On May 8, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the pivotal QuANTUM-R phase 3 study of single agent quizartinib met its primary endpoint of significantly prolonging overall survival compared to salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations after first-line treatment with or without hematopoietic stem cell transplantation (HSCT) (Press release, Daiichi Sankyo, MAY 8, 2018, View Source [SID1234526274]). Safety appears consistent with that observed at similar doses in the quizartinib program.

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"Single agent quizartinib is the first FLT3 inhibitor to show a significant improvement in overall survival compared to cytotoxic chemotherapy in a randomized phase 3 study of patients with relapsed/refractory AML with FLT3-ITD mutations, a very aggressive form of the disease with limited treatment options," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We sincerely thank all of the investigators and patients who participated in this study and will share the results of the QuANTUM-R study at an upcoming medical meeting. We look forward to working with regulatory authorities worldwide to potentially bring quizartinib to patients as quickly as possible."

QuANTUM-R is a pivotal, global, phase 3, open-label randomized study that enrolled 367 patients with FLT3-ITD-mutated AML who were refractory to or in relapse (with duration of remission of six months or less) following standard first-line AML therapy with or without HSCT. Patients were randomized in a 2:1 ratio to receive either single agent oral quizartinib or salvage chemotherapy. The primary objective of the study was to determine whether single agent quizartinib prolonged overall survival compared to salvage chemotherapy.

Daiichi Sankyo intends to initiate regulatory submissions worldwide for quizartinib on the basis of the QuANTUM-R results. The topline results of QuANTUM-R will be presented at an upcoming scientific conference.

About Quizartinib

Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in phase 3 development for relapsed/refractory (QuANTUM-R) and newly-diagnosed (QuANTUM-First) AML with FLT3-ITD mutations globally, and phase 2 development for relapsed/refractory AML with FLT3-ITD mutations in Japan.

Quizartinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory AML. Quizartinib also has been granted Orphan Drug designation by the FDA and European Medicines Agency (EMA) for the treatment of AML. Quizartinib is an investigational agent that is not approved for any indication in any country. Safety and efficacy have not been established.

About Acute Myeloid Leukemia with FLT3-ITD Mutations

AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.1 The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.1

FLT3 gene mutations are one of the most common genetic abnormalities in AML.2 The FLT3-ITD mutation is the most common FLT3 mutation, affecting approximately one in four patients with AML.3,4,5,6 Patients with FLT3-ITD-mutated AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse,and a higher likelihood of relapse following HSCT as compared to those without this mutation.7,8

On May 8, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the UBS Global Healthcare Conference on Tuesday, May 22, 2018. Bill Chase, executive vice president and chief financial officer, will present at 7:30 a.m. Central time (Press release, AbbVie, MAY 8, 2018, View Source [SID1234526194]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available

On May 8, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported financial results for the quarter ended March 31, 2018 (Press release, Aeglea BioTherapeutics, MAY 8, 2018, View Source [SID1234526225]).

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"The first quarter was a terrific start to our year, with a number of positive and encouraging developments in our lead clinical investigational program, pegzilarginase," said Anthony G. Quinn, M.B Ch.B, Ph.D., interim chief executive officer of Aeglea. "I’m excited that we are seeing the first evidence that marked and sustained reductions in plasma arginine with pegzilarginase translated into clinically relevant treatment effects for two patients with Arginase 1 Deficiency. We plan to continue to build on this momentum by reporting additional repeat dose data in patients with Arginase 1 Deficiency in the third quarter of 2018 and finalizing our pivotal study design by the end of the year. In addition, we expect to report topline safety and clinical data from our cancer trials in the fourth quarter of 2018.

"Our April follow-on offering provides us with capital to continue to advance our planned operations and further develop our capabilities as we transition into a pivotal study and start planning for a commercial launch. Our strong cash position and our worldwide commercial rights for pegzilarginase position us favorably to build on recent clinical achievements with investments focusing on accelerating our clinical and pipeline programs."

Corporate Update

Arginase 1 Deficiency:

Aeglea presented initial data that it believes demonstrated clinically relevant treatment effects with pegzilarginase in two Arginase 1 Deficiency patients after only eight weeks of dosing and confirmed the utility of standardized assessment tools in quantifying disease manifestations at the 2018 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics (ACMG) in April. This built upon data presented at the 2018 Annual Meeting of The Society for Inherited Metabolic Disorders (SIMD) that demonstrated pegzilarginase produces marked and sustained reductions in plasma arginine in patients with Arginase 1 Deficiency.
Aeglea expects to report additional pediatric and adult repeat dose data in patients with Arginase 1 Deficiency in the third quarter of 2018.
Cancer:

Aeglea dosed the first patients with pegzilarginase in two small cell lung cancer (SCLC) trials: the single-agent Phase 1 cohort expansion and the Phase 1/2 combination trial with KEYTRUDA, an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada).
Aeglea presented Phase 1 dose escalation data regarding pegzilarginase in patients with advanced solid tumors at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April.
The Company expects to report topline data, including safety and clinical activity, for the advanced solid tumor cohort expansions and the SCLC combination trial in the fourth quarter of 2018.
Aeglea expects to initiate Phase 2 of its combination trial for patients with SCLC in the third quarter of 2018.
Upcoming Events

Aeglea will participate and provide a corporate update at the UBS Global Healthcare Conference in New York, May 21-23, 2018.

First Quarter 2018 Financial Results

As of March 31, 2018, Aeglea had available cash, cash equivalents and marketable securities of $43.5 million, which excludes approximately $37.7 million in net proceeds from a follow-on public offering which closed on April 23, 2018. Based on Aeglea’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations through the middle of 2020.

Aeglea recognized grant revenues of $1.5 million in the first quarter of 2018, compared with $1.0 million in the first quarter of 2017. The grant revenues were the result of a $19.8 million research grant received from the Cancer Prevention and Research Institute of Texas (CPRIT). The revenue increase was primarily due to higher qualifying expenditures associated with the clinical trials for pegzilarginase in cancer patients in the first quarter of 2018 compared with the first quarter of 2017.

Research and development expenses totaled $6.8 million for the first quarter of 2018, compared with $4.9 million for the first quarter of 2017. The increase was primarily due to expanded clinical activity for Aeglea’s lead product candidate, pegzilarginase, as Aeglea advanced a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and initiated three single-agent cohort expansions in advanced solid tumor patients and a Phase 1/2 combination trial with KEYTRUDA in patients with small cell lung cancer.

General and administrative expenses totaled $2.8 million for the first quarter of 2018, compared with $2.3 million in the first quarter of 2017. This increase was primarily due to additional employee headcount and compensation costs to further strengthen Aeglea’s management team and support expanding research and development activities.

Net loss totaled $8.1 million and $6.2 million for the first quarter of 2018 and 2017, respectively.

Inducement Grants

Aeglea also announced today that the Compensation Committee of its Board of Directors has granted non-qualified stock options to purchase an aggregate of 21,000 shares of Aeglea’s common stock to three new employees under Aeglea’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Aeglea (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Aeglea, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $9.76 per share, which is equal to the closing price of Aeglea’s common stock on May 3, 2018. Each of the option awards vests as to 25% of the shares on the one-year anniversary of its grant, with the remainder of the shares vesting ratably over 36 months thereafter

On May 8, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 10:40 a.m. PDT on Wednesday, May 16, at the Bank of America Merrill Lynch Health Care Conference 2018 (Press release, Puma Biotechnology, MAY 8, 2018, View Source [SID1234526241]). The conference will be held at Encore at the Wynn in Las Vegas.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com . The presentation will be archived on the website and available for 30 days.

About Puma Biotechnology

On May 8, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, has entered a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s ImmunoPulse IL-12 with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase II clinical trial (Press release, OncoSec Medical, MAY 8, 2018, View Source [SID1234526258]). The planned clinical trial will evaluate the safety and efficacy of the combination in patients with inoperable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously failed at least one systemic chemotherapy or immunotherapy.

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"We are pleased to initiate a second clinical trial collaboration with Merck – one of the world’s leading immuno-oncology companies – in late stage TNBC, a disease which has few treatment options," said Daniel J. O’Connor, Chief Executive Officer of OncoSec. "This collaboration is another example of OncoSec’s strategy to work with innovative immuno-oncology leaders, combining our ImmunoPulse IL-12 program with checkpoint inhibitor therapies to advance the care of patients."

Eligible patients for this Phase II study will be those with TNBC who have inoperable locally advanced or metastatic disease and progressed on at least one previous treatment of systemic chemotherapy or immunotherapy. Under the collaboration agreement, OncoSec will sponsor and fund the study and Merck will provide KEYTRUDA. Additional details of the collaboration were not disclosed.