On April 23, 2018 Pfizer Inc. (NYSE:PFE) reported that the European Commission has approved MYLOTARG (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL) (Press release, Pfizer, APR 23, 2018, View Source [SID1234525590]). MYLOTARG is the first and only AML therapy approved in the European Union (EU) that targets CD33, an antigen expressed on AML cells in up to 90% of patients.1,2,3

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"The marketing authorization of MYLOTARG provides a much-needed treatment option offering renewed hope for many acute myeloid leukemia patients in Europe," said Andreas Penk, M.D., regional president, Pfizer Oncology. "In clinical trials, the addition of MYLOTARG to standard chemotherapy resulted in deeper, more durable remission, thus providing an additional treatment option with the potential to prevent relapse for these patients."

AML is a rapidly progressing, life-threatening blood and bone marrow cancer.4 If left untreated, patients with AML will die within months, if not weeks, of their disease. AML is the most common type of acute leukemia in adults and accounts for approximately 80% of all cases of acute leukemia.5About 16,800 people are expected to be newly diagnosed with AML in Europe annually.6 The goal of AML treatment is for the patient to achieve a complete, prolonged remission. Longer periods of remission prior to relapse are associated with better long-term outcomes for patients. Thus, medicines that delay the time until the disease comes back and extend life can provide meaningful clinical benefit.

"I am thrilled that MYLOTARG will be available soon in Europe as a first-line treatment for patients with acute myeloid leukemia," said Doctor Sylvie Castaigne, Professeur des Universités, Université de Versailles – Saint Quentin, Praticien Hospitalier, Centre Hospitalier de Versailles, and lead investigator of the ALFA-0701 study. "This important milestone is a result of close collaboration between Pfizer and clinical investigators around the world, particularly the ALFA investigators in France, who believed in the promise of this therapy. We thank all of the investigators, nurses and patients who participated in these studies."

The European Commission’s approval of MYLOTARG was based on data from an investigator-led, Phase 3 randomized, open-label study (ALFA-0701) in previously untreated, de novo patients. MYLOTARG received approval by the U.S. Food and Drug Administration in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

Pfizer is advancing a broad range of therapies that leverage multiple pathways and mechanisms of action (MOAs) to address acute and chronic leukemias, myeloproliferative disorders and lymphomas. Pfizer currently has four marketed therapies for hematologic cancers worldwide as well as several therapies in clinical development. Pfizer is also forging collaborations with a diversity of industry, academic and community partners to study multiple paths to advancing treatment. By working together, Pfizer and its partners aim to overcome the challenges of hematologic cancers and deliver meaningful benefits to patients.

Indication for MYLOTARG (gemtuzumab ozogamicin) in the EU

MYLOTARG is approved in combination with daunorubicin and cytarabine for the treatment of patients age 15 and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL).

IMPORTANT MYLOTARG (gemtuzumab ozogamicin) SAFETY INFORMATION in the EU

The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukemia from the combination therapy study ALFA-0701, monotherapy studies, and from post-marketing experience.

Hepatotoxicity, including life-threatening, and sometimes fatal hepatic failure and VOD/SOS have been reported in patients treated with MYLOTARG. Other special warnings and precautions include myelosuppression and infusion-related reactions.

In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), hemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%). In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).

The most common adverse reactions (> 30%) in the combination therapy study were hemorrhage and infection. In monotherapy studies the most common adverse reactions (> 30%) included pyrexia, nausea, infection, chills, hemorrhage, vomiting, thrombocytopenia, fatigue, headache, stomatitis, diarrhea, abdominal pain, and neutropenia.

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, hemorrhage and infection. The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, hemorrhage, multi-organ failure, and VOD.

The EU Summary of Product Characteristics (SmPC) will be available at View Source

About MYLOTARG (gemtuzumab ozogamicin)

MYLOTARG is an antibody-drug conjugate (ADC) composed of the cytotoxic agent calicheamicin, attached to a monoclonal antibody (mAB) targeting CD33, an antigen expressed on the surface of myeloblasts in up to 90 percent of AML patients.1,2,3When MYLOTARG binds to the CD33 antigen on the cell surface it is absorbed into the cell and calicheamicin is released causing cell death.2,3

MYLOTARG was approved by the U.S. Food and Drug Administration in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

MYLOTARG originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing, clinical development and commercialization activities for this molecule.

Pfizer also collaborated with SFJ Pharmaceuticals Group on the registrational program for MYLOTARG.

On April 23, 2018 Pfizer Inc. (NYSE:PFE) reported that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar (Press release, Pfizer, APR 23, 2018, View Source [SID1234525591]). In the CRL, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application. Pfizer is working closely with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the U.S.

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Pfizer believes that biosimilars are critically important to the future of cancer care, with the potential to increase patient access to life-changing therapies that will help address the evolving needs of healthcare systems, patients, physicians and payers.

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of April 23, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer’s proposed trastuzumab biosimilar, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; uncertainties regarding the company’s ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when any applications for Pfizer’s proposed trastuzumab biosimilar may be filed with regulatory authorities in any other jurisdictions; whether and when the FDA may approve the biologics license application for Pfizer’s proposed trastuzumab biosimilar and whether and when regulatory authorities in any other jurisdictions may approve any such other applications that are pending or that may be filed for Pfizer’s proposed trastuzumab biosimilar, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether Pfizer’s proposed trastuzumab biosimilar will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Pfizer’s proposed trastuzumab biosimilar ; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

On April 21, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that preliminary results from the ongoing Phase 2 study of MP0250 with bortezomib and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) were presented at the 1st European Myeloma Network Meeting in Turin (Press release, Molecular Partners, APR 21, 2018, View Source [SID1234525567]).

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The presentation in Turin focused on results from the first dose cohort of MP0250 with respect to safety and efficacy. Eight patients were treated with 8 mg/kg of MP0250 and five out of these eight patients showed a documented response: Four patients reached a partial response (PR) and one patient reached a very good partial response (VGPR) at the cut-off date. Four out of the five patients are still on treatment with individual treatment durations of 13, 21, 24 and 33 weeks, respectively. The safety profile was consistent with the known safety profiles of bortezomib and MP0250, respectively. The independent dose escalation committee recommended to continue the clinical study at the higher dose of 12mg/kg and the first patient in the second dose cohort has been dosed recently.

Prof. Dr. Hartmut Goldschmidt (Medical Clinic V, University clinic Heidelberg), the Primary Investigator of the phase 2 study, commented: "We are encouraged by the initial efficacy and good tolerability data of MP0250 in combination with bortezomib and dexamethasone. Despite upcoming new treatment options, multiple myeloma remains an incurable disease and new molecules with innovative mechanism of actions are needed."

"We are pleased by the remarkable activity and the good safety profile that we have seen in the first cohort of this study. We are looking forward to patients being treated with the higher dose of MP0250 (12 mg/kg) and the additional phase 1b/2 study of MP0250 in combination with osimertinib in EGFR-mutated NSCLC," said Dr. Andreas Harstrick, Chief Medical Officer at Molecular Partners.

MP0250 is a proprietary DARPin drug candidate neutralizing VEGF and HGF and thus blocking key escape pathways and resistance. Increases in VEGF and HGF are associated with disease progression in multiple myeloma and have been linked to poor prognosis. They are known to be able to stimulate neovascularization, bone destruction, and myeloma proliferation, migration, and adhesion in the bone marrow. MP0250 shows activity in many preclinical tumor models, including in multiple myeloma models in which it enhances the effects of bortezomib on inhibition of M protein production and bone lysis and reduces invasion of tumor cells. MP0250 has shown a favorable safety profile in a phase 1 clinical study in 45 patients with advanced solid tumors.

In the ongoing phase 2 clinical study[1], the safety and efficacy of MP0250 is examined in combination with bortezomib (Velcade) and dexamethasone in patients with relapsed and refractory multiple myeloma (RRMM) who have failed standard therapies. The study is performed in Germany, Poland and Italy. A total of 40 patients are planned to be treated, 12 patients in the dose-escalation phase (Part 1) to establish a safe dose, and an additional 28 patients in the dose-expansion phase (Part 2) resulting in a total of 34 patients at the target dose.

Additional safety and efficacy data are expected by the end of 2018.

An additional phase 1b/2 study will evaluate MP0250 in combination with osimertinib in patients with EGFR-mutated NSCLC pretreated with osimertinib. The study is conducted in the US and is open for patient enrollment2.

[1] ClinicalTrials.gov identifier NCT03136653
2 ClinicalTrials.gov identifier NCT03418532

Financial Calendar
April 26, 2018 – Q1 2018 Management Statement
August 30, 2018 – Publication of 2018 Half-year Results
November 01, 2018 – Q3 2018 Management Statement
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.
Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On April 20, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported promising early data from an investigator-initiated pilot study evaluating the combination of CDX-301 and stereotactic body radiotherapy (SBRT) in patients with advanced non-small cell lung cancer (NSCLC). CDX‑301 (recombinant human Flt3 ligand) is a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells (Press release, Celldex Therapeutics, APR 20, 2018, View Source [SID1234525560]). This translational study is the culmination of significant preclinical research into strategically combining radiation and immunotherapy to effectively treat aggressive tumors and is supported by a Small Business Innovation Research (SBIR) grant from the National Cancer Institute to Celldex in collaboration with Albert Einstein College of Medicine, part of Montefiore. The data were presented during a plenary session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 earlier this week by Nitin Ohri, M.D., Attending Physician, Montefiore and Assistant Professor, Department of Radiation Oncology, Einstein, and principal investigator on the study.

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The concept that increasing the number of dendritic cells with Flt3 ligand combined with an ablative course of radiation to the primary tumor induces a systemic anti-tumor response, suppresses metastases and promotes survival and immune memory was demonstrated through preclinical studies led by Dr. Chandan Guha and colleagues at the Einstein College of Medicine.1 Based on this seminal work, a Phase 2 pilot study of CDX-301 in combination with SBRT was initiated at the Montefiore Einstein Center for Cancer Care. The study is currently enrolling up to 29 patients, and the primary objective is progression-free survival at four months after treatment (PFS4). Key secondary objectives include evaluation of dose-limiting toxicities and response rate in non-irradiated tumors, where tumor shrinkage from radiation therapy or CDX-301 independently would not be expected. Responses were particularly impressive when classified by PERCIST (PET Response in Solid Tumors) criteria, in which a partial response is at least a 45% reduction of total glycolytic activity, a volumetric measure of disease burden. The presentation included data from nine patients, seven of whom were previously treated with anti-PD(L)1 checkpoint inhibitors. The one-week course of treatment included subcutaneous injections of CDX-301 and SBRT directed to a single lung tumor lesion.

Key Highlights

PFS4 was achieved in 56% (5/9) of patients overall (n=9; enrollment ongoing) and in 100% (5/5) of patients who experienced partial responses (PRs) by PERCIST
Notably, PRs were observed in non-irradiated tumors in 56% (5/9) of patients at two months; 3 PRs (3/9) were confirmed by immune-related response criteria (irRC)
In the patients previously treated with immune checkpoint inhibitors, 71% (5/7) experienced PRs and PFS4 versus 0% (0/2) in patients not treated with an anti-PD(L)1 therapy
SBRT in combination with CDX-301 induced and reactivated anti-tumor immune responses in patients who had progressive disease on checkpoint inhibitors
No dose-limiting toxicities were observed
"The combination of CDX-301 and radiation produced a significant decrease in tumor burden after just one course of treatment, even in non-irradiated tumors. We saw a longer period of survival for several of our patients with advanced lung cancer," said Dr. Ohri. "We are looking forward to completing enrollment in the study, determining an optimal dosing regimen and identifying additional immune modulating agents."

"Of particular interest is the potential correlation of clinical benefit with those patients who previously were treated with PD-1 blockade therapy, suggesting SBRT and CDX-301 may be able to reboot the immune system for an effective anti-tumor response," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "We believe that the activity of this combination may potentially be augmented by the addition of CDX-1140, our unique CD40 agonist antibody, which is designed to activate dendritic cells and is currently in a Phase 1 dose-escalation study."

Additionally, Celldex and its collaborating investigators presented four posters at the AACR (Free AACR Whitepaper) Annual Meeting 2018:

Poster CT058: Molecular and clinical activity of CDX-3379, an anti-ErbB3 monoclonal antibody, in head and neck squamous cell carcinoma: A preoperative "window of opportunity" study (Duvvuri, et al)

A "window-of-opportunity" study enrolled 12 patients to evaluate the effect of CDX-3379 on phosphorylated ErbB3 (pErbB3) and other potential biomarkers in patients with head and neck squamous cell carcinoma (HNSCC). Patients with newly diagnosed HNSCC received two doses of CDX-3379, at a two-week interval prior to tumor resection. CDX-3379 reduced pErbB3 levels in 83% (10/12) of patient samples, with greater than or equal to 50% decreases in 58% of patients (7/12), which met the primary study objective. Stable disease was observed in 92% (11/12) of patients prior to surgery, and a patient with HPV-negative disease experienced significant tumor shrinkage (92% in primary tumor; 26% in metastatic lesion). CDX-3379 was well-tolerated, and no treatment-related adverse events were observed.
Poster 876: Effective reduction of PD-L1 expression by simultaneous blockade of EGFR and HER3 (ErbB3) in head and neck cancer (Chen, et al)

Investigators examined the effects of combining CDX-3379, a monoclonal antibody targeting ErbB3, and cetuximab, a monoclonal antibody targeting EGFR, in xenograft models of head and neck squamous cell carcinoma. Combining CDX-3379 and cetuximab inhibited tumor growth more potently than cetuximab alone. Mechanistic studies demonstrated a reduction of PD-L1 expression from the combination.
Poster 3816: Efficacy of CDX-1140, an agonist CD40 antibody, in preclinical tumor models (Thomas, et al)

Building off previously presented preclinical work, CDX-1140 was further characterized showing tumor shrinkage and prolonged survival in several xenograft models. These preclinical studies support the potential of CDX-1140 having direct anti-tumor effects on CD40-positive tumors that may supplement its activity as an immune activating agent.
Poster 5624: Development of novel bispecific immune modulating antibodies (Vitale, et al)

Celldex’s initial bispecific antibody (BsAb) couples CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway, using novel highly active anti-PD-L1 antibodies. The BsAb was more potent in human T cell activation and anti-tumor activity, compared to the combined CD27 and PD-L1 antibodies. Enhanced efficacy has been attributed to more efficient cross-linking of the BsAb/CD27 receptor, resulting in stronger T cell activation.
The CDX-301 presentation and all posters are available on the "Publications" page of the "Science" section of the Celldex website.

About CDX‑301
CDX-301 (Flt3L) is a potent hematopoietic cytokine that has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies, including CD141+ dendritic cells critical for cross-presenting tumor antigens to cytotoxic T cells. In addition, CDX‑301 has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. Celldex believes this ligand may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company’s portfolio.

About CDX-3379
CDX-3379 is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that selectively binds and inhibits ErbB3 activity. ErbB3 may be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies, and it is expressed in many cancers, including head and neck, thyroid, breast, lung and gastric cancers, as well as melanoma. The proposed mechanism of action for CDX-3379 sets it apart from other drugs in development in this class due to its ability to block both ligand-independent and ligand-dependent ErbB3 signaling by binding to a unique epitope. It has a favorable pharmacologic profile, including a longer half-life and slower clearance relative to other drug candidates in this class. CDX-3379 also has potential to enhance anti-tumor activity and/or overcome resistance in combination with other targeted and cytotoxic therapies to directly kill tumor cells.

About CDX-1140
CDX-1140 is a fully human monoclonal antibody targeted to CD40, a key activator of immune response that is found on dendritic cells, macrophages and B cells and is also expressed on many cancer cells. Potent CD40 agonist antibodies have shown encouraging results in early clinical studies; however, systemic toxicity associated with broad CD40 activation has limited their dosing. CDX-1140 has unique properties relative to other CD40 agonist antibodies: potent agonist activity is independent of Fc receptor interaction, contributing to more consistent, controlled immune activation; CD40L binding is not blocked, leading to potential synergistic effects of agonist activity with activated T cells in lymph nodes and tumors; and the antibody does not promote cytokine production in whole blood assays. CDX-1140 activates dendritic cells and other CD40 expressing cells and has also shown direct anti-tumor activity in preclinical models of lymphoma. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.

References
1. Chakravarty, et al. Cancer Res. 1999. 59(24):6028-32.

On April 20, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, May 4, 2018 to discuss its first quarter operating results (Press release, ImmunoGen, APR 20, 2018, View Source [SID1234525561]). Management also will provide a brief update on the business.

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Conference Call Information
To access the live call by phone, dial 719-325-4799; the conference ID is 2070974. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through May 18, 2018