Carrick Therapeutics to Present First Clinical Data on Samuraciclib (CT-7001), a First-In-Class Inhibitor of CDK7 at the European Society for Medical Oncology (ESMO) Congress 2021

On August 17, 2021 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported two presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, to be held from September 16-21, 2021 (Press release, Carrick Therapeutics, AUG 17, 2021, View Source [SID1234586690]). An e-poster will be available from 07:30 BST (02:30am ET) on September 16, 2021, and a mini-oral presentation from 17:10 BST (12:10pm ET) on September 18, 2021.

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Poster and oral presentation details are as follows:

Poster Presentation Title: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+ BC)
Presenting Author: Sacha Howell, The Christie NHS Foundation Trust Manchester, UK
Abstract number: 1346 (265P)

Oral Presentation Title: First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies
Presenting Author: Matthew G. Krebs, The Christie NHS Foundation Trust & University of Manchester, UK
Abstract number: 943 (230MO)

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. It is currently being evaluated in Phase 2a studies targeting CDK4/6 inhibitor resistant second-line HR+, HER2- metastatic breast cancer, in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer and in combination with chemotherapy for the treatment of locally advanced or metastatic TNBC.

Ascendis Pharma A/S Announces Second Quarter 2021 Financial Results and Business Update Conference Call on August 25

On August 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will hold a conference call and live webcast on Wednesday, August 25, 2021 at 4:30 p.m. Eastern Time (ET) to review its second quarter 2021 financial results and provide a business update (Press release, Ascendis Pharma, AUG 17, 2021, View Source [SID1234586726]).

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Conference Call Details

A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

Fosun Kate’s Achilles injection is included in the breakthrough drug program

On August 17, 2021, Fosun Kate Biotechnology Co., Ltd. reported that the National Medical Products Administration (NMPA) has officially designated the company’s CD19 target autologous CAR-T cell therapy product Akilunsai injection for new indications Included in the breakthrough treatment drug program, the proposed indication is the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (r/r iNHL) after receiving second-line or above systemic treatment, including follicular lymphoma (FL) and Marginal zone lymphoma (MZL) (Press release, Gilead Sciences, AUG 17, 2021, View Source [SID1234633500]).

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Indolent non-Hodgkin’s lymphoma (iNHL) is a malignant tumor that has slow clinical progress but becomes more aggressive over time. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common subtypes. FL is also the second most common type of lymphoma in the world, accounting for approximately 22% of confirmed cases of NHL worldwide. MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL. Although with the progress of disease management, the long-term survival rate of FL patients has been greatly improved, but the prognosis is very different. At present, there is no standard treatment plan for the relapsed and refractory FL patients after second-line treatment and above, and the treatment options for the relapsed and refractory MZL patients are also very limited.

Akilunza injection is Fosun Kate’s introduction of Yescarta (axicabtagene ciloleucel) from Kite (a company of Gilead) in the United States in early 2017 for technology transfer in China, and is authorized to locally produce the human CD19 autologous CAR- T cell therapy products. It is used to treat adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, unspecified type, primary mediastinal large B-cell lymphoma, high-grade New drug applications for B-cell lymphoma and diffuse large B-cell lymphoma transformed by follicular lymphoma have been approved by the NMPA for marketing in June 2021.

In the United States, Yescarta was approved by the FDA on October 18, 2017 for the treatment of adult patients with relapsed and refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) non-specific, primary Mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL transformed from follicular lymphoma are the first CAR-T cell drugs approved by the US FDA for specific non-Hodgkin lymphoma. On March 5, 2021, its application for extended indications for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) received accelerated approval from the US FDA, becoming the world’s first CAR- approved to be marketed for FL. T cell therapy products.

Fosun Kite Biotechnology Co., Ltd. is a joint venture between Shanghai Fosun Pharmaceutical Group and Kite of the United States. It is committed to the R&D, innovation, industrialization, commercialization, and standardized development of tumor cell therapy products for the benefit of Chinese patients. The company is headquartered in Shanghai Zhangjiang Hi-Tech Park, and a CAR-T industrial production base of 10,000 square meters has been established and officially opened in Zhangjiang Innovative Medicine Industrial Base. In addition, the company also has a 2000 square meter cell therapy R&D center and a team of innovative talents. Through independent innovation and international cooperation, the company focuses on CAR-T early R&D and clinical evidence-based projects to create a sustainable innovative R&D pipeline.

Mr. Huang Hai, CEO of Fosun Kate, said: "The inclusion of Akirensai injection in the breakthrough therapeutic drug program demonstrates NMPA’s support for clinical value-oriented drug innovation, and also shows that this drug is effective in treating relapsed or refractory drugs. The clinical advantages and potential of sexually inert non-Hodgkin’s lymphoma. The company will accelerate the clinical stage of the drug’s new indications, actively communicate and communicate with the drug review center, and provide more non-Hodgkin’s lymphoma in China as soon as possible. Tumor patients bring new hope and opportunities."

PROMIS NEUROSCIENCES INC. ANNOUNCES US$15 MILLION OFFERING OF UNITS

On August 17, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that it has filed today a preliminary prospectus supplement (the "Supplement") to its final short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus") in connection with a proposed commercially reasonable efforts public offering of units (the "Units") for gross proceeds to the Company of up to US$15,000,000, exclusive of the Agent’s Option (as defined herein) (the "Offering") (Press release, ProMIS Neurosciences, AUG 17, 2021, View Source [SID1234586691]).

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Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at any time up to 60 months following Closing (as defined below), subject to an acceleration provision such that in the event that following the Closing the Common Shares have a volume weighted average price on the Toronto Stock Exchange ("TSX") greater than three (3) times the Warrant exercise price for each of ten (10) consecutive trading days (based on the Bank of Canada noon exchange rate on the applicable trading day), then the Company may accelerate the expiry date of the Warrants to a date that is 30 days after the date on which the Company gives notice of the acceleration to the holders of Warrants.. The Units offered under the Offering will be priced in the context of the market and pricing will be reflected in a final prospectus supplement.

The Supplement was filed with the securities regulatory authorities in each of the province and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement other jurisdictions where the Offering can lawfully be made.

In connection with the Offering, the Company intends to enter into an agency agreement with Leede Jones Gable Inc. (the "Agent") and certain other agents to be added to the syndicate. The Company expects to close the Offering on or about August 24, 2021, or other such date as may be mutually agreed to by the Company and the Agent (the "Closing"), subject to satisfaction of customary closing conditions, including the approval of the listing of the Common Shares and the Warrant Shares on the TSX.

The Company has agreed to grant to the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two (2) business days prior to the date of Closing.

The Company intends to use the net proceeds from the Offering to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug ("IND") application to enable a first clinical trial, including working with a qualified vendor to manufacture drug product to GMP (Good Manufacturing Practice) standards, developing manufacturing assays as necessary for regulatory approvals, conducting animal toxicology studies to GLP (Good Laboratory Practice) standards at a qualified vendor, conducting additional in vivo testing of PMN310, and conducting formulation work with a qualified vendor to support potential development of a subcutaneous delivery form of PMN310, expanding the ProMIS portfolio of antibodies and patents, including further development of targets that have been disclosed (such as tau in Alzheimer’s disease, or RACK1 in amyotrophic lateral sclerosis (ALS), as well as addressing novel mis-folded protein targets implicated in disease with the ProMIS technology platform and general corporate purposes. Any additional proceeds from the Offering, such as those from the possible exercise of the Agent’s Option will be used to: (a) conduct activities that might speed the progress to file an IND and, subject to the U.S. Federal Drug Administration’s approval, to commence a clinical trial for PMN310; (b) accelerate other research and development programs with additional in vitro and in vivo work; (c) increase the rate of hiring additional key personnel in critical areas such as Clinical Operations and Discovery Operations; and/or (d) increase expenditures on shareholder and investor relations.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Boehringer, CureVac Terminate Lung Cancer Project on Poor Performance

On August 17, 2021 CureVac reported that it has revealed in its latest financial report that its lung cancer program with German biotechnology company Boehringer Ingelheim has been terminated (Press release, CureVac, AUG 17, 2021, View Source [SID1234586796]).

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The move ends a €500m exclusive treatment exploration and development partnership which both parties signed seven years ago (2014). The collaboration focused on the viability of using CureVac’s CV9202 therapeutic mRNA vaccine with afatinib in patients who have been diagnosed with advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). It was also being tested in combination with chemo-radiation therapy in patients who have unresectable stage III NSCLC.

However, in a brief statement hidden among its financials, CureVac said that it had terminated the agreement in June, with the process expected to be finalized by November 2021.

The company said that despite the decision to discontinue their partnership on the project, the two firms will still continue to find ways to collaborate on other ways to use CureVac’s RNA technology for other potential treatment purposes. While it did not explicitly state a reason, CureVac added that they were working with a "legacy program" that used an older protamine formulation, which was being developed seven years ago. It also stated that it is continuing its Phase I of II clinical trial for the potential of BI1361849 for NSCLC.

CureVac did not provide any further details about the termination or any other plans moving forward. However, what is noticeable is that it comes just two months after it reported weak efficacy results of only 47% for an mRNA vaccine against COVID-19. Other rival medications had an efficacy of more than 90%. Industry observers had been setting their sights on the vaccine as it was thought to last longer and cost less.

"While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging," said CureVac’s Chief Executive Officer, Dr. Franz-Werner Haas, in a statement. "In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge."

The CureVac-Boehringer trial involved 40,000 participants, with 75% based in Latin America and 25% in Europe. The 47% who showed efficacy represented around 46 cases from the vaccinated group and 88 cases in the placebo group. As part of that deal, CureVac received €35 million and was set to achieve milestone payments of as much as €430 million plus royalties from future sales.

Boehringer has yet to issue an official statement about this revelation.