Y-mAbs Announces Data to be Presented at 2019 CTOS

On August 30, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is reported the acceptance of abstracts for a poster presentation and an oral presentation at the 2019 Connective Tissue Oncology Society (CTOS) Annual Meeting held November 13 through November 16, 2019 in Tokyo, Japan (Press release, Y-mAbs Therapeutics, AUG 30, 2019, View Source [SID1234539145]).

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The abstracts include the following presentations of omburtamab, one of the Company’s lead product candidates, which is currently being evaluated for the treatment of patients with CNS/Leptomeningeal metastasis from neuroblastoma, diffuse intrinsic pontine glioma ("DIPG"), and desmoplastic small round cell tumors ("DSRCT"):

· "Intraperitoneal radioimmunotherapy for desmoplastic small round cell tumor: Final results of a phase I study (clinicaltrials.gov identifier NCT01099644)," submitted by Memorial Sloan Kettering Cancer Center (MSK) in New York (poster presentation)

· "Whole abdominopelvic radiotherapy and radioimmunotherapy after complete resection of desmoplastic small round cell tumor (DSRCT): Major impact on survival," submitted by MSK in New York (oral presentation)

Ultragenyx to Present at Upcoming Investor Conferences

On August 30, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that Shalini Sharp, the company’s Chief Financial Officer, will present at the following conferences (Press release, Ultragenyx Pharmaceutical, AUG 30, 2019, View Source [SID1234539144]):

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Baird Global Healthcare Conference on Thursday, September 5, 2019 at 12:50pm ET in New York, NY

Morgan Stanley 17TH Annual Global Healthcare Conference on Wednesday, September 11, 2019 at 2:10pm ET in New York, NY
The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

Chugai Files for Additional Indication for Anti-HER2 Antibody Drug Conjugate Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer

On August 30, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed an application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for an additional indication for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla (generic name: trastuzumab emtansine), as adjuvant therapy in patients with HER2-positive early breast cancer (Press release, Chugai, AUG 30, 2019, View Source [SID1234539143]).

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"There is still a high unmet medical need for the development of treatment methods when pathologic complete response (pCR) is not obtained by neoadjuvant therapy. This application is the first step in providing patients with Kadcyla as a new treatment option of adjuvant therapy," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "Our HER2 franchise, consisting of Herceptin, Perjeta and Kadcyla has contributed to improving the outcomes of HER2-positive breast cancer. In this indication, we will continue to discuss with the regulatory authorities for the early approval of Kadcyla."

This application is based on results from an open-label, randomized, global phase III clinical study (the KATHERINE study), evaluating efficacy and safety of Kadcyla adjuvant therapy compared to Herceptin in almost 1,500 people with HER2-positive early breast cancer who had invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy including Herceptin. The primary endpoint of the study was invasive disease-free survival (IDFS) Based on the results of the study, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Kadcyla as adjuvant therapy and gave regulatory approval on May 3, 2019, which is just over 12 weeks after submission under the FDA’s Real-Time Oncology Review pilot program.

The main results from the KATHERINE study are as follows:
– According to the first interim analysis of the primary endpoint, the superiority of Kadcyla over Herceptin in IDFS has been confirmed (unstratified hazard ratio: 0.50 [95% confidence interval: 0.39-0.64, log-rank test, p<0.0001].
– No superiority of Kadcyla over Herceptin in overall survival was observed in the first interim analysis of the secondary endpoint conducted at the same time.
– Adverse events were observed in 731 patients (98.8%) in Kadcyla group, which was consistent with the safety profile of Kadcyla in patients with HER2-positive metastatic breast cancer. Kadcyla as an adjuvant therapy was also well tolerated in patients with HER2-positive early breast cancer.

As a leading company in the field of oncology, Chugai will work to obtain approval for the additional indication to further contribute to the treatment of HER2-positive breast cancer.

[Reference information]
Media release issued by Roche on May 6, 2019
Title: FDA approves Roche’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment
View Source

Alnylam to Webcast Presentation at 17th Annual Morgan Stanley Global Healthcare Conference

On August 30, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present a company overview at the 17th Annual Morgan Stanley Global Healthcare Conference on Monday, September 9, 2019 at 10:30 am ET at the Grand Hyatt in New York City (Press release, Alnylam, AUG 30, 2019, View Source [SID1234539142]).

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A live audio webcast of the presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after the event.

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".