On July 21, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that its leadership will participate at the Canaccord 40th Annual Growth Conference on Thursday, August 13, 2020 (Press release, TYME, JUL 21, 2020, View Source [SID1234562191]). The Company will present its corporate overview for 2020 with a special focus on multiple growth opportunities driven by advances in the science of cancer metabolism, pivotal and late-stage trials in pancreatic cancer, clinical trial in ultra-rare metastatic sarcoma and expanding clinical plans for its lead candidate SM-88 (racemetyrosine) in pancreatic, prostate, breast and hematological cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Event: Canaccord Virtual 40th Annual Growth Conference
Presentation Date: Thursday, August 13, 2020
Presentation Time: 3:00PM ET

The presentation will be accessible on the events page under the investor relations section of Tyme Technologies’ website at www.tymeinc.com. There are no planned webcasts for this event.

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-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.

On June 21, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported a poster presentation at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting being held virtually on August 17-19, 2020 (Press release, Cellectar Biosciences, JUL 21, 2020, (Press release, Cytokinetics, JUL 21, 2020, View Source [SID1234562185]) [SID1234562186]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster presentation details:

Poster Title CLR 131 Demonstrates 100% Overall Response Rate in Relapsed or Refractory Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom’s Macroglobulinemia (WM): Initial Results from Ongoing Phase 2 trial, CLOVER-1 Study

A copy of the presentation materials can be accessed on the Events and Presentations section of the Cellectar website once the presentation has concluded.

About CLR 131

CLR 131 is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in r/r multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

About the Phase 2 CLOVER-1 Study

CLOVER-1 is a Phase 2 study of CLR 131 being conducted in 10 leading cancer centers in the United States in patients with relapsed/refractory B-cell hematologic cancers. The hematologic cancers studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma/ Waldenstrom’s macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).

The study can enroll up to 80 patients with its primary endpoint being clinical benefit response (CBR), which is defined as the proportion of MM patients following infusion of CLR 131 with stringent complete response, complete response, very good partial response, partial response and stable disease per International Myeloma Working Group criteria, or the proportion of lymphomas patients (CLL/SLL, LPL, MZL, MCL, and DLBCL) following infusion of CLR 131 with CR, PR and SD per the Lugano classification CT-based response criteria or International Waldenstrom’s Macroglobulinemia Society criteria or the International Chronic Lymphocytic Leukemia criteria. Additional endpoints include overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy. Patients were treated with three different doses (<60mCi single cycle, >60mCi single cycle and >60 mCi multi-cycle total body dose).

The CLOVER-1 Phase 2 study completed the Part A dose-exploration portion conducted in relapsed/refractory (r/r) B-cell malignancies and is now enrolling in the Part B expansion cohorts in relapsed/refractory (r/r) multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM). Part B is evaluating the two cycle dosing of CLR 131 in additional patients. Each cycle is defined as two doses provided 14 days apart (+/- 1 day). Cycle 2 shall be given 8-weeks post the initial infusion. Additional cycles can be considered following an additional 8-week period. The Part A portion of the study met its primary and secondary endpoints with detailed data being announced on February 19, 2020.

Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the study. More information about the study, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

On July 21, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported the closing of its previously announced underwritten public offering of 8,385,417 shares of its common stock at a price to the public of $24.00 per share (Press release, Cytokinetics, JUL 21, 2020, View Source [SID1234562185]). This includes the exercise in full by the underwriters of their option to purchase up to 1,093,750 additional shares of common stock. The gross proceeds to Cytokinetics from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Cytokinetics, were approximately $201.3 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Goldman Sachs & Co. LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co. acted as joint book-running managers for the offering. Barclays Capital Inc. acted as an additional book-running manager for the offering. JMP Securities LLC acted as lead co-manager, and Raymond James & Associates, Inc. and H.C. Wainwright & Co., LLC acted as co-managers.

The securities described above were offered by Cytokinetics pursuant to a shelf registration statement (including a base prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and can be accessed for free on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by phone at (866) 471‐2526 or by email at [email protected]; Piper Sandler & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, New York 10022, or by email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone: 1-888-603-5847.

This press release shall not constitute an offer to sell or the 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 registration or qualification under the securities laws of any such state or jurisdiction.

On July 21, 2020 Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported the launch of the Company with a $32.5M Series A financing, initiation of the Phase 2 CRESTONE study, and new partnerships with Next Generation Sequencing diagnostic providers including Ashion Analytics, Strata Oncology, and Tempus to explore innovative models for real-time identification, patient referral, and enrollment of patients with tumors driven by rare genomic alterations (Press release, Elevation Oncology, JUL 21, 2020, View Source [SID1234562184]). The Series A financing was led by Aisling Capital and a syndicate of investors including Vertex Ventures HC, Qiming Venture Partners USA, Driehaus Capital Management, and BVF Partners.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At Elevation Oncology, we envision a future in which each unique genomic testing result can be matched with a purpose-built precision medicine and bring clarity to the patient treatment journey. Focused drug development paired with open collaboration will be instrumental for our industry to fully realize the potential of precision medicine for all patients with cancer," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "With our lead development program, seribantumab, and the partnerships announced today, we are taking our first steps toward this future."

Seribantumab and the Tumor-agnostic CRESTONE Study

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (ERBB3 or HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner gene to create chimeric NRG1 "fusion proteins."

Seribantumab was acquired in 2019 by Elevation Oncology, and the development program builds on prior clinical experience from over 800 patients demonstrating consistent safety and tolerability. Previous clinical trials with seribantumab did not select for tumors with an NRG1 fusion. The CRESTONE study leverages seribantumab’s rational design with recent discoveries on the significance of the NRG1 gene fusion and improvements in diagnostic sensitivity. Novel preclinical data generated by Elevation Oncology demonstrating the ability of seribantumab to prevent the activation of HER3 signaling in NRG1 fusion models are supportive of CRESTONE and are expected to be released in publications and at scientific conferences later this year.

Although rare, NRG1 gene fusions are oncogenic drivers that can be found in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, and neuroendocrine cancers, and sarcomas. Importantly, NRG1 gene fusions are mutually exclusive with other known driver mutations and are considered a unique oncogenic driver event essential for tumor cell survival. Following recent regulatory approvals of tumor-agnostic treatments associated with oncogenic drivers, CRESTONE is designed as a registration-enabling Phase 2 "basket trial" to evaluate the efficacy and safety of seribantumab in patients with any solid tumor that harbor an NRG1 fusion.

"Genomic testing and matched precision therapeutics are creating a revolution in oncology development and regulatory approval paths," said Lori Kunkel, MD, Chair of the Elevation Oncology Scientific Advisory Board and former Chief Medical Officer LOXO Oncology. "The FDA has recently approved several oncology therapeutics for tumor-agnostic indications. I am encouraged to see the evolution in our understanding of how to achieve better clinical outcomes to address the unmet clinical need among patients with a genomically defined cancer, regardless of its tissue of origin. The CRESTONE study potentially expands the actionability of genomic tests to tumors with an NRG1 fusion and is a promising approach for furthering this genomically-driven tumor-agnostic development pathway."

Innovative Models for Patient Enrollment

Sarah Cannon Research Institute (Sarah Cannon) has been selected as the first strategic site for CRESTONE and is open and enrolling patients today. Sarah Cannon’s world class clinical research leadership and insights as well as additional prospectively selected clinical sites are foundational to ensuring rigorous study conduct.

"Identifying potential driver alterations, such as NRG1 gene fusions, enables us to approach cancer treatment in a more targeted way," said David Spigel, MD, Chief Scientific Officer, Sarah Cannon Research Institute at Tennessee Oncology and one of the investigators of the CRESTONE study. "Today, all cancer patients facing a treatment decision without clear standard of care should consider comprehensive genomic testing for their tumor. Collaborations across the healthcare ecosystem help to ensure that the value of each genomic test is maximized and to expand access to critical treatment opportunities for patients."

Diagnostic partnerships will enhance traditional patient enrollment in the CRESTONE study through real-time, nationwide identification of NRG1 fusion positive patients within the Ashion, Strata Oncology, Tempus, and other partner networks. Through various partnership models, patients may also be enrolled in CRESTONE through active referral to current strategic sites or "just-in-time" site initiation.

These innovative models address specific challenges encountered by genomically-driven, tumor-agnostic trials such as the rarity of genomic driver alterations and the impracticality of comprehensive clinical site coverage by both geography and organ-system of study. In addition, these models may reduce the burden on patients by minimizing the number of diagnostic tests they may need and maximizing the treatment opportunities available to them, regardless of where they may live. Bringing clinical trials to patients using the "just-in-time" site initiation model can further help to minimize travel and keep patients safe in the face of ongoing travel restrictions due to COVID-19.

"With the strong backing of a dynamic and experienced investor syndicate, Elevation Oncology is well positioned to execute on our mission of delivering precision medicines to physicians and their patients with cancer," said Steve Elms, Chairman and Interim Chief Executive Officer of Elevation Oncology and Managing Partner of Aisling Capital. "Our development approach to seribantumab sets the stage for our broader vision: the elevation of precision medicine to the forefront of every patient journey through building a collaborative industry-wide ecosystem. Together with diagnostic developers, clinical researchers, patient advocates, and the Elevation Oncology team, we are looking to build a pipeline of precision oncology medicines that can amplify each other’s efforts towards our shared goal of improving patient outcomes."

On July 21, 2020 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported its consolidated half-year revenue and cash position at June 30, 2020, data that is currently being audited (Press release, Theradiag, JUL 21, 2020, View Source [SID1234562183]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Consolidated H1 2020 revenue of €4.9 million

Over the six months to June 30, 2020, Theradiag generated revenue of €4.9 million, versus €5.0 million in the first half of 2019 highlighting the robustness and quality of the products marketed despite a delicate economic and health situation.

The Theranostics business posted another half of solid growth, with revenue up +16.5%, primarily driven by sales of LISA TRACKER kits in routine use whose sales exceeded €2.4 million in the first half of 2020 (vs. €2.0 million at June 30, 2019). As has been the case for a number of semesters now, the Theranostics represents the Company’s recurring business, thus providing it with enhanced visibility.

The highly degraded context since mid-March 2020, notably with the implementation of the plan blanc emergency plan in French hospitals, disrupted activity in all regions. Nevertheless, Theradiag posted a decent performance in France with particularly satisfactory Theranostics sales of €1.0 million, up 13% compared with the first half of 2019. Activity in the United States generated revenue of €0.4 million, up 42%. In its export business, the Company maintained a highly acceptable level of activity (+10%).

The IVD (In Vitro Diagnostics) activity recorded an 18.6% fall in revenue to €2.4 million at June 30, 2020, compared with €2.9 million in the first half of 2019. This decrease was a result of the impact of the exceptional sales to former partner HOB Biotech recorded in the first half of 2019. Excluding this negative base effect, Theradiag has maintained a level of activity that is in line with its strategy despite the global economic situation.

Cash position

At June 30, 2020, Theradiag had net available cash of €1.7 million, versus €2.9 million at December 31, 2019. This cash position is in line with the Company’s roadmap despite weak second-quarter activity and late payments. Moreover, Theradiag has prepared the necessary paperwork to apply for a State-guaranteed loan.

Bertrand de Castelnau, Theradiag’s CEO, commented: "I’m particularly pleased with the work undertaken by Theradiag’s teams and their unwavering commitment during this turbulent semester. This commitment has enabled us to generate remarkable results in our Theranostics business, which is our strategic priority and is generating increasingly patent recurring performances each semester. As well as these successes in our flagship activity, we have been able to activate the necessary levers to address the diagnostics market within the framework of the battle against the Covid-19 pandemic. Our actions have led to the certification of four CE-marked tests, two of them manufactured by Theradiag. Despite this success, which allows these tests to be marketed in France and abroad, it is important to remain cautious regarding the economic impact of this milestone on our 2020 financial year. We are very closely monitoring the ongoing public health crisis we are facing, we will intensify our efforts to protect our employees and partners, and we will continue to focus on developing our sales, our partnerships and our R&D investments in order to maintain a positive momentum throughout 2020".

Pierre Morgon, Chairman of Theradiag’s Board of Directors, added: "The Theradiag team is continuing to deploy its strategy centering on Theranostics and has already generated a remarkable performance over the last semester despite the tumultuous economic situation. Beyond the half-year growth of our Theranostics activity, the teams have been able to capitalize on the Company’s DNA, innovation, to bolster its technological lead to help patients. Theradiag is still on a positive trajectory and is on course to balance its books again".

Update regarding the impact of the Covid-19 pandemic on Theradiag’s annual activity

Theradiag is continuing to assess the potential consequences of the Covid-19 pandemic on its business and is continuing to put required measures in place for its employees, clients and partners. As of the date of this press release, Theradiag is expecting 2020 revenue to probably be negatively impacted by around 10%, not including the potential effects of new business associated with the Covid-19 tests whose deployment has begun.

Reminder of the main H1 2020 highlights

– February 2020: Theradiag presents excellent results generated by its new i-Tracker kits in its TRACKER range at the ECCO Congress.

– February 2020: THERADIAG helps establish a new WHO international standard for biotherapy monitoring.

– March 2020: THERADIAG announces the CE Marking of the first four i-Tracker test kits in its TRACKER range.

– April 2020: Theradiag commits to fighting Covid-19 and assesses the likely impact on FYR 2020.

– May 2020: Theradiag announces the approval of a first Covid-19 test, ‘RT-PCR’.

– June 2020: Theradiag issues an update on its Covid-19 test activity, and the first Theradiag-labeled tests receive the CE mark.

– July 2020: The University of Tours and Theradiag sign two agreements simultaneously: an exclusive licensing agreement for the production of Covid-19 viral proteins and a global collaboration agreement that could lead to further partnerships in the future.

Next financial press release:

H1 2020 results, on Monday September 21, 2020