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CASI Pharmaceuticals Announces Submission Of Clinical Trial Application (IND) To Conduct Phase 1 Study For Anti-38 Monoclonal Antibody Program

On June 8, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that it submitted a Clinical Trial Application (CTA) (IND) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 monoclonal antibody for the treatment of multiple myeloma and other hematological malignancies (Press release, CASI Pharmaceuticals, JUN 8, 2020, View Source [SID1234560911]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Submitting this CTA is an important step in the clinical development of this promising therapy in our hematology oncology franchise. CID-103 demonstrated encouraging efficacy in preclinical models and we believe it has the potential to be best in class and can offer meaningful clinical benefits over the standard of care for patients with CD38 malignancies, including multiple myeloma."

Alexander Zukiwski, M.D., CASI’s Chief Medical Officer commented, "We look forward to launching our study for this novel biological entity as a potential treatment for patients with hematological malignancies. We will continue to monitor the COVID-19 related circumstances in the UK and are working on administrative activities in support of this trial. Based on the current environment and timetable of our clinical sites, we are targeting the study initiation in late 2020 or early 2021."

About CID-103 (Anti-CD38 Mab)

CID-103 (f/k/a TSK011010) is a novel anti-CD38 monoclonal antibody program. CASI licensed the global rights to CID-103, from Tusk Therapeutics, Ltd in April 2019. Preclinical data demonstrate CID-103 possesses enhanced activity against a broad array of malignancies expressing CD38, and potentially enhance safety and efficacy benefits when compared to other CD38 monoclonal antibodies. CASI maintains exclusive global rights to CID-103.

BIOLASE, Inc. Announces Pricing of $6.9 Million Registered Direct Offering Priced At-The-Market

On June 8, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported that it has entered into a securities purchase agreement with institutional investors to purchase approximately $6.9 million of its common stock in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common stock in a concurrent private placement (Press release, Biolase Technology, JUN 8, 2020, View Source [SID1234560910]). The combined purchase price for one share of common stock and warrant to purchase one share of common stock will be $0.64.

Under the terms of the securities purchase agreement, BIOLASE has agreed to sell 10,800,000 shares of common stock. In a private placement, which will be consummated concurrently with the Offering, BIOLASE also has agreed to issue warrants to purchase up to an aggregate of 10,800,000 shares of common stock. The warrants will be immediately exercisable, will expire 5.5 years from the date of issuance and will have an exercise price of $0.515 per common share.

The gross proceeds to the Company from the registered direct offering and concurrent private placement are estimated to be approximately $6.9 million before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about June 10, 2020, subject to the satisfaction of customary closing conditions.

Maxim Group LLC, The Benchmark Company, LLC & Colliers Securities LLC are acting as co-placement agents for the offering.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233172) previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement.

Innovent and Roche Enter into A Strategic Collaboration to Discover and Develop Multiple Products including Cellular Therapies and Bispecific Antibodies

On June 8, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported a strategic research and development collaboration with Roche covering multiple cell therapies and bispecific antibodies (Press release, Innovent Biologics, JUN 8, 2020, View Source [SID1234560909]).

The collaboration will focus on the discovery, clinical development and commercialization of bispecific antibodies and multiple cell therapies and will be directed to the treatment of hematological and solid cancers.

Under the terms of the agreement, Innovent will pay upfront, development and commercial milestone payments, and royalties, to non-exclusively access certain Roche technologies that enable the discovery and development of specific 2:1 T-cell bispecific antibodies (TCB) and the universal CAR-T platform. Innovent will create, develop, manufacture, and commercialize the products. Roche retains an option right to license each product for ex-China development and commercialization. Should Roche exercise all of its options, it will pay option exercise payments totaling $140 million plus additional development, approval, and sales milestone payments up to $1.96 billion if all products are successfully developed and commercialized. Additionally, Roche will pay double-digit up to mid teen percentage royalties on each product.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics commented, "Innovent first entered the cellular therapy space a few years ago, and with this partnership with Roche we are taking a much bolder step forward as we build upon Roche’s novel, universal CAR-T cell technology to enhance our cellular therapy discovery platform, and on Roche’s 2:1 T-cell bispecific antibody platform for selected targets to discover, develop, and commercialize new proprietary bispecific molecules. We are excited about working together as we rapidly advance these technologies to proof of concept stage in China, with Roche retaining an ex-China licensing option to carry the Ex-China development forward thereafter, potentially benefiting patients globally."

Alphamab Oncology and Sanofi Enter Collaboration on KN026 in HER2+ Breast Cancer

On June 8, 2020 Alphamab Oncology (stock code: 9966 HK) a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi (EURONEXT: SAN andNASDAQ: SNY), a global biopharmaceutical leader, reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co., Ltd (" Sanofi") to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere (Docetaxel) in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones (Press release, Alphamab, JUN 8, 2020, View Source [SID1234560908]).

KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.

Taxotere (Docetaxel) is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body. It is used to treat breast cancer, lung cancer, prostate cancer, gastric cancer. In China, Taxotere is indicated for breast cancer (BC) including: 1) single agent for locally advanced or metastatic BC after chemotherapy failure; 2) with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; 3) and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies. There are significant unmet need for the treatment of HER2-positive breast cancer. We hope, through the collaboration with Sanofi, a global biopharmaceutical leader, to further drive KN026’s China and global development strategy, to provide a superior therapeutic solution to Her-2 positive patients."

Pius S. Hornstein, PhD, General Manager General Medicines and Country Lead, Sanofi China commented, "Building on Sanofi’s heritage in oncology, we see a significant opportunity to impact the health of breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China. This strategic partnership also demonstrates Sanofi’s ambition to play a more active role in the Chinese healthcare ecosystem, offering more new treatments for the large Chinese population with joint efforts from other leading companies."

Under terms of the agreement, Jiangsu Alphamab and Sanofi will collaborate to evaluate the combination of KN026 and Taxotere (Docetaxel) for HER2+ breast cancer. Patient enrollment has started for the initial multicenter, open-label study.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has excellent safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

Microbiotica, Cancer Research UK and Cambridge University Hospitals Collaborate in Landmark Cancer Microbiome Study

On June 8, 2020 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, Cancer Research UK and Cambridge University Hospitals NHS Foundation Trust ("CUH"), reported a collaboration to identify and develop microbiome co-therapeutics and biomarkers for cancer patients receiving immune checkpoint inhibitor therapy (Press release, Microbiotica, JUN 8, 2020, View Source [SID1234560907]).

The collaboration is based on clinical studies conducted by CUH that evaluate immune checkpoint inhibitor drug response in cancer patients, combined with Microbiotica’s unrivalled microbiome profiling and analysis capability.

Two clinical studies are involved: MELRESIST, a completed class-leading melanoma study, and MITRE, a major landmark study in melanoma, lung and renal cancer, involving 1,800 patients, specifically designed for evaluation of microbiome and other biomarker effects.

The MITRE study will be co-led by Dr Trevor Lawley, Microbiotica’s co-founder and CSO, and Dr Pippa Corrie, Consultant in Medical Oncology at CUH, and will involve comprehensive patient sample collection, data collection and biochemical analysis, with medicines provided by the NHS. Microbiotica will undertake mass culturing of patient gut bacteria, microbiome sequencing and machine learning analysis.

Checkpoint inhibitors have transformed the management of cancer, due to the range of cancers that can be treated and their high levels of efficacy, including complete remission in some cases. However, response rates are low, typically in the range 10-40% of patients. There is therefore a major unmet need for co-therapies to extend the number of responders and for biomarkers to stratify patients for treatment.

Several studies have shown that the gut microbiome plays a critical and causative role in determining which patients respond to these medicines. However thus far they have failed to identify a consistent gut bacterial signature associated with treatment response or resistance. Microbiotica has used its unique microbiome profiling platform with MELRESIST data to identify for the first time a common signature predictive of drug response across multiple melanoma studies, and this is being progressed within the Company. MITRE will take this further by examining the effects in different cancers, a range of immunotherapy regimens, as well as association with side-effects of immunotherapy.

Microbiotica’s platform comprises the world’s leading Reference Genome Database and Culture Collection of gut bacteria, and an unrivalled capability to culture and characterise all gut bacteria from patients at scale. This is complemented by a suite of bioinformatic and machine learning tools that enable the identification of previously undetectable gut bacterial signatures linked to patient phenotype. The Company also has capabilities to develop and take such products to the clinic.

The collaboration will identify specific gut bacterial signatures correlated with drug efficacy and side effects in patients under treatment for melanoma, non-small cell lung cancer and renal cancer. From these signatures, Microbiotica will progress live bacterial products as co-therapies and microbiome biomarkers predictive of immunotherapy response and toxicity into the clinic.