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Amgen And Syapse Enter Precision Medicine Collaboration In Oncology

On May 2, 2019 Amgen (NASDAQ:AMGN), a world leader in biotechnology, and Syapse, a company powering precision medicine insights through its global provider network, reported a precision medicine collaboration in oncology (Press release, Amgen, MAY 2, 2019, View Source;p=RssLanding&cat=news&id=2396920 [SID1234535691]).

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Under the terms of the agreement, Amgen and Syapse will develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology. This effort will identify existing patients within the Syapse Learning Health Network that could be eligible for Amgen-sponsored clinical trials and seek to bring these trials to community health system sites. The companies will create opportunities for physicians and researchers within the Syapse Network to gain access to analytics, real-world evidence-based insights, and collaborative research opportunities. Amgen will have access to real-world evidence for potential use in regulatory filings in support of certain agreed upon development candidates in oncology. Amgen will also work with Syapse to develop real-world evidence standards to support the acceleration of therapies to market.

"As cancer remains one of the leading causes of death around the world, emerging software and data analytic tools are creating exciting opportunities to more rapidly develop and deliver targeted treatment options to patients," said Mike Nohaile, senior vice president of Strategy, Commercialization and Innovation at Amgen. "Our collaboration with Syapse supports this effort by leveraging real-world evidence to accelerate bringing new oncology treatments to market and empowers healthcare providers with more robust insights and decision-making tools to improve patient care."

"Syapse and Amgen share a common vision of ensuring that all cancer patients, regardless of income or location, receive access to the best possible care," said Ken Tarkoff, chief executive officer at Syapse. "Through this collaboration and the strategic relationships we’ve built with community health systems globally, we aim to develop evidence of clinical utility that can be used to bring molecularly targeted treatments to market more quickly and ensure more diverse groups of patients can access them."

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

Evelo Biosciences Reports First Quarter 2019 Financial Results and Recent Business Highlights

On May 2, 2019 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing oral biologics that act on cells in the small intestine with striking therapeutic effects throughout the body, reported financial results and provided a business update for the first quarter of 2019 (Press release, Evelo Biosciences, MAY 2, 2019, View Source [SID1234535675]).

"We continue to progress therapies targeting cells in the small intestine to drive systemic effects to treat major diseases. We look forward to clinical data from our first inflammatory disease trial of EDP1066 in healthy volunteers and psoriasis patients early in the third quarter and in atopic dermatitis patients shortly thereafter," said Simba Gill, Ph.D., chief executive officer of Evelo. "In addition, we have discovered novel formulations of monoclonal microbials which significantly improve potency in preclinical models. In parallel with completion of the current patient cohorts, we are advancing a novel formulation into our ongoing clinical studies, providing us with the opportunity for additional clinical readouts in the near term."

Business Highlights:

Platform Discovery: Novel Formulations with Increased Potency

Evelo has discovered a new formulation that enhances the pharmacological potency of monoclonal microbials by up to 30-fold in preclinical in vivo models.

This proprietary formulation enhances the probability of translating preclinical effects into patients and can be commercialized cost effectively.

Evelo plans to introduce this formulation into ongoing and new clinical trials beginning in the second half of 2019 across multiple monoclonal microbials.

Evelo continues to invest in enhanced forms and formulations of oral biologics.

Ongoing Clinical Studies and Anticipated Milestones

Inflammation:

EDP1066 – Phase 1b

Healthy volunteers and psoriasis patients – Evelo expects to complete dosing this quarter and to report initial clinical data early in the third quarter of 2019.

Atopic dermatitis patients – Following the recent addition of a new cohort of patients, Evelo expects to report initial clinical data in the third quarter of 2019.

New formulation – Evelo expects to report initial clinical data from cohorts of psoriasis and atopic dermatitis patients during the fourth quarter of 2019 and the first quarter of 2020, respectively.

EDP1815 – Phase 1b

Evelo completed dosing of EDP1815 in two dose-ascending healthy volunteer cohorts. Based on the data reviewed by the trial’s safety committee, the trial proceeded as planned into patients.

Following the addition of a new formulation into the trial, Evelo expects to report initial clinical data from psoriasis and atopic dermatitis patients in early 2020.

Anticipated Additional Studies

Evelo expects to continue to conduct immuno-pharmacology studies in healthy volunteers with EDP1066 and EDP1815 to explore additional doses and formulations.

Subject to data from ongoing trials, Evelo expects to initiate clinical trials in additional inflammatory disease indications in the second half of 2019.

Oncology:

EDP1503 – Phase 1/2

Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.

EDP1503 – Phase 2a

The University of Chicago is conducting a Phase 2a investigator-sponsored clinical trial of EDP1503 in combination with KEYTRUDA in naive melanoma patients and melanoma patients who have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data expected in second half of 2020.

First Quarter 2019 Financial Results

Cash Position: As of March 31, 2019, cash, cash equivalents and investments were $129.4 million, as compared to cash and cash equivalents of $147.9 million as of December 31, 2018. This decrease was due to cash used to fund operating activities and capital expenditures for the first quarter of 2019. Evelo expects that its cash, cash equivalents and investments will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.

Research and Development Expenses: R&D expenses were $15.7 million for the three months ended March 31, 2019, compared to $7.1 million for the three months ended March 31, 2018. The increase of $8.6 million was due primarily to increases in costs related to Evelo’s inflammation and oncology clinical development programs, and research platform expenses, as well as increased personnel costs.

General and Administrative Expenses: G&A expenses were $5.1 million for the three months ended March 31, 2019, compared to $3.3 million for the three months ended March 31, 2018. The increase of $1.8 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing R&D organization and public company infrastructure.

Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $20.3 million for the three months ended March 31, 2019, or $(0.64) per basic and diluted share, as compared to a net loss attributable to common stockholders of $12.9 million for the three months ended March 31, 2018, or $(3.29) per basic and diluted share.

Conference Call
Evelo will host a conference call and webcast today at 8:30a.m. ET. To access the call please dial (866) 795-3242 (domestic) and (409) 937-8909 (international) and provide the passcode 1838168. A live webcast of the call will be available on the Investors sections of the Evelo website at www.evelobio.com. The archived webcast will be available approximately two hours after the conference call and will be available for 30 days following the call.

Magenta Therapeutics Announces Pricing of Public Offering

On May 2, 2019 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported the pricing of its public offering of 4,250,000 shares of its common stock at a price to the public of $13.25 per share, for total gross proceeds of approximately $56.3 million (Press release, Magenta Therapeutics, MAY 2, 2019, View Source [SID1234535660]). All shares of common stock will be offered by Magenta. In addition, the underwriters have a 30-day option to purchase from Magenta up to 637,500 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on May 6, 2019, subject to customary closing conditions.

J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

Important Information

A registration statement relating to the offering has been filed with, and declared effective by, the United States Securities and Exchange Commission ("SEC"). The offering of these shares will be made only by means of a prospectus. Copies of the prospectus can be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, telephone: 631-274-2806.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Intrexon to Release First Quarter 2019 Financial Results on May 9th

On May 2, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release first quarter 2019 financial results after the market closes on Thursday, May 9th, 2019 (Press release, Intrexon, MAY 2, 2019, View Source [SID1234535658]). The Company will not host a conference call associated with the earnings release.

Agios Reports Business Highlights and First Quarter 2019 Financial Results

On May 2, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the first quarter ended March 31, 2019 (Press release, Agios Pharmaceuticals, MAY 2, 2019, View Source [SID1234535657]).

"We continued to deliver significant progress across our oncology and rare genetic disease programs during the first quarter. Importantly, our U.S. commercial team is driving TIBSOVO toward solid performance for its first full year on the market, and we are on track to achieve our internal forecast," said Jackie Fouse, Ph.D., chief executive officer at Agios. "We made progress on expansion opportunities for TIBSOVO across the frontline AML setting. FDA accepted our sNDA in newly diagnosed AML, the HOVON/AMLSG Phase 3 intensive chemotherapy combination study initiated, and we received Breakthrough Therapy Designation for the combination of TIBSOVO and azacitadine. We also advanced our mitapivat program. Our two pivotal trials in pyruvate kinase deficiency remain on track to complete enrollment this year, we have dosed the first patient in our Phase 2 thalassemia study, and we now expect a NIH-sponsored study in sickle cell disease to initiate this year."

FIRST QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS

Received FDA acceptance and Priority Review for the supplemental new drug application (sNDA) for single agent TIBSOVO for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation who are not eligible for standard therapy. The Prescription Drug User Fee Act (PDUFA) action date was set for June 21, 2019.
Presented updated data from the ongoing Phase 1 combination trial of TIBSOVO with azacitidine in patients with newly diagnosed AML with an IDH1 mutation at the 17th International Symposium on Acute Leukemias.
Received Breakthrough Therapy designation from FDA for TIBSOVO in combination with azacitidine for the treatment of newly diagnosed AML patients with an IDH1 mutation who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Supported the cooperative groups HOVON and AMLSG on the initiation of the Phase 3 randomized, placebo-controlled study of TIBSOVO or IDHIFA in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed AML with an IDH1 mutation.
Presented preclinical data for AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting.
Dosed the first patient in a Phase 2 proof-of-concept study for mitapivat in thalassemia.
Announced two newly created commercial leadership roles to support the commercialization of the company’s medicines in the U.S. and Europe. Darrin Miles, who has been with the company since 2015, most recently as vice president, oncology program leadership, was promoted to senior vice president, U.S. commercial and global marketing. In addition, a search is underway for the role of senior vice president, international.
KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in the remainder of 2019:

Cancer:

Potential U.S. approval and launch of single agent TIBSOVO for newly diagnosed AML with an IDH1 mutation not eligible for standard therapy by June 21, 2019.
Submit an sNDA to the FDA for TIBSOVO for second line or later IDH1 mutant cholangiocarcinoma by year-end.
Initiate a registration-enabling Phase 3 study of vorasidenib in low-grade glioma with an IDH1 mutation by year-end.
Determine recommended dose of AG-270 in methylthioadenosine phosphorylase (MTAP)-deleted tumors; initiate expansion arms, including a single-agent arm in a variety of MTAP-deleted tumors and two combination arms combining AG-270 and standard-of-care in non-small cell lung cancer and pancreatic ductal adenocarcinoma in the third quarter.
Begin dosing patients in the Phase 1 dose-escalation trial of AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH), in lymphoma in the first half of 2019.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency by year-end 2019:
ACTIVATE-T: A single-arm trial of up to 40 regularly transfused patients; enrollment was increased from 20 to 40 based on demand
ACTIVATE: A 1:1 randomized, placebo-controlled trial of 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
ANTICIPATED 2019 DATA PRESENTATIONS

The following abstracts have been accepted for presentation at 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:
Updated data from a Phase 1 study of single agent TIBSOVO in IDH1 mutant newly diagnosed AML ineligible for standard therapies.
Updated data from the Phase 1 combination study of TIBSOVO and azacitidine in newly diagnosed AML with an IDH1 mutation.
Results from the first cohort in a Phase 1 perioperative study of TIBSOVO and vorasidenib in recurrent IDH1 mutant low-grade glioma.
Topline data from the Phase 3 ClarIDHy study of TIBSOVO in IDH1 mutant second line or later cholangiocarcinoma to be reported in the first half and full data to be presented in the second half of 2019.
Data from the dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with MTAP-deleted tumors expected in the second half of 2019.
FIRST QUARTER 2019 FINANCIAL RESULTS

Revenue: Total revenue for the first quarter of 2019 was $30.2 million, which includes $17.9 million in collaboration revenue and $2.2 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene, and $9.1 million of net product revenue from U.S. sales of TIBSOVO. This compares to revenue of $8.8 million for the first quarter of 2018, which included $7.3 million in collaboration revenue and $1.4 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene.

Cost of Sales: We began U.S. sales of TIBSOVO in the third quarter of 2018. Cost of sales were $0.3 million for the first quarter of 2019.

Research and Development (R&D) Expenses: R&D expenses were $95.6 million for the first quarter of 2019 compared to $78.2 million for the first quarter of 2018. The increase in R&D expense was primarily attributable to clinical trial activity related to TIBSOVO frontline trials, the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia, and start-up activities for AG-636.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $31.8 million for the first quarter of 2019 compared to $24.6 million for the first quarter of 2018. The increase in SG&A expense was primarily attributable to costs to support commercialization of TIBSOVO and personnel costs related to increased headcount.

Net Loss: Net loss was $93.1 million for the first quarter of 2019 compared to $90.8 million for the first quarter of 2018.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of March 31, 2019 were $707.8 million compared to $805.4 million as of December 31, 2018. The net decrease of $97.6 million in cash position was primarily driven by net expenditures to fund operations, including a onetime cash expense of $19.2 million for bonus payouts during the first quarter. The company expects that its cash, cash equivalents and marketable securities as of March 31, 2019, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss first quarter 2019 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9573049. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.