On July 12, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to produce major improvements in treatment outcomes, and The University of Texas MD Anderson Cancer Center reported the launch of a multi-year strategic research collaboration to investigate and evaluate HMBD-002, Hummingbird’s VISTA antagonist antibody (Press release, Hummingbird Bioscience, JUL 12, 2021, View Source [SID1234584795]).

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Under the agreement, MD Anderson and Hummingbird will collaborate on the design and execution of clinical and translational research studies to better understand how HMBD-002 modulates the anti-tumor immune response, both as a monotherapy and in combination with other checkpoint inhibitors. Working with MD Anderson’s immunotherapy platform and its experts in comprehensive immunoprofiling, the teams will seek to identify biomarkers that may be used to predict clinical outcomes and adverse events.

"We are excited to be collaborating with MD Anderson to advance the clinical research of our novel immunotherapies," said Jerome Boyd-Kirkup, Ph.D., co-founder and CSO of Hummingbird Bioscience. "These studies will strengthen our understanding of VISTA and other emerging immuno-oncology targets and help us ensure that novel treatment strategies for challenging cancers get to patients as quickly as possible."

VISTA, an immune checkpoint protein, is an emerging immunotherapy target for cancer that suppresses the anti-tumor immune response. Studies indicate increased levels of VISTA are associated with the emergence of resistance to current cancer immunotherapies. HMBD-002 is designed to inhibit VISTA, removing the suppression of the immune system and allowing it to mount an anti-tumor response.

"Targeting VISTA is an exciting area of immunotherapy research with the potential to have an impact on a variety of cancer types," said Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology at MD Anderson. "This collaboration aligns our expertise in studying the anti-tumor immune response with Hummingbird’s novel therapeutic pipeline. We look forward to working with Hummingbird to advance immunotherapies that we hope will improve care for our patients."

Sharma and James Allison, Ph.D., regental chair of Immunology, are co-leaders of MD Anderson’s immunotherapy platform and will oversee the collaboration. Jordi Rodon, M.D., Ph.D., associate professor of Investigational Cancer Therapeutics and Genomic Medicine, will lead the clinical study of HMBD-002 at MD Anderson.

Disclosures

Drs. Sharma and Allison receive compensation as consultants to Hummingbird, and Dr. Sharma holds equity in the company. These financial relationships have been disclosed to MD Anderson in accordance with its COI Policy.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor.

Hummingbird’s first-in-class anti-VISTA therapeutic antibody advanced to clinical trials with a US$13.1 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

On July 12, 2021 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported the enrollment of its first patients in the CRC-PREVENT pivotal trial. The clinical study seeks to evaluate the safety and efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals, a group with no known co-morbidities associated with cancer risk and therefore more challenging to diagnose (Press release, Geneoscopy, JUL 12, 2021, View Source [SID1234584793]). The company’s innovative diagnostic was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in January of 2020.

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"We are pleased to initiate this important study and validate the use of Geneoscopy’s RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening," commented Dr. Erica Barnell, Geneoscopy’s co-founder and Chief Scientific Officer. "The ultimate goal of colorectal screening is cancer prevention, but this requires diagnostic screening options with the sensitivity to identify clinically relevant pre-cancerous lesions, including advanced adenomas. The RNA-FIT assay aims to deliver the necessary sensitivity and specificity in a simple, at-home collection kit."

The prospective, single-arm study will enroll more than 12,000 patients across all 48 contiguous United States. Patients will submit samples via the mail and subsequently undergo optical colonoscopy examination. All significant lesions discovered during colonoscopy will be biopsied or removed and sent for histopathology. A comparative analysis will be conducted to determine sensitivities and specificities, as applicable, for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies without findings.

"When it comes to detecting advanced adenomas, noninvasive tests are not currently hitting a 50% threshold. Until now, only colonoscopy can detect advanced adenomas reliably," commented Dr. David Lieberman, Professor of Medicine, Division of Gastroenterology and Hepatology at the Oregon Health Sciences University School of Medicine. "A noninvasive, at-home option that successfully detects these pre-cancerous lesions would represent an important, positive step in early detection for colorectal cancer prevention."

Geneoscopy’s initial clinical study demonstrated high sensitivity of its multifactor RNA-FIT assay compared with colonoscopy findings, demonstrating 95% sensitivity for colorectal cancer, 62% sensitivity for advanced adenomas, and 25% sensitivity for other non-advanced adenomas with an 85% specificity for no findings on a colonoscopy. The promising data was previously presented by Dr. Barnell, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting and the peer-reviewed article recently published in Clinical and Translational Gastroenterology.

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer related death in the United States.1 Disease progression begins with polyps that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the US, yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70% of CRC cases.

To learn more about the CRC-PREVENT clinical trial and join in the fight to help prevent colorectal cancer, visit View Source

1Colorectal Cancer Fact Sheet, American Cancer Society, 2021.

On July 12, 2021 Servier, a global independent pharmaceutical Group, and Nymirum, a pioneer in RNA-targeted small molecules, reported that they have entered into a strategic collaboration to identify and develop RNA-modulatory drugs for the treatment of neurological diseases (Press release, Servier, JUL 12, 2021, View Source [SID1234584792]).

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Under the collaboration agreement, Nymirum will leverage its proprietary DART Platform (Dynamic Atomic-Resolution RNA Targeting Platform) to discover novel small molecule therapeutics for multiple neurological targets. Servier is responsible for joint preclinical development and has the right to pursue further development on the current targets as well as expand the scope of the collaboration. The collaboration provides Nymirum with an initial payment, followed by future success payments.

"We are excited to pair Nymirum’s expertise in targeting RNA with Servier’s experience in CNS (Central Nervous System) to advance transformative therapies. The ability to resolve and leverage RNA’s dynamic structure opens a new chapter for drug discovery, enabling novel programs across all therapeutic areas," said Joshua Fairbank, Chief Executive Officer and Co-Founder of Nymirum. "Thanks to its expertise in CNS and small molecule therapeutics, Servier is a valuable partner in this collaboration, and together we look forward to accelerating the search for treatments for patients with severe neurological disorders."

"This new collaboration is the opportunity to progress innovative RNA-targeted approaches towards clinical assessment in patients with very limited or absent treatment options," stated Ross Jeggo, Global Head of Neuroscience and Immuno-inflammation Therapeutic Area at Servier. "We are delighted to work in partnership with Nymirum on multiple drug discovery projects, harnessing their platform to deliver RNA-targeting small molecules for neurodegenerative diseases. The therapeutic advantage associated to a small molecule versus other DNA- or RNA-based approaches is truly innovative and very promising for potential treatments for patients suffering from disorders of the central nervous system."

On July 12, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the closing of its underwritten public offering of 5,333,333 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions, including the exercise in full by the underwriters of their option to purchase up to an additional 695,652 shares of common stock in the offering (Press release, Ideaya Biosciences, JUL 12, 2021, View Source [SID1234584791]). The net proceeds from the offering were approximately $86.1 million, after deducting the underwriting discount and commissions and estimated offering expenses payable by IDEAYA. All shares in the offering were offered by IDEAYA.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under IDEAYA’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities acted as joint book-running managers for the offering.

The public offering was made by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

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

On July 12, 2021 Akeso, Inc. reported that, CD47 monoclonal antibody (AK117), a second-generation novel drug for immuno-oncology therapy independently developed by the Company, has completed phase I dose escalation trial in Australia (Press release, Akeso Biopharma, JUL 12, 2021, View Source [SID1234584790]). AK117 resulted in no dose-limiting toxicity (DLT) and no anemia of clinical significance in subjects in all dose escalation cohorts (with 0.3 mg/kg to 45 mg/kg administered once-weekly (QW)), and was well tolerated by subjects in all cohorts. Low-dose priming was not required.

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Akeso has obtained approval from the National Medical Products Administration (NMPA) of China to initiate phase Ib/II clinical trial of AK117 in combination with azacitidine for the treatment of acute myeloid leukemia (AML). AK117, a second-generation CD47 monoclonal antibody, has a significantly improved safety profile compared to the first-generation CD47 monoclonal antibody, and AK117 in combination with azacitidine is expected to perform better than similar drugs in the treatment of AML. Previous studies of AK117 in myelodysplastic syndromes (MDS) have shown its advantages of safety and the majority of MDS patients had hematologic improvement while receiving AK117 treatment. To date, clinical trials of AK117 in both solid tumors and hematologic tumors have been initiated and began patient dosing.

AML is a group of highly heterogeneous diseases with clonal proliferation abnormalities of hematopoietic stem cells and is the most common type of adult acute leukemia. CD47 is highly expressed on the surface of several tumor cells, including solid tumors and hematologic tumors, and is associated with poor prognosis. CD47 blockade stimulates phagocytosis of tumor cells by macrophages and promotes adaptive immune response. Preclinical data showed that CD47 monoclonal antibody in combination with azacitidine can further induce endogenous expression of calreticulin on the cell surface, thereby further enhancing the phagocytosis of tumors by macrophages. At the same time, there are clinical data showing that CD47 monoclonal antibody in combination with azacitidine is significantly more effective than azacitidine alone in treating AML subjects who are not suitable for chemotherapy at first treatment, and is safe and well tolerated.

Information about AK117 (CD47 Monoclonal Antibody)

AK117 is a novel humanized IgG4 mAb independently developed by the Company. It can bind with CD47 expressed on tumor cells to prevent the interaction between CD47 and its receptor, SIRPα, expressed on macrophages so as to enhance phagocytosis to inhibit the growth of tumor cells. Previously published data demonstrated exceptional safety profile. AK117 resulted in no DLT and no anemia of clinical significance in subjects in all doseescalation cohort (the highest dose cohort was 45 mg/kg QW), and was well tolerated by subjects in all cohorts. The CD47 receptor occupancy rate (RO) of the peripheral blood T cells has reached and maintained at 100% in the 3 mg/kg cohort.