Candel Therapeutics Appoints Mace L. Rothenberg, MD, as Senior Advisor to the Chief Executive Officer

On October 19, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported it has appointed Mace L. Rothenberg, MD, as a senior advisor to its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci (Press release, Candel Therapeutics, OCT 19, 2021, View Source [SID1234591544]). Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the company’s continued growth and acceleration.

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"I am delighted to welcome Mace as an advisor to Candel Therapeutics to further strengthen our team," said Dr. Tak. "His impressive background as a physician-executive along with his successful track record of regulatory approvals of numerous novel cancer therapies will bolster the company as it enters the next phase of development."

Prior to joining Candel, Dr. Rothenberg served as Chief Medical Officer of Pfizer. During that time, the company initiated, completed, and obtained emergency use authorization for its COVID-19 vaccine. Prior to that role, Dr. Rothenberg led clinical development for oncology at Pfizer for 10 years. In that period of time, his team developed and obtained regulatory approval for 11 new cancer medicines, including first-in-class medicines: IBRANCE (palbociclib) for patients with HR+/HER2- advanced breast cancer and XALKORI (crizotinib) for patients with ALK+ non-small cell lung cancer. Earlier in his career, Dr. Rothenberg was Professor of Medicine at Vanderbilt University and Ingram Professor of Cancer Research at the Vanderbilt-Ingram Cancer Center. He also served as an Associate Professor of Medicine at the University of Texas Health Science Center at San Antonio and Executive Officer of the Southwest Oncology Group.

Dr. Rothenberg is board-certified in Internal Medicine and Medical Oncology and is a Fellow of the American College of Physicians and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). He received his BA magna cum laude from the University of Pennsylvania and his MD from the New York University School of Medicine. Dr. Rothenberg completed his post-graduate training in internal medicine at Vanderbilt University and in medical oncology at the National Cancer Institute.

"Candel is at the forefront of one of the most exciting approaches in cancer immunotherapy," said Dr. Rothenberg. "I am excited by the opportunity to help Paul Peter advance the company’s promising oncology pipeline. He has built a terrific clinical development organization and I look forward to working with them in advancing Candel’s promising pipeline of compounds."

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

KemPharm, Inc. Announces Uplisting to The Nasdaq Global Select Market

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.

InnoCare Announces Approval of Clinical Trial of Novel SHP2 Allosteric Inhibitor ICP-189 in China

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."

Nordic Nanovector enters research collaboration with the University of Pennsylvania to generate a novel CD37-targeting CAR-T cell approach

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."

Thermo Fisher Scientific Announces Offering of USD-Denominated Senior Notes

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.