On May 8, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended March 31, 2018, and provided an overview of recent accomplishments and plans for its research and development programs (Press release, CytRx, MAY 8, 2018, View Source [SID1234526247]).

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"We’ve had a strong start to 2018, highlighted by the presentation of statistically significant breakthrough data for our four new albumin binding ultra high potency LADR (Linker Activated Drug Release) drug candidates at AACR (Free AACR Whitepaper) 2018," said Eric Curtis, CytRx’s President and Chief Operating Officer. "The potential competitive advantages of the LADR assets over antibody-drug conjugates are significant, including broader therapeutic utility and patient populations, lower risk of immune responses, lower cost of goods, simpler manufacturing, and no requirement for antibody receptors. Looking ahead to the remainder of 2018, we are laser-focused on securing a strategic alliance for the innovative LADR technology, with the goal of closing a transaction during the fourth quarter of 2018."

First Quarter 2018 and Recent Highlights

Eric L. Curtis is Named President and Chief Operating Officer. In early May 2018, CytRx announced that its Board of Directors had affirmed the appointment of Mr. Curtis to be the President and Chief Operating Officer of CytRx. Mr. Curtis will be part of CytRx’s executive management team and will utilize his significant development and operational expertise to partner the Company’s LADR technology and assets, as well as maximize the success of CytRx’s scientific programs. He had previously served as an independent consultant for the Company’s internal development efforts and external partner relationships. Mr. Curtis, who holds an M.B.A., brings more than 25 years of life science leadership experience to CytRx, with a proven track record in oncology and orphan diseases.
NantCell Inc.’s Aldoxorubicin Abstract Selected for Presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting. In April 2018, CytRx highlighted that an abstract submitted by aldoxorubicin licensee NantCell, Inc., a private subsidiary of NantWorks, LLC, entitled Lack of cardiac toxicity in patients treated with aldoxorubicin with doxorubicin equivalent doses beyond 1000mg/m2 was selected for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual meeting, to be held June 1 – 5 in Chicago. Dr. Sant Chawla, Principal Investigator and Director of the Sarcoma Oncology Center in Santa Monica, California, will be the presenter. CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to NantCell, Inc. in July 2017.
Presented Statistically Significant Breakthrough LADR Candidate Data at the AACR (Free AACR Whitepaper) 2018 Annual Meeting. In April 2018, CytRx presented three posters highlighting breakthrough data relating to its LADR drug candidates at the AACR (Free AACR Whitepaper) 2018 Annual Meeting in Chicago. The posters describe the positive scientific findings that led to the Company’s decision to select auristatin E (AE) derivatives LADR-7 and LADR-8, and maytansine derivatives LADR-9 and LADR-10, as the LADR candidates eligible to advance toward IND-enabling studies. The compounds demonstrated excellent, long-term antitumor activity across a wide range of human solid tumor cancer types, including lung, breast, ovarian, head and neck, renal cell, and melanoma. PDF copies of the presented posters (abstracts #1657, #2661, and #3703) can be accessed here.
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Selected Four LADR Candidates Eligible for IND-Enabling Clinical Studies. In March 2018, CytRx announced that four LADR candidates are eligible for advancement into IND-enabling studies. These candidates, named LADR-7, LADR-8, LADR-9 and LADR-10 were chosen from two distinct classes of highly cytotoxic drugs, auristatins and maytansinoids.
Patterson Derivative Action is Dismissed. In March 2018, the Vice-Chancellor of the Delaware Court of Chancery ruled that CytRx’s motion to dismiss was granted, with prejudice. Patterson v. Kriegsman et al., C.A. No. 2017-0636-TMR.
Initiation of Pharma Partnering Activities for the LADR Ultra-High Potency Drug Candidates. In February and March 2018, CytRx made two announcements that highlighted efforts to strengthen its strategic alliance team. First, CytRx announced that it had entered into an exclusive agreement with Destum Partners, Inc., a leading strategic advisory firm serving companies in the life sciences industry, to assist in executing a strategic alliance for CytRx’s LADR drug candidates. CytRx also announced that Mr. Eric L. Curtis, MBA, joined its team to provide strategic counsel to the Chairman and CEO for the Company’s ongoing programs, including its LADR discovery platform and the ultra-high potency drug candidates. Mr. Curtis will foster introductions to strategic partners from his extensive network of big pharma and biotech companies. He brings a wealth of drug development and commercialization experience to CytRx, and he, along with Destum Partners, made introductions at AACR (Free AACR Whitepaper).
Partner NantCell Dosed First Patient in Clinical Trial Investigating Cell-Based Therapy in Combination with Multiple Anti-Cancer Agents, including Aldoxorubicin, in Patients with Metastatic Pancreatic Cancer. In January 2018, CytRx announced that aldoxorubicin licensee NantCell, Inc. (a private subsidiary of NantWorks, LLC) dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with metastatic pancreatic cancer. The trial will investigate high-affinity natural killer (haNK) cell therapy in combination with several anti-cancer agents, including aldoxorubicin, in patients with metastatic pancreatic cancer whose cancer has progressed on or following standard-of-care chemotherapy. This trial is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of the various combination therapies with enrollment expected to be approximately 173 patients. The primary endpoint for the Phase 1b portion of the trial is safety and the primary endpoint for the Phase 2 portion of the trial is objective response rate (ORR) by RECIST.
Partner NantCell Dosed First Patient in Clinical Trial Evaluating Aldoxorubicin in Combination with Immuno-Oncology Agents and Cell-Based Therapies in Patients with Advanced Squamous Cell Carcinoma. In February 2018, CytRx announced that NantCell dosed the first patient in the Phase 1b portion of a Phase 1b/2 clinical trial for patients with advanced squamous cell carcinoma (SCC) of either the head and neck or non-small cell lung cancer, the second trial conducted by NantCell to investigate haNK cell therapy in combination with several anti-cancer agents, including aldoxorubicin, in certain high unmet need cancer indications. This single-center, open-label, Phase 1b/2 clinical trial is designed to evaluate the safety and efficacy of the various combination therapies, including combinations with aldoxorubicin, in subjects with SCC who have progressed on or after platinum-based chemotherapy and anti-PD1/PD-L1 therapy. Approximately 65 patients are expected to be enrolled. The primary endpoint for the Phase 1b portion of the trial is safety and the primary endpoint for the Phase 2 portion of the trial is objective response rate (ORR) by RECIST.
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First Quarter 2018 Financial Results

CytRx reported cash and cash equivalents of $35.1 million as of March 31, 2018.

Net loss for the quarter ended March 31, 2018, was $4.1 million, or $(0.15) per share, compared with a net loss of $11.0 million, or $(0.60) per share, for the quarter ended March 31, 2017, a reduction of $6.9 million. Net loss decreased by approximately 63% for the quarter ended March 31, 2018. During the first quarter of 2018, the Company recognized a non-cash gain of $0.45 million on the fair value adjustment of warrant derivative liabilities related to warrants issued in 2016, compared to a non-cash loss of $32,000 during the first quarter of 2017 related to now expired warrants.
Research and development (R&D) expenses were $1.5 million for the first quarter of 2018, which were primarily incurred for preclinical development of the new LADR albumin-binding, ultra-high potency drug candidates in the Company’s Freiburg, Germany lab. This is a reduction of approximately $5.3 million compared to R&D expenses of $6.8 million for the first quarter of 2017, which included clinical development expenses for aldoxorubicin.
General and administrative (G&A) expenses were $2.5 million for the first quarter of 2018, compared with $3.0 million for the first quarter of 2017, including non-cash stock-compensation expense of $0.4 million for the first quarter of 2018 as compared to 0.6 million for the first quarter of 2017. G&A expenses decreased by approximately 17 percent primarily due to a decrease in legal fees.
About the LADR Technology Platform
CytRx’s innovative LADR (Linker Activated Drug Release) technology employs a broad portfolio of novel linker molecules that selectively bind to circulating albumin and can be linked to a wide variety of anti-cancer payloads. The Company’s research efforts currently center on creating new molecules from the combination of ultra-high potency cytotoxic payloads with tunable linkers. The molecules that CytRx is currently evaluating concentrate at the tumor site providing targeted delivery of the cell killing payloads.

On May 8, 2018 Pieris Pharmaceuticals, Inc. presented Deutsche Bank Health Care Conference presentation (Presentation, Pieris Pharmaceuticals, MAY 8, 2018, View Source [SID1234526265]).

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On May 8, 2018 Medigene AG (MDG1, Frankfurt, Prime Standard), reported that researchers from Max-Delbrück-Center for Molecular Medicine (MDC) and Charité, both in Berlin, Germany, will present an update on the clinical trial preparations concerning a MAGE-A1-specific T cell receptor clinical investigator-initiated trial (IIT) at the 16th Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in Mainz, Germany, from 15 – 17 May (Press release, MediGene, MAY 8, 2018, View Source [SID1234526177]). CIMT (Free CIMT Whitepaper) is Europe’s largest meeting focused on cancer immunotherapy research and development.

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In the abstract that will be published today, the partners announce that the competent regulatory authority Paul-Ehrlich-Institute, Germany, has granted the clinical trial authorization for the planned Phase I trial and that the manufacturing license for the established GMP-compliant manufacturing process is expected to be issued in Q2 2018. More details on the trial design for the treatment of patients with relapsed or refractory multiple myeloma can be found in the abstract on the CIMT (Free CIMT Whitepaper) website: www.meeting.cimt.eu/program

The academic trial will be conducted under the responsibility of Charité and the Max-Delbrück Center. Medigene has supported both the MDC and Charité in regulatory affairs and other matters related to trial approval. Additionally, Medigene has certain rights of first negotiation for the TCR candidate utilized in this trial.

Independently, Medigene is currently conducting its own, company-sponsored phase I/II clinical trial with its proprietary TCR therapy MDG1011 in various blood cancer indications which commenced at the end of March 2018.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development. For more information, please visit www.medigene.com

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

On May 8, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the following upcoming investor conferences (Press release, bluebird bio, MAY 8, 2018, View Source [SID1234526202]):

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Deutsche Bank’s 43rd Annual Health Care Conference, Wednesday, May 9, at 10:00 a.m. ET at the Intercontinental Hotel, Boston, Massachusetts.
Bank of America Merrill Lynch 2018 Healthcare Conference, Tuesday, May 15, at 2:20 p.m. PT at the Encore at Wynn Hotel, Las Vegas, Nevada.
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the conferences.

On May 8, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its first quarter 2018 financial results and provided an update on the company, including its progress with IPI-549, a first-in-class oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma) and targets immune-suppressive tumor macrophages (Press release, Infinity Pharmaceuticals, MAY 8, 2018, View Source [SID1234526232]). Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in a Phase 1/1b study in approximately 200 patients with advanced solid tumors.

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"We continue to make important progress with IPI-549 and look forward to reporting clinical and translational data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June from the combination dose escalation portion of the trial, in addition to providing an update on the monotherapy portion of the trial and initial data from combination expansion cohorts initiated in early 2018," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "We expect that these data will provide additional insights into the activity, durability, safety and mechanism of action of IPI -549, including in combination with nivolumab."

Recent developments include the following:

IPI-549

Continued Progress with the Phase 1/1b Study: The monotherapy portions of the study and combination dose escalation portion of the study have been completed. Enrollment, which began in 2018, is ongoing for six disease-specific combination expansion cohorts, along with a seventh combination expansion cohort of patients pre-selected for having high baseline blood levels of myeloid derived suppressor cells (MDSCs).
2018 Program Goals for IPI-549

At ASCO (Free ASCO Whitepaper) report:
Data from the monotherapy expansion component of the study
Data from the combination dose-escalation component of the study
Initial data from six disease-specific combination expansion cohorts
Report more mature clinical and translational data (including insights from paired tumor biopsies) from the six disease-specific cohorts and initial data from the cohort of patients pre-selected for having high baseline blood levels of myeloid derived suppressor cells (MDSCs) in the combination expansion component of the study in the second half of 2018
First Quarter 2018 Financial Results

At March 31, 2018, Infinity had total cash, cash equivalents and available-for-sale securities of $47.8 million, compared to $57.6 million at December 31, 2017.
R&D expense for the first quarter of 2018 was $5.9 million, compared to $4.0 million for the same period in 2017. The increase in R&D expense was primarily due to higher clinical development expenses for IPI-549.
General and administrative expense was $3.6 million for the first quarter 2018, compared to $6.4 million for the same period in 2017. The decrease in G&A expense was primarily due to a reduction in bonus and stock compensation.
Net loss for the first quarter of 2018 was $9.5 million, or a basic and diluted loss per common share of $0.18, compared to a net loss of $10.5 million, or a basic and diluted loss per common share of $0.21 for the same period in 2017.
Financial Outlook
Infinity’s 2018 financial guidance remains unchanged:

Net Loss: Infinity expects net loss for 2018 to range from $35 million to $45 million.
Cash and Investments: Infinity expects to end 2018 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $15 million to $25 million.
Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities will be adequate to satisfy the company’s capital needs into the third quarter of 2019. Infinity’s financial guidance excludes additional funding or business development activities and does not include the potential $22 million payment from Verastem upon the first regulatory approval of duvelisib, or a potential $2 million payment from PellePharm, a private company, upon initiation of a Phase 3 study for the hedgehog inhibitor program, which Infinity licensed to PellePharm in 2013. Verastem announced that its New Drug Application for duvelisib was accepted by the U.S. Food and Drug Administration (FDA) and that it was given priority review with an FDA action date of October 5, 2018. With the potential Verastem payment, Infinity expects that its cash runway would extend into 2020.
Conference Call Information
Infinity will host a conference call today, May 8, 2018, at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 2479309. An archived version of the webcast will be available on Infinity’s website for 30 days.

About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.1, 2 As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.