On February 27, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor currently in a Phase 1 clinical trial focused on ovarian and breast cancers, and on SY-5609, its selective oral CDK7 inhibitor that the company has named as its next development candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 29-April 3 in Atlanta (Press release, Syros Pharmaceuticals, FEB 27, 2019, View Source [SID1234533752]).

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!

The presentation on SY-1365 will highlight data showing that alterations in the RB pathway are predictive of response to SY-1365 in patient-derived xenograft models of high-grade serous ovarian cancer, supporting exploration of RB alterations as potential biomarkers of response to SY-1365. The presentation on SY-5609 will describe in vitro and in vivo data on the selectivity, potency and anti-tumor activity of SY-5609 that supported its advancement into investigational new drug application (IND)-enabling preclinical studies.

The abstracts for these presentation are now available online on the AACR (Free AACR Whitepaper) website at View Source

Details on the presentation are as follows:

Presentation Title: Prospective identification of RB pathway alterations predict response to SY-1365, a selective CDK7 inhibitor, in a panel of high-grade serous ovarian cancer (HGSOC) patient derived xenograft (PDX) models
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Nan Ke, Syros
Abstract Number: 4409
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

Presentation Title: SY-5609, an orally available selective CDK7 inhibitor, demonstrates broad anti-tumor activity in vivo
Date & Time: Tuesday April 2, 1:00 – 5:00 p.m. ET
Session Title: Targeting the Cell Cycle: Development of Preclinical Models and Therapeutic Targets
Session Category: Molecular and Cellular Biology/Genetics
Presenter: Shanhu Hu, Ph.D., Syros
Abstract Number: 4421
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 37

On February 26, 2019 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Compugen, FEB 26, 2019, View Source [SID1234533677]).

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!

Compugen also announced a corporate restructuring to reduce costs by consolidating and streamlining R&D operations. Anticipated cost reductions are expected to extend the Company’s cash runway through mid-2020 to enable the planned expansion of the ongoing Phase 1 study for COM701, a first-in-class immunotherapy antibody targeting the PVRIG checkpoint, which continues to progress as planned. In addition, the Company will maintain investment in its proprietary computational discovery platform and will continue to advance its earlier stage immuno-oncology pipeline programs, which are the Company’s two long-term core value drivers.

"2018 was a pivotal year for Compugen in which two clinical trials were initiated for our computationally-discovered immuno-oncology programs, COM701 and BAY 1905254, and we partnered with Bristol-Myers Squibb and AstraZeneca," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "After reaching these important inflection points in our corporate development, the management team and Board undertook a strategic review of the Company’s operations and cost structure to ensure effective use of capital in support of the Company’s long-term objectives.

"This restructuring will allow us to focus the necessary resources to execute the COM701 study, including the initiation of combination studies with Opdivo. Of equal importance is the decision to consolidate and streamline our R&D infrastructure and continue investing in our two long-term core value drivers. These difficult decisions are necessary to effectively use our capital to ensure our future growth and the achievement of our strategic objectives. We will implement these organizational changes with the utmost respect for our employees, who I thank for their dedication and significant contributions made to our organization."

Corporate Restructuring
The restructuring includes:

Consolidation of R&D activities in one location (Israel). Positions and operations eliminated will also reduce overlapping R&D and G&A activities in Israel and the United States;

A 35% workforce reduction (approximately 35 employees), the majority of which is in R&D;

Certain preclinical activities will be outsourced to third-party service providers;

IND filing for COM902 in 2019 will proceed as planned. Initiation of the Phase 1 trial for this program will be dependent on the drug combination trials pursued under the collaboration with Bristol-Myers Squibb as well as available resources to support this trial;

Clinical development and business development activities will continue to operate in the United States; and

Compugen anticipates savings of up to $10 million on an annual basis. Cash expenditures for 2019 including one-time restructuring related costs, are expected to be in the range of $27 to $29 million, with the full effect of the savings reflected in 2020.

Recent Corporate Highlights

Published two peer-reviewed papers in Cancer Immunology Research demonstrating the role of PVRIG as a novel immune checkpoint target for cancer immunotherapy;

Awarded U.S. patent No. 10,124,061 from the U.S. Patent and Trademark Office for the method of using COM902, an anti-TIGIT monoclonal antibody, for activating T cells in cancer patients under the Cancer Moonshot program;

Signed a clinical trial collaboration with Bristol-Myers Squibb for a Phase 1 combination study of COM701 and Opdivo;

Received a $12 million investment from Bristol-Myers Squibb as part of the collaboration;

Initiated the COM701 monotherapy dose escalation Phase 1 clinical trial in advanced solid tumor patients; and

Bayer initiated a Phase 1 study for BAY 1905254, its first-in-class therapeutic antibody program targeting ILDR2, computationally-discovered by Compugen.

Financial Results
Revenues for the year ended December 31, 2018 were $17.8 million, compared with $0 in the comparable period of 2017. The revenues for 2018 reflect the upfront payment of $10 million from the license agreement with AstraZeneca and the $7.8 million milestone payment from Bayer AG in connection with the dosing of the first patient in the Phase 1 study of BAY 1905254.

R&D expenses for the fourth quarter and year ended December 31, 2018 were $7.5 million and $30.3 million, respectively, compared with $7.2 million and $28.6 million for the comparable periods in 2017. The increase reflects the expenses associated with the ongoing Phase 1 study of COM701.

Net loss for the fourth quarter of 2018 was $9.4 million, or $0.16 per diluted share, compared with a net loss of $9.3 million, or $0.18 per diluted share, in the comparable period of 2017. Net loss for the year ended December 31, 2018 was $22.6 million, or $0.41 per diluted share, compared with a net loss of $37.1 million, or $0.72 per diluted share, for the year ended December 31, 2017.

As of December 31, 2018, cash, cash related accounts, short-term and long-term bank deposits totaled $45.7 million, compared with $30.4 million at December 31, 2017. The Company has no debt.

Based on current cash and anticipated savings resulting from restructuring activities, the Company expects its cash runway to extend through mid-2020, not including potential cash inflow from existing or new business development arrangements.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its fourth quarter and full year 2018 results today, February 26, 2019, at 8:30 a.m. ET. To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0610 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On February 26, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage company developing novel epigenetic therapies, reported fourth quarter and full year 2018 financial results (Press release, Epizyme, FEB 26, 2019, View Source [SID1234533693]).

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!

"We made tremendous progress last year, leading into what is poised to be one of our most meaningful and value-creating years as a company in 2019, with two successive NDA submissions planned for tazemetostat and a robust clinical expansion strategy," said Robert Bazemore, president and chief executive officer of Epizyme. "Following our meeting with FDA late last year, we are confident in the submission path for accelerated approval for all patients with follicular lymphoma, regardless of EZH2 mutation status, who have been previously treated with two or more therapies. We believe tazemetostat, based on its ongoing safety and efficacy data, would be well-suited to address the unmet need and treatment goals for patients with this indolent disease. Our first NDA submission for tazemetostat for epithelioid sarcoma remains on track to be submitted in the second quarter, and if successful, would make tazemetostat the first commercially available EZH2 inhibitor and the first treatment specifically indicated for epithelioid sarcoma patients. We look forward to submitting both regulatory applications so that we may bring tazemetostat to patients who need it."

2019 Tazemetostat Program Outlook

Tazemetostat NDA Submission for Epithelioid Sarcoma (ES) on Track for Second Quarter: Epizyme is well underway with its preparations to submit its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat for patients with ES in the second quarter of 2019 based on the ongoing Phase 2 study. ES is an ultra-rare and difficult-to-treat sarcoma with no specifically indicated FDA-approved therapies today. If approved, tazemetostat could be the first treatment specifically indicated for patients with ES and could enhance regulatory efficiencies of future tazemetostat submissions for additional indications. The company anticipates reporting updated data from the Phase 2 study at a medical meeting in mid-2019.
NDA Submission Planned for Fourth Quarter for All-Comer Follicular Lymphoma (FL) Population Based on Fully Enrolled Study: In late 2018, Epizyme met with the FDA to review its planned registration strategy for tazemetostat for patients with FL who have been previously treated with two or more systemic therapies. Based on this interaction, the company has identified a path to a submission for accelerated approval for FL patients with EZH2 activating mutations and those with wildtype EZH2, based on the ongoing, fully enrolled Phase 2 study. The company anticipates reporting updated data from the study at a medical meeting in mid-2019 and submitting an NDA for accelerated approval for this patient population in the fourth quarter of 2019.
Plans Established to Expand Tazemetostat into Earlier FL Treatment Settings: Epizyme is planning to initiate a combination study in mid-2019 of tazemetostat with the chemo-free treatment regimen "R2" (Revlimid plus Rituxan) for the treatment of patients with relapsed/refractory FL who have received at least one prior therapy. The company is also finalizing plans for a trial of tazemetostat in combination with Rituxan for the treatment of patients with relapsed/refractory FL. Further, Epizyme is exploring the opportunity to expand the combination assessment of tazemetostat with R-CHOP into front-line, high-risk patients with FL.
Studies in Prostate Cancer and Platinum-Resistant Solid Tumors to Begin in 2019: Based on strong scientific rationale, as well as research and biomarker data, Epizyme anticipates initiating a combination study in patients with castration-resistant prostate cancer in mid-2019, followed by a combination study with a PARP inhibitor in patients with platinum-resistant solid tumors, such as small-cell lung cancer, triple-negative breast cancer and ovarian cancer, in the second half of 2019.
Pipeline Progress

EZM8266 on Track to Begin Clinical Development: Following the completion of IND-enabling studies, the company is on track to begin clinical development of its first-in-class G9a inhibitor, EZM8266, for the treatment of sickle cell disease in the second half of 2019 with a dose-finding and safety study.
Two Research Programs to Be Advanced under Boehringer Ingelheim Collaboration: In November 2018, Epizyme entered a strategic collaboration with Boehringer Ingelheim focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer. Specifically, these targets are enzymes within the helicase and histone acetyltransferase (HAT) families. The company received an upfront payment of $15 million and will receive an additional $5 million in research funding in 2019. Epizyme is eligible to receive a total of up to $280 million in additional payments for research, development, regulatory and commercial milestones.
Milestone Payment Earned from GSK: In December 2018, Epizyme earned an $8 million milestone payment from its partner GlaxoSmithKline (GSK) following initiation of patient dosing in a Phase 1 clinical trial of GSK3368715, a first-in-class protein arginine methyltransferase1 (PRMT1) inhibitor discovered by Epizyme and the second program to enter the clinic under the collaboration. The company has earned an aggregate of $89 million in up-front, research and milestone payments to date, and may earn up to an additional $375 million from GSK if all remaining milestones are met.
Financial Guidance

Based on current operating plans, Epizyme expects its current cash runway to extend into the second quarter of 2020.
Fourth Quarter and Full Year 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $240.3 million as of December 31, 2018, as compared to $276.4 million as of December 31, 2017. The decrease is primarily due to operating expenditures for the year off set by milestones received through collaborations and the company’s public offering of common stock that closed in October 2018.
Revenue: Collaboration revenue for the fourth quarter of 2018 was $9.7 million and $21.7 million for the full year ended December 31, 2018, compared to no revenue for the fourth quarter of 2017 and $10.0 million for the full year ended December 31, 2017. The increase in annual collaboration revenue is due to the company’s collaboration with Boehringer Ingelheim, which was initiated in November 2018, and a milestone payment earned from GSK for the initiation of clinical development of a PRMT1 inhibitor discovered at Epizyme.
R&D Expenses: Research and development (R&D) expenses were $21.8 million for the fourth quarter of 2018 and $105.8 million for the full year ended December 31, 2018, compared to $28.9 million for the fourth quarter of 2017 and $109.7 million for the full year ended December 31, 2017. The reductions in expenses are primarily due to decreases in our discovery research expenses and decreases in clinical trial expenses, offset by greater tazemetostat manufacturing costs.
G&A Expenses: General and administrative (G&A) expenses were $12.2 million for the fourth quarter of 2018 and $44.0 million for the full year ended December 31, 2018, compared to $8.4 million for the fourth quarter of 2017 and $37.2 million for the full year ended December 31, 2017. The increase is primarily due to an rise in medical affairs and commercial costs as a result of organizational development in preparation for tazemetostat commercialization.
Net Loss: Net loss was $22.9 million, or $0.29 per share, for the fourth quarter of 2018 and $123.6 million, or $1.72 per share, for the full year ended December 31, 2018, compared to was $36.2 million, or $0.52 per share, for the fourth quarter of 2017 and $134.3 million, or $2.18 per share, for the full year ended December 31, 2017.
Conference Call Information
Epizyme will host a conference call today, Feb. 26, at 8:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 1088195. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast and slides will be archived for 60 days following the call and presentation.

On February 26, 2019 Immunomic Therapeutics, Inc. reported that its’ Senior Vice President and Co-Founder, Teri Heiland, Ph.D., will participate in the closing plenary on Innovation and Technology in Healthcare at the Congressional Hispanic Caucus Initiative (CHCI) Health Summit on March 14, 2019 at 2:00 pm EST at the Newseum, Knight Conference Center in Washington, DC (Press release, Immunomic Therapeutics, FEB 26, 2019, View Source [SID1234533713]).

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!

As a sponsor of the CHCI Health Summit, Immunomic Therapeutics is pleased to support the initiatives of the event which include attracting and retaining greater diversity in clinical trials, ensuring equitable health outcomes for the Latino community and considering how the latest technological innovations will support Latino’s health needs. Dr. Heiland will discuss innovation during the closing plenary session and what companies like Immunomic can do to accelerate the development and approval of novel therapies, such as Immunomic’s investigational vaccines, for illnesses that greatly affect Latinos including cancer, allergy and infectious diseases.

For more information, please visit the CHCI summit website at View Source

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On February 26, 2019 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 financial results for the year ended December 31, 2018, and provided a corporate update (Press release, Cellectar Biosciences, FEB 26, 2019, View Source [SID1234533678]).

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!

Fourth Quarter and Recent Corporate Highlights

·Announced additional positive top-line results from the relapse refractory multiple myeloma cohort in its ongoing Phase 2 clinical study of CLR 131, the company’s lead product candidate. In patients with an average of 5 prior lines of systemic therapy, CLR 131 achieved a 30% overall response rate in the first 10 evaluable patients. The company previously announced an overall response rate of 33% in patients with R/R diffuse large B-cell lymphoma (DLBCL) also receiving the single, 25mCi/m2 dose of CLR 131. All patients reported here were administered one, single 30-minute infusion of 25mCi/m2, which is approximately 60% less drug than fractionated dose currently being tested in the ongoing Phase 1 study.

·Initiated Cohort 6 of its ongoing Phase 1b study evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).
oCohort 6 is evaluating up to four patients with each receiving two doses of 18.75 mCi/m2 of CLR 131 administered one week apart.
oThis fractionated dosing regimen will result in each patient being treated with an increase in average total exposure of approximately 60% over the Phase 2 efficacious dose of 25mCi/m2.
oThe fractionated dose administered in Cohort 5 indicated enhanced tolerability and safety compared with the single dose administered in Cohort 4 despite an 18% increase in the average dose. Additionally, patients in Cohort 5 experienced fewer adverse events.
oBased on these results and the DMC recommendation, Cellectar modified the single-dose regimen of its ongoing Phase 2 study of R/R hematologic malignancies to fractionated dosing and proceeded with Cohort 6 of the Phase 1 study.

·Granted the patent titled "Phospholipid Analogs as Diapeutic Agents and Methods of Use Thereof" by the Japanese Patent Office. The patent provides composition of matter and use protection for the company’s proprietary phospholipid ether (PLE) analogs and specifically the use of CLR 131 in breast, brain, leukemias, and a variety of other cancers

·Announced median overall survival (mOS) of 22 months in the single dose Cohorts 1-4 of the company’s ongoing Phase 1 clinical study evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM). All of these patients were heavily pretreated, averaging five prior lines of systemic therapy.

"We continue to make meaningful progress with the clinical development of CLR 131 and have now reported activity in three cohorts of our ongoing Phase 2 study in challenging relapse/refractory hematologic cancers: diffuse large B cell, Waldenstrom’s lymphoma and multiple myeloma. The recently announced 30% response rate in relapsed/refractory multiple myeloma coupled with the median overall survival of 22 months in patients receiving a single dose from the Phase 1 study is very encouraging," said James Caruso, president and CEO of Cellectar. "Going forward, we believe CLR 131, with a higher and more patient-friendly fractionated dosing regimen, has the potential to further improve upon its product profile and be an effective treatment in relapsed/refractory hematologic cancers. We look forward providing further updates and data for CLR 131 during 2019."

2018 Financial Highlights

Research and development expense for the year ended December 31, 2018 was $6.8 million, compared to $9.5 million for the year ended December 31, 2017. The overall decrease in research and development expense of 28% was due primarily to a decrease in accelerated depreciation expense due to the reassessed estimated useful life of the leasehold improvements and laboratory equipment in 2017. The reassessment of the useful lives for these assets was due to the company’s decision to close its manufacturing facility and outsource all of its manufacturing.

General and administrative expense for the year ended December 31, 2018 was $4.8 million, compared to $4.1 million for the year ended December 31, 2017. The increase of 17% for 2018 was primarily related to an increase of approximately $229,000 in purchased services related to accounting, investor relations and public company costs offset by a decrease in legal fees of approximately $157,000; and an increase of approximately $510,000 in personnel related costs.

The net loss attributable to year ended December 31, 2018 was ($15.5) million, or ($5.23) per share, respectively, compared with a net loss attributable to common stockholders for the year ended December 31, 2017 of ($15.0) million, or ($10.70) per share.

As of December 31, 2018, the company had cash, cash equivalents and restricted cash of $13.3 million compared to $10.1 million at December 31, 2017. The increase was largely attributable to cash received from financing activities of approximately $15.0 million, offset by cash used in operating activities of $11.4 million and cash used in investing activities of approximately $330,000. Consistent with prior guidance, the company believes its cash on hand is adequate to fund operations into the first quarter of 2020.