On May 2, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications, reported its financial and operational results for the first quarter ended March 31, 2019 (Press release, Idera Pharmaceuticals, MAY 2, 2019, View Source [SID1234535694]).

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"The first quarter of this year represented another period of solid execution from everyone on our team," stated Vincent Milano, Idera’s Chief Executive Officer. "During this quarter, we completed enrollment of ILLUMINATE-204, positioning ourselves to provide a full analysis from this trial in the fourth quarter of this year. We’ve also made significant progress with the enrollment of Idera’s first pivotal trial, ILLUMINATE-301, for which we expect to complete accrual during the fourth quarter. And, we recently presented the data from the ILLUMINATE-101 monotherapy trial at AACR (Free AACR Whitepaper), strengthening the body of translational and clinical evidence that tilsotolimod stimulates an immune response within the tumor microenvironment. We believe that this may be a key to enhancing the outcomes of existing immunotherapy regimens."

Milano continued, "Lastly, we’ve made great strides in preparing to initiate the expansion of activities for tilsotolimod through the ILLUMINATE-206 multi-cohort trial, which we anticipate will launch this quarter. We appreciate the financial commitment and teamwork from our collaboration partner, Bristol Myers Squibb, which assisted us in taking on this endeavor. Overall, this has been a highly productive quarter for our team and the momentum continues to swell as we advance towards these critical catalysts for our company."

ILLUMINATE (tilsotolimod) Clinical Development

ILLUMINATE 301 — Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:

· Overall Response Rate (ORR) and Overall Survival (OS) as primary endpoints;

· Trial initiated in the first quarter of 2018;

·Sites planned in 12 countries: 85 sites activated;

· Planned enrollment of approximately 300 patients; and

· Completion of enrollment expected during the fourth quarter of 2019.

ILLUMINATE 206 — Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).

· On March 11, 2019 entered into a second clinical trial collaboration with Bristol Myers Squibb (BMS) in which BMS has agreed to manufacture and supply YERVOY (ipilimumab) and OPDIVO (nivolumab) at its cost and for no charge for use in ILLUMINATE-206;

·Received notice from the U.S. Food and Drug Administration that we can proceed to implement the ILLUMINATE-206 clinical trial under a new Investigational New Drug (IND) application; and

· Both trial cohorts of SCCHN and MSS-CRC expected to initiate in the second quarter of 2019.

ILLUMINATE 204 — Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

· Completed enrollment with 52 patients dosed in Phase 2 expansion at tilsotolimod 8 mg with ipilimumab;

·Completed target enrollment of at least 40 patients in the primary enrollment population constituting patients who are naïve to prior ipilimumab treatment in the metastatic setting;

· Presented an interim data update in December 2018 which showed:

· 32.4% ORR of the first 34 patients evaluable for efficacy including 9% (n=3) achieve Complete Response (CR); 24% (n=8) achieving Partial Response (PR); and 76.5% (n=26) achieving disease control (CR, PR or Stable Disease [SD]); and

· Final overall response rate (ORR) data from the ipilimumab combination arm of ILLUMINATE-204 expected in the fourth quarter of 2019.

ILLUMINATE 101 — Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:

· Completed enrollment in all dose cohorts of the trial; and

· Poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting on April 2, 2019 which demonstrated:

Safety Data

· No dose limiting toxicities or treatment-related adverse events were observed;

· No treatment-emergent adverse events (TEAEs) leading to treatment or study discontinuation or death occurred; and

· The most common grade 3/4 TEAEs were anemia, hyponatremia, pain, sepsis (n=3 each), fatigue and thrombocytopenia (n=2 each).

Efficacy Data

· Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease assessment of stable disease (SD), with a disease control rate of 45%;

· Of the 13 patients with SD, 5 (38%) had maximum tumor shrinkage >10% below baseline;

· Duration of SD ranged from 1.3 to 9.7+ months from start of treatment, with 3 patients ongoing; and

· No correlations between dose and efficacy were observed.

Translational Data

· Fresh flow cytometry in 2 of 3 analyzed patients showed HLA-DR (MHC Class II) upregulation at 24 hours compared with pre-treatment; and

·Robust activation and upregulation of type I IFN pathway was observed across analyzed tumor types, demonstrated by increased IRF7, IFIT1, and IFIT2 gene expression, and early increases in type I IFN signaling.

Financial Results

First Quarter Results

Net loss applicable to common stockholders for the three months ended March 31, 2019 was $11.0 million, or $0.40 per basic and diluted share, compared to net loss applicable to common stockholders of $20.1 million, or $0.81 per basic and diluted share, for the same period in 2018. Revenue for each of the three months ended March 31, 2019 and 2018 was nominal. Research and development expenses for the three months ended March 31, 2019 totaled $8.1 million compared to $13.6 million for the same period in 2018. General and administrative expense for the three months ended March 31, 2019 totaled $3.1 million compared to $3.5 million for the same period in 2018. Merger-related costs, net for the three months ended March 31, 2018 totaled $3.4 million and related to our contemplated merger transaction. No such costs were incurred for the same period in 2019. Restructuring costs for the three months ended March 31, 2019 was nominal and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred for the same period in 2018.

As of March 31, 2019, our cash, cash equivalents and investments totaled $59.9 million compared to $71.4 million as of December 31, 2018. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the second quarter of 2020.

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.

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]).

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"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.

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.

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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.

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.

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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

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