On November 14, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the first commercial sale of DARZALEX (daratumumab) in Japan has taken place, triggering USD 25 million in milestone payments from Janssen Biotech, Inc. (Janssen). The milestone was mentioned at the time of the September 2017 announcement of the approval of DARZALEX for the treatment of adults with relapsed or refractory multiple myeloma in Japan (Press release, Genmab, NOV 14, 2017, View Source [SID1234522064]). As a result of this milestone, Genmab is updating its 2017 financial guidance.

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"We’re pleased that DARZALEX is now commercially available for patients with relapsed or refractory multiple myeloma who are living in Japan," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

OUTLOOK
MDKK Revised Guidance Previous Guidance
Revenue 2,110 — 2,310 1,950 — 2,150
Operating expenses (1,000) — 1,100) (1,000) — (1,100)
Operating income 1,060 — 1,260 900 — 1,100
Cash position at end of year* >4,900 >4,500
*Cash, cash equivalents, and marketable securities

Genmab is improving its 2017 financial guidance last published on November 8, 2017 due to the inclusion of the DARZALEX milestones totaling USD 25 million associated with first commercial sale of DARZALEX in Japan.

Operating Result
We expect our 2017 revenue to be in the range of DKK 2,110 — 2,310 million, an increase of DKK 160 million compared to the previous guidance. We have increased our projected daratumumab milestones to DKK 960 million (previously DKK 800 million) due to inclusion of USD 25 million in milestone payments triggered by the first commercial sale of DARZALEX in Japan. We expect DARZALEX royalties to remain in the range of DKK 930 — 1,100 million, which are based on an estimated USD 1,100 — 1,300 million of DARZALEX sales in 2017. The remainder of the revenue mainly consists of Arzerra royalties, DuoBody milestones, and non-cash amortization of deferred revenue.
We anticipate that our 2017 operating expenses will remain in the range of DKK 1,000 —1,100 million.
As a result of the increased revenue, we now expect the operating income for 2017 to be approximately DKK 1,060 — 1,260 million, compared to DKK 900 — 1,100 million in the previous guidance.

Cash Position
As a result of the above and proceeds from the exercise of warrants during the year, we are now projecting a cash position at the end of 2017 of greater than DKK 4,900 million.

Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX and Arzerra sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2017 that could materially affect the results.

On November 14, 2017 Bayer reported that the company has entered into an exclusive global collaboration with Loxo Oncology, Inc., a biopharmaceutical company based in Stamford, Connecticut, US, (NASDAQ: LOXO) for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195 (Press release, Bayer, NOV 14, 2017, View Source [SID1234522040]). Both compounds are being investigated in global studies for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

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"The collaboration with Loxo Oncology represents another milestone in our endeavor to strengthen our oncology presence and underlines our commitment to this therapeutic area", said Dieter Weinand, Member of the Board of Management of Bayer AG and President of the Pharmaceuticals Division. "Loxo Oncology’s very innovative approach complements Bayer’s oncology pipeline with highly differentiated compounds across different treatment modalities, which are being developed to make a meaningful difference for patients suffering from various types of cancer."

Larotrectinib is an oral, potent and highly selective TRK inhibitor. LOXO-195 is a next-generation, selective TRK inhibitor capable of addressing potential mechanisms of acquired resistance that may emerge in patients receiving larotrectinib or multikinase inhibitors with anti-TRK activity. Larotrectinib is currently the only selective TRK inhibitor in clinical development with the comprised clinical data set showing clinically meaningful and durable responses with an overall response rate of 75 percent, confirmed by an independent review committee, regardless of tumor type and age. The first filing for larotrectinib is planned in the U.S. in late 2017 or early 2018, with the EU filing expected in 2018.

"We see great potential in larotrectinib and moreover the follow-on compound LOXO-195 which has the potential to provide additional benefit for patients who might progress on an initial TRK inhibition therapy. These agents have the potential to fullfil the promise of precision medicine, where tumor genetics rather than tumor site of origin define the treatment approach for patients", said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer.

"This is a transformational collaboration for the company as we prepare for commercialization," said Jacob Van Naarden, chief business officer of Loxo Oncology. "Bayer has a history of successful co-promotion efforts with emerging biopharmaceutical companies and we are confident that their oncology team has the global reach and expertise, including an existing field force dedicated to cancer, to complement our existing commercial plans. We look forward to working with Bayer and believe that together we can bring our TRK inhibitors to more patients more quickly."

Under the terms of the agreement, Loxo Oncology will receive an upfront payment of USD 400 million and is eligible for USD 450 million in milestone payments upon larotrectinib regulatory approvals and first commercial sale events in certain major markets and an additional USD 200 million in milestone payments upon LOXO-195 regulatory approvals and first commercial sale events in certain major markets. Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and share development costs on a 50/50 basis. Bayer will lead ex-U.S. regulatory activities, and worldwide commercial activities. In the U.S., where Bayer and Loxo Oncology will co-promote the products, the parties will share commercial costs and profits on a 50/50 basis. Loxo Oncology will remain responsible for the filing in the U.S. Bayer will pay Loxo Oncology tiered double-digit percentage royalties on future net sales outside of the U.S. and U.S. and ex-U.S. sales milestones totaling USD 500 million.

About Larotrectinib (LOXO-101) and LOXO-195
Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.

In an analysis of 55 RECIST-evaluable TRK fusion adult and pediatric patients, larotrectinib demonstrated a 75 percent independently-reviewed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. Larotrectinib received orphan drug designation in the US for the treatment of solid tumors harboring NTRK-fusion proteins and in Europe for soft tissue sarcoma. Additionally, the FDA granted breakthrough therapy designation to larotrectinib for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.

LOXO-195 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that have acquired resistance to initial TRK therapy such as larotrectinib. Though drugs such as larotrectinib can induce durable responses in these patients, the cancer may eventually begin to grow again. This phenomenon is called "acquired resistance," in that the cancer has acquired features conferring resistance to the initial therapy that was once effective. Emerging data in the field of TRK inhibition suggest that acquired resistance may emerge due to TRK kinase point mutations. LOXO-195 was designed to address these new point mutations and induce a new response in the patient’s cancer. In July 2017, a multi-center Phase I/II trial in patients with TRK fusion cancers who have progressed while receiving another TRK inhibitor or are intolerant to another TRK inhibitor was initiated.

For additional information about the larotrectinib or LOXO-195 clinical trials, please refer to www.clinicaltrials.gov or visit www.loxooncologytrials.com. Neither larotrectinib nor LOXO-195 are approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.

About TRK Fusion Cancer
TRK fusions are chromosomal abnormalities that occur when one of the NTRK genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another, unrelated gene (e.g. ETV6, LMNA, TPM3). This abnormality results in uncontrolled TRK signaling that can lead to cancer. TRK fusions occur rarely but broadly in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. TRK fusions can be identified through various diagnostic tests, including targeted next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH). For more information, please visit www.TRKtesting.com.

Cancers Harboring Genetic Alterations
Scientists have long been working to better understand how a normal cell becomes a cancer cell to deliver better therapies with fewer side effects. Some people develop cancers that are caused by a single inappropriate DNA change, known as "oncogenic drivers." When a genetic test identifies a patient with an oncogenic driver, there is the potential for use of highly selective drugs that inhibit oncogenic drivers in cancer. While there has been made notable progress in improving outcomes for people living with cancer over the last several decades, there has been a growing interest in developing highly targeted medicines to treat cancer, to further maximize the patients’ clinical benefit. This development is supported by the increasing use of genetic testing in cancer clinical medicine and improving chemistry approaches to building highly selective inhibitors against single targets in the cancer cell.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes four marketed products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

On November 14, 2017 GTx, Inc. (Nasdaq:GTXI) reported financial results for the third quarter of 2017 and highlighted recent accomplishments and upcoming milestones (Press release, GTx, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316925 [SID1234522065]).

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"During the quarter, we achieved a key milestone for the company when we reported positive results from our first clinical trial in stress urinary incontinence," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Remarkably, 18 out of 18 women who received enobosarm for 12 weeks responded. These responses also appear to be durable, lasting months after dosing. These exciting results provided the basis for our recently initiated, placebo-controlled clinical trial of enobosarm for the treatment of SUI."

"Recent data suggests 50 percent of women report SUI, for which there are no FDA-approved pharmaceutical therapies. An orally-available therapy would offer numerous advantages over existing treatments including surgery, and would provide a significant new option that many women would choose in order to address this medical condition," said Kenneth M. Peters, M.D., Chairman of Urology, Oakland University William Beaumont School of Medicine and the principal investigator in the trial.

Third Quarter 2017 Clinical Highlights and Anticipated Milestones

Stress Urinary Incontinence (SUI):

Enobosarm, a Selective Androgen Receptor Modulator (SARM), is being evaluated in Phase 2 clinical development for SUI, the Company’s lead indication. Recent important milestones are summarized as follows:

Reported positive results from the Phase 2 proof-of-concept (POC) clinical trial of enobosarm 3 mg administered orally in post-menopausal women with SUI. With the inclusion of the final patient completing treatment in the POC clinical trial, data from the 18 evaluable patients completing the required 12 weeks of daily treatment showed a clinically meaningful reduction (50 percent or greater) in stress leaks per day, compared to baseline. The mean decrease in stress leaks per day was 81 percent overall (5.17 mean leaks/day at baseline to 1.0 mean leaks/day at 12 weeks).
Patients are being followed for an additional 28 weeks post-treatment to assess the durability of treatment effect. Durability of response for patients who completed the 28-week observation phase has resulted in a 41 to 100 percent reduction in stress leaks/day from baseline (N=6). For those patients who have not completed the 28-week observation phase, the durability of response, measured beginning 4 weeks post dosing, continues to be sustained.
Highlighted the Phase 2 POC results at the International Continence Society (ICS) annual meeting in a poster entitled, "Kegels in a Bottle: Preliminary Results of a Selective Androgen Receptor Modulator (GTx-024) for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women", which subsequently was voted best poster for the conference.

Initiated a second clinical trial, Assessing Enobosarm for Stress Urinary Incontinence Disorder (ASTRID): a randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of two doses of enobosarm (1 mg and 3 mg) administered orally in post-menopausal woman with SUI compared to placebo. The primary endpoint of the trial is the percentage of patients with at least a 50 percent reduction in mean leaks/day, compared to baseline. This trial is expected to enroll approximately 400 patients across 70 clinical sites in the U.S. Top-line results are expected to be available by the end of 2018.
Breast Cancer:

Enobosarm is also being evaluated as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer in a Phase 2 clinical trial for this advanced breast cancer population. As reported earlier for the 9 mg cohort, the Phase 2 trial pre-specified threshold for success, clinical benefit response (CBR), was attained and therefore met the primary efficacy endpoint. In addition, the 18 mg cohort has also met the primary efficacy endpoint. The trial has now completed enrollment of the predefined number of evaluable patients in both dosage arms with at least 44 patients in each of two cohorts receiving 9 mg or 18 mg daily doses of enobosarm.

In the 9 mg cohort, following 24 weeks of treatment, a total of 14 patients achieved a CBR out of 49 evaluable patients confirmed as AR positive (28.6%), with two patients achieving a partial response and 12 reporting stable disease. Currently, four patients in this cohort remain on study. In the 18 mg cohort, with 48 evaluable patients, 12 patients achieved a CBR (25%) at 24 weeks with one patient demonstrating a partial response and 11 patients reporting stable disease. Three patients remain on study in the 18 mg cohort. Both doses of enobosarm appear to be safe and generally well tolerated. A complete summary of the study results will be submitted for presentation or publication in 2018.

Although both the 9 mg and 18 mg cohorts met the primary efficacy endpoint in the Phase 2 clinical trial, after evaluating the drug development environment for breast cancer, where treatment paradigms are shifting to immunotherapies and/or combination therapies, the Company has decided that the time and cost of conducting the necessary clinical trials for approval in this indication do not warrant further development of enobosarm in this indication at this time.

Duchenne Muscular Dystrophy (DMD):

SARMs have also been evaluated in preclinical models of DMD, in which GTx SARMs have increased lean muscle mass and physical function. The Company is pursuing a potential strategic collaboration with biopharma companies experienced in orphan drug development to continue the development of a SARM for the treatment of DMD.

Prostate Cancer:

The Company has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer (CRPC). The Company has ongoing mechanistic preclinical studies designed to select the most appropriate compound to advance into a first-in-human clinical trial.

Third Quarter 2017 Corporate Highlights and Financial Results

During the quarter, GTx raised net proceeds of $45.6 million in a private placement of its common stock and warrants to purchase its common stock. GTx sold 5,483,320 immediately separable units, comprised of an aggregate of 5,483,320 newly-issued shares of common stock and warrants to purchase up to 3,289,988 additional shares of common stock. Both the common stock and warrants have been registered for resale with the Securities and Exchange Commission.

As of September 30, 2017, cash and short-term investments were $53.6 million compared to $21.9 million at December 31, 2016.

Research and development expenses for the quarter ended September 30, 2017 were $5.9 million compared to $4.6 million for the same period of 2016.

General and administrative expenses for the quarter ended September 30, 2017 were $2.6 million compared to $2.3 million for the same period of 2016.

Net loss for the three months ended September 30, 2017 was $8.5 million compared to a net loss of $6.9 million for the same period in 2016.

Net loss for the nine months ended September 30, 2017 was $21.2 million compared to a net loss of $10.9 million for the same period in 2016. The nine months ended September 30, 2016 included a non-cash gain of $8.2 million due to the change in fair value of the Company’s warrant liability. During the first quarter of 2016, the Company modified its outstanding warrants with no further adjustment to the fair value of these warrants being required.
GTx had approximately 21.5 million shares of common stock outstanding as of September 30, 2017. Additionally, there are warrants outstanding to purchase approximately 6.4 million shares of GTx common stock at an exercise price of $8.50 per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.

GTx has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, GTx, 2017, NOV 14, 2017, View Source [SID1234522055]).

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On November 14, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells, reported that the Company has launched its AWE Program or Actinium Warhead Enabling Program (Press release, Actinium Pharmaceuticals, NOV 14, 2017, View Source [SID1234522039]).

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The AWE Program is designed to provide biopharmaceutical companies with access to the Company’s proprietary AWE technology platform in order to allow development of actinium-225 enabled conjugates wherein targeting agents are labeled with the alpha particle emitting radioisotope, actinium-225. Utilizing the AWE Technology Platform, the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. can potentially be improved via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents, provide an opportunity to extend intellectual property protection by the creation of "Biobetters" or improved versions of the approved agent. Actinium is currently conducting a Phase 2 clinical trial for its drug candidate Actimab-A and a Phase 1 clinical trial for its drug candidate Actimab-M, both of which are fruits of the AWE Technology Platform and are comprised of actinium-225 labeled to an antibody that targets the antigen CD33 in patients with acute myeloid leukemia and multiple myeloma, respectively.

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Recently, Actinium announced that it successfully labeled the anti-CD38 monoclonal antibody daratumumab, a blockbuster therapy for patients with multiple myeloma, with actinium-225. Stability and target engagement was similar between the unlabeled and actinium-225 labeled antibody, demonstrating that the Company’s AWE Technology can successfully label a CD38 targeting agent without disrupting binding. In-vitro experiments with both the labeled and unlabeled antibody were performed in the same cell lines that initially established daratumumab’s proof of concept. In each CD-38 expressing cell line, improved cell killing was observed with the actinium-225 enabled daratumumab. The previous maximum reported cell killing was 62% with the naked daratumumab. However, at 1/10 of that antibody concentration the cell killing was 97% with the actinium-225 enabled daratumumab. Additionally, the cell-killing effect demonstrated both a time and concentration dependency. Importantly, specificity is demonstrated as no cell killing was observed when a cell line that does not express the target CD38 was treated with the actinium-225 labeled daratumumab. Data from this study were accepted as an abstract for poster presentation at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting Annual which can be viewed in the following link: View Source

Sandesh Seth, Actinium’s Chairman and CEO said, "The element actinium-225 is tremendously potent yet highly specific given its short path length, making it the ideal warhead for oncology indications when labeled to monoclonal antibodies. Through the development of our drug candidates, we have gained significant expertise and know-how in the application of actinium-225 and we look forward to providing our proprietary technology and highly specialized know how and supply chain capabilities to potential partners via our AWE Program. This expertise is evidenced by the recent results showing that actinium-225 increased the cell killing power of the blockbuster multiple myeloma antibody therapy daratumumab at 10-fold lower antibody concentration in Daudi cells. We are currently utilizing our technology toward generating potential "Biobetters" of selected commercial targeting agents and believe that our technology can be applied to a significant number of antibodies, peptides, Fab fragments or other targeting moieties. We look forward to working in collaboration via the AWE Program with biopharmaceutical companies that would like to increase the efficacy of their commercial or development stage antibodies to improve patient outcomes and also to better manage the lifecycle of their commercial antibodies."

About Our Actinium Warhead Enabling Technology Platform

The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Despite this superior cell killing power, actinium-225 when delivered in a targeted manner is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of radioimmunoconjugates, management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with actinium-225. In addition to increased efficacy, these actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of "Biobetters" or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating Biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at [email protected].