On October 19, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that its shares of common stock have been approved for listing to The Nasdaq Global Select Market (Press release, KemPharm, OCT 19, 2021, View Source [SID1234591543]). Trading on the exchange will commence effective with the open of business on October 19, 2021, under KemPharm’s current ticker symbol, "KMPH".

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"KemPharm’s advancement to The Nasdaq Global Select Market continues a year of tremendous growth and accomplishment for our company during which time we transformed our business, solidified our financial position and, most importantly with AZSTARYS, succeeded in bringing forth to market the first truly differentiated ADHD medication in years," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "The Nasdaq Global Select Market is recognized as having the highest initial listing standards of any exchange in the world and is considered a mark of achievement and stature for qualified companies. KemPharm is honored to be amongst this class of company, and we are excited by the opportunity to attract a new echelon of potential investors to our stock."

KemPharm was previously listed on The Nasdaq Capital Market, following its uplisting to the exchange in January. The Nasdaq Global Select Market consists of 1,450 stocks that meet Nasdaq’s strict financial and liquidity requirements and corporate governance standards on both an initial and continuing basis.

About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

On October 19, 2021 InnoCare Pharma (HKEX: 09969) reported that the Company has received Investigational New Drug (IND) approval from the NMPA for its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189, which is the company’s 9th innovative drug candidate entering clinical development (Press release, InnoCare Pharma, OCT 19, 2021, View Source [SID1234591541]).

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This China-based Phase Ia/Ib open, single-arm, multicenter study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ICP-189 as a monotherapy and combined treatment in patients with advanced solid tumors.

ICP-189 is being developed for the treatment of solid tumors as a single agent and/or in combinations with other antitumor agents.

Preclinical study shows that ICP-189 is a potent oral allosteric inhibitor of SHP2 with excellent selectivity over other phosphatases. SHP2 is a non-receptor protein tyrosine phosphatase involved in mediating MAPK signaling pathway and immune checkpoint pathway for the regulation of cellular proliferation and survival.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, "We are excited to see another drug candidate for solid tumors approved for clinical trials. ICP-189 demonstrates excellent drug properties. ICP-189 is our 9th innovative drug candidate entering clinical trials, and we will make every effort to accelerate clinical development to benefit patients."

On October 19, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that it has entered into a research collaboration with the University of Pennsylvania ("Penn") to generate a CD37-targeting CAR-T cell approach as a potential treatment for patients with B-cell malignancies (Press release, Nordic Nanovector, OCT 19, 2021, View Source [SID1234591539]).

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The collaboration aims to combine Nordic Nanovector’s expertise around CD37, a protein present on the surface of B-cell tumour cells, with the world-class expertise in CAR-T cell therapies at Penn. Specifically, researchers at Penn will look to combine CD37-targeting molecules (antibodies and antibody fragments) and linkers provided by Nordic Nanovector, with the proprietary CAR-T technologies developed at Penn, including its proprietary universal immune receptor developed in the laboratory of Daniel J. Powell Jr., PhD, of the Center for Cellular Immunotherapies in Penn’s Perelman School of Medicine, that can direct CAR T cells against multiple tumor associated antigens.

Nordic Nanovector has obtained an option to license exclusive worldwide rights to any CD37-targeting CAR-T cells that result from this collaboration for further development.

Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer, said: "It is really exciting to be collaborating with the institute that pioneered CAR-T cell therapy and to leverage our CD37 biology expertise towards the generation of new agents with a different mechanism of action to Betalutin and other molecules in our pipeline. We believe that CD37 is an important, yet under-exploited target for new treatments for B-cell malignancies including non-Hodgkin lymphomas. CAR-T therapies in development for this group of diseases have already demonstrated they can be highly effective, and we look forward to the outcome of this collaboration, which has the potential to expand our CD37 franchise in a new direction."

"We are very pleased to be entering into a collaboration with Nordic Nanovector, a company that has extensive knowledge of CD37 biology and its utility as a therapeutic target," said Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research at Penn. "Nordic Nanovector has demonstrated the safety and efficacy of targeting CD37 in clinical trials using radioimmunotherapy, and we hope to build on this experience with our CAR-T platform to develop therapies for B-cell malignancies."

On October 19, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it intends to offer (the "Offering") USD-denominated senior notes (the "Notes") (Press release, Thermo Fisher Scientific, OCT 19, 2021, View Source [SID1234591536]).

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Thermo Fisher intends to use the net proceeds of the Offering to pay a portion of the cash consideration payable for the proposed acquisition of PPD, Inc., a Delaware corporation (the "PPD Acquisition"). Thermo Fisher may also determine to use a portion of the net proceeds of the Offering for general corporate purposes, which may include the acquisition of companies or businesses, repayment and refinancing of debt, working capital and capital expenditures or the repurchase of its outstanding equity securities or it may temporarily invest the net proceeds in short-term, liquid investments until they are used for their ultimate purpose.

The joint book-running managers for the Offering are Barclays Capital Inc., Morgan Stanley & Co. LLC, BofA Securities, Inc., Citigroup Global Markets Inc. and Mizuho Securities USA LLC.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and the Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in the Offering will arrange to send you the prospectus if you request it by calling Barclays Capital Inc. toll-free at 1-888-603-5847; Morgan Stanley & Co. LLC toll-free at 1-866-718-1649; BofA Securities, Inc. toll-free at 1-800-294-1322; Citigroup Global Markets Inc. toll-free at 1-800-831-9146; or Mizuho Securities USA LLC toll-free at 1-866-271-7403.

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

On October 19, 2021 ONO PHARMA USA, INC. (President and CEO, Kunihiko Ito) reported the initiation of a Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody, in patients with relapsed or refractory T-cell Lymphoma in the U.S (Press release, Ono, OCT 19, 2021, View Source [SID1234591535]).

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This study is a multicenter, open label, dose escalation Phase 1 study to evaluate ONO-4685 in patients with relapsed or refractory T-cell lymphoma (ONO-4685-03). For more information, please visit the following website at View Source (NCT05079282).

"We are excited to initiate the Phase 1 study of ONO-4685, an anti-PD-1/CD3 bispecific antibody with a novel mechanism of action, and hope that ONO-4685 will provide benefit to the patients with relapsed or refractory T-cell lymphoma in the U.S. one day," said Masahiro Katayama, Executive Vice President, US/EU Head of Clinical Development, ONO PHARMA USA, INC.

About T-cell Lymphoma

T-cell lymphomas are rare types of cancer, which are categorized as tumors of mature T-cell or natural killer (NK)-cell origin and comprise approximately 10 to 15% of non-Hodgkin’s lymphoma (NHL). T-cell lymphoma can develop in lymphoid tissues and/or outside of lymphoid tissues such as liver, skin, blood and others. The main subtypes of T-cell lymphoma are peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) which have a poorer prognosis than that seen in most B-cell NHL subtypes. Therefore, new treatment options are needed to improve patient outcomes for patients with T-cell lymphoma.

About ONO-4685

ONO-4685 is an investigational anti-PD-1/CD3 bispecific antibody, which binds specifically to human PD-1 and CD3 being developed as a potential treatment of both autoimmune diseases and hematologic malignancies. PD-1 is an inhibitory receptor specifically expressed and increased on activated T and B cells. In addition, PD-1 is expressed on malignant T-cells in some subtypes of Tcell lymphomas. CD3 is a component protein of the T-cell receptor. CD3-bispecific antibody therapy is one of cancer immunotherapy approaches and engages T-cells with malignant cells, consequently inducing anti-tumor activity. Based upon the non-clinical study data, ONO-4685 has the potential to be active against T-cell lymphomas.