On December 22, 2020 Bayer and Veracyte (Nasdaq: VCYT) reported a new collaboration to advance the Precision Oncology Patient Identification Program in thyroid cancer (Press release, Veracyte, DEC 22, 2020, View Source [SID1234573201]). Through the program, Bayer will offer testing with Veracyte’s Afirma Xpression Atlas (XA) to identify underlying genomic drivers, including NTRK gene fusions, within patients’ tumors. The program will focus on patients with advanced or metastatic thyroid cancer that is radioactive iodine refractory (RAIR) who may potentially benefit from biomarker-driven therapies.

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"Patients whose thyroid cancer contains actionable alterations and no longer responds to traditional radioactive iodine therapy now have targeted treatment options available to them. Our goal is to identify such patients so physicians can make more informed treatment decisions for their patients," said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "With its comprehensive ability to identify broad genomic alterations through its Afirma XA test and its widespread reach among physicians who diagnose thyroid cancer, Veracyte is an ideal collaborator for this program."

The Afirma XA uses RNA whole-transcriptome sequencing to identify 905 DNA variants and 235 RNA fusions in 593 genes, including novel NTRK fusions, on fine needle aspirates taken from thyroid nodules or lymph nodes.1 Through this collaboration, Bayer will provide Afirma XA testing at no cost to all eligible patients when ordered by the physician, regardless of the final results and treatment decision. Additionally, physicians of patients found to harbor NTRK gene fusions as an underlying driver in their thyroid cancer will be alerted of the results. The companies anticipate the program to launch in the first quarter of next year.

"Our collaboration with Bayer will help ensure that all eligible thyroid cancer patients can be tested and identified for actionable genomic alterations – at no cost to them – so they may potentially benefit from biomarker-driven therapies," said Bonnie Anderson, Veracyte’s Chairman and Chief Executive Officer. "This is the first collaboration between the two companies, and we anticipate continued strategic programs to further precision oncology."

Approximately 53,000 people in the United States are expected to be diagnosed with thyroid cancer this year.2 For most of these patients, the cancer is contained in the thyroid when diagnosed.3 However, in approximately 30% of cases, the cancer has metastasized – most often to the nearby lymph nodes.4 NTRK gene fusions, which may drive tumor growth in some cancers, are more common in patients with RAIR thyroid cancer (2.4%-12% of patients).5-8

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On December 22, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported the completion of a 105 million USD crossover financing (Press release, Transcenta, DEC 22, 2020, View Source [SID1234573217]). China Structural Reform Fund led the financing round, participated by new investors including Country Garden Venture Capital, Qatar Investment Authority, and other prominent institutional investors. Existing investors including CCT China Merchants Fund, Lilly Asia Ventures, Teng Yue Partners, Sequoia Capital China and others also participated in this round. China Renaissance acted as the lead financial advisor for this transaction, and Bank of China International as joint financial advisor.

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The year 2020 has marked many significant milestones for Transcenta. Multiple senior clinical leaders joined the company during the last six months. With multiple assets in clinical stage, the Company has been pushing the robust pipeline forward aggressively. TST001, a CLDN18.2 targeting antibody and one of its leading programs, has been moving quickly in clinic in both US and China. Transcenta will also file IND soon for TST005, a second generation PDL1-TGFβ bifunctional molecule. Transcenta has also expanded its Hangzhou facility with a fill & finish line as well as 2000L bioreactors. Its perfusion biomanufacturing platform has achieved further breakthroughs including achieving industry leading productivity of more than 4 g/L per day for multiple cell lines and successful scale-up of perfusion process to 200L for GMP production for an in-house bispecific antibody. Within the past months, Transcenta has also sealed strategic partnership with international technology innovators such as Merck KG to advance its continuous manufacturing technology capabilities.

"Transcenta has been focusing on discovering, developing and delivering novel and high quality antibody therapeutics at affordable price. We appreciate the support of new and existing investors for their confidence in Transcenta. The proceeds from new funding will be used to accelerate our ongoing clinical programs and prepare for commercialization," commented Dr. Xueming Qian, Transcenta’s Co-Founder and CEO.

"We are excited to welcome new investors in this crossover financing. Joined by multiple long-term investors, including international funds, sovereign funds, as well as China mega funds, Transcenta is strategically positioned to sustain long-term growth, bringing quality and affordable biotherapeutics to patients worldwide," said Transcenta’s Co-Founder and Chairman Dr. Jonathan Y. Zhao.

Ran Wei, General Manager of Chengtong Fund Management, which manages China Structural Reform Fund commented, "As the next-generation leader in novel drug development and commercialization, Transcenta is a platform company with fully integrated capabilities focusing on biotherapeutics. We are pleased to join hands with the other new and existing shareholders to support Transcenta along its journey of bringing the best treatment to the market."

Kevin Xie, Managing Director of China Renaissance, commented, "We are fortunate to have witnessed all the milestones that Transcenta has accomplished since its merger, and pleased to have helped seal the 2 financing rounds. We look forward to more breakthroughs the Company is to bring and the successful story it continues to write."

On December 22, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the issuance of a U.S. patent (US 10,450,340) covering compositions of matter for a novel family of camsirubicin analogs (Press release, Monopar Therapeutics, DEC 22, 2020, https://ir.monopartx.com/news/detail/23/monopar-announces-issuance-of-u-s-patent-covering-compositions-of-matter-for-a-novel-family-of-camsirubicin-analogs [SID1234573202]). The patent, which expands the Company’s camsirubicin intellectual property portfolio, is expected to expire in 2038 not including any patent term extensions.

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"The analogs covered in this patent have been designed to retain the potentially favorable non-cardiotoxic chemical backbone of camsirubicin and the potent broad-spectrum antitumor activity of doxorubicin; further, preclinical evidence suggests that this new family of 2-pyrrilino camsirubicin analogs could be active in doxorubicin-resistant tumor cells. This may enable us to address additional cancer types beyond those possible with camsirubicin," said Andrew Mazar, PhD, Monopar’s Chief Scientific Officer.

Doxorubicin is FDA approved in 14 different types of cancers including soft tissue and bone sarcomas; metastatic stomach, ovarian, thyroid, lung, and breast cancer; acute myeloid and lymphoblastic leukemia; Hodgkin and non-Hodgkin lymphoma; and neuroblastoma. However, cumulative dose effects of doxorubicin can result in irreversible heart damage and death, which is why a restrictive lifetime cumulative dose limitation has been placed on its use.

"If successful, camsirubicin and its analogs could overcome the restrictive dose limitation and be administered at higher doses and for longer periods of time than doxorubicin," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "This could lead to improved efficacy and better patient outcomes."

Monopar’s clinical trial collaboration partner, Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcomas, is on track to initiate an open-label Phase 2 clinical study in early 2021 evaluating camsirubicin head-to-head against doxorubicin in advanced soft tissue sarcoma (ASTS), where doxorubicin is currently the first-line treatment.

On December 22, 2020 Inhibikase Therapeutics, Inc. (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related disorders that arise inside and outside of the brain, reported the pricing of its initial public offering of 1,800,000 shares of common stock at a public offering price of $10.00 per share, for gross proceeds of $18 million, before deducting underwriting discounts and commissions and other offering expenses payable by Inhibikase (Press release, Inhibikase Therapeutics, DEC 22, 2020, View Source [SID1234573218]). All of the shares are being offered by Inhibikase. In addition, Inhibikase has granted the underwriters a 45-day option to purchase up to an additional 270,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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The shares are expected to begin trading on the Nasdaq Capital Market on December 23, 2020 under the ticker symbol "IKT." The offering is expected to close on December 28, 2020, subject to the satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission (SEC) on December 22, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, or by email at [email protected]. These documents may also be obtained free of charge, when they are available, by visiting the SEC’s website at www.sec.gov.

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 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

On December 22, 2020 Polymed Biopharma reported that it recently submitted two patent applications for the discovery of novel PROTAC molecules for treatment of cancer and autoimmune diseases (Press release, Polymed Biopharmaceuticals, DEC 22, 2020, View Source [SID1234630612]). These molecules have demonstrated activities in the degradation of target proteins and proliferation inhibition of disease model cell line. Polymed plans to further study the safety and effectiveness of these molecules in related animal disease models.

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