On April 18, 2018 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that it is presenting pre-clinical data from ongoing research of RGX-202, a small molecule compound in development designed to inhibit SLC6a8, a creatine transporter, integral to cancer cell energy metabolism (Press release, Rgenix, APR 18, 2018, View Source [SID1234525519]). In a poster presentation today at the 2018 American Association of Cancer Research Annual Meeting, "RGX-202, a first-in-class small-molecule inhibitor of the creatine transporter SLC6a8, is a robust suppressor of cancer growth and metastatic progression", the data showed RGX-202 to be a robust inhibitor of creatine uptake in cancer cells and to be active in several pre-clinical gastrointestinal cancer models both as a single agent and in combination with chemotherapy.

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RGX-202 is a small molecule that inhibits a novel cancer metabolism target, SLC6a8, which is involved in supplying energy to cancer cells. SLC6a8 is over-expressed in several prevalent cancer types, including gastrointestinal malignancies such as colorectal cancer.

More than 140,000 patients are diagnosed with colorectal cancer annually in the U.S. With approximately 50,000 deaths in the U.S. attributed to the condition annually, it is a leading cause of cancer deaths. Creatine metabolism has been shown to spur the growth of colon cancer. This pathway is activated by colon cancer cells to allow uptake of phosphorylated creatine that can be converted to ATP to fuel survival of cancer cells as they proliferate and spread. RGX-202 inhibits this pathway by blocking the ability of SLC6a8 to import phosphocreatine into cancer cells.

In the pre-clinical research presented today, the impact of RGX-202 was studied alone, and in combination with standard of care chemotherapy agents such as 5-FU.

On its own, RGX-202 induced cancer cell death in vivo and demonstrated anti-tumor activity in both KRAS mutant and KRAS wild-type models of gastrointestinal cancer. RGX-202 also suppressed colon cancer and pancreatic cancer liver metastatic colonization, a model of metastatic cancer progression. Importantly, RGX-202 significantly extended survival of tumor-bearing mice as a single agent.

Studies combining RGX-202 with 5-FU resulted in additive anti-tumor activity, with complete tumor regressions among 50% of treated mice and significantly prolonged survival versus 5-FU treatment alone.

Masoud Tavazoie, MD, PhD, and Chief Executive Officer of Rgenix, said, "The data presented today is just a snapshot of our pre-clinical progress on our research of RGX-202. These data show the strong potential for RGX-202 and support further research of the compound. With these data, we are building a strong foundation for future clinical development of RGX-202, which, with regulatory approval, would diversify our clinical pipeline."

On APril 18, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the pricing of its initial public offering (IPO) in the United States. The offering produced gross proceeds of USD 207,832,000 from the sale of 2,075,000 new ordinary shares in the form of 8,300,000 American Depositary Shares ("ADSs") at a price of USD 25.04 per ADS. Each ADS will represent 1/4 of a MorphoSys ordinary share (Press release, MorphoSys, APR 18, 2018, View Source [SID1234525575]).

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Furthermore, MorphoSys has granted the underwriters an option to purchase up to 1,245,000 additional ADSs, representing 15% of the total number of ADSs placed in the offering. This option can be exercised during the 30-day period commencing April 18, 2018.

The new ordinary shares underlying the ADSs and, if the option will be exercised, the additional ADSs will be issued from MorphoSys’s authorized capital 2017-II, excluding pre-emptive rights of existing shareholders and representing up to 8.1% (including the underwriters’ option to purchase additional ADSs) of the registered share capital of MorphoSys prior to the consummation of the offering.

MorphoSys’s ordinary shares are listed on the Frankfurt Stock Exchange under the symbol "MOR".

The ADSs are expected to begin trading on the Nasdaq Global Market on April 19, 2018, under the symbol "MOR".

The closing of the offering is expected to occur on April 23, 2018, subject to customary closing conditions.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Leerink Partners LLC, are acting as lead book-running managers, and Berenberg Capital Markets, LLC and JMP Securities LLC are acting as co-managers for the ADS offering.

A Registration Statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission on April 18, 2018.

Within the United States of America, the securities referred to in this release are offered only by means of a prospectus. A copy of the prospectus can be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 1-212-902-9316 or by e-mailing [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by e-mailing [email protected].

On April 18, 2018 Kymab Group Limited ("Kymab"), a biopharmaceutical company developing fully human monoclonal antibody therapeutics, reported data on KY1044 (a novel anti-ICOS antibody) and KY1055 (a novel ICOS/PD-L1 bispecific antibody), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual meeting held April 14-18, 2018 in Chicago, Illinois, USA (Press release, Kymab, APR 18, 2018, View Source [SID1234537006]).

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The AACR (Free AACR Whitepaper) Annual Meeting covers the latest basic, translational, clinical, and prevention-focused research in the field, including important areas such as early detection, cancer interception, and survivorship in all populations.

Notes to Editors
About Kymab’s AACR (Free AACR Whitepaper) Posters
KY1044 poster

Title: The combination of immune checkpoint blockers with the anti-ICOS KY1044 antibody results in a strong tumour response (#2792)

Session Title: Therapeutic Antibodies, Including Engineered Antibodies 2

Session Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM

Link to the Poster (1.4 Mb PDF)

KY1055 poster

Title: KY1055, a novel ICOS/PD-L1 bispecific antibody, efficiently enhances T cell activation and delivers a potent anti-tumour response in vivo. (#LB-153)

Session Title: Late-Breaking Research: Clinical Research 1

Session Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM

On April 18, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that promising preclinical data with its lead AXL inhibitor bemcentinib (formerly BGB324) has been presented in a poster at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on 14-18 April in Chicago, IL, USA (Press release, BerGenBio, APR 18, 2018, View Source [SID1234525486]).

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The data highlight bemcentinib’s potential to reverse tumour immune suppression and enhance immune checkpoint inhibitor efficacy.

The authors show that bemcentinib targets immune suppression mechanisms in the tumour microenvironment that improve immunotherapy in murine tumour models of non-small cell lung (NSCLC), triple negative breast (TNBC) and pancreatic cancer. Bemcentinib treatment reduces myeloid-derived suppressor cells and the altered immune landscape is associated with increased tumour infiltration of T cells (NK and CD8+) and enhanced therapy responses.

A validated AXL immunohistochemistry (IHC) method for use on patient samples to identify the presence of AXL on tumour cells and immune cells in the tumour microenvironment was presented. The authors report that across 92 banked tumour biopsies from patients with TNBC or NSCLC 70% were found to stain positive for AXL using this IHC method. The IHC method is now in use to analyse biopsies taken in connection with the company’s phase II combination trials of bemcentinib with KEYTRUDA in patients with advanced NSCLC or TNBC.

Professor James Lorens, BerGenBio Chief Scientific Officer, commented: "These results highlight a clear and important role for AXL in aggressive disease and resistance to immune therapy in particular. They provide continued confidence in the potential of combining bemcentinib with immune checkpoint inhibitors to improve cancer treatment, and support for our Phase II clinical trial programme of bemcentinib combined with the blockbuster immune checkpoint inhibitor KEYTRUDA, interim results from which are expected during 2018."

The poster is available online – www.bergenbio.com/investors/presentations/

Nearly two months after Eli Lilly secured an expanded approval indication for its cancer drug Verzenio, the company unveiled final data from the MONARCH 3 trial that won the latest nod from the U.S. Food and Drug Administration for the treatment of some breast cancer patients (Press release, BioSpace, APR 18, 2018, View Source [SID1234525503]).

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During a presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago this weekend Lilly revealed that Verzenio (abemaciclib), a cyclin-dependent kinase inhibitor, provided even longer progression-free survival than originally believed. Last fall Eli Lilly released interim-data from the MONARCH 3 trial that showed PFS was estimated at 14 months. Now though data shows Verzenio in combination with an aromatase inhibitor (AI) provides progression-free survival of 28 months.

"That’s a significant prolongation in progression-free survival that is important for the lives of patients," Levi Garraway, senior vice president of global development and medical affairs at Eli Lilly told BioSpace in an exclusive interview. "We’ve been happy with the news that this gives women with breast cancer one more option."

In February the FDA gave approval for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. That approval marked the third time the FDA gave the drug the green light since its first regulatory win in September 2017.

By adding abemaciclib to endocrine therapy as part of a treatment regimen, Eli Lilly said the program demonstrated improved progression-free survival in patients with HR+/HER2-negative breast cancer. In patients with measurable disease, the objective response rate was 55.4 percent in the abemaciclib arm and 40.2 percent in the placebo arm, according to data.

Within the MONARCH 2 and MONARCH 3 clinical trial subgroup populations, researchers at Eli Lilly identified certain clinical characteristics of the disease that typically confer a less favorable prognosis. Eli Lilly believes this information may help clinicians optimize treatment decisions, including the use of CDK4 & 6 inhibitors, and potentially provide the groundwork for more individualized therapy.

During the conference Garraway said he engaged with several doctors about the use of cyclin-dependent kinases inhibitors in the treatment of breast cancer. He said the response they have seen from prescribers is positive, which indicates there is a path for cyclin-dependent kinases inhibitors.

"These doctors, they’ve been seeing some positive moves and are gaining confidence in its (Verzenio) use," Garraway said.

With the success that Eli Lilly has had with Verzenio, the company now aims to determine if it can be used as a treatment in other types of breast cancer, as well as other cancer indications. Currently, the company has Verzenio in a study in the high-risk adjuvant breast cancer setting, as well as an ongoing Phase II study in Her2+ breast cancer. Garraway said data from the mid-stage trial is expected by the end of the year. While Garraway did not provide many details on the Phase II study, He said it was designed so that if the data readout is strong enough there is a chance Eli Lilly could seek regulatory approval on that data alone. But, he quickly noted that it depends on whether or not there is a large enough of an effect from the treatment for the company to go into regulatory discussions as opposed to a Phase III study.

"There’s a biological rationale for the testing and we’re looking forward to seeing the results later this year," Garraway said.

For potential uses outside of breast cancer Garraway would not disclose what areas the company is exploring with Verzenio, he said the company has identified some areas "that are worth the investment."

Not related to Eli Lilly’s presentations at AACR (Free AACR Whitepaper), this morning the company announced a partnership with Boehringer Ingelheim and the University of Oxford to investigate the effects of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death, in adults with established chronic kidney disease with and without diabetes. The primary outcome of the study is to assess the effect of Jardiance on time to clinically relevant kidney disease progression or cardiovascular death.