ImmunoGen Announces Successful Completion of Interim Analysis for FORWARD I Phase 3 Trial of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer

On April 26, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the FORWARD I Phase 3 registration trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer will continue as planned without modification (Press release, ImmunoGen, APR 26, 2018, View Source [SID1234525743]). The decision follows a recommendation by the Independent Data Monitoring Committee (IDMC) based upon successful completion of a pre-specified interim futility analysis after 80 progression-free survival (PFS) events as determined by blinded, independent central review. ImmunoGen has also completed full enrollment of the trial two months ahead of schedule and expects top-line results from FORWARD I during the first half of 2019.

"Ovarian cancer is the leading cause of death from gynecological cancers, and patients diagnosed with this life-threatening disease have limited treatment options, especially once they develop platinum-resistant disease," said Anna Berkenblit, M.D., vice president and chief medical officer of ImmunoGen. "We are encouraged that the IDMC recommended FORWARD I proceed as planned and are pleased that the trial has reached full enrollment earlier than expected. We look forward to assessing top-line data in the first half of 2019."

FORWARD I is an ongoing Phase 3 trial designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of folate receptor alpha (FRα) who have been treated with up to three prior regimens. The primary endpoint of this study is PFS, which is being assessed in the entire study population and in the subset of patients with high FRα expression. Enrollment was initially planned to be completed by the end of June.

ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which is being conducted in North America and Europe. This trial is intended to support full marketing approval of mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer.

About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill these targeted cancer cells.

Mirvetuximab is also being assessed in combination regimens for both platinum-resistant and platinum-sensitive disease in the Phase 1b/2 FORWARD II trial.

About Ovarian Cancer and FRα
It is estimated that 22,000 women are diagnosed annually with ovarian cancer in the US. With more than 14,000 deaths each year, ovarian cancer accounts for more deaths than any other cancer of the female reproductive system.1

Standard first-line therapy for ovarian cancer is a platinum-based combination regimen. Once the cancer becomes platinum-resistant, treatment options include single-agent cytotoxic therapies such as pegylated liposomal doxorubicin, paclitaxel, or topotecan, and combination therapies that include Avastin.

There is a significant need for more effective, better-tolerated therapies for recurrent ovarian cancer. It is estimated that approximately 19,000 women in the US and approximately 24,000 women in the EU have platinum-resistant ovarian cancer requiring second-line or later treatment.2 ImmunoGen estimates that 60% of ovarian cancer cases have medium or high FRα expression.

Curis to Release First Quarter 2018 Financial Results and Hold Conference Call on May 3, 2018

On April 26, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that the Company will release its first quarter 2018 financial results on Thursday, May 3, 2018, before the U.S. financial markets open (Press release, Curis, APR 26, 2018, View Source [SID1234525769]). The Company’s management will also host a conference call on the same day at 8:30 a.m. EDT.

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To access the live conference call, please dial (877) 870-4263 from the United States or (412) 317-0790 from other locations, shortly before 8:30 a.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com

Synthetic Biologics to Report First Quarter 2018 Operational Highlights and Financial Results on May 8, 2018

On April 26, 2018 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported that the Company intends to release its operational highlights and financial results for the quarter ended March 31, 2018 on Tuesday, May 8, 2018, and to host a conference call the same day at 4:30 p.m. EDT (Press release, Synthetic Biologics, APR 26, 2018, View Source [SID1234525768]). The dial-in information for the call is as follows:

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U.S. (toll free): 1-888-347-5280
International: +1 412-902-4280

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

Baxter Reports First-Quarter 2018 Results and Increases Financial Outlook for Full-Year 2018

On April 26, 2018 Baxter International Inc. (NYSE: BAX) reported results for the first quarter of 2018 and increased its full-year 2018 guidance (Press release, Baxter International, APR 26, 2018, View Source [SID1234525763]).

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"Baxter is off to a strong start in 2018," said José (Joe) E. Almeida, chairman and chief executive officer. "Solid top-line performance coupled with a relentless focus on increasing operational efficiency were key drivers of earnings growth in the quarter. We look forward to building on this momentum and sharing the next chapter in Baxter’s ongoing transformation at our upcoming investor conference on May 21st. At the conference, we will highlight the strategic roadmaps for our six global businesses and provide investors an opportunity to learn more about Baxter’s promising innovation pipeline that will help fuel the company’s growth going forward."

First-Quarter Financial Results

In the first quarter, worldwide sales totaled approximately $2.7 billion, an increase of 8 percent on a reported basis, 4 percent on a constant currency basis and 3 percent on an operational basis compared to the prior-year period. Operational sales in the first quarter adjust for the impact of foreign exchange, generic competition for U.S. cyclophosphamide, and the Claris Injectables (Claris) acquisition.

Sales in the U.S. totaled $1.1 billion, increasing 4 percent on a reported basis and 2 percent on an operational basis. International sales of $1.5 billion increased 12 percent on a reported basis, 4 percent on a constant currency basis and 3 percent on an operational basis. Drivers of growth included strong demand for the company’s continuous renal replacement therapies due to an intense flu season, and increased sales of injectable pharmaceuticals and advanced surgery products as well as U.S. IV solutions and peritoneal dialysis therapies.

In line with the financial outlook shared on February 1, 2018, first quarter sales were negatively impacted by approximately $25 million due to the temporary manufacturing disruptions in Puerto Rico caused by Hurricane Maria. All manufacturing facilities in Puerto Rico are operating at pre-hurricane production levels, and the company does not expect any further revenue impact related to recovery efforts. In addition, the company continues to import select products from Baxter facilities under temporary special importation FDA grants, and is grateful to FDA for its continued support in the recovery efforts.

In March, Baxter completed the acquisition of two surgical products from Mallinckrodt plc: RECOTHROM Thrombin topical (Recombinant), the first and only stand-alone recombinant thrombin, and PREVELEAK Surgical Sealant, which is used in vascular reconstruction. Both products complement and broaden Baxter’s surgical portfolio of hemostats and sealants. Sales of these products in the quarter were immaterial and going forward will be reported in the company’s Advanced Surgery business.

As previously disclosed, Baxter now reports its operating results based on three reportable geographic segments: Americas (North and South America), EMEA (Europe, Middle East and Africa) and APAC (Asia Pacific). Net sales are reported based on these reportable segments, as well as by the company’s new Global Business Units (GBUs). Please see the schedules accompanying this press release for more details on sales performance in the quarter.

Baxter reported income from continuing operations of $389 million, or $0.71 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the first quarter. These results included special items totaling $16 million ($(1) million net after-tax), primarily related to business optimization, intangible amortization and a settlement agreement related to the Claris acquisition. On an adjusted basis, Baxter’s first quarter income from continuing operations totaled $388 million, or $0.70 per diluted share. Adjusted earnings per share growth of 21 percent in the quarter was driven by solid top-line performance and the ongoing benefit from the company’s business transformation initiatives as well as a favorable tax rate.

During the quarter, Baxter’s Board of Directors approved a $1.5 billion increase in authorization for the company’s existing share repurchase plan. After accounting for repurchases during the first quarter of $522 million or approximately 8 million shares, the company had approximately $2.1 billion remaining under the authorization as of March 31, 2018. Baxter anticipates that it will continue to repurchase shares in the open market or through private transactions at times and amounts determined by the company based on its evaluation of market conditions and other factors.

In the first quarter of 2018, Baxter generated $447 million in operating cash flow, an increase of $241 million driven by improved operational performance, the ongoing impact of programs focused on enhancing the company’s working capital and a benefit from the settlement of certain claims related to the acquisition of Claris. As a result, the company generated an increase of approximately $210 million in free cash flow to $292 million (operating cash flow less capital expenditures of $155 million) as compared to the prior-year period.

2018 Financial Outlook

For full-year 2018: Based on the company’s strong first quarter, Baxter is raising its financial outlook for the year. The company now expects sales growth of approximately 7 to 8 percent on a reported basis, approximately 5 percent on a constant currency basis and 4 to 5 percent on an operational basis*. Baxter expects adjusted earnings from continuing operations, before special items, of $2.85 to $2.93 per diluted share for the full year.
For the second quarter: The company expects sales growth of approximately 9 percent on a reported basis, approximately 5 percent on a constant currency basis and 3 to 4 percent on an operational basis*. The company expects adjusted earnings from continuing operations, before special items, of $0.69 to $0.71 per diluted share.
*Full-year and second quarter operational sales have been adjusted for the impact of foreign exchange, generic competition for U.S. cyclophosphamide and the benefit from the acquisitions of Claris and the two Mallinckrodt assets.

Please see the schedules accompanying this press release for a reconciliation between the projected 2018 adjusted earnings per diluted share and projected GAAP earnings per diluted share.

A webcast of Baxter’s first quarter 2018 conference call for investors can be accessed live from a link on the company’s website at www.baxter.com beginning at 7:30 a.m. CDT on April 26, 2018. Baxter will be hosting an investor conference on Monday, May 21, 2018, in New York City. The investor conference will feature an innovation hall displaying product and therapy advancements from Baxter’s pipeline beginning at 7:00 a.m. EDT and presentations by members of the Baxter management team will begin at 8:00 a.m. EDT. To register for the conference and for more information, click here. Please see www.baxter.com for more information regarding this and future investor events and webcasts.

CANbridge Receives China Food and Drug Administration Approval for CAN002 as Cancer Adjuvant Therapy

On April 26, 2018 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that it received an Import Medical Device Market Approval from the China Food and Drug Administration (CFDA) for CAN002 as a cancer adjuvant therapy, on April 2, 2018. CAN002, marketed as Caphosol in 47 countries, is an oral rinse for the treatment of oral mucositis, the inflammation and ulceration of the mucous membranes lining the mouth that occurs frequently in cancer patients undergoing high-dose chemotherapy, radiation and hematopoietic stem cell transplants (Press release, CANbridge Life Sciences, APR 26, 2018, View Source [SID1234525762]). CAN002 is CANbridge’s first commercialized product.

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In 2014, CANbridge entered into an exclusive partnership with EUSA Pharma for the right to commercialize Caphosol in China. EUSA Pharma is a specialty pharmaceutical company with a focus on oncology and oncology supportive care, with commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world.

"We are delighted with the approval by the CFDA of CAN002, which marks our transition into a commercial stage company," said James Xue PhD, Chairman and CEO, CANbridge Life Sciences. "There is currently no standard-of-care in China for this painful and often debilitating condition that affects so many patients undergoing cancer treatment, as well as those dealing with other diseases. We are particularly proud to be able to bring this proven treatment to patients in mainland China, as we continue in our mission to shorten the runway between Western approval and availability in China. With CAN030 (Nerlynx) queued up as the next product closest to market, we anticipate CANbridge’s accelerated growth as a commercial company."

About CAN002 (Caphosol)

Caphosol is a supersaturated calcium phosphate oral rinse solution to treat oral mucositis (OM)—inflammation and ulcers in the mouth— caused by radiation, high-dose chemotherapy, and bone-marrow transplants to treat blood cancers. Approved in 48 countries, it has demonstrated robust clinical efficacy in preventing and treating OM, and has an excellent safety profile. The incidence of oral mucositis varies across cancer patient populations. However, according to the Oncology Nursing Society, it affects almost all patients undergoing radiation therapy for head and neck cancers; 80% of patients under going a stem cell transplant to treat blood cancer; and nearly half (40%) of patients receiving standard chemotherapy.