On October 9, 2020 Exelixis, Inc. (Nasdaq: EXEL) and Aurigene Discovery Technologies Limited (Aurigene) reported disclosed new preclinical data showing that AUR102 has potent anti-tumor activity in a large panel of cancer cell lines (Press release, Aurigene Discovery, OCT 9, 2020, View Source [SID1234568259]). AUR102 is a potent, selective, and orally bioavailable covalent inhibitor of cyclin-dependent kinase 7 (CDK7), which is an important regulator of the cellular transcriptional and cell cycle machinery . Exelixis has an exclusive option for AUR102 under its July 2019 exclusive collaboration, option and license agreement with Aurigene. The new data will be presented in a poster (Abstract 170) at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium, which is being held virtually on October 24-25, 2020.

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"CDK7 plays a critical role in regulating cellular transcription and cell cycle machinery, making it an exciting target for cancer therapy"

"CDK7 plays a critical role in regulating cellular transcription and cell cycle machinery, making it an exciting target for cancer therapy," said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. "The data to be presented at ENA 2020 demonstrate that AUR102 effectively engages CDK7 and inhibits a key mediator of the cell cycle and transcription. The ability to inhibit CDK7 activity with an orally available therapeutic such as AUR102 holds great potential to improve care and outcomes for patients with diverse cancer indications, including breast cancer, prostate cancer, leukemia and lymphoma."

The abstract provides a summary of results from a detailed characterization of AUR102 in cancer cell lines and animal tumor models. Additional data will be presented in the poster. Key findings included in the abstract are:
• AUR102 exhibited potent anti-proliferative activity in a large panel of cell lines with induction of cell death in cell lines derived from multiple cancer types.
• The observed anti-proliferative activity correlated with cellular CDK7 target engagement and decreased levels of P-Ser5 RNAPII, a key mediator of transcription.
• AUR102 studies showed synergy when used in combination with multiple chemotherapies.
• Oral dosing with AUR102 resulted in dose-dependent anti-tumor activity, including complete tumor regression in diffuse large B-cell lymphoma, acute myeloid leukemia, and triple-negative breast cancer xenograft models.
• Inhibition of tumor growth was accompanied by complete target engagement as demonstrated in a parallel PK-PD study.
• AUR102 significantly impacts several pathways and key cancer driver and immune-response genes.

The study authors conclude that the data support clinical evaluation of AUR102 as a single agent and in combination with chemotherapies for the treatment of cancer.

"The exciting AUR102 data to be presented at ENA 2020 provide further validation of our partnering strategy, which gives us multiple opportunities to build a pipeline of best-in-class cancer therapies," said Peter Lamb, Ph.D., Executive Vice President of Scientific Strategy and Chief Scientific Officer of Exelixis. "AUR102 could be the subject of an Investigational New Drug filing later this year, which would be an important value driver for the program itself and for our collaboration with Aurigene. We commend the Aurigene team on their ongoing success in building a robust body of data supporting the broad clinical potential of AUR102."

Under the terms of the July 2019 agreement, Exelixis made an upfront payment of $10 million for exclusive options to license three preexisting programs from Aurigene. In addition, Exelixis and Aurigene initiated three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional upfront option payments of $2.5 million per program. Exelixis is also contributing research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. As the programs mature, Exelixis will have the opportunity to exercise an exclusive option for each program up until the time of Investigational New Drug (IND) filing acceptance. If Exelixis decides to exercise an option, it will make an option exercise payment to Aurigene and assume responsibility for that program’s future clinical development and commercialization including global manufacturing. Aurigene will be eligible for clinical development, regulatory, and sales milestones, as well as royalties on sales. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.

On October 9, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported a poster presentation and oral discussion at the upcoming 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held virtually October 24 – 25, 2020 (Press release, ORIC Pharmaceuticals, OCT 9, 2020, View Source [SID1234568258]). The presentation will highlight preclinical data in prostate cancer cell lines that demonstrate the company’s glucocorticoid receptor (GR) antagonist, ORIC-101, reversing GR-mediated resistance to an androgen receptor (AR) degrader.

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In the study, it was observed that upon treatment of prostate cancer cell lines with an AR degrader, GR mRNA and protein levels were significantly upregulated, similar to the GR upregulation seen after dosing with enzalutamide. This GR upregulation translated into GR activation that conferred resistance to the AR degrader, permitting prostate cancer cells to continue to grow. ORIC-101 was shown to completely reverse these effects and block tumor cell growth and androgen-regulated gene expression. These data demonstrate that GR may be a mechanism of resistance to AR degraders and that in vitro, ORIC-101 overcomes GR-driven resistance to AR degradation.

GR has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with Xtandi (enzalutamide) in metastatic prostate cancer and Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. ORIC expects to report interim data from one of the trials in the first half of 2021 and from the other trial in the second half of 2021.

Details of the poster presentation are as follows:

Title: ORIC-101 Overcomes GR-driven Resistance to AR Degradation in Castration-Resistant Prostate Cancer Models
Date: October 25, 2020; 2:30 p.m. CEST
Session: Poster Discussion Session
Topic: Approaches to Overcoming Therapeutic Resistance
Abstract: PD-050

On October 9, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its third quarter 2020 financial results after the close of the U.S. financial markets on October 29, 2020 (Press release, Exact Sciences, OCT 9, 2020, View Source [SID1234568257]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 2379459. The webcast, conference call and replay are open to all interested parties.

On October 8, 2020 CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that Matt David, M.D., Executive Vice President and Chief Financial Officer of CorMedix, will present a company overview and host one-on-one meetings during the 2020 BIO Investor Forum Digital, being held virtually October 13 – 15, 2020 (Press release, CorMedix, OCT 8, 2020, View Source [SID1234569345]). The Company’s presentation will be available on demand for BIO Investor Forum attendees.

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On October 8, 2020 Everest Medicines Limited ("Everest Medicines" or the "Company"; Stock Code: 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported the allotment results of the global offering (the "Global Offering") (Press release, Everest Medicines, OCT 8, 2020, View Source [SID1234568263]). The Offer Price has been determined at HK$55.00 per Offer Share.

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The Hong Kong Public Offer Shares initially offered under the Hong Kong Public Offering have been very significantly over-subscribed. A total of 308,757 valid applications have been received pursuant to the Hong Kong Public Offering through the White Form eIPO service and through the CCASS EIPO service for a total of 4,158,771,500 Hong Kong Public Offer Shares, representing approximately 654.41 times of the total number of 6,355,000 Hong Kong Public Offer Shares initially available for subscription under the Hong Kong Public Offering.

As the over-subscription in the Hong Kong Public Offering represents more than 100 times of the total number of Offer Shares initially available under the Hong Kong Public Offering, the reallocation procedure as disclosed in the section headed "Structure of the Global Offering – The Hong Kong Public Offering – Reallocation" in the Prospectus has been applied and 25,419,000 Offer Shares have been reallocated from the International Offering to the Hong Kong Public Offering. The final number of Offer Shares under the Hong Kong Public Offering is 31,774,000 Offer Shares, representing approximately 50% of the total number of Offer Shares initially available under the Global Offering (before any exercise of the Over-allotment Option).

The Offer Shares initially offered under the International Offering have been over-subscribed, representing approximately 27.0 times of the total number of Offer Shares initially available under the International Offering. After reallocation of the Offer Shares to the Hong Kong Public Offering from the International Offering, the final number of Offer Shares under the International Offering is 31,773,000 Shares, representing approximately 50% of the total number of Offer Shares initially available under the Global Offering (before any exercise of the Over-allotment Option). There has been an over-allocation of 9,532,000 Offer Shares and there are a total of 213 placees under the International Offering.

Based on the Offer Price of HK$55.00 per Offer Share, the net proceeds from the Global Offering to be received by the Company, after deduction of underwriting fees and commissions and estimated expenses payable by the Company in connection with the Global Offering, are estimated to be approximately HK$3,284.1 million (assuming the Over-allotment Option is not exercised).

The Company intends to apply the net proceeds from the Global Offering to develop and commercialize its four anchor products, to fund ongoing and planned clinical trials, preparation for registration filings and potential commercialization of other drug candidates in the Company’s pipeline, to fund the Company’s business development activities and the expansion of its drug pipeline, and for working capital and general and administrative purposes.

Dealings in the Shares on the Main Board of the Stock Exchange are expected to commence at 9:00 a.m. on Friday, October 9, 2020. The Shares will be traded in board lots of 500 Shares each, the stock code of the Shares is 1952.HK.

Goldman Sachs (Asia) L.L.C. and Merrill Lynch Far East Limited are the Joint Sponsors. Goldman Sachs (Asia) L.L.C., Merrill Lynch (Asia Pacific) Limited, Citigroup Global Markets Asia Limited, China International Capital Corporation Limited and Credit Suisse (Hong Kong) Limited are the Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers. Citigroup Global Markets Limited (in relation to International Offering), Nomura International (Hong Kong) Limited and Brocade River Asset Management Limited are the Joint Bookrunners and Joint Lead Managers.