IntelGenx Amends Stock Options

On August 24, 2020 IntelGenx Technologies Corp. ("IntelGenx", or the "Company") (TSX-V: IGX) (OTCQB:IGXT) reported that the Company’s board of directors amended the expiration time of Stock Options granted to Andre Godin, President and CFO, under the 2006 Stock Option Plan on July 20, 2015 (Press release, IntelGenx, AUG 24, 2020, View Source [SID1234563974]).

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The extension was granted following the end of an insider trading black-out period during which the stock options automatically extended in accordance with the insider trading black-out provision of the Company’s Second Amended 2016 Stock Option Plan.

The new expiration date is July 19, 2025, the original exercise price of CAD$0.75 (US$0.58) and all other terms remain unchanged.

The amendment is subject to final TSX-Venture Exchange approval.

Veracyte Named a San Francisco Bay Area “Top Workplace” for Seventh Consecutive Year

On August 24, 2020 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that it has been awarded a Top Workplaces 2020 honor by the Bay Area News Group for the seventh consecutive year (Press release, Veracyte, AUG 24, 2020, View Source [SID1234563971]). The annual award is based solely on employee feedback gathered through an anonymous, third-party survey.

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"I am so proud that as our company continues to grow and evolve, including expanding internationally, we’ve been able to maintain our positive and inclusive work culture," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We strive to ensure our more than 325 employees feel appreciated, well informed and empowered to share their points of view, and it is so gratifying to see our efforts reflected in the 2020 Top Workplace survey responses."

The Top Workplaces award winners are determined by results of a survey administered by Energage, LLC, a leading provider of technology-based engagement tools. The survey measures several key aspects of workplace culture, including organizational alignment, effective execution and meaningful connection with employees.

Veracyte’s innovation and industry leadership have been recognized consistently since the company was founded in 2008. Employees participating in the 2020 Top Workplaces survey ranked the company most highly for "doing things efficiently and well," having senior managers who understand what is happening at the company, having strong interdepartmental coordination, encouraging different points of view, and making employees feel well-informed about important decisions at the company.

"These responses reflect our deep commitment to improving the lives of patients, which requires that we trust and collaborate with each other and that we constantly seek opportunities to improve how we work together," said Ms. Anderson.

The Bay Area News Group published the complete list of 2020 Top Workplaces on Sunday, August 23. The list of winners is available at the Bay Area News Group website.

Onconova Therapeutics Announces Topline Results from the Pivotal Phase 3 INSPIRE Trial

On August 24, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX) a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that INSPIRE, the company’s pivotal Phase 3 study assessing the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients, did not meet its primary endpoint of improved survival (Press release, Onconova, AUG 24, 2020, View Source [SID1234563970]).

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"Onconova would like to thank the MDS community for its participation in the INSPIRE trial. We report these results with great disappointment, and we remain deeply indebted to every patient, physician, and family member involved in the study," said Steven M. Fruchtman, M.D., President and Chief Executive Officer. "Onconova is fortunate to have built a product pipeline that includes multiple promising agents, including oral rigosertib and ON 123300. Both compounds target meaningful cancer pathways, and we look forward to further efforts with these programs. The Company will review pipeline and in-licensing opportunities both internally and with external advisors."

The primary endpoint of the trial was overall survival, comparing IV rigosertib plus best supportive care to physician’s choice (PC) plus best supportive care in patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. A pre-specified analysis in the very high risk (VHR-MDS) patient subgroup was also conducted.

Results of INSPIRE demonstrated that in the intent-to-treat analysis patients randomized to IV rigosertib achieved overall survival of 6.4 months, versus 6.3 months for PC (p=0.33) in the overall HR-MDS population. Overall survival in the pre-specified VHR-MDS subgroup of patients was also not significantly different between the two study arms. There was an increase in overall survival in the PC arm post-interim analysis that was unexpected. The Company is conducting additional analyses.

Safety analysis indicates that IV rigosertib was generally well tolerated, with reported adverse events similar to those observed in previous clinical studies with IV rigosertib in MDS. Serious adverse events (SAEs) were uncommon, with a similar profile of SAEs in both study arms.

"While the INSPIRE data readout in HR-MDS is a disappointment, as a RAS pathway inhibitor oral rigosertib could address a number of oncology settings outside of hematology," said Richard C. Woodman, M.D., Chief Medical Officer of Onconova. "We plan to take learnings from genomic analyses of the INSPIRE trial to inform the future development of rigosertib. We also look forward to the continued expansion of the investigator-initiated study program with oral rigosertib beyond the ongoing Phase 1/2a study in KRAS+ lung adenocarcinoma into additional solid tumors. Our novel CDK4/6 + ARK5 inhibitor, ON 123300, could also represent a meaningful advance over existing products."

The Company will host a conference call today, August 24, 2020, at 8:30 a.m. Eastern Time. Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic callers and (210) 229-8823 for international callers, and using conference ID 8087044.

To facilitate an on-time conference call start, Onconova recommends that participants dial in 15 minutes before the 8:30 a.m. ET start time.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

Ligand Announces Amgen’s KYPROLIS® Approved by FDA as Combination Regimen with DARZALEX® and Dexamethasone in Once- and Twice-Weekly Dosing Regimens for Patients with Relapsed/Refractory Multiple Myeloma

On August 24, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that a major Captisol customer Amgen (NASDAQ: AMGN) has received U.S. Food and Drug Administration (FDA) approval for the expansion of the KYPROLIS (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX (daratumumab) plus dexamethasone (DKd) in once- and twice-weekly dosing regimens for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy (Press release, Ligand, AUG 24, 2020, View Source;and-twice-weekly-dosing-regimens-for-patients-with-relapsedrefractory-multiple-myeloma [SID1234563969]).

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"We are proud of the ongoing work by Amgen to expand the use of KYPROLIS in combination with other therapies. This FDA approval came earlier than we had anticipated and allows for KYPROLIS to be used with DARZALEX and dexamethasone in patients in the U.S. with an incurable type of blood cancer," said John Higgins, Chief Executive Officer of Ligand. "We are very pleased with the impact that Captisol-enabled medicines are having to-date in 2020 for the treatment of multiple serious diseases, including relapsed/refractory multiple myeloma and COVID-19."

The CANDOR trial was the first Phase 3 randomized trial to compare DKd versus KYPROLIS and dexamethasone (Kd) alone in R/R MM patients. The study met its primary endpoint and resulted in a 37% reduction in the risk of disease progression or death in patients receiving DKd (HR=0.63; 95% CI: 0.464, 0.854; 1-sided p-value=0.0014) compared to Kd alone.

In CANDOR, the safety of DKd was generally consistent with the known safety profiles of the individual agents. The most frequently reported (≥ 20% of subjects in either the DKd or Kd treatment arm) treatment-emergent adverse events (AEs) included infusion-related reactions, anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection, thrombocytopenia, neutropenia, lymphopenia, cough, dyspnea and insomnia, headache and back pain. The incidence of treatment-emergent Grade 3 or higher, serious and fatal AEs was higher in the DKd arm compared to the Kd arm. The most common reason for fatal treatment-emergent AEs in both arms was infection. The rate of treatment discontinuation due to AEs was similar in both arms.

The expansion of KYPROLIS’s prescribing information to include once-weekly dosing of KYPROLIS within the DKd regimen was supported by the open-label, multi-cohort Phase 1b EQUULEUS trial, in which the safety and efficacy of DKd was assessed among R/R MM patients using a once-weekly dosing regimen for KYPROLIS.

Amgen has submitted additional marketing applications globally.

DARZALEX is a registered trademark of Janssen Pharmaceutica NV.

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Gilead’s VEKLURY, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development.

About CANDOR

CANDOR, a randomized, open-label Phase 3 study of KYPROLIS, DARZALEX and dexamethasone (DKd) compared to KYPROLIS and dexamethasone (Kd), has evaluated 466 relapsed or refractory multiple myeloma patients who have received one to three prior therapies. Patients were treated until disease progression. The primary endpoint was progression-free survival (PFS), and the key secondary endpoints were overall response rate, minimal residual disease and overall survival. PFS was defined as time from randomization until disease progression or death from any cause.

In the first arm, patients received KYPROLIS twice weekly at 56 mg/m2 and dexamethasone in combination with DARZALEX. In the second arm (control), patients received KYPROLIS twice weekly at 56 mg/m2 and dexamethasone.

CANDOR was initiated as part of a collaboration with Janssen, and under the terms of the agreement, Janssen co-funded the study. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688.

About EQUULEUS

EQUULEUS was an open-label, Phase 1b, multi-cohort trial that evaluated the combination of KYPROLIS with intravenous DARZALEX and dexamethasone in 85 patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy.

KYPROLIS was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

The most frequently reported all-grade, treatment-emergent AEs (occurring in 20% or more of patients) were thrombocytopenia, respiratory tract infection, anemia, nausea, fatigue, vomiting, diarrhea, pyrexia, neutropenia, lymphopenia, infusion related reactions, dyspnea, cough, insomnia, hypertension, headache and back pain.

At a median follow-up of 16.6 months, the overall response rate was 81% in all treated patients: 21% achieved a stringent complete response, 14% a complete response, 33% a very good partial response and 13% a partial response.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and life-threatening disease that accounts for approximately one percent of all cancers.2,3 Worldwide, approximately 160,000 people are diagnosed with multiple myeloma each year, and 106,000 patient deaths are reported on an annual basis.4

About KYPROLIS (carfilzomib)

Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.4 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.4,5

Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS.6 KYPROLIS is approved in the U.S. for the following:

for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with
Lenalidomide and dexamethasone; or
Dexamethasone; or
Daratumumab and dexamethasone.
as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, S. Africa, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.

U.S. KYPROLIS (carfilzomib) Important Safety Information

INDICATIONS

KYPROLIS (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
KYPROLIS is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
IMPORTANT SAFETY INFORMATION FOR KYPROLIS

Cardiac Toxicities

New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of KYPROLIS. Some events occurred in patients with normal baseline ventricular function. Death due to cardiac arrest has occurred within one day of administration.
Monitor patients for signs or symptoms of cardiac failure or ischemia. Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
While adequate hydration is required prior to each dose in Cycle 1, monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate.
For patients ≥75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias may be at greater risk for cardiac complications and should have a comprehensive medical assessment prior to starting treatment with KYPROLIS and remain under close follow-up with fluid management.
Acute Renal Failure

Cases of acute renal failure, including some fatal renal failure events, and renal insufficiency adverse events (including renal failure) have occurred. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.
Tumor Lysis Syndrome

Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred. Patients with a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly, and withhold until resolved.
Pulmonary Toxicity

Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred. Some events have been fatal. In the event of drug–induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension

Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.
Dyspnea

Dyspnea was reported in patients treated with KYPROLIS. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart based on a benefit/risk assessment.
Hypertension

Hypertension, including hypertensive crisis and hypertensive emergency, has been observed, some fatal. Control hypertension prior to starting KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold KYPROLIS and evaluate. Consider whether to restart based on a benefit/risk assessment.
Venous Thrombosis

Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed. Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone. The thromboprophylaxis regimen should be based on an assessment of the patient’s underlying risks.
Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment.
Infusion Reactions

Infusion reactions, including life–threatening reactions, have occurred. Signs and symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if they occur.
Hemorrhage

Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate.
Thrombocytopenia

KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure

Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate.
Thrombotic Microangiopathy

Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known.
Posterior Reversible Encephalopathy Syndrome (PRES)

Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known.
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients

In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.
Embryo-fetal Toxicity

KYPROLIS can cause fetal harm when administered to a pregnant woman.
Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the final dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the final dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Adverse Reactions

The most common adverse reactions in the combination therapy trials: anemia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, cough, upper respiratory tract infection, hypertension.
The most common adverse reactions in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral.

Prelude Therapeutics Announces Closing of $50M Series C Financing

On August 24, 2020 Prelude Therapeutics, a privately-held, clinical-stage precision oncology company, reported that it has completed a $50 million Series C financing round led by Prelude’s two existing institutional investors, including OrbiMed Advisors LLC, and a new investor, Fidelity Management & Research Company LLC (Press release, Prelude Therapeutics, AUG 24, 2020, View Source;utm_medium=rss&utm_campaign=prelude-therapeutics-series-c [SID1234563966]).

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"We are pleased to have the support of this sophisticated group of investors who share our vision of bringing effective new therapies to cancer patients in areas of high unmet need," said Kris Vaddi, Ph.D., founder and Chief Executive Officer of Prelude Therapeutics. "With proceeds from this financing, we believe we are well positioned to continue to execute on building and advancing our pipeline of therapies designed to target key drivers of cancer cell growth, survival and resistance to existing treatments."

Proceeds from the Series C financing will be used to support the growth and advancement of Prelude’s pipeline, including the Company’s lead product candidates, PRMT5 inhibitors PRT543 and PRT811, and PRT1419, a potent and selective inhibitor of the anti-apoptotic protein, MCL1. The Company is currently evaluating PRT543 in a Phase 1 trial with an initial focus in select solid tumors and myeloid malignancies, and PRT811 in a Phase 1 clinical trial in solid tumors, including glioblastoma multiforme. Prelude is also initiating clinical trial activities for PRT1419 in selected hematological malignancies.

The Company also reported the appointment of two new members to its Board of Directors:

Mardi C. Dier: Ms. Dier most recently served as Executive Vice President, Chief Financial Officer and Chief Business Officer of Portola Pharmaceuticals, Inc. prior to its acquisition by Alexion Pharmaceuticals in July 2020. She was responsible for leading the corporate finance, accounting, information technology, global supply chain, business development, investor relations and corporate communications functions. During her tenure at Portola, she successfully led a series of private, public and alternative financings and helped lead the company through its pivotal transition into a commercial organization. Previously, Ms. Dier served as Vice President of Investor Relations at Chiron Corporation from 2003 until its acquisition by Novartis Pharmaceuticals in 2006. Prior to joining Chiron, she worked as an investment banker at Prudential Securities, Inc., where she focused on client development, equity underwriting and mergers and acquisitions for biotechnology and other life sciences companies, and prior to that was in the audit department of KPMG Peat Marwick. She holds a B.S. in Biology from Stanford University and an M.B.A. from the Anderson Graduate School of Management at the University of California, Los Angeles. Ms. Dier is a member of the Board of Directors of Adamas Pharmaceuticals, Inc. and ORIC Pharmaceuticals, Inc.
Victor Sandor, M.D.: Dr. Sandor was most recently Chief Medical Officer at Array BioPharma, Inc. prior to its acquisition by Pfizer Inc. At Array, Dr. Sandor was instrumental in obtaining the approval of Braftovi (encorafenib) and Mektovi (binimetinib). Prior to joining Array, he was Senior Vice President for Global Clinical Development at Incyte Corporation, where he played a critical role in the approval of Jakafi (ruxolitinib). Dr. Sandor was also Vice President and Chief Medical Officer for Oncology at Biogen Idec and held positions of increasing responsibility in oncology product development at AstraZeneca, where he played an important role in the registration of Arimidex (anastrozole) for adjuvant use and the development of several early stage programs through proof of concept. Dr. Sandor received his M.D.C.M. from McGill University in Montreal, Canada, and completed his Fellowship in Medical Oncology at the National Institutes of Health. Dr. Sandor is a member of the Board of Directors of Merus N.V. and ADC Therapeutics SA.