On May 14, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that management team members will be attending and presenting at Bio€quity Europe (17-19 May) (Press release, Mission Therapeutics, MAY 14, 2021, View Source [SID1234579981]).

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Anker Lundemose, CEO, David Luther, CFO, and Paul Wallace, CBO, will attend the digital event and will be available for partnering meetings. Mission’s corporate presentation is available to all delegates via the partneringONE digital event platform.

In addition, Anker will present on 19 May at 10:00 CET as part of the 10th CEO Workshop: Hiring and Team Building in the Age of COVID. The workshop will explore how best practices for hiring A-list talent have evolved during the pandemic, including what is expected to be the long-term impact. The panel will also discuss how they have kept their teams motivated and productive over the past year.

Bio€quity Europe Digital is an international networking platform that enables financial dealmakers and biopharma executives to meet rising biotechs. Industry leaders will debate the big questions framing the future of biopharma innovation and identify where Europe will continue to be a global leader. The three-day virtual event will include strategic panels focused on ‘Europe’s Next Act’ and will support one-to-one virtual meetings, with over 130 corporate presentations available from European and Asian biotechs.

On May 14, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal third quarter ended March 31, 2021 and provided a corporate update (Press release, Kintara Therapeutics, MAY 14, 2021, View Source [SID1234579980]).

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Fiscal Third Quarter Highlights and Recent Developments

Commenced patient recruitment of Kintara’s VAL-083 arm of the glioblastoma multiforme (GBM) AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our CMBC Phase 3 trial for CMBC patients.

Extended calendar year cash runway from previously announced Q4 2021 to Q2 2022 primarily due to the exercise of previously issued warrants as well as operational and resource synergies realized through the Adgero acquisition.

Enhanced corporate and scientific leadership teams with appointments of Tamara A. Seymour to the Board of Directors and Dr. Mario Lacouture to the Scientific Advisory Board with an initial focus on CMBC.

Completed patient enrollment of the recurrent arm of the Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) for GBM patients who have been pre-treated with temozolomide prior to disease recurrence.

Presented positive data updates at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from the ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.
"As we head into the final fiscal quarter of 2021, we continue to make steady progress on our late-stage clinical pipeline, as well as making valuable additions to our leadership and advisory teams, and continuing to secure our foothold as a leader in oncology indications with clear unmet medical needs," commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. "Commencing VAL-083’s enrollment in the GBM AGILE registrational study was a significant milestone during the period, along with continued progress with both of our ongoing Phase 2 clinical trials, of which the MD Anderson study is anticipated to report topline results in the second quarter of calendar 2021."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 THIRD QUARTER ENDED MARCH 31, 2021

At March 31, 2021, the Company had cash and cash equivalents of approximately $15.7 million. The cash and cash equivalents at March 31, 2021 are expected to be sufficient to fund the Company’s planned operations into the second quarter of calendar year 2022.

For the three months ended March 31, 2021, the Company reported a net loss of approximately $6.6 million, or $0.23 per share, compared to a net loss of approximately $2.0 million, or $0.17 per share, for the three months ended March 31, 2020. For the nine months ended March 31, 2021, the Company reported a net loss of approximately $31.6 million, or $1.47 per share, compared to a net loss of approximately $5.3 million, or $0.52 per share, for the nine months ended March 31, 2020. The increase in loss for the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.

On May 14, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of an investigational hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it will present new clinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) in an oral presentation at the 2021 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually on May 11-14, 2021 (Press release, Genenta Science, MAY 14, 2021, View Source [SID1234579979]).

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The data presented at ASGCT (Free ASGCT Whitepaper) are from Genenta’s ongoing trial of Temferon in patients with GBM. The presentation focuses specifically on patients who have undergone a follow-up surgical procedure for their cancer. In addition to being a treatment option, follow-on surgery provides investigators with an opportunity to understand the impact of therapies at a cellular and molecular level.

The ASGCT (Free ASGCT Whitepaper) presentation shows that genetic markers of Genenta’s Temferon were detectable in tumor specimens from all four patients with progressive disease who underwent follow-on surgery. Furthermore, the expression of interferon- (IFN) responsive gene signatures in those tumors was increased compared with pre-treatment levels, which suggests that interferon-α (IFN-α) had been released locally in the tumor by cells derived from Genenta’s investigational treatment.

Carlo Russo, Chief Medical Officer at Genenta Science, said: "These preliminary results provide exciting indications that Temferon acts in the way we anticipated even in the relatively inaccessible setting of glioblastoma multiforme. The data are encouraging and in line with our pre-clinical results, with early evidence that Temferon delivers biological effects that may impact the progression of individual lesions."

One of the four patients had two lesions removed at the second surgery; one was a prior lesion that had not been removed during the first surgery and was stable; the other was a relapsing progressing lesion that had developed at the first surgery site. Compared with the progressing tumor, the stable lesion displayed a higher proportion of T cells and Tie2 Expressing Monocytes (TEMs) within the myeloid infiltrate and had a higher IFN-response signature.

The data presented at ASGCT (Free ASGCT Whitepaper) also supported the initial safety and tolerability profile of Temferon. Concentrations of IFN-α in the plasma and cerebrospinal fluid of patients remained low, while IFN-α responses were identified in myeloid cells that infiltrate tumors. Temferon-derived differentiated cells also persisted in peripheral blood and bone marrow for up to 18 months at lower levels, indicating the potential durability of the intervention. No dose limiting toxicities have been identified.

Presentation Details:

Title: Changes in the Tumor Microenvironment in Patients with Glioblastoma Multiforme Treated with IFN-a Immune Cell & Gene Therapy (TEM-GBM_001 Study)

Time: Friday May 14, 2021 at 1.30 PM Eastern Time (7.30 PM CET)

Presenting: Carlo Russo, CMO

On May 14, 2021 Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, reported that it has agreed to issue bonds with an aggregate principal amount of USD 1.5 billion across two tranches (Press release, Fresenius, MAY 14, 2021, View Source [SID1234579978]):

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USD 850 million bonds with a maturity in December 2026 and an annual coupon of 1.875% and
USD 650 million bonds with a maturity in December 2031 and an annual coupon of 3.000%.
The proceeds will be used for general corporate purposes, including the refinancing of outstanding indebtedness.

The expected settlement date is May 18, 2021.

On May 14, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and the National Cancer Center Japan (Headquarters: Tokyo, President: Hitoshi Nakagama, "National Cancer Center") reported that both parties have entered into a joint research and development (R&D) agreement concerning "Basic research on the drug discovery and development to accelerate development of anticancer drugs in treatment of patients with rare cancers and refractory cancers", and that research activities have commenced (Press release, Eisai, MAY 14, 2021, View Source [SID1234579977]). This R&D project is to be carried out with funding under the program "Cyclic Innovation for Clinical Empowerment (CiCLE)" established by the Japan Agency for Medical Research and Development (AMED).

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Rare cancer is a disease for which it is difficult for pharmaceutical companies to develop new drugs solo due to the extremely small number of patients, and there are only a limited number of drugs for rare cancers that can be approved for manufacturing and marketing. Also, among certain types of cancer with a large number of patients, refractory cancers, for which standard treatment has not been established, face barriers to creating new drugs due to difficulty of research and development. In order to promptly deliver effective treatments to patients with rare or refractory cancers, it is essential to provide predictability of clinical outcomes with high accuracy and efficiency in non-clinical research that confirms in advance the effectiveness of the drug, to transfer seamlessly non-clinical research to clinical studies, and moreover to elucidate the mechanism of drug resistance, actual therapeutic effects and side effects. Both parties aim to realize these capabilities in this R&D project using Patient-Derived Xenografts (PDX) library, a model in which cancer tissue derived from patients is transplanted into immunodeficient mice with high predictability of clinical outcomes, as well as cancer genome data.

Eisai is advancing the research and development of new anticancer drugs, targeting cancer genomics and the tumor microenvironment, with its experience and knowledge from globally approved in-house discovered compounds: microtubule dynamics inhibitor eribulin mesylate (product name: Halaven) and multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product names: Lenvima).

The National Cancer Center is a leading institution in basic research, epidemiological research, and clinical studies for all cancer types including rare cancers in Japan. As of May 2020, with a grant from AMED CiCLE, the National Cancer Center has established a large-scale PDX library,"J-PDX", derived from Japanese cancer patients with information on clinical outcomes, and has also completed the development of research infrastructure and framework. More than 410 types of PDX, including rare cancers and refractory cancers, have already been established in J-PDX (as of March 2021).

In research and development under the agreement, Eisai and the National Cancer Center will jointly conduct tumor-agnostic non-clinical research on new drug candidates created by Eisai, using J-PDX with relevant clinical and biological information, and will determine the drugs and the target cancer types to be transferred to clinical studies. After that, investigator-initiated studies will be conducted for rare cancers and refractory cancers in order to confirm clinical benefits of these new drugs, with the aim to apply for approval of them. Further, both parties will consider expanding into new drug discovery research, with establishment of PDX with tumor tissues taken from patients before and after treatment, comparative analyses of drug responsiveness and cancer genome, as well as search for new drug discovery targets and elucidation of drug resistance mechanisms. Through these efforts, both parties aim to establish a drug discovery and development research system that accelerates the development of new anticancer drugs in Japan.

Through research and development based on the agreement, Eisai and the National Cancer Center will work to develop therapeutic drugs for rare cancers and refractory cancers with high unmet medical needs, thereby aiming to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.