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Jazz Pharmaceuticals Announces FDA Approval of Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection for the Treatment of Adults with Newly-Diagnosed Therapy-Related Acute Myeloid Leukemia (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC)

On August 3, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) has approved Vyxeos (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rapidly progressing and life-threatening blood cancer (Press release, Jazz Pharmaceuticals, AUG 3, 2017, View Source [SID1234520026]). Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC.

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"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community."

Designed with Jazz’s CombiPlex proprietary technology, Vyxeos is a unique liposomal formulation that delivers a fixed-ratio of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models. Vyxeos is the first product developed with the company’s proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies.

"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage over the standard of care in a Phase 3 randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Jeffrey E. Lancet, MD, Chair of the Department of Malignant Hematology at Moffitt Cancer Center. "The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance."

Vyxeos will be commercially available within a week. For more information about Vyxeos in the United States, please visit View Source

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

The FDA approval is based on data from a pivotal Phase 3 clinical trial that evaluated the efficacy and safety of Vyxeos compared to cytarabine and daunorubicin (7+3) in 309 patients 60 to 75 years of age with newly diagnosed t-AML or AML-MRC. In the Vyxeos arm, patients received 44mg/100mg per m2 (daunorubicin and cytarabine) liposome intravenously via a 90 minute infusion on days 1, 3 and 5 of induction (days 1 and 3 if a second induction was needed) and 29mg/65mg per m2 (daunorubicin and cytarabine) liposome on days 1 and 3 for consolidation. Patients in the 7+3 arm received induction with cytarabine 100mg/m2/day on days 1-7 by continuous infusion and daunorubicin 60mg/m2/day on days 1-3. For consolidation, cytarabine was dosed on days 1-5 and daunorubicin on days 1-2. For the primary endpoint of overall survival, Vyxeos demonstrated an improvement that was superior to the 7+3 treatment regimen. The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (p = 0.005; HR = 0.69 [0.52, 0.90]). Vyxeos also demonstrated a statistically significant improvement in complete response rate of 38 percent versus 26 percent; p=0.036. The overall, all-cause 30-day mortality was 6 percent in the Vyxeos arm and 11 percent in the control arm. Six percent of patients in both the Vyxeos and control arm had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease. During the first 60 days of the study, 14 percent of patients died in the Vyxeos arm versus 21 percent of patients in the 7+3 arm. In addition, the overall rate of hematopoietic stem cell transplant (HSCT) was 34 percent in the Vyxeos arm and 25 percent in the 7+3 arm. In the Phase 3 study, the most common adverse reactions (incidence ≥ 25%) were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders and vomiting.

About VyxeosTM

Vyxeos (daunorubicin and cytarabine) liposome for injection 44mg/100mg is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion.1 Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC. The FDA granted the Vyxeos application Priority Review status, designated Vyxeos as a Breakthrough Therapy and also granted Fast Track Designation. Vyxeos received Orphan Drug Designation by the FDA and the European Commission for the treatment of AML.

Important Safety Information

Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.

Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles or legs
unusual tiredness
Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
Vyxeos contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Please see full Prescribing Information for Vyxeos before prescribing: View Source

About AML

Acute myeloid leukemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body’s new blood cells.2 AML cells crowd out healthy cells and move aggressively into the bloodstream to spread cancer to other parts of the body.3 AML is a relatively rare disease representing 1.3 percent of all new cancer cases.4 It is estimated that more than 21,000 people will be diagnosed with AML in the United States this year with the potential for nearly 11,000 people to die from the disease.5 The median age at diagnosis is 68 years old,4 with rising age associated with a progressively worsening prognosis.6 There is also a reduced tolerance for intensive chemotherapy as patients age.7 AML has the lowest survival rate of any other form of leukemia.4 Patients with newly diagnosed t-AML or AML-MRC may have a particularly poor prognosis.8-10 A hematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.11

Curis Reports Second Quarter 2017 Financial Results

On August 3, 2017 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported its financial results for the second quarter ended June 30, 2017 (Press release, Curis, AUG 3, 2017, View Source [SID1234520025]).

Curis also reported today data from the interim analysis of the Phase 2 trial of CUDC-907 in patients with MYC-altered DLBCL. Of the 36 evaluable patients with MYC-altered DLBCL in the interim analysis, 7 patients experienced confirmed durable objective responses (19.4% ORR), including 3 with complete responses. In addition, and consistent with the original hypothesis, all 7 responders in the Phase 2 study had MYC-altered disease, while no objective responses were observed in 12 patients with MYC-negative disease status.

"The ability of CUDC-907 treatment to result in durable complete responses, and the continued correlation of this benefit selectively in patients with MYC-altered disease, is encouraging for the continued development of CUDC-907," said Ali Fattaey, President and CEO. "While we believe the results from this Phase 2 trial are insufficient to serve as the basis of a request for accelerated approval of CUDC-907, we are evaluating alternative designs for a separate registration-enabling trial to demonstrate CUDC-907’s benefit for patients with MYC-altered DLBCL."

"The reported response rate is impressive, especially in this population of patients with relapsed/refractory MYC-altered lymphomas who rarely respond to salvage therapies," said Dr. Daniel J. Landsburg, Assistant Professor of Clinical Medicine at the Abramson Cancer Center at the Hospital of the University of Pennsylvania. "I believe this agent warrants continued investigation."

Second Quarter 2017 Financial Results

Curis reported a net loss of $14.1 million, or $0.10 per share, on both a basic and diluted basis for the second quarter of 2017, as compared to a net loss of $11.3 million, or $0.09 per share, on both a basic and diluted basis for the same period in 2016. Curis reported a net loss of $29.8 million, or $0.21 per share, on both a basic and diluted basis for the six months ended June 30, 2017, as compared to a net loss of $20.7 million, or $0.16 per share on both a basic and diluted basis for the same period in 2016.

Revenues for the second quarter of 2017 were $2.1 million, as compared to $1.7 million for the same period in 2016. Revenues for the six months ended June 30, 2017 were $4.2 million, as compared to $3.4 million for the same period in 2016. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $15.2 million for the second quarter of 2017, as compared to $12.4 million for the same period in 2016. Operating expenses for the six months ended June 30, 2017 were $32.4 million, as compared to $22.9 million for the same period in 2016, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the second quarter of 2017 and 2016. Cost of royalty revenues for the six months ended June 30, 2017 and 2016 were $0.2 million for both periods.

Research and Development Expenses. Research and development expenses were $11.3 million for the second quarter of 2017, as compared to $8.8 million for the same period in 2016. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and CA-170 and increased employee-related expenses primarily due to additional headcount to support the multiple programs. Research and development expenses were $24.8 million for the six months ended June 30, 2017 as compared to $15.7 million for the same period in 2016.

General and Administrative Expenses. General and administrative expenses were $3.8 million for the second quarter of 2017 as compared to $3.4 million for the same period in 2016. The increase in general and administrative expenses was driven primarily by higher personnel costs and stock-based compensation expense due to increased headcount. General and administrative expenses were $7.4 million for the six months ended June 30, 2017, as compared to $7.1 million for the same period in prior 2016.

Other expense, net was $1.0 million for the second quarter of 2017, as compared to $0.6 million for the same period in 2016. Other expense, net primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations. Other expense, net was $1.7 million and $1.2 million for the six months ended June 30, 2017 and 2016, respectively.

As of June 30, 2017, Curis’s cash, cash equivalents, marketable securities and investments totaled $51.0 million and there were approximately 143.9 million shares of common stock outstanding. On a fully-diluted basis, which includes 18.6 million options, there were 162.5 million shares outstanding.

Recent Operational Highlights

Precision oncology (CUDC-907: HDAC / PI3K inhibitor program):

The following summarizes the CUDC-907 Phase 1 trial results and Phase 2 interim analysis:

View Source

Immuno-oncology (CA-170: PD-L1 / VISTA antagonist program; Aurigene collaboration):

In May 2017, Curis presented the CA-170 Phase 1 trials-in-progress poster at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through September 2017:

CA-170 poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Conference (Sept. 8-12, 2017) in Madrid.

CTI BioPharma Reports Second Quarter 2017 Financial Results

On August 3, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the second quarter ended June 30, 2017 (Press release, CTI BioPharma, AUG 3, 2017, View Source [SID1234520024]).

Clinical / Regulatory

In July 2017, the first patient was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy. PAC203 is designed to evaluate the dose response relationship for safety and efficacy (spleen volume reduction at 12 and 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in the Phase 3 PERSIST-2 trial of pacritinib in patients with myelofibrosis. The trial is expected to enroll up to approximately 105 patients.
In July 2017, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
In August 2017, enrollment was completed in the PIX306 Phase 3 trial of PIXUVRI (pixantrone). The PIX306 trial is evaluating PIXUVRI combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). PIXUVRI has previously been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The trial is being conducted as a post-authorization requirement of conditional marketing authorization. If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.
Financing and Partnerships

In June 2017, received gross proceeds of $45 million through an underwritten public offering.
In April 2017, CTI BioPharma announced the expansion of the existing license and development collaboration agreement with Servier for PIXUVRI. Under the expanded agreement, Servier will have rights to PIXUVRI in all markets except in the U.S. where CTI BioPharma will retain the commercialization rights. In May 2017, CTI BioPharma received €12 million from Servier, which includes €2 million for a new milestone previously achieved, and Servier purchased a certain amount of PIXUVRI drug product for an additional €0.9 million. CTI BioPharma is eligible to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.
Board of Directors

In July 2017, Laurent Fischer, M.D. was appointed to the Board of Directors (BOD). Dr. Fischer has more than 20 years of experience in developing and commercializing novel medicines in the biopharmaceutical industry and currently serves as liver therapeutic area head at Allergan following its acquisition of Tobira Therapeutics in 2016.
In June 2017, David Parkinson, M.D. was appointed to the BOD. Dr. Parkinson has significant experience in oncology clinical development and currently is President and Chief Executive Officer of Essa Pharmaceuticals, Inc and has also served as a venture partner at New Enterprise Associates (NEA), Inc. since 2012 moving into the role of venture advisor to NEA in 2016.
"Over the last quarter we have worked hard to become a leaner, more focused company that is adequately financed to meet our objectives," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "The EMA validated the MAA for pacritinib which is now under review and the PAC203 trial is now enrolling. Our cash position has improved through an expanded partnership with Servier and the recent $45 million financing. Changes to the board have added three new independent board members with many years of experience in successfully developing and commercializing novel therapeutics."

Second Quarter Financial Results

Total revenues for the second quarter and six months ended June 30, 2017, were $22.2 million and 23.0 million, respectively, compared to $7.4 million and $43.8 million for the respective periods in 2016. The increase in total revenues for the second quarter compared to the same period in 2016 is primarily due to license and contract revenue that includes the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI with Servier and the receipt of a payment from Teva Pharmaceutical Industries Ltd. related to the achievement of sales milestones for TRISENOX (arsenic trioxide). The decrease in total revenues for the six months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the second quarter and six months ended June 30, 2017, were $0.3 million and $1.0 million, respectively, compared to $1.1 million and $2.3 million for the respective periods in 2016

GAAP operating income for the second quarter was $5.3 million and GAAP operating loss for the six months was $14.0 million for the period ended June 30, 2017, compared to GAAP operating loss of $19.1 million and $14.9 million for the respective periods in 2016. Non-GAAP operating income, which excludes non-cash share-based compensation expense, for the second quarter was $6.4 million and non-GAAP operating loss for the six months was $11.1 million for the period ended June 30, 2017, compared to non-GAAP operating loss of $16.7 million and $8.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2017, was $1.1 million and $2.9 million, respectively, compared to $2.3 million and $6.2 million for the respective periods in 2016. Operating income in the second quarter of 2017 as compared to an operating loss for the same period in 2016 resulted primarily from the increase in license and contract revenue as mentioned above and decrease in research and development and selling, general and administrative expenses. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net income for the second quarter of 2017 was $1.0 million, or $0.03 per share, compared to a net loss of $19.8 million, or ($0.71) per share, for the same period in 2016. Net loss for six months ended June 30, 2017, was $18.8 million, or ($0.63) per share, compared to a net loss of $16.5 million, or ($0.59) per share, for the same period in 2016.

As of June 30, 2017, cash and cash equivalents totaled $74.7 million, compared to $44.0 million at December 31, 2016.

Corvus Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update

On August 3, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the second quarter ended June 30, 2017, and provided a business update (Press release, Corvus Pharmaceuticals, AUG 3, 2017, View Source [SID1234520021]).

"We continue to make significant progress in advancing the clinical development of our lead product candidate, CPI-444, and other product candidates in our immuno-oncology pipeline," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We presented results from our ongoing Phase 1/1b study at the recent ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating promising clinical activity with CPI-444 in patients with non-small cell lung cancer and renal cell cancer who are resistant or refractory to prior anti-PD-(L)1 therapy. This is a difficult-to-treat and growing patient population, as there are very few treatment options for patients who have been given checkpoint inhibitor therapy, but whose disease has either continued to advance or has returned. With CPI-444 and other product candidates in our pipeline targeting the adenosine pathway, we now have several novel agents focused on this important new target in immuno-oncology."

RECENT ACHIEVEMENTS AND UPCOMING MILESTONES
Clinical and Preclinical

Continued enrolling patients in four expansion cohorts in the ongoing disease-specific expansion part of the Phase 1/1b clinical study of CPI-444, the Company’s lead oral checkpoint inhibitor. The expanded cohorts include treatment with CPI-444 both as a single agent and in combination with atezolizumab (Tecentriq), an anti-PD-L1 antibody, in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC). Corvus plans to present additional data from this study at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in November 2017.
Presented interim safety and efficacy data from 75 patients with RCC or NSCLC enrolled in the Phase 1/1b study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting. The data showed that treatment with CPI-444 both as a single agent and in combination with atezolizumab resulted in anti-tumor activity in patients resistant or refractory to prior treatment with anti-PD-(L)1 antibodies and in patients with PD-L1 negative tumors.
Entered into a second collaboration agreement with Genentech to evaluate CPI-444 in combination with atezolizumab in a Phase 1b/2 clinical study as second-line therapy in patients with NSCLC who are resistant/refractory to prior anti-PD-(L)1 antibody therapy. Genentech and Corvus will share the costs of the trial that is expected to be initiated in the fourth quarter of 2017.
Continued to progress the anti-CD73 antibody program toward Phase 1 study initiation in the first half of 2018.
Continued to progress both A2B receptor antagonist and ITK inhibitor programs. Preclinical findings with a candidate A2B receptor antagonist indicate that it may enhance immune responses to certain tumors. These findings, which suggest the possible use of A2A receptor and A2B receptor antagonists in combination therapy, may lead to selection of a lead clinical candidate A2B receptor antagonist in 2018.
Initiated development of an in-licensed antibody-based product candidate that inhibits a novel target in the adenosine pathway.
Corporate

Held an R&D Day titled "The Adenosine Pathway: Extending the Reach of Cancer Immunotherapy." An archive of the webcast is available in the "Investors" section of the Company’s website.
Licensed global rights to an undisclosed novel immuno-oncology program, which includes a lead product candidate, from Monash University.
FINANCIAL RESULTS
At June 30, 2017, Corvus had cash, cash equivalents and marketable securities totaling $110.3 million. This compared to cash, cash equivalents and marketable securities of $134.9 million at December 31, 2016.

Research and development expenses for the three months ended June 30, 2017, totaled $12.4 million compared to $7.1 million for the same period in 2016. The increase of $5.3 million was primarily due to an increase of $3.0 million in outside clinical trial and contracted research costs associated with the Phase 1/1b clinical trial for CPI-444, an increase of $1.2 million in drug manufacturing costs for the anti-CD73 antibody program, and an increase of $0.7 million in drug manufacturing costs for the ITK program.

General and administrative expenses for the three months ended June 30, 2017, totaled $2.8 million compared to $1.7 million for the same period in 2016. The increase of $1.1 million was primarily due to an increase of $0.4 million in personnel and associated costs, primarily due to an increase in headcount, a $0.3 million increase in legal and accounting costs, and an increase of $0.3 million in costs associated with being a public company.

The net loss for the three months ended June 30, 2017, was $15.0 million compared to $8.6 million for the same period in 2016. Total stock compensation expense for the three months ended June 30, 2017, was $1.5 million compared to $1.1 million for the same period in 2016.

Bristol-Myers Squibb to Acquire IFM Therapeutics to Strengthen Oncology Pipeline Focus on Innate Immunity

On August 3, 2017 Bristol-Myers Squibb Company (NYSE:BMY) and IFM Therapeutics (IFM) reported that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders (Press release, Bristol-Myers Squibb, AUG 3, 2017, View Source [SID1234520020]).

The acquisition will give Bristol-Myers Squibb full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer, and is an example of Bristol-Myers Squibb’s continued focus on leveraging external innovation to expand and develop its portfolio of transformative medicines. IFM’s STING agonist program includes a lead asset that accelerates the company’s efforts against this target, while the NLRP3 agonist program includes a potential first-in-class pipeline candidate.

"Targeting innate immunity pathways represents a potentially differentiated approach in immuno-oncology designed to initiate and augment immune responses that may help the body’s natural defenses better recognize and attack tumors," said Thomas Lynch, Jr., M.D., executive vice president, chief scientific officer, Bristol-Myers Squibb. "The addition of STING and NLRP3 agonist programs broadens our ability to investigate additional pathways across the immune system and complements our immuno-oncology portfolio. We look forward to advancing the development of these important programs initiated by Gary Glick, his leadership team and leading academic and industry experts across immunology and oncology."

"A comprehensive body of preclinical data support the continued research of IFM’s NLRP3 and STING agonists with a goal of uncovering their potential benefit to patients, particularly those not served by currently available cancer immunotherapeutics. Based on its deep expertise and leadership positions in immunology, oncology, and immuno-oncology, Bristol-Myers Squibb is uniquely positioned to accelerate these programs and maximize their potential," said Gary D. Glick, Ph.D., CEO and co-founder of IFM Therapeutics.

"The company is delighted by the validation this deal brings to IFM’s technology, and under the stewardship of Bristol-Myers Squibb, researching the promise it holds for potentially improving the lives of patients," said Jean-François Formela, M.D., chair of the IFM board.

Under the terms of the agreement, Bristol-Myers Squibb will pay $300 million upon closing of the transaction. IFM stockholders also will be entitled to additional contingent payments of up to $1.01 billion for each of the first products from the two programs upon the achievement of certain development, regulatory and sales milestones. Also, IFM is eligible for additional contingent milestone payments for further products resulting from these programs. In connection with the acquisition, a newly formed entity will be established by the current shareholders of IFM – IFM Therapeutics LLC – and it will retain IFM’s current personnel and facilities, as well as its remaining research programs, which include an NLRP3 antagonist program focused on curbing immune responses that lead to inflammatory diseases and fibrosis. In consideration of an additional payment at closing and future investment, Bristol-Myers Squibb will be granted at closing certain rights against the newly formed entity’s NLRP3 antagonist program, including a right of first refusal.

The transaction has been approved by the boards of directors of both companies and by the stockholders of IFM.

Bristol-Myers Squibb and IFM anticipate the transaction will close during the third quarter of 2017. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.