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Bayer submits larotrectinib for marketing authorization in Japan for the treatment of TRK fusion cancer

On May 22, 2020 Bayer reported that it has submitted an application for marketing authorization for its precision oncology treatment larotrectinib to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Bayer, MAY 22, 2020, View Source [SID1234558519]). Larotrectinib is an oral TRK inhibitor that has been developed specifically to treat adults and children with locally advanced or metastatic solid tumors that have the rare genomic alteration called a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The product is already approved in several countries under the brand name Vitrakvi, including the U.S., Brazil, Canada and countries of the European Union (EU). Filings in other regions are underway or planned.

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"With this submission, we are one step closer to providing patients and physicians in Japan with a highly selective treatment exclusively designed for adults and children with TRK fusion cancer, that has the potential to significantly improve treatment outcomes regardless of tumor type or patient age," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. "While cancers have previously been treated mainly in the body, larotrectinib was developed specifically to treat patients with TRK fusion cancer, regardless of where in the body the tumor originates. Larotrectinib represents an important advancement in the fight against this rare cancer, as it could replace costly treatment that is not targeted specifically to this cancer and does not have proven efficacy and safety in this patient population."

The submission to the MHLW is based on clinical trial data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, cholangiocarcinoma, soft tissue sarcomas, salivary gland and infantile fibrosarcoma.

TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.

About larotrectinib
Larotrectinib, a specific oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and durable responses with a favorable safety profile over three years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset published in The Lancet Oncology and additional updates planned to be presented at upcoming scientific meetings.

Larotrectinib was approved in September 2019 in the European Union under the brand name Vitrakvi for the treatment of adult and pediatric patients with solid tumors that display an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. Vitrakvi has also received regulatory approval in additional markets, including the U.S, Brazil and Canada. Filings in other regions are underway or planned.

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer has obtained the exclusive licensing rights for the global development and commercialization, including in the U.S., for larotrectinib and the investigational another TRK inhibitor selitrectinib (BAY 2731954) progressing through clinical development.

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 now expands to six marketed products and several other assets 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.

QIMR Berghofer researchers secure $10.2 million in NHMRC Investigator Grants

On May 22, 2020 More than $10.2 million dollars in National Health and Medical Research Council (NHMRC) Investigator Grants has been awarded to five QIMR Berghofer scientists to further their cutting-edge research in their respective fields of cancer, infectious diseases and mental health (Press release, QIMR Berghofer Medical Research Institute, MAY 22, 2020, View Source [SID1234558427]).

Investigator Grants are awarded to high-performing researchers at all career stages to allow them flexibility to pursue innovative research and to form collaborations without being restricted to a specific research project.

The grants were announced this week by the Federal Health Minister Greg Hunt.

QIMR Berghofer Senior Scientist and head of the Institute’s Cancer Genetics group, Professor Georgia Chenevix-Trench, was awarded more than $2.73 million to find more genetic risk factors for breast cancer.

Professor Chenevix-Trench has been involved in identifying more than 200 regions of the genome that contain variants that increase breast cancer risk. She will use the five-year grant to try to find the remaining genetic risk factors, explore how they work and what genes they influence, and if the information can be used to find new drug treatments for the disease.

Senior Scientist and head of QIMR Berghofer’s Molecular Parasitology group, Professor Don McManus, received $2.71 million to continue his work in developing new strategies to control and eliminate parasitic worm infections that affect the world’s poorest people.

Senior Scientist and the head of the Institute’s Oncogenomics group Professor Nick Hayward will use his $2.23 million grant to explore genetic approaches to increase survival and find potential cures for melanoma.

The head of the Institute’s Cancer program, Associate Professor Steven Lane, will utilise his $1.91 million grant to find clinical treatments that target genetic changes in patients with blood cancer.

Early career researcher, Dr Luke Hearne, was awarded an Emerging Leader Investigator Grant of $645,205 to investigate how deviations in brain networks give rise to symptoms of psychiatric disorders.

QIMR Berghofer’s Director and CEO, Professor Fabienne Mackay, welcomed the funding.

"These are all outstanding leaders in their research fields and these Investigator Grants will ensure they can continue to help lead health and medical advances for all Australians," Professor Mackay said.

"While a lot of the world’s attention is presently on the COVID-19 pandemic, it’s vital that other potentially life-saving research into other heath conditions and diseases continues as well."

The Investigator grant round is the NHMRC’s largest funding scheme with grants commencing in January 2021.

Luminex Corporation Declares Second Quarter Cash Dividend

On May 22, 2020 Luminex Corporation (Nasdaq: LMNX) (the "Company"), reported that its board of directors declared a cash dividend for the second quarter of 2020 of $0.09 per share of common stock payable on July 9, 2020 to stockholders of record as of the close of business June 18, 2020 (Press release, Luminex, MAY 22, 2020, View Source [SID1234558424]).

Nektar Therapeutics Announces Publication of Results from Phase 1 Dose-Escalation Study for Bempegaldesleukin Plus Nivolumab in ‘Cancer Discovery’ Journal

On May 22, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported the publication of Phase 1 clinical data for its lead immuno-oncology candidate, bempegaldesleukin (BEMPEG: NKTR-214) in combination with nivolumab, in Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Nektar Therapeutics, MAY 22, 2020, View Source [SID1234558423]). Previously published Phase 1 data in Cancer Discovery on BEMPEG, a CD122-preferential IL-2 pathway agonist, demonstrated that when administered as a monotherapy, it was well tolerated and showed clinical activity, including tumor shrinkage and durable disease stabilization, in heavily pretreated patients with solid tumor cancers.1 The manuscript published today presents the safety, immune-activation and efficacy results from a Phase 1 dose-escalation study conducted in 38 patients with immunotherapy-naïve, advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

This manuscript, entitled "Bempegaldesleukin (NKTR-214) Plus Nivolumab in Patients With Advanced Solid Tumors: Phase 1 Dose-Escalation Study of Safety, Efficacy & Immune Activation (PIVOT-02)," is published online and can be accessed here View Source

Dr. Adi Diab, lead author, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center noted: "Our data show that BEMPEG, in combination with nivolumab, increases T-cell infiltration into the tumor microenvironment and increases PD-L1 expression on-treatment, leading to very encouraging response rates. Of equal importance, our data did not show an increase in the inflammatory T-cell subtype Th-17, which is known to play a crucial role in mediating the typical checkpoint inhibitor immune-related adverse events. In other words, BEMPEG in combination with nivolumab is well tolerated and induces meaningful tumor and immune responses in solid tumors, such as melanoma, RCC, and NSCLC."

Dr. Daniel C. Cho, Associate Professor at NYU Grossman School of Medicine, Phase 1 clinical trial director at NYU Langone Health’s Perlmutter Cancer Center, one of the co-senior authors on the study, added: "While checkpoint inhibitors are effective in several tumor types, only a subset of patients derive durable response; the combination of BEMPEG plus nivolumab not only demonstrated encouraging clinical activity irrespective of baseline PD-L1 status, across tumor types, but it also deepened with additional cycles of treatment and in many cases is maintained off treatment."

Key findings are summarized below:

Established the recommended Phase 2 dose (RP2D) of BEMPEG 0.006 mg/kg q3w plus nivolumab 360 mg q3w
AEs were manageable and generally transient and reversible
Combination of BEMPEG plus nivolumab increased absolute numbers and proliferation of CD8+ T- and NK cells in the peripheral blood, and increased expression of genes relating to immune activation in the tumor microenvironment, including the genes encoding the interferon gamma inflammatory response to PD-L1
BEMPEG plus nivolumab demonstrated encouraging ORRs across multiple tumor types, independent of baseline PD-L1 expression. These responses continued to deepen over time
Total ORR was 59.5%, CR was 18.9%, and DCR 83.8%
ORR in PD-L1+ and PD-L1- patients was respectively 64.7% and 50.0%
Among the 22 patients with confirmed objective responses, median TTR was 1.9 months (range 1.3-7.8) and median DOR was not reached
"These PIVOT-02 data further demonstrate the scientific and clinical rationale for combining BEMPEG with nivolumab for a range of advanced solid tumors. We are excited that this combination is now being developed in several ongoing Phase 2 and 3 registration trials. We look forward to the continued development of this promising combination treatment regimen," remarked Dr. Jonathan Zalevsky, Chief Research & Development Officer of Nektar Therapeutics.

BEMPEG in combination with nivolumab is being evaluated in multiple clinical trials including metastatic melanoma (NCT03635983), muscle-invasive bladder cancer (NCT04209114), metastatic cis-ineligible urothelial cancer (NCT03785925) and metastatic renal cell carcinoma (NCT03729245).

Seneca Biopharma Announces Pricing of $5 Million Registered Direct Offering Priced At-the-Market

On May 22, 2020 Seneca Biopharma, Inc. (Nasdaq:SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 5,000,000 shares of the Company’s common stock, at a purchase price of $1.00 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Seneca Biopharma, MAY 22, 2020, View Source [SID1234558422]). The closing of the offering is expected to occur on or about May 27, 2020, subject to the satisfaction of customary closing conditions.

The gross proceeds to the company are expected to be approximately $5 million, prior to deducting placement agent fees and estimated offering expenses. Seneca intends to use the net proceeds from the offering for general working capital.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The shares of common stock are registered pursuant to a registration statement on Form S-3 (File No. 333-218608) which became effective by the Securities and Exchange Commission (SEC) on June 23, 2017. The offering will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.