On January 13, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported that it has exceeded its 2019 financial guidance with unaudited full-year TYMLOS (abaloparatide) injection U.S. net revenue surpassing the upper range of $172 million (Press release, Radius, JAN 13, 2020, View Source [SID1234553084]). Radius closed 2019 with approximately $160 million cash, cash equivalents and investments balance, achieving its year-end guidance to exceed $130 million. The Company plans to report its complete fourth quarter and audited full-year 2019 financial and operating results in February 2020.

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"I am very pleased with the continued growth of TYMLOS, which has become the preferred treatment for postmenopausal osteoporosis patients starting on anabolic therapy. We are confident that in 2020 we will reach leadership in the U.S. TRx anabolic market and complete the recruitment of our three ongoing Phase 3 studies with abaloparatide-SC in male osteoporosis, abaloparatide-patch and elacestrant," said Jesper Hoeiland, President and Chief Executive Officer of Radius.

TYMLOS exited the year reaching market leadership in new anabolic patient starts with a 52% market share and a 42% total U.S. anabolic market share in December. A 7.9% price increase for TYMLOS took effect on January 1, 2020.

For 2020, Radius expects full-year TYMLOS U.S. net revenue to be between $220 to $235 million and its full-year cash burn to be below $80 million.

Radius’ strategy is to expand the TYMLOS label to include treatment for male osteoporosis, as well as transform the use of anabolic therapy to serve unmet needs of high-risk osteoporosis patients with the development and potential launch of abaloparatide-patch. The Company’s abaloparatide-patch Phase 3 wearABLe study was initiated in August 2019 and is expected to deliver top-line results in the second half of 2021.

The Company’s elacestrant Phase 3 EMERALD study is on track to complete recruitment in the third quarter of this year. Given its refined focus on bone health and targeted endocrine diseases, the Company is evaluating strategic options for its oncology assets to maximize their potential value.

US Anabolic Osteoporosis Market; New Patients to Brand: NBRx PMOT. (Source: IQVIA)

Cash, cash equivalents, and investments

On January 10, 2020, the Company entered into a secured, non-dilutive credit facility for up to an aggregate amount of $95 million, comprised of a term loan of up to $55 million and a $20 million revolving credit facility based on accounts receivable and inventory, with the right, subject to certain conditions, to increase the revolver by $20 million. The credit facility has a maturity date of June 1, 2024. This funding is intended to support pre-launch activities for abaloparatide-patch, evaluation of opportunities in targeted endocrine diseases, and to strengthen the Company’s minimum cash balance towards profitability.

Radius’ major objectives and anticipated business outlook over the next three years (2020 – 2022) include the following:

TYMLOS Revenue > 20% compound annual growth rate;

Financial strength and flexibility to support ongoing business and existing pipeline and achieve profitability;

Top-line data readouts from abaloparatide-SC male osteoporosis, abaloparatide-patch and elacestrant Phase 3 studies;

Potential approval, pre-launch preparation and market launch of abaloparatide-patch;

Strategic exit from oncology; and

Expansion of clinical pipeline in bone health and targeted endocrine diseases.

The Company will present further details at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:30 a.m. PST at the Westin St. Francis Hotel in San Francisco. A live webcast of the presentation will be available by visiting the Investors section of Radius’ website at View Source A replay of the webcast will be archived on Radius’ website for 90 days following the presentation.

On January 13, 2020 Oncology Venture A/S ("OV" or the "Company") reported that an update of its ongoing clinical development of the PARP inhibitor, 2X-121, will be presented at an upcoming meeting in Boston on January 28-30th (Press release, Oncology Venture, JAN 13, 2020, View Source [SID1234553101]).

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Oncology Venture, a company developing novel cancer treatments along with its best in class companion diagnostic technology, the Drug Response Predictor (DRP), today announces that an update of the company’s ongoing clinical development of its proprietary PARP inhibitor 2X-121 "Titled: A novel drug specific multigene mRNA biomarker for the PARP/Tankyrase inhibitor 2X-121" has been accepted for poster presentation at the upcoming PARP & DDR Inhibitor Summit taking place in Boston on January 28th-30th, gathering VPs, Heads and Directors of Translational Oncology, Target Discovery, and Early Drug Development companies. The poster includes data from the use of a 2X-121 specific DRP biomarker that the company has developed to enable the selection of patients most likely to respond to the drug.

Title: "A novel drug specific multigene mRNA biomarker for the PARP/Tankyrase inhibitor 2X-121"

Session: Poster Session

Date and Time: January 29th at 3:15 pm Eastern Time

Presenter: Dr. Marie Foegh

"We are delighted to be presenting some of our development data in support of our PARP inhibitor 2X-121 at the upcoming PARP & DDR summit meeting as we expect it will enhance the awareness for our unique compound and the DRP platform." said Steve Carchedi, President and Chief Executive Officer of Oncology Venture. "Our novel multi-targeted approach to hitting both PARP and Tankyrase, we believe will provide an improved clinical impact compared to other PARP inhibitors currently approved and/or under development. We look forward to sharing the data set following its presentation later this month".

The company has chosen to publish this announcement now, even though the company is of the opinion that the contents of this announcement does not constitute information which will impact the company’s share price.

However, in the light of the recent events the company finds that expedited access to this information is relevant in order to provide the highest level of transparency for the members of the general public interested in the news flow from the company.

On January 13, 2020 InterVenn Biosciences reported multiple achievements in its development of AI-enabled glycoproteomics, as it looks to solving difficult challenges in various disease areas of unmet medical need (Press release, InterVenn Biosciences, JAN 13, 2020, View Source [SID1234553118]). Over the last 12 months, InterVenn has received positive interim results from its first clinical trial (V.O.C.A.L.) evaluating a new, simple blood test for the care of patients with ovarian tumors; secured partnerships with seven leading cancer research organizations, including the University of Iowa and the Parker Institute for Cancer Immunotherapy, to develop novel approaches in immuno-oncology; and made a freemium version of its proprietary, AI-powered mass spectrometry analysis software, OpenPIP, publicly available to the research community. In the coming weeks, InterVenn will complete a move to a new facility in South San Francisco, with research laboratories capable of high throughput sample processing to expand the company’s repertoire of interrogating additional indications, as well as a CLIA-CAP-accredited facility.

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"Until now, glycoproteomics has been considered simply too complex to lend itself to discovering and applying meaningful information to help patients, despite its huge promise that we have been aware of for a long time," said Aldo Carrascoso, Chief Executive Officer of InterVenn Biosciences. "We have made it our absolute priority to interface our technology with a number of key institutional and industry players to deploy and validate our array of AI- and deep machine learning-based tools to allow transitioning the powerful realm of glycoproteomics into an actionable armamentarium for patient care and drug discovery. This will enable us to massively accelerate all of our partners’, collaborators’, and alliances’ workflows."

Over the last 15 years, glycobiology has developed into an increasingly solid scientific discipline, based on the seminal work of Professors Carolyn Bertozzi (Stanford) and Carlito Lebrilla (UC Davis), both of whom helped co-found InterVenn and are serving as members of the company’s Scientific Advisory Board. InterVenn has demonstrated that combining proteomics with glycomics, along with relevant phenotypical annotations and a powerful bioinformatics approach, affords critical advances in biomarker and target discovery not realized with other technologies. InterVenn’s approach to glycoproteomics leverages the power of ultra-high-pressure- liquid-chromatography, coupled-mass-spectrometry for high-resolution, accurate-mass generation of post-translational protein modification data with the prowess of artificial intelligence and machine learning technology to streamline and expedite the processing and analysis of these data. At the same time, InterVenn’s algorithms ensure that the vagaries and variabilities inherent in any clinical study – from patient recruitment bias/variability, sample collection, sample processing, all the way to instrument measurements – are minimized, and the results are reproducible. OpenPIP, the company’s AI-enabled mass spec analysis software, dramatically reduces the time and cost of integrating and quantifying mass spectrometry data while increasing the quality of output and interpretation by eliminating observer-based bias.

InterVenn’s study investigating its leading product, a clinical decision-making tool for ovarian cancer aimed at distinguishing malignant pelvic tumors from benign ones, with neither compromising diagnostic accuracy nor subjecting women to undergoing potentially unnecessary and harmful surgery, is currently actively enrolling patients in a multicenter, international clinical trial (V.O.C.A.L.) in the U.S., Australia, and Southeast Asia, with interim results indicating that the InterVenn test performs significantly better than the currently most widely used ovarian cancer test, CA 125, in terms of both specificity and sensitivity. InterVenn expects to complete enrollment and receive preliminary data from the V.O.C.A.L. trial in late 2020.

In the fall of 2019, InterVenn added Klaus Lindpaintner, M.D., MPH, FACP, FACMG, to the team as Chief Scientific Officer and Chief Medical Officer, a role in which he will lead all of InterVenn’s global scientific operations and clinical affairs. Dr. Lindpaintner is spearheading collaborations with a number of institutional and industry partners with the promise of finding new, actionable diagnostic and therapeutic approaches for a broad spectrum of diseases. Klaus also oversees both InterVenn’s Scientific and Medical Advisory Boards, notable members of which include Giuila Kennedy, Ph.D., Chief Scientific Officer and Chief Medical Officer of Veracyte; and Tony Wyss-Coray, Ph.D., Professor of Neurology & Neurological Sciences at Stanford University School of Medicine, among other luminaries.

"We have known for some time that diseased cells exhibit different protein glycosylation patterns compared to healthy cells, but the scientific community has so far been unable to accurately, and on a real-time scale, quantify and monitor what these changes are, how they occur, and how they specifically relate to disease biology," said Dr. Lindpaintner. "With InterVenn’s technology’s powerful platform of wet- and dry-lab tools, we have reached the inflection point where technological advances meet biological complexity to reveal unprecedentedly powerful insights into pathobiology that have been elusive for so long."

To find out more about InterVenn Biosciences and how the company is leveraging artificial intelligence and mass spectrometry to the transformation of medical technology, visit View Source For all general and media inquiries about InterVenn Biosciences, please contact Andrea Vuturo at [email protected].

On January 13, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), through its wholly-owned subsidiary Universal Cells, Inc. and Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that they have entered into a co-development and co-commercialization agreement to bring new stem-cell derived allogeneic T-cell therapies to people with cancer (Press release, Astellas, JAN 13, 2020, View Source [SID1234553157]).

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Astellas and Adaptimmune will agree on up to three targets and co-develop T-cell therapy candidates directed to those targets. These targets will exclude target specific T-cell products in pre-clinical or clinical trials or those developed for other partners at Adaptimmune. The collaboration will leverage Adaptimmune’s target identification and validation capabilities for generating target-specific T-cell Receptors (TCRs), chimeric antigen receptors (CARs), and HLA-independent TCRs that recognize surface epitopes independently of the HLA profile of the tumor cell. The collaboration will also utilize Astellas’ Universal Donor Cell and Gene Editing Platform it obtained through the acquisition of Seattle-based Universal Cells.

Adaptimmune has been collaborating with Universal Cells since 2015 on development of gene-edited iPSC cell lines, for which Adaptimmune has rights to develop and commercialize resulting T-cell therapy products using its proprietary process for generating T cells from stem cells without the use of feeder cell lines.

Astellas will fund research up until completion of a Phase 1 trial for each candidate. Upon completion of the Phase 1 trial for each candidate, Astellas and Adaptimmune will elect whether to progress with co-development and co-commercialization of the candidate, or to allow the other Party to pursue the candidate independently through a milestone and royalty bearing licence, with the agreement allowing for either company to opt out. The companies will each have a co-exclusive licence covering the co-development and co-commercialization of the product candidates within the field of T-cell therapy. If a candidate is developed by one company only, the appropriate licences will become exclusive to the continuing party.

"Astellas positions immuno-oncology as one of its strategic areas of primary focus, and it is engaged in the development of novel therapies for cancer patients using a new modality/technology," stated Naoki Okamura, Representative Director Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, Astellas. "In addition to NK cells, T-cells are an important component of cell therapy for immuno-oncology, and we look forward that this agreement with Adaptimmune will enable us to create new stem-cell derived allogeneic T-cell therapies for a variety of cancers, including solid tumors, in the future. We will continue to dedicate our efforts in delivering novel treatments for diseases with high unmet medical needs, pursuing cutting-edge science and technological advances."

"We are delighted to establish this significant co-development partnership with Astellas, which builds upon and substantially extends an existing collaboration focused on gene editing of iPSC cells," said Helen Tayton-Martin, Adaptimmune’s Chief Business Officer and Co-Founder. "This new collaboration may encompass both CAR-T and TCR T-cell approaches, including our novel HLA-independent TCR ("HiT") platform. It brings together highly complementary skills and expertise across the two organizations, and will enable the accelerated development of new, off-the-shelf T-cell therapy products for people with cancer."

Astellas will also have the right to select two targets and develop allogeneic cell therapy candidates independently. Astellas will have sole rights to develop and commercialize these products, subject to necessary licenses and the payment of milestones and royalties.

Under the terms of the agreement, Adaptimmune may receive up to $897.5 million in payments, including:

an upfront payment of $50 million.
development milestones totalling up to $73.75 million for each product if the collaboration product discovered in this partnership is co-developed and commercialized by both companies
Up to $147.5 million in milestone payments per product and up to $110 million in sales milestones for products developed unilaterally by Astellas.
In addition, Adaptimmune will receive research funding of up to $7.5 million per year.

Finally, Adaptimmune would receive tiered royalties on net sales in the mid-single to mid-teen digits.

Under the terms of the agreement, Astellas may receive up to $552.5 million, including:

Up to $147.5 million in milestone payments per product and up to $110 million in sales milestones
for products developed unilaterally by Adaptimmune.
In addition, Astellas would receive tiered royalties on net sales in the mid-single to mid-teen digits.

To the extent that Astellas and Adaptimmune co-develop and co-commercialize any T-cell therapy, they will equally share the costs of such co-development and co-commercialization, with the resulting profits from co-commercialization also shared equally. Further details governing co-development and co-commercialization will be articulated in a product-specific commercialization agreement.

The impact of this transaction on Astellas’ financial results in the fiscal year ending March 31, 2020 will be limited.

On January 13, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16, 2020, at 9:00 a.m. PT (Press release, MacroGenics, JAN 13, 2020, View Source [SID1234553175]).

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An audio and slide webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of this webcast on its website for 30 days after the conference.