On July 21, 2021 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, reported the initiation of a Phase I/II clinical trial of ECT204, a GPC3 targeting ARTEMIS T-cell therapy for the treatment of hepatocellular carcinoma (HCC), the predominant type of liver cancer. The Phase I portion of the ARYA-3 study is now open for enrollment (Press release, Eureka Therapeutics, JUL 21, 2021, View Source [SID1234585026]).

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Glypican 3 (GPC3) is a promising target for HCC therapies and is found in more than 70% of HCC cells. The GPC3 protein is also expressed in other solid tumors including ovarian and lung cancer. During the ECT204 ARYA-3 investigational study, a patient’s T cells will be collected, engineered to express Eureka’s proprietary ARTEMIS cell receptors targeting GPC3, and infused back into the patient’s body to target and kill GPC3-expressing cancer cells.

The ARYA-3 trial is being run in parallel with Eureka’s ongoing ET140203 ARYA-1 trial. With ET140203, the ARTEMIS receptor targets an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells using a TCR-mimic antibody. With ECT204, since the antibody directly recognizes GPC3 and does not require the patient to be HLA-A2 positive, the therapy is potentially available to a larger liver cancer patient population.

"We look forward to working with City of Hope on our ARYA-1 and ARYA-3 clinical trials," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "ECT204 and ET140203 ARTEMIS T cells were engineered with our proprietary tumor infiltration and controlled cytokine release technologies that we believe can improve on the performance of engineered T cell therapies in solid tumors. Effective treatment for HCC is a highly unmet medical need, and we are committed to bringing our therapies to patients faster."

"We are excited to provide City of Hope patients with both GPC3 and AFP targeted therapy options to treat HCC," said Dr. Daneng Li, Program Lead of the Hepatobiliary Tumor Program and principal investigator of the trial at City of Hope, a comprehensive cancer center near Los Angeles. "Engineered T-cell therapy is a novel approach, and it has the potential to transform how solid tumors will be treated in the future."

The ARYA-3 study is an open-label, dose escalation, multi-center, Phase I/II clinical trial of ECT204 ARTEMIS T cell therapy to initially assess the safety and determine the recommended phase II dose (RP2D) in adult patients with advanced GPC3-positive HCC. Additional information about Eureka’s Phase I/II study may be found at ClinicalTrials.gov, using Identifier NCT: NCT04864054.

Patients, caregivers, and healthcare professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.

Liver cancer is the fourth leading cause of cancer death worldwide, accounting for an estimated 782,000 deaths in 2018. About 43,000 new cases, and 30,000 deaths from liver cancer are expected to occur in the U.S. in 2020. The rate of liver cancer diagnosis has more than tripled since 1980, according to the American Cancer Society. Patients with advanced HCC have a poor prognosis and limited treatment options.

On July 21, 2021 TRACON Pharmaceuticals (NASDAQ: TCON) ("TRACON" or the "Company"), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 3,926,702 shares of common stock of the Company at a price to the public of $3.82 per share, less underwriting discounts and commissions (Press release, Tracon Pharmaceuticals, JUL 21, 2021, View Source [SID1234585053]). In addition, the Company has granted the underwriter a 30-day option to purchase up to an additional 589,005 shares of common stock at the public offering price, less underwriting discounts and commissions. The closing of the public offering is expected to occur on or about July 26, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $15.0 million, prior to deducting underwriting discounts, commissions and estimated offering expenses and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from this offering to support the continued clinical development of envafolimab, as well as for working capital and general corporate purposes.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-229990) that was filed with the U.S. Securities and Exchange Commission ("SEC") on March 1, 2019, as amended, and declared effective on October 8, 2019. The shares of common stock are offered only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, and, when filed, the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (646) 975-6996.

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 July 21, 2021 Samsung Biologics, one of the world’s leading contract development and manufacturing organization (CDMO), reported that signed a strategic partnership agreement with Kineta, Inc., a clinical-stage biotech company developing novel immunotherapies in oncology (Press release, Kineta, JUL 21, 2021, View Source;schBoardCtgryCcd=&schString=&schBoardYear=&boardDtm=1626706800000&page=1#new_tab&utm_source=rss&utm_medium=rss&utm_campaign=kineta-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-vista-antibody-immunotherapy [SID1234586786]). Samsung Biologics will provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s novel anti-VISTA antibody in development for the treatment of solid tumors.

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VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1, and also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.

The manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco, and its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.

"We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market," said John Rim, CEO of Samsung Biologics. "We will fully utilize our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success."

"Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year", said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. "We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy".

Samsung Biologics offers seamless one-stop CDMO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Bringing quality-driven development services at a greater speed, the company delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.

On July 21, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported entering into its second clinical collaboration agreement with MSD (Merck & Co., Inc., Kenilworth, N.J. USA), to collaborate in the upcoming Phase 2 clinical trial of NOXXON’s NOX-A12 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as second-line therapy in pancreatic cancer (Press release, NOXXON, JUL 21, 2021, View Source [SID1234585027]).

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This Phase 2 study will evaluate the safety and efficacy of NOX-A12, NOXXON’s anti-CXCL12 agent, in combination with KEYTRUDA and two different chemotherapy regimens in patients with microsatellite stable pancreatic cancer. The vast majority of pancreatic cancer patients have microsatellite stable tumors which are resistant to checkpoint inhibitor monotherapy. The study will enroll up to 70 patients and will contain an interim go/no-go in each arm in addition to usual safety and efficacy endpoints. MSD will provide pembrolizumab and expert advice for the study protocol, while NOXXON will sponsor the trial that will be conducted in clinical centers in the US and Europe.

The study will include two treatment arms to determine the most efficacious treatment combination to move forward into a registrational trial:

Arm 1: NOX-A12 + pembrolizumab + gemcitabine + nab-paclitaxel

Arm 2: NOX-A12 + pembrolizumab + nano-liposomal irinotecan + 5-fluorouracil + leucovorin

Dr. Jarl Ulf Jungnelius, Senior Medical Advisor at NOXXON, commented: "Checkpoint inhibitors have rapidly become first-line treatment options for many cancer types but have failed to demonstrate benefits in microsatellite stable pancreatic cancer as monotherapy or in combination with standard of care chemotherapy. We believe that tackling the microenvironment is a promising approach to deliver in pancreatic cancer the clinical benefits demonstrated by anti-PD-1 therapy in other tumor types."

Aram Mangasarian, CEO of NOXXON commented: "We are excited to continue our successful collaboration with MSD, a key global player in the immuno-oncology space. We expect this upcoming Phase 2 to confirm the excellent safety and more clearly define the clinical benefits that NOX-A12 can provide in combination with KEYTRUDA to patients suffering from highly aggressive cancers, such as pancreatic cancer."

About NOX-A12

NOXXON’s lead compound NOX-A12 is a highly selective inhibitor of CXCL12, a critical tumor microenvironment chemokine that shields the tumor from the immune system and promotes vasculogenesis, significantly reducing cancer treatment efficacy and promoting tumor growth. NOX-A12 acts by two potential mechanisms of action:

Reducing the CXCL12 shield around the tumor, leading to an improved access of immune effector cells like T lymphocytes to the tumor;
Blocking tumor blood vessel rebuilding by vasculogenesis post radiotherapy.
NOX-A12 is currently developed in second-line pancreatic cancer in combination with Keytruda and in glioblastoma in combination with radiotherapy.

About KEYTRUDA

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

On July 21, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its intention to move forward towards the submission of a BLA to the US Food and Drug Administration (FDA) for eryaspase in hypersensitive acute lymphoblastic leukemia (ALL) patients following feedback from the agency in a pre-BLA meeting (Press release, ERYtech Pharma, JUL 21, 2021, View Source [SID1234585095]).

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The purpose for the meeting was to discuss clinical, non-clinical and quality content and expectations for the Company’s potential BLA submission. Based on the discussion and the totality of the available information to the Company to date, ERYTECH believes its regulatory package can potentially support an approval of eryaspase in hypersensitive ALL patients. Pending successful completion of remaining steps, the Company anticipates submitting a BLA in the fourth quarter of 2021.

"We are encouraged by the interactive dialogue with the agency, and grateful for the feedback and guidance we received on a potential path to approval," said Gil Beyen, CEO of ERYTECH. "This is an important milestone for ERYTECH as it advances our lead product candidate eryaspase as an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase, while our Phase 3 trial in second line pancreatic cancer is nearing completion. If all goes well, we could be in a position to make this product candidate available to ALL and pancreatic cancer patients in the course of next year."

In December 2020, positive Phase 2 clinical results were presented by the Nordic Society of Pediatric Hematology and Oncology, at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting. Eryaspase, in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.