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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On August 25, 2021 NovaRock Biotherapeutics Limited, a clinical-stage biopharmaceutical company delivering innovative specialty pharmaceuticals to address patients’ unmet medical needs, reported that they have entered into an exclusive license agreement and strategic partnership with Flame Biosciences (Press release, NovaRock Biotherapeutics, AUG 25, 2021, View Source [SID1234586891]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to be partnering with Flame and their world-class clinical team," said Dr. Han Li, CEO of NovaRock. "The collaboration with Flame marks a solid step towards getting NovaRock’s innovative portfolio into the global market. The proceeds from this collaboration will be primarily used to fund the clinical advancement of NBL-012 and NBL-015 as well as the advancement of our preclinical programs."

NBL-015 is a fully human anti-Claudin 18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC, and ADCP effects. Its Investigational New Drug Application has also been approved by the U.S. FDA in May 2021.

Under the terms of the Agreement, NovaRock has granted Flame Biosciences the exclusive rights to NBL-015 outside of Greater China (including mainland China, Hong Kong, Macau, and Taiwan). Flame shall be responsible for the development, regulatory approval, and commercialization of NBL-015. NovaRock will, at Flame Biosciences’s expense, collaborate with Flame on the discovery and preclinical development of two new bispecific antibodies based on NovaRock’s NovaTE bi-specific antibody technology platform and subsequently grant Flame Biosciences the exclusive rights to further develop, manufacture and commercialize the Licensed Products. The lead product candidates from this collaboration are expected to enter clinical development in late 2023.

NovaRock will receive an upfront payment of US$7.5 million and is eligible to receive development milestone payments of up to US$172.5 million subject to achievement of the development milestone events. NovaRock is also eligible to receive sales milestone payments of up to US$460 million subject to the achievement of the sales milestone events and royalties based on a certain percentage of the net sales of the Licensed Products in the Territory.

About NBL-015

NBL-015 is a fully human anti-Claudin 18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC, and ADCP effects. Preclinical studies have demonstrated that NBL-015 has significant advantages over similar drugs in terms of low immunogenicity, good safety, high affinity, and high anti-tumor activity, providing a promising prospect of becoming the best-in-class target therapy to treat pancreatic and gastric cancer. NBL-015 has been granted the orphan-drug designation for the treatment of pancreatic cancer and gastric cancer, including cancer of gastroesophageal junction by the U.S. Food and Drug Administration (FDA). Its Investigational New Drug Application (IND) has also been approved by the U.S. FDA in May 2021.

About NovaTE bi-specific antibody technology platform

NovaTE is a novel tumor antigen and CD-137 bispecific antibody technology platform that is designed to selectively activate the antigen-experienced T cells in the tumor microenvironment. Its proprietary scaffold can maximize the tumor cell engaging and T cell activation while minimizing the systematic adverse events. Antibodies developed using NovaTE have demonstrated superior efficacy and safety in preclinical studies. Moreover, the unique bi-specific antibody structure offers exceptional stability and manufacturability.

On August 25, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the, "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the first patient who received INKmune as a potential treatment for high-risk myelodysplastic syndrome (MDS) has successfully shown the NK activation and functional differentiation predicted by previously published in vitro experiments (Press release, INmune Bio, AUG 25, 2021, View Source [SID1234586926]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

NK cells need multiple activating signals to progress from a resting state to the triggering of cytolysis and cytokine secretion. INmune Bio has studied these pathways extensively and demonstrated that binding of NK cells with INKmune provides multiple activating signals and drives resting NK to the phenotype of memory-like NK (mlNK) cells with enhanced cancer-killing function. The company believes that this is the first ever successful generation of mlNK cells in patients.

"The INmune Bio team has been developing the concept of tumor cell-primed NK cells since 2004 with the creation of the first pharmaceutical-grade tumor line for NK priming a critical first step in testing whether these primed, memory-like NK cells could be generated in vivo." said Dr. Lowdell PhD, chief scientific officer of INmune Bio. "In the lab, INKmune binds to multiple NK ligands and initiates the activation of over 3,000 genes associated with function, trafficking, proliferation, and survival to form memory-like NK cells, which have superior cancer killing function. In our hands, no single cytokine has such broad physiological effects on NK cells compared to INKmune-primed NK cells, and this has inspired us to refer to INKmune as a pseudokine."

Preliminary data from the first patient shows that formation of mlNK cells can be achieved in vivo and without toxicity. INKmune was delivered in three doses on days one, eight and 15. INKmune therapy cause proliferation of NK cells with a doubling of the number of peripheral blood NK cell numbers on day 8. Over 50% of the expanded NK cells had an activated profile (CD69+/CD25+) on days eight and 15 and increased to over 70% by day 29. More than 80% of the activated NK cells expressed markers associated with a memory-like NK cell (CD57++, NKG2D+, NKG2A-ve, NKp46-ve). In vitro, the INKmune activated NK cells were better at killing cancer cells than the patient’s own NK cells prior to treatment, with an 82% increase in lysis of K562 leukemia cells and a 47% increase in lysis of NK-resistant RAJI lymphoma cell tumor cells as early as day eight. Despite this high level of activated NK cells and tumor killing, the patient showed no symptoms of Cytokine Release Syndrome (CRS).

"We are always cautious of single patient data but seeing these significant changes in peripheral blood NK cell populations in a patient treated at the lowest dose of INKmune is encouraging and identical to what we observed in pre-clinical studies," added Dr. Lowdell.

"Data from this patient demonstrates that INKmune can produce memory-like NK cells in patients," said RJ Tesi, M.D., chief executive officer of INmune Bio. "These biomarker data demonstrate that, even in a heavily pre-treated patient, INKmune can cause proliferation of the patients NK cells and convert them into the type of NK cells that are superior at killing cancer cells."

At least nine additional patients with high-risk MDS will be enrolled in the ongoing Phase I trial. A video overview of the INKmune platform can be found by clicking here.

About INKmune

INKmuneTM is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.