On August 25, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. ( hereinafter referred to as "ImmuneOnco") reported that 3 phase Ib/IIa trials of company’s lead drug candidate, IMM01, Fc fusion protein targeting CD47，the first in China, combined with Azacytitin for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with Rituximab for relapsed/refractory B-cell lymphoma and with Inetetamab (CipterbinTM) in her2-positive solid tumors have been approved by the National Drug Products Administration (NMPA) (Press release, ImmuneOnco Biopharma, AUG 25, 2021, View Source [SID1234655626]). All clinical trials will be Initiated in the near future. The clinical trial of IMM01 combined with Inetetamab (CipterbinTM) will be cooperated with Sunshine Guojian (stock code , SHA: 688336) and mainly conducted by it. So far, total five clinical trial applications for IMM01 have been approved, which further establishes ImmuneOnco leading position in the research and development of CD47 target drugs.

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The ongoing Phase I study of IMM01 monotherapy for the treatment of patients with relapsed/refractory lymphoma (NHL & HL) has completed all scheduled doses of participants. No dose-limiting toxicity (DLT) is observed and no subjects developed anti-drug antibodies (ADA) except for minor infusion response in some patients. There were no drug-related serious adverse events (SAE). At the same time, some patients had an exciting indication efficacy response, especially for patients with recurrent/refractory classic Hodgkin’s lymphoma: 1 case of PR and 3 cases of SD in 5 patients with cHL, and the disease control rate reached 80%. Among them, the patient with PR was drug-resistant to PD-1 therapy. Currently, PR has lasted for 40 weeks and is still receiving treatment. In 1.5mg/kg dose group (the highest escalation dose group), four of the five patients enrolled had SD, two of them were SD with tumor shrinkage (17% and 33%, respectively). CR for 26 weeks was also observed in one patient.

"We are very pleased to see that the National Food and Drug Administration (NMPA) has approved clinical studies of IMM01 combined with Azacytitin, Rituximab and Inetetamab. The drug candidate IMM01, which is being tested in phase I clinical trials, has achieved long-lasting efficacy in some patients with advanced lymphoma at a low dose range with a good safety profile. Those clinical benefits are supported by the proprietary molecular design of IMM01. IMM01 does not bind to human red blood cells at all so as to avoid "Antigenic sink". Due to that in vivo infusion of the molecule doesn’t produce ADA and a smaller molecule (half molecular weight of regular IgG), it has higher tissue permeability and bioavailability. IMM01 has been tested in preclinical experiments in vitro in combination with various targeting and immunotherapeutic agents, efficacy appeared to be robust in tumor suppressive activity and potential to be applied to solid tumors. "We believe that IMM01 in combination with other drugs will provide significant advantages in clinical development." Dr. Tian Wenzhi, the founder of ImmuneOnco, is very confident of the IMM01 clinical trials. "We plan to expand IMM01 to apply in new indications and combination studies in the future to benefit more patients," he said.

On August 25, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that it will host its first R&D event focused on in vivo gene editing at 8:00 am ET on Thursday, September 9, 2021 (Press release, Precision Biosciences, AUG 25, 2021, View Source [SID1234591429]).

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Precision’s gene editing event will feature presentations from Company management as well as featured guest speakers and will outline Precision’s development strategy to advance its in vivo gene editing portfolio. The agenda will include an overview of ARCUS, Precision’s proprietary platform for in vivo gene correction, new pre-clinical data, timelines for leading in vivo gene editing programs, and updates from academic and industry collaborators.

Company Conference Call and Webcast Information

Registration for the live webcast is available under Events & Presentations in the Investors section of the Precision BioSciences website at investor.precisionbiosciences.com. The dial-in conference call numbers for domestic and international callers are (866) 970-2058 and (873) 415-0216, respectively. The conference ID number for the call is 6376435. An archived replay of the webcast will be available on the Company website for one year following the presentation.

On August 25, 2021 LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, and BridgeBio Pharma, Inc. (Nasdaq: BBIO) reported the first patient has been treated in a Phase 2a clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations (Press release, BridgeBio, AUG 25, 2021, View Source [SID1234586874]).

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"Infigratinib is a potent and selective FGFR inhibitor that has demonstrated compelling clinical activity across multiple tumor types with FGFR alterations," said Yizhe Wang, Ph.D., chief executive officer of LianBio. "Given the disproportionately high prevalence rate of gastric cancer in China, LianBio is pursuing a region-specific development strategy focused on this area of great unmet need. This study marks LianBio’s first trial initiation and demonstrates our continued progress in delivering potentially transformational medicines to patients in Asia."

TRUSELTIQ (infigratinib) is an oral selective inhibitor of FGFR1-3 that is approved in the United States for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. It is also being further evaluated in clinical trials based on demonstration of clinical activity in patients with advanced urothelial carcinoma with FGFR3 genomic alterations. LianBio in-licensed rights from BridgeBio for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau.

The Phase 2a trial is a multicenter, open-label, single-arm study in China designed to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR alterations. The primary endpoint is objective response rate (ORR). Secondary endpoints include duration of response, safety, disease control rate, progression-free survival and overall survival.

Preclinical data have demonstrated the potential infigratinib may have for patients with gastric cancer. These results, published in Cancer Discovery, demonstrated tumor regression in multiple in vivo FGFR2 amplified gastric models.1

"We believe that infigratinib could have a meaningful impact for people living with gastric cancer as well as many other cancers with FGFR alterations, and are pleased LianBio is initiating this clinical trial in China where more therapeutic options are needed to match the growing diagnosis rate," said BridgeBio founder and chief executive officer Neil Kumar, Ph.D. "On the heels of TRUSELTIQ recently obtaining accelerated approval in the United States, we are hopeful that this trial will yield pivotal results in another subset of cancer patients as we continue to build our portfolio of oncology indications with the aim of reaching as many people in need as possible."

About TRUSELTIQ (infigratinib)

TRUSELTIQ (infigratinib) is an orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR) that received accelerated approval from the FDA in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. TRUSELTIQ targets the FGFR protein, blocking downstream activity. In clinical studies, TRUSELTIQ demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response. TRUSELTIQ is not FDA-approved for any other indication in the United States and is not approved for use by any other health authority, including any Chinese or other Asian health authority. It is currently being evaluated in clinical studies for first-line cholangiocarcinoma, urothelial carcinoma (bladder cancer), locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations.

On August 25, 2021 RenovoRx, Inc., a biopharmaceutical company and innovator in targeted cancer therapy, reported the pricing of its underwritten initial public offering of 1,850,000 units at a public offering price per unit of $9.00 (Press release, Renovorx, AUG 25, 2021, View Source [SID1234586890]). Each unit consists of one share of common stock and one warrant to purchase one share of common stock. The warrants have an exercise price of $10.80 per share and are exercisable for a period of five years after the issuance date. All of the units are being offered by RenovoRx. In addition, RenovoRx has granted the underwriters a 45-day option to purchase up to an additional 277,500 shares of its common stock and/or warrants to purchase up to an additional 277,500 shares of its common stock, at the initial public offering price, less the underwriting discounts and commissions.

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In connection with the offering, the Company’s common stock has been approved for listing on The Nasdaq Capital Market. The shares are expected to begin trading on The Nasdaq Capital Market on August 26, 2021, under the ticker symbol "RNXT." The offering is expected to close on August 30, 2021, subject to customary closing conditions.

RenovoRx Announces Pricing of Initial Public Offering

The gross proceeds to RenovoRx from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $16.65 million.

Roth Capital Partners is acting as the sole book-running manager for the offering. Maxim Group LLC is acting as lead manager for the offering.

The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (Registration No. 333-258071) that was previously filed with the U.S. Securities and Exchange (the "SEC") and declared effective on August 25, 2021. This offering is being made only by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the preliminary prospectus can be accessed through the SEC’s website at www.sec.gov. Copies of the final prospectus relating to the initial public offering can be obtained, when available, through the SEC’s website at www.sec.gov or from: Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, CA 92660, Attention: Equity Capital Markets at (800) 678-9147 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 25, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported that it will host a virtual KOL event for analysts, investors, and the scientific community on Wednesday, September 8, 2021 (Press release, Cardiff Oncology, AUG 25, 2021, View Source [SID1234586875]).

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The webinar will include presentation of new data from Cardiff Oncology’s Phase 1b/2 clinical trial evaluating onvansertib in combination with standard-of-care FOLFIRI/bevacizumab in KRAS-mutated mCRC, featuring the clinical trial principal investigator, Heinz-Josef Lenz, M.D., FACP, USC Norris Comprehensive Cancer Center, key clinical advisor Afsaneh Barzi, M.D., Ph.D., City of Hope Comprehensive Cancer Center, and members of the Cardiff Oncology management team. A question & answer session will follow the formal presentations.

Heinz-Josef Lenz, M.D., FACP, is the associate director for clinical research and co-leader of the gastrointestinal (GI) cancers program at the University of Southern California Norris Comprehensive Cancer Center. Dr. Lenz is professor of medicine and preventive medicine, section head of gastrointestinal oncology in the division of medical oncology and co-director of the Colorectal Center at the Keck School of Medicine of the University of Southern California. Dr. Lenz received his medical degree from Johannes-Gutenberg Universität in Mainz, Germany, in 1985. He completed a residency in hematology and oncology at the University Hospital Tübingen in Germany, a clerkship in oncology at George Washington University in Washington, DC, and a clerkship in hematology at Beth Israel Hospital of Harvard Medical School in Boston, Massachusetts. He served subsequent fellowships in biochemistry and molecular biology at the University of Southern California Norris Comprehensive Cancer Center. An active researcher, Dr. Lenz focuses on topics including the regulation of gene expression involved in drug resistance, patients at high risk of developing colorectal cancer, and determination of carcinogenesis, methods of early detection, and better surveillance of these cancers. He is a member of several professional societies, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the American Gastroenterology Association, and the National Society of Genetic Counselors. He also serves on the National Advisory Board of several professional organizations. Dr. Lenz is the author of numerous peer-reviewed publications and invited papers, reviews, and editorials. He also serves as co-chair of the GI Committee and Correlative Science Committee for SWOG. He is a member of the National Cancer Institute (NCI) Task Force for Gastroesophageal Cancer, the NCI Steering Committee, and the NCI Translational Science Committee.

Afsaneh Barzi, M.D., Ph.D., is a practicing medical oncologist, associate clinical professor for gastrointestinal oncology, and clinical director of AccessHope at City of Hope Comprehensive Cancer Center. Prior to joining City of Hope, Dr. Barzi was an associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California. She earned her M.D. from Tehran University of Medical Sciences, then went on to earn a Master’s in Health Informatics and a Doctorate in Public Health Management and Policy Sciences from the University of Texas Health Science Center in Houston. Dr. Barzi completed a fellowship in hematology and oncology at the Cleveland Clinic’s Taussig Cancer Center. Her research and practice are focused on gastrointestinal malignancies with an emphasis on colorectal cancers. Her unique perspective on patterns of care in patients with colorectal cancer arises from the combination of her expertise in real-world data and her experience with biomarker discovery and the use of biomarkers for personalized care.