertise to ensure the timely development and commercialization of the novel CDH17 CAR T cell therapy, bringing the promise of cell therapy and curative potential to more patients with cancer.

Chimeric’s Executive Chairman Paul Hopper said "We are delighted to have secured the exclusive rights to this promising asset from one of the world’s pre-eminent cell therapy centres which has been a powerhouse in CAR T innovation for many years. We look forward to utilizing the deep cell therapy expertise of our team to develop and commercialize this CAR T."

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper

On July 28, 2021 Bridge Medicines and Cornell University reported an exclusive license agreement to develop UBR5 Inhibitors for the treatment of certain difficult-to-treat cancers such as triple-negative breast cancer (TNBC) (Press release, Bridge Medicines, JUL 28, 2021, View Source [SID1234585273]).

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UBR5 is a cellular enzyme (an E3 ubiquitin ligase) that is involved in the labeling of other proteins within a cell to designate them for destruction. UBR5 has recently been shown to be a key regulator in certain cancers, such as breast and ovarian cancers, enabling the cancer cells to survive and resist standard treatments.

Pioneering research by Dr. Xiaojing Ma and Dr. Gang Lin and their colleagues at Weill Cornell Medicine have identified a distinctive and profound role of UBR5 in the growth and metastasis of triple negative breast cancer (TNBC). An analysis of TNBC specimens revealed strong gene amplifications of UBR5 associated with the disease. UBR5 overexpression in TNBC tissues was confirmed at mRNA and protein levels. Dr. Ma and his colleagues discovered that tumor-derived UBR5 facilitated tumor growth in a manner dependent upon immune cells within the microenvironment, rendering them less able to kill the cancer cell. Consequently, attacking the UBR5 target may work well in combination with other immune regulators, such as those that target the PD-L1 pathway. The combined targeting of UBR5 and PD-L1 yields strong therapeutic benefit to tumor-bearing hosts in preclinical studies. Collectively, these data support targeting UBR5 as a novel immunotherapy to treat highly aggressive breast cancers that resist conventional therapies.

"Work in my laboratory has demonstrated the critical importance of the UBR5 pathway in enabling major cancers to resist chemo- and immuno-therapies," said Dr. Xiaojing Ma, professor of microbiology and immunology at Weill Cornell Medicine. "This resistance results in advancing cancers and ultimately death in many patients despite currently available treatments. This is an important unmet medical need. We believe that by developing an effective anti-UBR5 approach, we may be able to provide life-saving outcomes for patients who are out of options."

The Tri-Institutional Therapeutics Discovery Institute, Inc. (Tri-I TDI) advanced the pioneering discoveries from the Ma Laboratory into early-stage drug molecules. Tri-I TDI’s mission is to work with innovative scientists at its founding institutions, The Rockefeller University, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medicine, in a close collaboration with Takeda Pharmaceutical Company Ltd, to accelerate the discovery of new drug molecules. Bridge Medicines will further develop and advance these molecules with the goal of bringing a new treatment to patients.

"We are very excited to bring the UBR5 program into Bridge Medicines," said Bill Polvino, CEO of Bridge Medicines. "The preclinical data are very compelling, and we look forward to developing a novel, first in class therapy for cancers that resist current treatments, such as triple negative breast and ovarian cancers."

"Drug discovery is essential for advancing healthcare, ensuring the translation of cutting-edge science into powerful medicines that are available to patients who need it most," said Dr. John Leonard, senior associate dean for innovation and initiatives at Weill Cornell Medicine. "The Tri-I TDI-Bridge Medicines continuum is invaluable to realizing that promise and serves as a vital component of the Weill Cornell Medicine Enterprise Innovation ecosystem. We are excited that the UBR5 program, based on Drs. Ma and Lin’s groundbreaking research, has achieved this important milestone with Bridge Medicines."

Weill Cornell Medicine Enterprise Innovation accelerates the best of biomedical innovation to market, translating groundbreaking research into revolutionary care. Enterprise Innovation provides a bridge between academic researchers and industry stakeholders, brokering engagements and alliances, engaging with and educating faculty about biotech commercialization and business development—which includes patenting, licensing, and marketing—and developing entrepreneurial programming, education, mentoring, and other resources.

About TNBC
Triple-negative breast cancer (TNBC), as defined by the negative expression of the estrogen receptor (ER) and progesterone receptor (PR) as well as human epidermal growth factor receptor-2 (HER-2), represents approximately 15% to 20% of all invasive breast carcinomas. TNBCs are highly aggressive with large tumor mass, high nuclear grade, and increased lymph node involvement at the time of diagnosis, contributing to the highest risk of recurrence and metastasis of all breast cancer types at an early time. Particularly, because of the heterogeneity and no well-defined molecular targets, patients with metastatic TNBC have a poor 5-year survival despite standard treatment. It is urgent to discover new therapeutic targets that are involved in shaping the highly aggressive behavior of TNBC.

About Tri-I TDI
The Tri-I TDI connects researchers from Memorial Sloan Kettering Cancer Center, The Rockefeller University and Weill Cornell Medicine with collaborators from across the globe to remove barriers that impede drug discovery in academic settings. Tri-I TDI empowers the Tri-I community to advance their groundbreaking biological discoveries through preclinical studies by providing industrial-scale technical support for academic projects, making it possible to rapidly assess the utility of specific therapeutic targets in disease-relevant contexts. Working in close collaboration with Takeda Pharmaceutical Company, Ltd. and Bridge Medicines, Inc., Tri-I TDI accelerates the discovery of next generation drugs. For more information about Tri-I TDI, please visit www.tritdi.org or contact [email protected].