On July 7, 2021 Inceptor Bio, a Research Triangle Park, North Carolina-based cell and gene therapy biotechnology company, reported that it has launched FastBack Bio, the first of multiple next-generation cell and gene therapy platform companies that Inceptor Bio is building (Press release, Inceptor Bio, JUL 7, 2021, View Source [SID1234584677]).

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FastBack Bio’s core technology is the M-STIM platform, from which multiple co-stimulatory domains may be derived. M-STIM co-stimulatory domains are powerful modulators of T cell responses and endow CAR-T cells with a number of beneficial characteristics. In vitro data show that the first M-STIM co-stimulatory domain, M83, provides CAR-T cells with differentiated expansion kinetics and a balanced mix of effector memory and central memory phenotypes compared to CAR-T cells made with commonly used co-stimulatory domains including CD28 and 4-1BB. Additionally, M83-based CAR-T cells are resistant to exhaustion in vitro and exhibit an enhanced metabolism that may be beneficial in the tumor microenvironment (TME).

Dr. Mike Nicholson, Chief Science Officer at Inceptor Bio, said, "CAR-T therapy has demonstrated impressive results fighting liquid tumors, but the field hasn’t been as successful treating solid tumors. In murine models of renal cell carcinoma, M83-based CAR-T cells are far superior to CD28 or 4-1BB-based CAR-T cells. Those data, coupled with in vitro characterization, lead us to believe that M83-based CAR-T cells will be more efficacious against solid tumors."

FastBack Bio launches with technology licensed from Dr. Lishan Su’s laboratory at the University of North Carolina at Chapel Hill. Dr. Su earned his Ph.D. in virology from Harvard and held a post-doctoral position in immunology and stem cell biology at Stanford. Dr. Su spent 24 years at UNC Chapel Hill, with appointments in the UNC Lineberger Cancer Center and the Department of Microbiology & Immunology. In October 2020, he was appointed Head of the Maryland Institute of Human Virology.

Dr. Su, who will continue to support development of the M83 platform through sponsored research and as an advisor to FastBack Bio, said, "I am excited to support FastBack Bio as an Inceptor Bio portfolio company. FastBack Bio will have access to world-class facilities and a team with an exceptional track record that will allow us to accelerate the development of T cell-based therapeutics with our novel co-stimulatory domain."

Abe Maingi, Co-Founder, Board Member, and VP of Business Operations at Inceptor Bio, noted, "At Inceptor Bio, we are committed to building therapeutic companies with the leading innovators in cell and gene therapy to progress treatments that have potential to cure difficult-to-treat cancers. We are thrilled to announce that the University of North Carolina and Dr. Su are the first partners in our mission to advance cell and gene therapies to cure cancer."

Inceptor Bio was established to pursue a diversified portfolio of cell therapy platforms across multiple cell types, including CAR-T, CAR-M, and NK/NKT, with novel mechanisms that enhance immune cell performance within the tumor microenvironment. Inceptor Bio has a new website at www.inceptor.bio to provide information on the company’s vision and activities.

On July 7, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that Steven O’Day, MD, Chief Medical Officer of Agenus, will participate in a panel discussion at the William Blair Biotech Focus Conference 2021 titled "Novel Mechanisms and Strategies for Addressing PD-(L)1 Refractory/Resistant Tumors (Press release, Agenus, JUL 7, 2021, View Source [SID1234584713])."

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The panel will take place on Wednesday, July 14, 2021, from 4:20 p.m. to 5:20 p.m. ET. The event will be webcast live and may be accessed on the Company’s website at View Source

On July 7, 2021 Akari Therapeutics, Plc (Nasdaq: AKTX) ("Akari" or the "Company"), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, reported that it has entered into definitive securities purchase agreements with certain accredited and institutional investors, led by existing investors of the Company, including Dr. Ray Prudo, the Company’s Chairman, to receive gross proceeds of approximately $12 million through a private placement of its equity securities (Press release, Akari Therapeutics, JUL 7, 2021, View Source [SID1234584645]).

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In connection with the offering, the Company will issue unregistered American Depository Shares, each representing 100 of the Company’s ordinary shares ("ADSs"), at a purchase price of $1.55 per ADS. The closing of the offering is expected to take place during or before the week of July 12, 2021, subject to the satisfaction of customary closing conditions.

Paulson Investment Company, LLC, is acting as the exclusive placement agent in connection with this offering.

The ADSs described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder, and have not been registered under the Act or state securities laws, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 7, 2021 UroGen Pharma Ltd (Nasdaq:URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will present at the Ladenburg Thalmann Healthcare Conference on July 14, 2021 at 12:00pm Eastern Time (Press release, UroGen Pharma, JUL 7, 2021, View Source [SID1234584662]).

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A live webcast of the presentation will be available on the Investors section of UroGen’s website, www.urogen.com. A replay of each webcast will be available on the website for approximately 30 days.

On July 7, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported the publication of an analysis highlighting that Bladder EpiCheck can reduce both patient burden and healthcare system costs in the U.S. and European countries for low grade intermediate risk non-muscle invasive bladder cancer (NMIBC) (Press release, Nucleix, JUL 7, 2021, View Source [SID1234584678]). The analysis, titled "Alternating Cystoscopy with Bladder EpiCheck in the Surveillance of Low-Grade Intermediate-Risk NMIBC: A Cost Comparison Model," was published in the peer-reviewed journal Bladder Cancer.

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This analysis was performed in an effort to better understand the economic impact of such an approach across 10 different countries with varied healthcare cost structures. Researchers developed a decision analysis model to compare standard surveillance with a modified surveillance that alternated between standard methods and use of Bladder EpiCheck every three to six months. The alternating schedule saved 8-14% of the cost for the system in 70% of the countries and resulted in a negligible cost increase in the other countries.

"Bladder cancer is the fifth most common cancer across the world, yet surveilling its recurrence remains one of the most invasive, intensive and costly processes across the oncology landscape. This includes cystoscopy: a painful procedure patients must undergo every few months," said Aharona Shuali, M.D., vice president of medical at Nucleix. "The findings of this analysis show that Bladder EpiCheck can be used to help reduce this burden to patients with a cost saving in most countries and a negligible cost increase in remaining countries."

Authors attributed the cost-effectiveness of this alternative strategy to Bladder EpiCheck’s high specificity of 86%. This is because lower specificity often results in patients receiving additional cystoscopies, ultimately leading to higher overall costs to the healthcare system. Importantly, for such an alternating schedule to be clinically acceptable, high sensitivity for high-grade disease is key to ensure patients with a high-grade recurrence, who are at risk of disease progression, are detected promptly and treated.

"We are currently over-monitoring low-grade NMIBC patients, which creates an enormous burden on the patients and the system, however, eliminating surveillance of these patients altogether is not an option, due to the small but significant risk of progression to high-grade disease," said Yair Lotan, M.D., Professor of Urology at University of Texas Southwestern Medical Center. "This analysis demonstrates that a robust urine marker, such as Bladder EpiCheck, can be used to reduce the frequency and burden of cystoscopies without additional costs to the healthcare system and patients."

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-risk cancer is present1. Bladder EpiCheck is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.