On July 18, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the appointment of Friedrich Graf Finckenstein, M.D., as chief medical officer (Press release, Iovance Biotherapeutics, JUL 18, 2019, View Source [SID1234537598]). Dr. Graf Finckenstein brings over 19 years of experience in clinical development and translational research to the company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are very pleased to have Dr. Finckenstein join Iovance as we move forward with pivotal studies for lifileucel in metastatic melanoma and LN-145 in metastatic cervical cancer," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "Dr. Finckenstein’s experience with prior approval of checkpoint therapy as well as his breadth of involvement with translational medicine will be of great value to Iovance while we progress our late-stage development programs toward commercialization and expand the utility of TIL in new indications."

"I am very pleased to be part of a dedicated team working on bringing a novel cell therapy to patients with very limited approved therapeutic options," commented Friedrich Graf Finckenstein, M.D. "I’m excited to be able to contribute to development of TIL therapy as we work on the important next steps involved in preparing for regulatory submission."

Dr. Graf Finckenstein is a physician-scientist with decades of experience in clinical medicine, laboratory cancer research, and drug development in the biopharmaceutical industry. Prior to joining Iovance he was Global Head of Oncology Translational Medicine at Roche Pharma Research and Early Development (pRED) in Basel, Switzerland, where he led all clinical development aspects in the Oncology Discovery and Translational Area, including the design and conduct of clinical trials, exploratory development studies and translational medicine, biomarker and personalized healthcare strategy. Prior to that, Dr. Graf Finckenstein held multiple clinical leadership roles at Bristol-Meyers Squibb Company, where he worked on an array of products from early clinical development to late stage, including key contributions to the approval of Opdivo in lung cancer. Dr. Graf Finckenstein has a medical degree from the University of Hamburg in Germany. He holds a German medical license, a pediatric board certification, and has conducted basic cancer research at the Ludwig Institute, San Diego Branch, the Children’s Hospital Los Angeles and the University of Hamburg.

On July 18, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported the pricing of its initial public offering of American Depositary Shares (ADSs) in the United States (the "Offering") and the listing of the ADSs on the Nasdaq Global Select Market under the symbol "GMAB (Press release, Genmab, JUL 18, 2019, View Source [SID1234537583])." The offering will produce gross proceeds of $505,875,000 from the sale of 2,850,000 ordinary shares of Genmab in the form of 28,500,000 ADSs at a price of $17.75 per ADS. Each ADS will represent one-tenth of one ordinary share of Genmab. In addition, Genmab has granted the underwriters an option to purchase up to 4,275,000 additional ADSs, representing 427,500 ordinary shares to cover any over-allotments (the "Option"). The Option can be exercised during the 30-day period commencing July 17, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In connection with the anticipated listing of our ADSs on the Nasdaq Global Select Market, we have requested that Nasdaq Copenhagen change the symbol for our ordinary shares from "GEN" to "GMAB" to become effective in connection with the admission to trading of the ordinary shares underlying the ADSs on Nasdaq Copenhagen, expected to occur on July 23, 2019.

Summary of the Offering:

The Offering will consist of an offering of a total of 28,500,000 ADSs, corresponding to 2,850,000 underlying ordinary shares of Genmab (the "New Shares"), which in their entirety are expected to be subscribed for by BofA Merrill Lynch, Morgan Stanley and Jefferies (the "Joint Book-Running Managers"), as representatives of the several underwriters, with an instruction to deliver such new shares to Deutsche Bank Trust Company Americas acting as depositary for the underlying New Shares in the Offering;
The public offering price is $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per underlying ordinary share at an exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of 10 to 1;
The Joint Book-Running Managers, as representatives of the several underwriters, have been granted an Option to acquire an additional 4,275,000 ADSs, exercisable in whole or in part through August 16, 2019 to cover over-allotments.
The New Shares underlying the ADSs will correspond to 4.4% of Genmab’s entire share capital assuming no exercise of the Option and 5.0% of Genmab’s entire share capital assuming full exercise of the Option;
Gross proceeds from the Offering will amount to $505.9 million (DKK 3,368.1 million) assuming no exercise of the Option and $581.8 million (DKK 3,873.3 million) assuming full exercise of the Option;
Allocation of the ADSs has been determined by the board of directors in consultation with the Joint Book-Running Managers; and
A timetable of expected future principal events can be seen below:
Event Expected date
The ADSs start trading on the Nasdaq Global Select Market… July 18, 2019
Filing in the United States of the final prospectus …………….. July 18, 2019
Closing of the Offering …………………………………………… July 22, 2019
Registration of the New Shares underlying the ADSs
with the Danish Business Authority ……………………………..

July 22, 2019
Admission for listing of the New Shares underlying the
ADSs on Nasdaq Copenhagen ……………………………………..

July 23, 2019
In addition, Genmab announced that the board of directors of Genmab has today determined (i) to increase the size of the Offering from up to 27,800,000 ADSs to a total of 28,500,000 ADSs, and to issue a total of 28,500,000 ADSs (excluding any ADSs that may be sold or issued as part of the Option (as defined below)) and 2,850,000 underlying new Genmab shares, and (ii) that the public offering price for the ADSs issued as part of the Offering is $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per underlying share issued at an exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019. In connection with the pricing of the Offering the board of directors of Genmab has today decided to repeal the decision of July 9, 2019 to exercise its authorization to increase the share capital by up to 3,197,000 new shares underlying the ADSs and simultaneously in accordance with article 4A of Genmab’s articles of association exercised an authorization granted by Genmab’s annual general meeting held on April 10, 2018, to increase Genmab’s share capital by issue of up to 3,277,500 new shares underlying the ADSs, of which 2,850,000 cover the shares being issued in connection with the Offering and 427,500 will cover shares in case the Option is exercised.

The registration statement on Form F-1 relating to the ADSs, including the preliminary prospectus forming a part thereof, has been declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering of the ADSs is being made only by means of such prospectus.

BofA Merrill Lynch, Morgan Stanley and Jefferies are acting as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets are acting as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen are acting as co-managers for the Offering. A copy of the preliminary prospectus and, when available, the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the preliminary prospectus and, when available, the final prospectus related to the Offering are also available, or will be available, at www.sec.gov. No Danish prospectus will be issued or offered.
This Company Announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 18, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported it has received the approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with a Phase 1/2a clinical trial of TG6002 administered by intrahepatic artery (IHA) infusion in colorectal cancer patients with unresectable liver metastases (CRLM) (Press release, Transgene, JUL 18, 2019, View Source [SID1234537599]).

TG6002 is a next-generation oncolytic virus (OV), which has multiple mechanisms of action. It has been engineered to combine the killing of cancer cells (oncolysis), the production of 5-FU, a widely used chemotherapeutic agent, in the tumor site, and the eliciting of an immune response against tumor cells. TG6002 expresses the proprietary FCU1 gene in the cancer cells it has infected, leading to local conversion of the pro-drug 5-FC (administered orally) into 5-FU. This is particularly important as most gastrointestinal tumors are 5-FU sensitive. TG6002 has been shown to induce both response in the primary tumor and an immune-mediated regression of distant metastases in preclinical experiments1.

"Current systemic therapies prolong survival of CRLM patients at the cost of significant side effects. We believe that TG6002 therapy administered via an IHA infusion potentially offers an additional effective and well tolerated treatment modality for these difficult to treat patients. By administering it via the intrahepatic artery, we believe we can conveniently deliver more concentrated doses of TG6002 to the tumor, to achieve better outcomes for unresectable colorectal cancer, whilst limiting systemic exposure. In parallel, Transgene is conducting a Phase 1/2 trial to investigate TG6002 in colorectal cancer patients when given intravenously," said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

Dr. Adel Samson, MB ChB PhD, Medical Oncologist at St. James’ University Hospital, is the Chief Investigator of the trial.
This trial is a single-arm open-label Phase 1/2a trial evaluating the safety, pharmacokinetics and efficacy of repeated and ascending doses of TG6002 administered by IHA route in combination with oral 5-FC, a non-cytotoxic pro-drug that can be converted in 5-FU. The study is expected to start in Q4 2019 and could enroll up to 75 patients.

— End–

About TG6002
TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and allow the local production of chemotherapy (5-FU) in the tumor. TG6002 is a modified Vaccinia virus, with double gene deletion (TK-RR-), and expressing the proprietary FCU1 gene in the cancer cells it has infected, leading to the local conversion of the non-cytotoxic pro-drug, flucytosine (5-FC), into 5-FU, a widely used cancer chemotherapy. The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models. Transgene believes that TG6002 may represent a new therapeutic option in recurrent cancer patients.
Another Phase 1/2 trial using TG6002 administered intravenously is ongoing in Europe in patients with advanced gastrointestinal tumors.

About Colorectal cancer
Colorectal cancer (CRC) is the second most commonly diagnosed cancer in Europe and a leading cause of death both in Europe and worldwide. In 2012, there were 447,000 new cases of CRC in Europe with 215,000 deaths and worldwide, there were 1.4 million new cases with 694,000 deaths (Ferlay J. et al., 2013, Ferlay J. et al., 2015). Approximately half of all CRC patients develop liver metastases, only a small proportion of whom being suitable for potentially curative hepatic resection (Leporrier J, 2006). Over the last decade, the clinical outcome for patients with metastatic CRC (mCRC) has improved. Today, the median overall survival (OS) for patients with mCRC is ∼30 months.

On July 17, 2019 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2019 (Press release, Abbott, JUL 17, 2019, View Source [SID1234537568]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Second-quarter worldwide sales of $8.0 billion increased 2.7 percent on a reported basis and 7.5 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.56 in the second quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.82, above the previous guidance range.
Abbott is raising its full-year 2019 outlook. Abbott projects organic sales growth of 7.0 to 8.0 percent1, diluted EPS from continuing operations on a GAAP basis of $2.06 to $2.12, and full-year adjusted diluted EPS from continuing operations of $3.21 to $3.27, reflecting double-digit growth.
FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, achieved worldwide sales of $433 million in the quarter, an increase of 63.9 percent on a reported basis and 72.9 percent on an organic basis versus the prior year. In the U.S., FreeStyle Libre is now reimbursed for approximately 75 percent of people with private pharmacy benefit insurance.
Worldwide sales of MitraClip were $169 million in the quarter, an increase of 26.7 percent on a reported basis and 30.6 percent on an organic basis versus the prior year, including U.S. growth of 56.1 percent. Earlier this week, Abbott announced U.S. FDA approval of its next-generation MitraClip device, which offers enhancements and more sizes to offer doctors further options.
In July, Abbott received U.S. FDA approval for its Alinity-S diagnostics system, the latest technology for screening and protecting the U.S. blood and plasma supply. Alinity-S is designed to provide faster and more efficient results within a smaller space versus commercially available competitive systems, while maintaining the highest levels of accuracy.
"Our sales growth accelerated and is sustainable," said Miles D. White, chairman and chief executive officer, Abbott. "We have great momentum and are raising our guidance above the strong outlook we previously set for the year."

* See note on organic growth below.

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes the prior year first and second-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the second quarter:

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2019 worldwide sales of $8.0 billion increased 2.7 percent on a reported basis. On an organic basis, worldwide sales increased 7.5 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 0.9 percent on a reported basis in the second quarter. On an organic basis, sales increased 5.1 percent. Refer to tables titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 0.1 percent on a reported basis in the second quarter, including an unfavorable 2.8 percent effect of foreign exchange, and increased 2.9 percent on an organic basis. Sales performance in the quarter was led by broad-based growth across several brands, and included above-market growth in several countries in Latin America and Asia.

Worldwide Adult Nutrition sales increased 2.0 percent on a reported basis in the second quarter and increased 7.9 percent on an organic basis. International Adult Nutrition sales increased 3.4 percent on a reported basis and 10.4 percent on an organic basis in the second quarter. Sales performance in the quarter was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Worldwide Diagnostics sales increased 1.7 percent on a reported basis in the second quarter, including an unfavorable 4.5 percent effect of foreign exchange, and increased 6.2 percent on an organic basis.

Core Laboratory Diagnostics sales increased 3.6 percent on a reported basis and 9.4 percent on an organic basis in the second quarter. Sales performance in the quarter was led by above-market growth internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments. In July, Abbott received U.S. FDA approval for its Alinity-S (blood and plasma screening) diagnostics system and several testing assays, designed to provide faster and more efficient results within a smaller space, while maintaining the highest levels of accuracy.

Molecular Diagnostics sales decreased 12.4 percent on a reported basis in the second quarter, including an unfavorable 3.1 percent effect of foreign exchange, and decreased 9.3 percent on an organic basis. As expected, sales growth in the quarter was negatively impacted by non-governmental organization (NGO) purchasing patterns in Africa.

Point of Care Diagnostics sales increased 5.0 percent on a reported basis in the second quarter, including an unfavorable 0.7 percent effect of foreign exchange, and increased 5.7 percent on an organic basis. Sales growth was led by Abbott’s market-leading i-STAT handheld system in the U.S. and internationally.

Rapid Diagnostics sales decreased 0.1 percent on a reported basis in the second quarter, including an unfavorable 2.9 percent effect of foreign exchange, and increased 2.8 percent on an organic basis. Organic sales growth was led by infectious disease testing in developed markets and cardio-metabolic testing globally.

Established Pharmaceuticals sales decreased 1.8 percent on a reported basis in the second quarter, including an unfavorable 7.9 percent effect of foreign exchange, and increased 6.1 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 1.4 percent on a reported basis in the second quarter, including an unfavorable 9.3 percent effect of foreign exchange, and increased 7.9 percent on an organic basis, which was led by strong growth across several countries, including India and China.

Other sales decreased 3.1 percent on a reported basis in the second quarter, including an unfavorable 3.2 percent effect of foreign exchange, and increased 0.1 percent on an organic basis. As expected, Other sales growth was negatively impacted in the quarter by the recent discontinuation of a non-core, low-margin supply agreement.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Note: Insertable Cardiac Monitor (ICM) sales, which had previously been reported in Electrophysiology, are now included in Rhythm Management. Historical periods have been adjusted to reflect this change.

Worldwide Medical Devices sales increased 6.4 percent on a reported basis in the second quarter and increased 10.5 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, growth was led by strong performance in cardiac diagnostic and ablation catheters, which are used to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, growth was driven by market adoption of Abbott’s HeartMate 3 left ventricular assist device following U.S. FDA approval as a destination (long-term use) therapy in late-2018.

Growth in Structural Heart was led by MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation (backflow of blood through a leaky mitral heart valve). Earlier this year, Abbott received U.S. FDA approval for a new, expanded indication for MitraClip to treat clinically significant secondary mitral regurgitation as a result of underlying heart failure. This new indication significantly expands the number of people that can be treated with MitraClip. Earlier this week, Abbott announced U.S. FDA approval of its next-generation MitraClip device, MitraClip G4, which offers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

In Diabetes Care, sales increased 28.2 percent on a reported basis and 35.3 percent on an organic basis in the second quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $433 million, an increase of 63.9 percent on a reported basis and 72.9 percent on an organic basis versus the prior year.

ABBOTT’S GUIDANCE FOR 2019
Abbott projects 2019 organic sales growth of 7.0 to 8.0 percent1, and diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $2.06 to $2.12. Abbott forecasts net specified items for the full year 2019 of $1.15 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.21 to $3.27 for the full year 2019.

Abbott is issuing third-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.53 to $0.55. Abbott forecasts specified items for the third quarter 2019 of $0.30 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.83 to $0.85 for the third quarter.

ABBOTT DECLARES 382ND CONSECUTIVE QUARTERLY DIVIDEND
On June 14, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable Aug. 15, 2019, to shareholders of record at the close of business on July 15, 2019.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On July 17, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that it plans to advance the development of flotetuzumab, its investigational bispecific CD123 x CD3 DART molecule, in patients with primary refractory acute myeloid leukemia (AML), a difficult-to-treat patient population (Press release, MacroGenics, JUL 17, 2019, View Source [SID1234537584]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To date, MacroGenics has enrolled 50 patients at the recommended Phase 2 dose (RP2D) in the Phase 1 monotherapy study, including 30 patients with primary refractory AML. The updated clinical data from this study will be submitted for presentation at the 2019 American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. MacroGenics plans to meet with the FDA in the third quarter to discuss future development of flotetuzumab, and to define a potential registration path for this molecule as monotherapy.

In parallel, MacroGenics plans to initiate a study in relapsed or refractory AML patients combining flotetuzumab with MGA012, a proprietary anti-PD-1 antibody, as a potential means to both broaden and lengthen the duration of response of AML patients on flotetuzumab. The combination is supported by a strong scientific rationale based on data previously reported by MacroGenics. The Company is positioned to begin to enroll patients imminently.

MacroGenics and Laboratoires Servier will terminate their collaboration and license agreement, with an effective date of January 15, 2020, unless sooner agreed to by the parties. As a result, MacroGenics will regain full global rights to develop and commercialize flotetuzumab. MacroGenics entered into an agreement with Servier in September 2012 to develop and commercialize flotetuzumab and other earlier stage DART molecules, in all regions other than North America, Japan, South Korea and India. Servier recently informed MacroGenics of its intention to terminate the agreement.

"We have made significant progress to advance flotetuzumab during our collaboration with Servier and we thank them for their participation," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "As MacroGenics has been leading the ongoing multi-national clinical effort, we anticipate no disruption or impact to our continued development of flotetuzumab and are excited about the potential of the program going forward."

About Flotetuzumab

Flotetuzumab is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, is over-expressed on cancer cells in a wide range of hematological malignancies, including AML and myelodysplastic syndromes (MDS). The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cancer cells.

Flotetuzumab is currently being evaluated in the U.S. and Europe in a Phase 1/2 dose expansion study designed to assess the safety, tolerability, and initial anti-leukemic activity of the molecule in patients with relapsed/refractory AML. Data from 31 patients were presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2018, demonstrating anti-leukemic activity in patients with relapsed/refractory AML. In 27 response evaluable patients, the overall response rate (ORR) was 26% (7/27), with a complete response (CR) rate (a composite of both CR and CRi responses) of 19% (5/27). Notably, in primary refractory patients, an extremely challenging population to treat, the ORR was 35% (6/17) with a CR rate of 29% (5/17). The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), and occurred in 93% (29/31) of patients. Grade 3 or greater IRR/CRS was observed in 13% (4/31) of patients.

The U.S. Food and Drug Administration has granted orphan drug designation to flotetuzumab for the treatment of AML.