Johnson & Johnson to Participate in the 2019 Morgan Stanley 17th Annual Global Healthcare Conference

On August 29, 2019 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 2019 Morgan Stanley 17th Annual Global Healthcare Conference on Tuesday, September 10th, at The Grand Hyatt Hotel in New York (Press release, Johnson & Johnson, AUG 29, 2019, View Source;johnson-to-participate-in-the-2019-morgan-stanley-17th-annual-global-healthcare-conference-300909436.html [SID1234539127]). Peter F. Lebowitz, M.D., Ph.D. Global Therapeutic Area Head, Oncology and Scott White, Company Group Chairman North America Pharmaceuticals will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately two hours after the live webcast.

Ascendis Pharma A/S Announces Three Investor Presentations in September

On August 29, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will participate in three upcoming investor conferences in September (Press release, Ascendis Pharma, AUG 29, 2019, View Source [SID1234551449]). Company executives will provide a business overview and update on the company’s pipeline programs.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details

Event 2019 Wells Fargo Healthcare Conference
Location Boston
Date Wednesday, September 4, 2019
Time 2:25 p.m. Eastern Time

Event Morgan Stanley 17th Annual Global Healthcare Conference
Location New York
Date Tuesday, September 10, 2019
Time 2:55 p.m. Eastern Time

Event Bank of America Merrill Lynch Global Healthcare Conference 2019
Location London
Date Thursday, September 19, 2019
Time 10:40 a.m. British Summer Time
A live webcast of the Wells Fargo and Morgan Stanley conferences will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

ADCendo accepted into the Creation House program of BioInnovation Institute (BII), securing a convertible loan of 10 million DKK

On August 29, 2019 ADCendo, a spin-out from the University of Copenhagen and Rigshospitalet, reported having been accepted into the BioInnovation Institute (BII) Creation House program (Press release, ADCendo, AUG 29, 2019, View Source [SID1234573153]). As part of the program, ADCendo has secured a convertible loan of 10 million DKK for furthering its novel antibody-drug conjugates (ADCs) being developed for treatment of cancers.
In 2017, following publication of scientific proof-of-concept, ADCendo was established as a spin-out from the Finsen Laboratory of Rigshospitalet and the University of Copenhagen, with the purpose of developing a new type of targeted anti-cancer drug, in the form of antibody-drug conjugates (ADCs) directed at a novel target receptor, uPARAP. An approach that potentially enables targeted therapy in several cancer forms where expression of the target has been found to be highly upregulated, including soft-tissue sarcoma, osteosarcoma, glioblastoma multiforme (GBM) and triple-negative breast cancer. Furthermore, recent research suggests that targeting uPARAP-positive stromal cells (healthy cells surrounding a solid tumor) with this approach, may potentially offer opportunities for treating several much more commonly occurring carcinomas, including breast, colon, pancreatic, prostate, ovarian and renal cancers.

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CSO of ADCendo and group leader at The Finsen Laboratory, Niels Behrendt, explains: "Based on our early results obtained at the Finsen laboratory, we were granted a pre-seed grant from Novo Holdings enabling us to make significant improvements to the overall performance of our early ADC candidates. Our results have been very well received by our international ADC network, and with the expanded access to BII, as well as the additional financial support, we are looking forward to furthering the development of our clinical candidate. Having created the scientific basis of the company through many years of basic cancer research, we are of course very excited about this opportunity to take our results further towards clinical utilization, and we are very proud of having been selected for the Creation House program at BII".

Commenting on the ADCendo spin-out, Bo Porse, head of the Finsen Laboratory, notes: "At the Finsen Laboratory, we have a strong focus on the translational aspects, in addition to our basic research. The successful path of ADCendo from basic cancer research by its founders at the Finsen Laboratory, to a spin-out biotech, nicely illustrates how our research strategy may contribute to development of novel, innovative anti-cancer treatments".

ADCendo is, in parallel with furthering its ADCs, preparing pre-clinical and clinical development plans for metastatic soft tissue sarcoma (STS), a serious disease where patients have a median survival of only 12-18 months. Importantly, ADCendo aims to fill the gap following the drug Lartruvo (Olaratumab, an anti-PDGFR-α antibody), which was withdrawn from the STS market in early 2019 following a failed confirmatory phase III study. At launch, Lartruvo was the first new drug to be approved for first-line treatment of STS in 40 years, and the drug was well received and hoped to provide treatment for STS patients with substantial unmet needs. Going forward, ADCendo aims at developing its ADC strategy for STS, based on a development track similar to Lartruvo, which was granted orphan designation, fast track, breakthrough therapy designation, priority review status, and accelerated approval for STS, enabling a faster and more cost-effective clinical development path.

Henrik Stage, CEO of ADCendo explains: "In short, ADCendo’s business strategy is aimed at moving its lead compound into the clinic for STS patients, preferably based on an orphan drug designation, and hopefully receiving conditional approval for the drug to fill the gap after Lartruvo. Having been accepted for the BII program and receiving the convertible loan funding is an important step towards maturing the company, and preparing for the additional investments needed from investors and partners, to enable us to fulfil our ambitions of bringing our novel ADC drug to the market for treatment of patients with an unmet medical need".

Commenting on ADCendo’s acceptance for the BII program, Hervør Lykke Olsen, Senior Scientific Business Developer at BioInnovation Institute, says: "The goal for ADCendo is to develop a new drug for soft tissue sarcoma (STS), which is a heterogenous groups of tumors notorious for their recurrence, overall complexity, and difficulty to treat. Research from the ADCendo team has shown that the novel target, uPARAP, is highly overexpressed on the surface of cancer cells of STS tumors, making it very well suited for targeting with ADCendo’s ADCs. BII’s support on funding and business development can boost ADCendo to succeed in commercialization of the treatment to benefit patients".

Kyowa Kirin Announces an Partial Change Approval Application of FENTOS®TAPE (Code: HFT-290) Submission by Hisamitsu Pharmaceutical in Japan

On August 29, 2019 Kyowa Kirin Co., Ltd., (Kyowa Kirin, President and CEO: Masashi Miyamoto) reported that Hisamitsu Pharmaceutical Co., Inc. (Hisamitsu Pharmaceutical, President and CEO: Kazuhide Nakatomi) has submitted a new drug application for the additional indications of opioid analgesic naïve cancer pain relief for the transdermal, pain management patch FENTOSTAPE (Development code: HFT-290, generic name: fentanyl citrate, "the product") in Japan (Press release, Kyowa Hakko Kirin, AUG 29, 2019, View Source [SID1234539111]).

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Hisamitsu Pharmaceutical has conducted the clinical study in opioid analgesic naïve cancer pain patients with the product (starting dose at 0.5mg) and confirmed the efficacy and safety of the product.

The product was granted the approval for the treatment of pain relief in various cancers that accompany moderate to severe pain in April 2010 and the additional indication approval for chronic pain in June 2014. In addition, the product was granted the additional approval of a new dose of 0.5mg in July 2018.

Kyowa Kirin and Hisamitsu Pharmaceutical have jointly carried out product distribution and activities of the provision and collection of information (1 brand, 2 channels) since June 2010. Through providing appropriate information of the product with Hisamitsu Pharmaceutical, Kyowa Kirin looks forward to giving further contribution to improve quality of life in patients suffering from cancer pain or chronic pain.

Hisamitsu Pharmaceutical expects to receive a manufacturing and marketing approval of the additional indications by February 2021.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Regulus Therapeutics to Present at the Wells Fargo Healthcare Conference

On August 29, 2019 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present a company overview at the Wells Fargo Healthcare Conference in Boston on Thursday, September 5, 2019 (Press release, Regulus, AUG 29, 2019, View Source [SID1234539128]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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