On June 12, 2020 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that data from the completed Phase 1 Zella 101 study evaluating the investigational agent alvocidib, a potent CDK9 inhibitor, in adult patients with newly diagnosed acute myeloid leukemia (AML) (Press release, Tolero Pharmaceuticals, JUN 12, 2020, View Source [SID1234561070]). These results were presented in a poster presentation at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress, being held June 11-14, 2020.

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Updated findings from the Phase 1, dose-escalation, safety and biomarker study of alvocidib followed by cytarabine and daunorubicin (7+3) induction therapy showed encouraging clinical activity and a tolerable safety profile in adults with newly diagnosed AML. In the study, 71% (n=22 of 31) of evaluable patients achieved complete remission (CR), with an overall response rate (ORR) of 77% (n=24 of 31). Additionally, an exploratory cohort of the study found that 89% (n=8 of 9) of patients achieved measurable residual disease (MRD)-negativity. At a median of 9.2 months follow-up, overall survival was not reached, with 62% of patients alive at data cut-off.1

The maximum tolerated dose of alvocidib was determined to be 30 mg/m2 IV bolus followed by 60 mg/m2 IV over 4 hours and no dose-limiting toxicities (DLTs) were observed. The most frequently observed treatment-emergent, nonhematologic adverse events of Grade 3 or higher were diarrhea, tumor lysis syndrome and hypocalcemia, which all resolved with supportive care.1

"AML is an aggressive blood cancer which can progress rapidly and remains difficult to treat. We are pleased with the clinical responses, including overall survival, observed in newly diagnosed AML patients treated with alvocidib followed by standard induction therapy. In addition, the high level of MRD-negativity, a meaningful indicator of durable response, is particularly encouraging," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "We are excited to continue the advancement of this program and further investigate the potential role of alvocidib in contributing to a durable complete remission and achievement of MRD-negativity."

Below are the details for the presentation:

Abstract Title

Details

Author

Alvocidib Followed by 7+3 Induction in
Newly Diagnosed AML Achieves High
Rates of MRD-Negative CR: Results of a
Phase 1 Dose Escalation Study

Poster# 551

June 12, 2020

8:30 a.m. CEST

e-Poster Presentation

Joshua F. Zeidner, M.D.,
University of
North Carolina

About Alvocidib

Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in the ongoing Phase 2 Zella 202 study in patients with acute myeloid leukemia (AML) who have either relapsed from or are refractory to venetoclax in combination with azacitidine or decitabine (NCT03969420). Alvocidib is also being evaluated in Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with azacitidine or decitabine (NCT03593915) and in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax (NCT03441555).

About CDK9 Inhibition and MCL-1

MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.2 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.3 MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.2,4 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).5,6 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.5 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.2

On June 12, 2020 Q BioMed (OTC: QBIO) reported that proud to be a Supporter of the Living Beyond Breast Cancer (LBBC) 2020 Virtual Conference on Metastatic Breast Cancer taking place June 13 and 14, 2020 (Press release, Q BioMed, JUN 12, 2020, View Source [SID1234561069]). Over 1,100 patients will be participating in this virtual conference, which has been providing people living with metastatic breast cancer and their families a safe, collaborative space to gather information and discover practical resources they need to make decisions for their physical and emotional health for almost 15 years.

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Sessions will cover the latest medical updates specific to cancer subtype, managing symptoms and side effects, caregiving, resiliency, managing the financial impact of cancer and more. The virtual conference is free. Please visit the conference website to participate https://metsconf.lbbc.org; The Conference tag is #lbbcmetsconf.

"Q BioMed is proud to be a Supporter of this important conference and to provide metastatic breast cancer patients who are living with painful bone metastases information about Strontium89, our recently launched non-opioid drug for the treatment of pain from metastatic cancer in the bone," stated Q BioMed CEO Denis Corin.

As cancer treatment and survival rates improve, bone mets are likely to become more common.[1]Unfortunately, up to 45% of patients with cancer-induced bone pain report poor pain control, and breast cancer is one of the two cancers most likely to metastasize to bone and cause pain.[2]

Studies have shown that breast cancer patients with painful bone mets can respond well to treatment with Strontium89. In the Strontium89 pivotal trial, as many as 79% of patients experienced pain relief with Strontium89, and twice as many patients treated with Strontium89 had no pain for 3 months compared with placebo. New pain sites were less frequent in patients treated with Strontium89[3],[4]. Strontium89 is administered once every 3 months via injection, and patients can be re-treated if needed. Please see Important Safety Information below and learn more at www.Strontium89.com.

INDICATION AND IMPORTANT SAFETY INFORMATION:

INDICATION

Strontium89 (strontium chloride Sr-89 Injection, USP) is used for the relief of bone pain in patients with bone metastases. You should only use Strontium89 if you have been diagnosed with metastatic bone cancer.

Important Safety Information:

Strontium89 may affect bone marrow and may cause white blood cell and platelet counts to be lower than normal. To monitor these effects, your doctor will perform regular blood tests before and after your injection, usually at least every other week until your levels have recovered. This may take up to 6 months. Your doctor will decide if it is safe for you to get a repeat injection, 90 days later, if needed. If you already have seriously decreased bone marrow function, your doctor may decide that you should not receive Strontium89.
Tell your doctor if you are pregnant or planning to become pregnant. Strontium89 may cause harm to your unborn baby and should not be used if you are pregnant or planning to become pregnant. You should not nurse your baby while using Strontium89.
You should not use Strontium89 if you do not have cancer in your bone.
You should not use Strontium89 if you are younger than 18 years old.
You may feel flushed (your skin may get red and warm) right after your injection.
Side effects in clinical studies:
– One patient died from a blood infection caused by a severely low white blood cell count.
– A small number of patients reported a mild and brief increase in bone pain within 36 to 72 hours after injection that was controlled with oral pain medication.
– One patient had chills and fever 12 hours after injection but recovered.
These are not all of the side effects of Strontium89. If you have any questions or concerns about side effects, you should contact your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.

References:

1. Lipton A, Uzzo R, Amato RJ, et al. The science and practice of bone health in oncology: managing bone loss and metastasis in patients with solid tumors. J Natl Compr Canc Netw. 2009;7 Suppl 7:S1-29; quiz S30.

2. Smith HS, Barkin RL. Painful boney metastases. Am J Ther. 2014;21(2):106-130.

3. STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC [package insert]. Angleton, TX: IsoTherapeutics Group, LLC; 2020.

4. Porter AT, McEwan AJB, Powe JE, et al. Results of a randomized phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer. Int J Radiat Oncol Biol Phys. 1993;25(5):805-813.

On June 12, 2020 AbbVie (NYSE:ABBV) reported that it has been notified that TRC Capital Investment Corporation (TRC Capital) has commenced an unsolicited "mini-tender" offer, dated June 1, 2020, to purchase up to 1,500,000 shares of AbbVie common stock at $88.05 per share (Press release, AbbVie, JUN 12, 2020, View Source [SID1234561068]). The offer price is approximately 4.99 percent below the closing price of the AbbVie common stock on May 29, 2020 ($92.67), the last trading day before the date of the offer. AbbVie is not associated in any way with TRC Capital, its mini-tender offer, or the offer documentation.

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AbbVie does not endorse TRC Capital’s offer. This mini-tender offer is at a price below the closing price for AbbVie’s shares (as of the day prior to the offer) and is subject to numerous conditions. AbbVie recommends that shareholders obtain current quotes for the shares, review terms and conditions, and consult with their broker.

AbbVie shareholders who have already tendered may withdraw their shares by providing the written notice described in the TRC Capital offering documents prior to the expiration of the offer, which is currently scheduled at 12:01 a.m. New York City time on June 30, 2020.

AbbVie encourages brokers, dealers, and other investors to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure, which can be found here: View Source

AbbVie requests that a copy of this news release be included with all distribution of materials related to TRC Capital’s offer for shares of AbbVie common stock.

On June 12, 2020 Foundation Medicine, Inc., reported that it has completed the acquisition of Lexent Bio, Inc., a precision oncology company located in California, developing novel multiomics liquid biopsy platforms to advance cancer care (Press release, Foundation Medicine, JUN 12, 2020, View Source [SID1234561067]). This acquisition will accelerate Foundation Medicine’s research and development strategy and expand its existing liquid biopsy platforms to advance cancer care for patients. The technology developed by Lexent Bio complements Foundation Medicine’s existing efforts and partnerships aimed at developing advanced diagnostics for physicians, as well as genomically evaluating disease progression and informing treatment decisions at earlier stages of disease.

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"Lexent Bio’s platforms align well with our liquid biopsy research and development strategy, which ultimately aims to bring the latest research innovations into routine clinical use in metastatic disease and at potentially earlier stages of patient care," said Cindy Perettie, chief executive officer at Foundation Medicine. "They bring with them an accomplished group of clinicians, scientists and engineers who share our patient-centric, science-first mission to transform cancer care. We’re thrilled to welcome them to our team and look forward to their contributions to our research and development efforts to deliver new breakthroughs that advance precision medicine and patient care."

Lexent Bio’s novel monitoring platform is currently in development and is based on low-pass whole genome sequencing (WGS) and DNA methylation analysis. Foundation Medicine plans to further incorporate WGS and methylation into new assay platforms to support treatment decision-making across all stages of disease. Methylation analysis has been shown to reveal important aspects of underlying cancer biology and allows oncologists to identify patients at high risk of disease progression, potentially intervene sooner and improve patient outcomes in earlier stages of disease.1,2 These collective capabilities will enable the expansion of Foundation Medicine’s current tumor-informed personalized cancer monitoring initiatives into universal tumor-agnostic approaches in the future.

This technology adds to Foundation Medicine’s portfolio of tissue and liquid biopsy platforms and will aim to support new approaches for developing targeted therapies, from discovery research through clinical development. With this acquisition and the integration of Lexent Bio’s monitoring platform, Foundation Medicine will expand its capabilities to support adaptive clinical trial designs and accelerate therapeutic development in both early and late stage disease, ultimately bringing new options to oncologists and patients.

"Our team is passionate about changing the way we understand and treat cancer. We’ve spent years building a platform that, once developed and available, will help guide oncologists to identify patients at higher risk for disease progression, and to make better treatment decisions earlier in patient care," said Ken Nesmith, co-founder of and chief executive officer at Lexent Bio. "The team is pleased to join Foundation Medicine and work collaboratively to bring these capabilities to physicians and their patients."

On June 12, 2020 NOXXON Pharma N.V. (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has issued the third and fourth tranche of Convertible Bonds under the financing agreement published on April 23, 2020 (Press release, NOXXON, JUN 12, 2020, View Source [SID1234561066]).

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The investor, Atlas Special Opportunities, LLC, has received 967 Convertible Bonds (including 17 Convertible Bonds issued in relation to the transaction fee) with a nominal value of €1,000 each.

NOXXON maintains an updated summary table of issued convertible bonds in the Investors’ section of its website.

The characteristics, terms, conditions and dilutive potential of the financing may be found in the Annex to the press release published on April 23, 2020 available on the company’s website.