On December 7, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to improving patient outcomes through the power of the innate immune system, reported its registrational pathway, updated clinical development plans and the estimated market opportunity for the Company’s lead candidate AFM13 – a first-in-class innate cell engager – at its Research & Development Day in New York City (Press release, Affimed, DEC 7, 2018, View Source [SID1234531950]).

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Affimed plans to initiate a Phase 2 study evaluating the safety and efficacy of AFM13 as monotherapy in relapsed or refractory peripheral T cell lymphoma (PTCL) and transformed mycosis fungoides (TMF), a subset of cutaneous T cell lymphoma (CTCL) in the first half of 2019. Based on preliminary feedback from the U.S. Food and Drug Administration (FDA) and on data presented at this week’s America Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Affimed believes that results from an open-label, single-arm Phase 2 study could form the basis for a Biologics License Application (BLA) submission and support an accelerated approval, given the unmet medical need for safe and effective new treatments in this hard-to-treat population.

"We believe that the clinical development plan shared today for AFM13 provides potential for accelerated approval and helps to lay the groundwork for further investigations of CD16A innate immune engagers," said Dr. Adi Hoess, Affimed’s CEO. "Through our fit-for-purpose ROCK platform, we continue to generate novel engagers, like AFM13, to broaden our leadership in innate immunity. We look forward to continuing this important work to enhance current immuno-oncology approaches, with the ultimate goal of giving patients back the body’s innate ability to fight cancer."

The broader clinical development strategy for AFM13 includes expanding into other CD30-positive lymphoma indications and additional treatment lines with significant unmet need. In collaboration with strategic partners, Affimed plans to investigate AFM13 in combination with other immunotherapy agents, such as an anti-PD-1/PD-L1 antibody agent and with adoptive NK cell transfer.

"AFM13’s clinical profile to date is very encouraging," said Dr. Leila Alland, Chief Medical Officer of Affimed. "The recently presented data at ASH (Free ASH Whitepaper) increase our confidence that AFM13 holds significant therapeutic value for patients with CD30-positive lymphoma. Our team is looking forward to initiating the registrational study for AFM13 in the first half of 2019 and it is our commitment to develop this potential treatment for patients as quickly as possible."

"Our market research suggests a sizable near-term commercial opportunity for AFM13 with an estimated initial eligible population of about 2,500 patients per year with relapsed or refractory PTCL in the U.S.," said Denise Mueller, Head of Commercial Strategy and Business Development of Affimed. "We believe our clinical development plan for AFM13 combination therapies will further expand the market potential of AFM13 in CD30-positive lymphoma indications such as Hodgkin lymphoma and T cell lymphoma."

Additional Research & Development Day Program Highlights

Dr. Steven M. Horwitz, Associate Attending, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, presented on the current treatment landscape and unmet needs in patients with peripheral and cutaneous T cell lymphomas and Hodgkin lymphoma.

Dr. Ahmed Sawas, Assistant Professor of Medicine, Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, Principal Investigator of the investigator-sponsored Phase 1b/2a trial of AFM13 in CD30-positive lymphoma with cutaneous manifestation led by Columbia University Medical Center, discussed data from the study recently presented at the ASH (Free ASH Whitepaper) Annual Meeting.

Affimed reviewed the updated data from the Phase 1b study of AFM13 as a combination therapy with Merck’s anti-PD-1 antibody Keytruda (pembrolizumab) in relapsed or refractory Hodgkin lymphoma (HL) patients that was presented at the ASH (Free ASH Whitepaper) Annual Meeting.

Dr. Yago Nieto, Professor of Medicine, Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, discussed data from the preclinical research of cord blood derived natural killer cells loaded with AFM13 as off-the-shelf cell therapy for CD30-positive malignancies conducted under Affimed’s sponsored research collaboration with MD Anderson. He concluded that the encouraging data observed in this study, which was featured in an oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting, provide a strong rationale for clinically investigating the strategy of an off-the-shelf adoptive immunotherapy with AFM13-loaded CB-NK cells in patients with relapsed/refractory CD30+ malignancies. Dr. Nieto outlined plans to conduct a clinical study in patients with CD30-positive lymphoma.

Webcast Information

The archived webcast and slides of the presentation are available under the "News & Events" section of Affimed’s website at View Source and will be available for 30 days following the event.

About AFM13
AFM13 is a first-in-class tetravalent, bispecific NK cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in Hodgkin lymphoma (HL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy in a monotherapy setting in studies in HL and CD30-positive lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD-1 antibody Keytruda (pembrolizumab) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition. AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration.

About Affimed’s ROCK Platform
Affimed’s proprietary, versatile and modular ROCK (Redirected Optimized Cell Killing) platform enables the generation of first-in-class, tetravalent, multi-specific immune cell engagers. Based on its modularity, ROCK allows for antibody engineering of highly customizable innate immune cell and T cell engagers to generate clinical candidates tailored to multiple disease indications and settings, including generation of molecules against validated oncology targets to address the limitations of existing treatments of hematologic and solid tumors.

On December 7, 2018 The board of directors of Medtronic plc (NYSE:MDT) reported the fiscal year 2019 third quarter cash dividend of $0.50 per ordinary share, representing a 9 percent increase over the prior year (Press release, Medtronic, DEC 7, 2018, View Source;p=RssLanding&cat=news&id=2379925 [SID1234531967]). This quarterly declaration is consistent with the dividend announcement made by the company in June 2018. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 41 consecutive years. The dividend is payable on January 18, 2019, to shareholders of record at the close of business on December 28, 2018.

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On December 7, 2018 DiaMedica Therapeutics Inc. ("DiaMedica") (NASDAQ:DMAC) (TSX‑V:DMA), a clinical stage biopharmaceutical company, reported the pricing of its initial public offering in the United States of 4,100,000 of its common shares at a price to the public of $4.00 per share (Press release, DiaMedica, DEC 7, 2018, View Source [SID1234531951]). All of the common shares are being offered by DiaMedica. The common shares are expected to begin trading December 7, 2018 on The Nasdaq Capital Market under the symbol "DMAC." The offering is expected to close on December 11, 2018, subject to the satisfaction of customary closing conditions.

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DiaMedica expects to use the net proceeds from the offering to fund clinical development of DiaMedica’s lead drug candidate, DM199, to conduct research activities and for working capital and general corporate purposes. Craig-Hallum Capital Group LLC is acting as the sole managing underwriter for the initial public offering.

A registration statement relating to these securities has been filed with and was declared effective by the U.S. Securities and Exchange Commission on December 6, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering is being made only by means of a prospectus. A copy of the final prospectus related to the offering may be obtained, when available, from Craig-Hallum Capital Group LLC at 222 South Ninth Street, Suite 350, Minneapolis, Minnesota 55402, Attention: Equity Capital Markets, by telephone at 612-334-6300, or by e-mail at [email protected].

On December 7, 2018 Celgene Corporation (NASDAQ: CELG) reported results from the Phase 3 AUGMENT study, showing that REVLIMID (lenalidomide) in combination with rituximab (R 2 ) has resulted in a progression-free survival (PFS) higher in patients with relapsing / refractory indolent lymphoma than patients treated with rituximab plus placebo (R-placebo) (Press release, Celgene, DEC 7, 2018, View Source [SID1234531952]). The data were presented by John Leonard during an oral presentation at the 60th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), which took place in San Diego, California.

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The international randomized, double-blind phase 3 clinical study evaluated the efficacy and safety of the experimental combination of R 2 compared to rituximab plus placebo in patients (n = 358) with follicular lymphoma (n = 295) and lymphoma of the area marginal (n = 63) recurrent / refractory. In the study, the R 2 arm demonstrated a statistically significant improvement in the primary progression-free survival endpoint (PFS), assessed by an independent review board, compared to the R-placebo arm. Mean PFS was 39.4 months for patients treated with R 2 versus 14.1 months for patients treated with R-placebo (P <0.0001; HR: 0.46; 95% CI, 0.34-0.62).

«Data from the AUGMENT study, with R 2 more than doubling progression-free survival compared to rituximab monotherapy, represents a possible new and important treatment option for patients with follicular lymphoma or the relapsing / refractory marginal zone» , said John Leonard , researcher responsible for the AUGMENT study, The Richard T. Silver Distinguished Professor of Hematology and Medical Oncology and Director of the Joint Clinical Trials Office at Weill Cornell Medicine, who also served as a consultant for Celgene.

Overall survival (OS), a secondary endpoint, showed a positive trend in terms of improvement in the R 2 arm compared to the control arm (lethal events: 16 vs 26) (HR: 0.61; 95% CI, 0, 33 to 1.13). The two-year OS rate was 93% for patients treated with R 2 and 87% for patients treated with R-placebo.

The overall response rate (ORR), another secondary endpoint, was 78% (n = 138) in the R 2 arm compared to 53% (n = 96) of the R-placebo arm, according to the independent review committee. The duration of the response (DoR) was significantly increased for R 2 compared to R-placebo with medial DoR of 37 vs 22 months respectively (P = 0.0015; HR: 0.53; 95% CI, 0.36-0 , 79).

The most frequent adverse event (AE) in the R 2 arm was neutropenia (58%), vs. 22% in the R-placebo arm. Other AEs commonly seen in more than 20% of patients included diarrhea (31% in the R 2 arm vs. 23% in the R-placebo arm), constipation (26% vs. 14%, respectively), cough (23% vs. 17% ) and fatigue (22% vs. 18%). Adverse events most commonly reported (> 10%) in the R arm 2 were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and acute exacerbation of symptoms tumor ( tumor flare reaction) . During the AUGMENT study no unexpected results were observed in terms of safety.

"These data represent a new, potential treatment strategy for patients with relapsing / relapsing indolent non-Hodgkin’s lymphomas , " said Celgene’s president of Global Clinical Development, Alise Reicin . "We are anticipating the submission of authorization applications for the first quarter of 2019. to allow patients to access this important combination as soon as possible . "

The use of REVLIMID , alone or in combination with other agents, is currently not approved in any country in the treatment of follicular lymphoma or in that of marginal zone lymphoma.

Information on REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (des) is indicated for the treatment of patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated in the treatment of patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS) at low or intermediate risk 1, associated with a cytogenetic abnormality with 5q deletion, with or without further cytogenetic abnormalities.

REVLIMID is indicated for the treatment of patients with recurrent mantle cell lymphoma (MCL) or with progression of the disease after 2 previous therapies, one of which includes bortezomib.

REVLIMID is not recommended or recommended for the treatment of patients with chronic lymphatic leukemia (LLC) outside of controlled clinical trials.

On December 7, 2018 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported its positive preclinical data on the company’s lead clinical candidate, ARV-471, for advanced or metastatic ER-positive/HER2-negative breast cancer at the 2018 San Antonio Breast Cancer Symposium (SABCS), taking place December 4-8 in San Antonio, Texas (Poster P5-04-18; Session 5: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance) (Press release, Arvinas, DEC 7, 2018, View Source [SID1234531969]). In this study, orally administered ARV-471 demonstrated improved potency and anti-tumor activity both as a monotherapy and in combination with a CDK4/6 inhibitor, compared to current standard of care treatment regimens.

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"We believe that ARV-471 has the potential to be the first oral protein degrader for the treatment of patients with metastatic ER-positive/HER2-negative breast cancer, when used either as a single-agent or in combination with other routinely used anti-cancer agents," said John Houston, Ph.D., President and CEO of Arvinas. "This data reinforces our growing confidence that our PROTAC protein degraders have the potential to provide distinct advantages over existing approaches across a broad range of disease targets and to improve clinical outcomes over current standard of care. We continue to expect to initiate our Phase 1 clinical trial of ARV-471 in mid-2019."

Key highlights from the poster "ARV-471, an oral estrogen receptor PROTAC degrader for breast cancer":

Orally bioavailable ARV-471 demonstrated potent ERa degradation in wild-type and mutant ERa-expressing cell lines.
Oral administration of ARV-471 caused near-complete ERa degradation and resulted in tumor shrinkage in an orthotopic MCF7/estradiol breast cancer preclinical model; ARV-471 demonstrated superior tumor growth inhibition and ERa degradation compared to standard-of-care agent, fulvestrant.
Combination of ARV-471 and a CDK4/6 inhibitor demonstrated superior tumor growth inhibition when compared to the combination of fulvestrant and a CDK4/6 inhibitor.
ARV-471 inhibited growth of tamoxifen-resistant and ERa gene (ESR1) mutant tumors while also reducing tumor ERa levels.
ARV-471 displayed no ER agonist activity.