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Tyme Technologies to Present at H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020

On September 2, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that its leadership will participate at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 (Press release, TYME, SEP 2, 2020, View Source [SID1234564337]). The Company will present its corporate overview for 2020 with a special focus on multiple growth opportunities driven by advances in the science of cell metabolism, SM-88 (racemetyrosine) pivotal and late-stage trials in pancreatic cancer, SM-88 HopES trial in ultra-rare metastatic sarcoma, proof-of-concept RESPOnD trial evaluating TYME-19 in COVID-19, and expanding clinical plans for its cancer-metabolism pipeline candidate SM-88 in pancreatic, prostate, breast and hematological cancers.

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Event: H.C. Wainwright 22nd Annual Global Investment Conference
Presentation Date: Tuesday, September 15, 2020
Presentation Time: 9:30 AM ET

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-19

TYME-19 is a potent, well characterized synthetic antiviral bile acid that is being evaluated as a potential oral therapy for COVID-19. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity in treated cells.

COVID-19 hijacks a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. COVID-19 accomplishes this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables the virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress. TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

Humanigen to Present at Upcoming Investor Conferences

On September 2, 2020 Humanigen, Inc., (HGEN) ("Humanigen"), reported that Cameron Durrant, MD, MBA, Chief Executive Officer, Dale Chappell, MD, MBA, Chief Scientific Officer, and Timothy Morris, Chief Operating and Financial Officer of Humanigen will present company overviews and business updates at the following upcoming investor conferences (Press release, Humanigen, SEP 2, 2020, View Source [SID1234564336]):

LD Micro 500 Conference at 2:20 p.m. on Thursday, September 3, 2020
Baird’s 2020 Global Healthcare Conference at 3:45 p.m. on Wednesday, September 9, 2020
H.C. Wainwright 22nd Annual Global Investment Conference at 9:30 a.m. ET on Wednesday, September 16, 2020
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 10:50 a.m. on Wednesday, September 23, 2020
The conferences are being held in a virtual format. Webcast information for these events will be available on the Humanigen’s investor page at View Source Archived replays will be available on the Company website for 30 days following each event.

THE APTORUM GROUP ANNOUNCES NEW POSITIVE RESULTS ON SACT-1 AGAINST NEUROBLASTOMA AND OTHER TYPES OF POTENTIAL TUMORS

On September 2, 2020 Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group"), a biopharmaceutical company specializing in the development of new therapies, particularly for orphan diseases and oncological indications, reported new positive results from its latest in vivo studies showing significant activity against neuroblastoma tumor reduction when treated with its lead compound, SACT-1, in combination with standard chemotherapy therapy (SOC) (Press release, Aptorum, SEP 2, 2020, View Source [SID1234564334]).

Separately, SACT-1 has also been studied for its in vitro activity against over 300 cancer cell lines and has shown positive results in a number of types of cancer including colorectal cancer, leukemia and lymphoma, etc. .

Our repositioned drug candidate, SACT-1, is in the preparation phase with a view to regulatory filing of an IND (Investigational New Drug) file with a view to considering the start of phase Ib / IIa clinical trials according to the 505 procedure ( b) (2) of the US FDA.

" Neuroblastoma is one of the most common solid cancer in children, representing 8 to 10% of all childhood tumors, about 15% of all cancer deaths in children 1 . For the high-risk group of patients, the 5-year survival rate for this disease is approximately 40-50%, as observed by the American Cancer Society 2 based on existing treatment. We are very happy to see the progress of our SACT-1, one of our first active ingredients from our SMART-ACT platform.. We are pleased to observe the significant effect of SACT-1 on tumor reduction when used in combination with standard chemotherapy in our latest in vivo studies. In addition, we believe that SACT-1 may have potential applications in a number of other types of cancer, including non-orphan cancers, which we will continue to study further for their wider application , "said Dr Clark. Cheng, Medical Director and Executive Director of the company.

The summary of our in vivo assessment against neuroblastoma and our in vitro assessment against other cancers is discussed below.

Assessment of neuroblastoma in vivo

Based on initial data from a recent study we conducted in a mouse model of neuroblastoma using a xenograft model, SACT-1 was administered orally daily at 60 mg / kg in combination with standard chemotherapy treatment (SOC), which resulted in statistically significant tumor reduction (unpaired student t-test, p <0.01) from day 15 to 22, compared to the control group who received treatment only standard (SOC) by chemotherapy. This is because the combination reduced tumor size by up to 54.2% in the first 22 days compared to the control group (SOC only). The combination of SACT-1 appears to be effective in accelerating effect of SOC in the early stages (day 1 to day 7 compared to the control group). This confirms our previous conclusions that SACT-1 is effective in accelerating the effect of SOC in the early stages (day 1 through day 7 compared to the control group). Which further reinforces our previous observationin vitro showing that SACT-1 promotes tumor DNA damage and tumor cell death.

Assessment of other types of cancer in vitro

In addition, the activity of SACT-1 was also examined in vitro in a panel of more than 300 cancer cell lines. As in our previous findings on neuroblastoma cell lines, SACT-1 exhibits similar anti-tumor efficacy for one or more other important cancer types, including, but not limited to colorectal cancer, leukemia, and cell lines. cell lymphoma. Therefore, besides treating neuroblastoma, SACT-1 may have potential applications in the treatment of other cancers. Based on this finding, the company plans to continue in vivo studies on the efficacy of SACT-1 against other types of cancers aimed at maximizing the potential of SACT-1.

About SACT-1

As part of Aptorum Group’s SMART-ACT platform, SACT-1 was discovered on our SMART-ACT platform focused on untreated orphan diseases. SACT-1 is a repositioned drug intended for the treatment of neuroblastoma (and potentially other types of cancer), particularly in combination with standard treatment (SOC) with chemotherapy. The mechanism of SACT-1 has been shown in vitro to improve DNA damage and tumor cell death.

Treadwell Announces Initiation of Patient Dosing in TWT-101, a Phase 1/2 Study of HPK1 Inhibitor, CFI-402411, in Patients with Solid Tumors

On September 2, 2020 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel small molecule therapeutics for highly aggressive cancers, reported the initiation of patient dosing in TWT-101, its Phase 1/2 study to evaluate its third therapeutic candidate, CFI-402411, an oral, first-in-class inhibitor of hematopoietic progenitor kinase 1 (HPK1) in patients with solid tumors as a monotherapy or in combination with PD1 pathway blockade (Press release, Treadwell Therapeutics, SEP 2, 2020, View Source [SID1234564330]). Dosing of the first patient in the trial commenced August 25th with Sarah Cannon Research Institute at Tennessee Oncology, Nashville TN, with Dr. Johanna C. Bendell, MD, as Investigator.

"The dosing of the first patient with our first-in-class, highly-potent, oral HPK1 inhibitor is an important milestone for Treadwell as HPK1 represents a novel, orally-targetable node of therapeutic intervention in the immune-oncology space," said Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder. "Preclinical studies have demonstrated CFI-402411’s promise as a potential monotherapy and in combination with existing checkpoint inhibitors in a wide array of solid and haematological cancer models. We look forward to continuing to explore the possibility of this novel agent as a treatment option in patients with solid and haematological cancers."

This Phase 1/2 clinical trial of CFI-402411, an oral immunomodulatory kinase inhibitor with potent activity toward HPK1, is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CFI-402411, as well as to determine optimal dosing as a monotherapy and in combination with the anti-PD1 antibody, pembrolizumab. The trial will enroll approximately 170 patients at up to 20 sites in North America and Asia. It will involve 5 arms including monotherapy and combination dose escalation and expansion in a variety of tumor types, as well as biomarker backfills.

CFI-402411 is a highly potent inhibitor of HPK1, which in preclinical studies has been shown to have an immune-activing effect including the alleviation of inhibition of T cell receptors (TCR), disruption of abnormal cytokine expression, alteration of the tumor immunosuppressive environment through effector cells (i.e. Regulatory T cells or Treg), and potent anti-leukemic effects in several mouse models.

Merck Places Hybrid Bond Amounting to €1.0 billion

On September 2, 2020 Merck, a leading science and technology company, reported that successfully placed a hybrid bond amounting to €1.0 billion (Press release, Merck & Co, SEP 2, 2020, View Source,coupon%20of%201.625%20%25%20payable%20annually. [SID1234564329]). The placement has a maturity of 60 years with an early redemption option for Merck after six years and a coupon of 1.625 % payable annually. In addition to the new issue, Merck also announced a cash tender offer to repurchase an outstanding hybrid bond with an amount of up to €1.0 billion. This maturing hybrid bond has a first call date in June 2021.

"The early refinancing of the upcoming €1.0 billion hybrid redemption next year in combination with the tender offer is in line with our prudent financial policy. It also reinforces our commitment to hybrid capital as part of our toolkit to maintain a strong balance sheet," said Marcus Kuhnert, Member of the Executive Board and Chief Financial Officer.

Receiving equity credit treatment from all three rating agencies Moody’s, Scope Ratings and Standard & Poor’s, the new hybrid bond, like the outstanding bond, supports Merck’s credit rating. The bond is equal in rank to the existing hybrid bonds and subordinated to all of Merck’s other existing financial liabilities.

The bond issued today achieved a well-diversified distribution among a wide range of institutional investors such as fund managers, insurance companies, pension funds, and banks and was significantly oversubscribed. Active bookrunners of the transaction were Barclays, BNP Paribas and Société Générale.

Merck is rated "A" (stable outlook) by Standard & Poor’s, "A–" (stable outlook) by Scope and "Baa1" (stable outlook) by Moody’s.