On July 21, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields (Press release, Immunomic Therapeutics, JUL 21, 2021, View Source [SID1234585069]). The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert". Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

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"Dr. Sampson’s contributions to advancing the research in glioblastoma is widely known in our scientific community and we are excited that his significant impact is being recognized on a global level by Expertscape," commented Dr. William Hearl, CEO of ITI. "This recognition is especially important today, on Glioblastoma Awareness Day, where we honor the patients, families, and care givers who have faced this complex and deadly type of brain cancer. We look forward to continuing to collaborate with Dr. Sampson to advance our glioblastoma immunotherapy program, ITI-1000, through Phase 2 and toward patients in need."

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 Alloy Therapeutics and Echo Investment Capital reported the formation of Wheeler Bio, a new biomanufacturing company built to accelerate the translation of therapeutic innovation into clinical impact (Press release, Alloy Therapeutics, JUL 21, 2021, View Source [SID1234585043]). Wheeler’s comprehensive discovery-to-IND programs are designed to provide emerging biopharma companies a faster and more predictable path to the clinic.

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With an initial focus on antibody therapeutics, Wheeler’s biomanufacturing programs will seamlessly integrate with Alloy Therapeutic’s preclinical antibody platforms and discovery capabilities. Wheeler’s state-of-the-art development and cGMP operations and business headquarters are located in Oklahoma City, OK and are supported by a pilot lab inside Alloy’s Boston, MA facility.

"Accelerating the translation of therapeutic innovation into clinical impact in the biopharma industry requires new kinds of biomanufacturing businesses. We created Wheeler Bio to provide best-in-class biomanufacturing speed, capabilities, and service to the next generation of drug developers," stated Dr. Jesse McCool, co-founder and CEO of Wheeler. "Through our parallel integration with discovery and unique partnering model, we will be able to offer customers groundbreaking turnaround times at fair prices."

"Finding a CDMO that cares as much about your preclinical batches as your commercial batches is a challenge we regularly face in drug development. Alloy is excited to partner with Wheeler and is confident that Jesse and his team will deliver the turnkey and high-quality CMC services that Alloy’s ecosystem of partners require to achieve their clinical goals," said Errik Anderson, Founder and CEO of Alloy Therapeutics. "What Wheeler is building aligns completely with Alloy’s mission to democratize access to foundational drug development technologies and capabilities."

Wheeler launched its Boston-based operations in Q1 2021 and will open its 35,000 sq. ft. cGMP Oklahoma City facility in Q4 2022. Through its partnership with Echo Investment Capital, Wheeler will have preferred access to expand its biomanufacturing offering to commercial scale production in the recently announced 400,000 sq. ft. manufacturing complex in the Oklahoma City Innovation District led by commercial real estate developers Richard Tanenbaum and Mark Beffort.

"Oklahoma City’s investment in bioscience and workforce development over the last 30 years has allowed Echo to rapidly enter the biomanufacturing arena with a compelling offering that connects coastal biopharmaceutical companies to critical resources at industry leading customer-first terms," said Christian Kanady, Founding Partner of Echo Investment Capital. "Our close affiliation with the OKC Innovation District and the greater healthcare ecosystem allows us to connect Wheeler’s customers with exceptional development and clinical resources like Wheeler, Stephenson Cancer Center, Harold Hamm Diabetes Center, and Oklahoma Children’s Hospital."

On July 21, 2021 Ascentage Pharma (6855.HK), a globally focused biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the US Food and Drug Administration (FDA) recently granted an Orphan Drug Designation (ODD) to the company’s MDM2-p53 inhibitor, APG-115 (alrizomadlin), for the treatment of stage IIB-IV melanoma (Press release, Ascentage Pharma, JUL 21, 2021, View Source [SID1234585042]). This marks the fifth ODD granted to alrizomadlin, after those for the treatment of gastric cancer, acute myeloid leukemia, soft tissue sarcoma, and retinoblastoma. To date, Ascentage Pharma has obtained a total of twelve ODDs from the FDA, continuing to set the record for the number of ODDs granted to any Chinese biopharmaceutical company.

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The term "orphan drugs" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. In the United States, an orphan indication is defined as a disease or condition with a prevalence of less than 200,000 patients in the country. Since the Orphan Drug Act was passed in 1983, the US government has provided incentives and policy support to encourage development of orphan drugs. This ODD by the FDA qualifies alrizomadlin for a range of development incentives, including a tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, possible research grant awarded by the FDA, and most importantly, 7 years of US market exclusivity upon approval.

Melanoma is a potentially deadly dermatologic malignancy that has been increasingly prevalent globally. The current lifetime risk of developing melanoma is 1 in 63 in the US1. In 2019, an estimated 96,480 patients have been diagnosed with melanoma and about 7230 patients with melanoma have died in the United States2. The prognosis of patients with of melanoma is closely associated with the stage of the disease at diagnosis. A US Surveillance, Epidemiology, and End Results (SEER) database review of melanoma cases from 2011 to 2015 identified approximately 75% of patients were diagnosed at stage I, 15% at stage II, 7.5% at stage III, and 2.5% at stage IV3.

Since 2011, remarkable progress has been achieved in the clinical treatment of patients with metastatic or unresectable melanoma. Targeted therapies such as mitogen-activated protein (MAP) kinase inhibitors and immunotherapies have dramatically improved patients’ overall survival and quality of life4-6. Immunotherapies, namely immune checkpoint inhibitors (ICIs) such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 monoclonal antibodies have been extensively studied and broadly used in clinical treatment. However, significant number of patients will eventually develop resistance to ICIs, and there is no approved treatment yet for patients with ICI-resistant melanoma.

Being developed by Ascentage Pharma, alrizomadlin is an orally administered, selective, small-molecule MDM2-p53 inhibitor. Preclinical studies showed that alrizomadlin combined with PD-1 blockade enhances antitumor activities by triggering adaptive antitumor immunity. At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma reported updated results from a Phase II study of alrizomadlin in combination with pembrolizumab that demonstrated promising antitumor activity and safety. The PD-1/PD-L1 inhibitor-resistant melanoma cohort which was treated with alrizomadlin plus pembrolizumab reported 1 patient with complete response, an objective response rate (ORR) of 24.1%, and a disease control rate of 55.2%. These results signified the synergy between alrizomadlin and immune-oncologic drugs, and a potential regimen that could bring hope to patients with ICI-resistant melanoma.

"At present, there is a large unmet medical need for the treatment of melanoma. Therefore, this ODD for alrizomadlin bears tremendous significance," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "As the fifth ODD granted to alrizomadlin, and the twelfth obtained by Ascentage Pharma, this designation reaffirms Ascentage Pharma’s leadership in the number of ODDs granted to any Chinese biopharmaceutical company, demonstrating our capabilities in global innovation. Moving forward, we will continue to pursue our mission of addressing unmet medical needs in China and around the world. The FDA’s supporting policy for orphan drug development will help us to further accelerate the clinical development of alrizomadlin and other drug candidates in our pipeline and hopefully we can bring these potential novel therapies to patients as soon as possible."

On July 21, 2021 AnchorDx, a world-leading developer of cancer screening and early detection solutions, on July 13, 2021, reported that it was awarded a Breakthrough Device Designation ("BTD")[1] by the US Food and Drug Administration (FDA) for UriFind (or "the Test"), an early detection test for bladder cancer based on urine DNA methylation detection (Press release, AnchorDx, JUL 21, 2021, View Source [SID1234585041]). This is the first BTD granted to liquid biopsy test for bladder cancer detection in China.

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Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine. The performance of the Test has shown to be as strong as that of cystoscopy, and significantly better than exfoliative cytology and Fluorescence in situ hybridization (FISH) in the detection of early and non-muscle invasive bladder cancer (NMIBC). The Test demonstrates increased advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer.

The Test’s research achievements have been published in The Journal of Clinical Investigation[2] and Clinical Epigenetics. Following years’ of real-world sample accumulation and verification by AnchorDx, the accuracy, sensitivity and specificity of UriFind have now reached 89.3%, 87.4% and 91.5% respectively. During the FDA-BTD approval process, AnchorDx provided head-to-head experiment results with another internationally approved product, proving the Test’s superior performance in detection sensitivity and ease-of-use.

UriFind’s detection method has been included into the newly released 2021 Guidelines for Diagnosis and Treatment of Bladder Cancer in China and has also gained EU CE marking. In addition, AnchorDx has also passed the medical device quality management system certification – TUV ISO 13485 Certification.

At present, AnchorDx’s UriFind has entered the registered clinical trials stage in China, and clinical trials in the United States will be launched soon. Once the Test obtains the US market authorization from FDA, a four-year national medicare coverage[3] will be provided. As an innovative biotechnology enterprise in China with a global perspective, AnchorDx constantly promotes the registration and certification of advanced cancer early detection technology around the world and is making every effort to accelerate the global market authorization of UriFind, with a view to enabling it to serve more population in need as soon as possible.