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DiaMedica Announces Pricing of Initial Public Offering and Nasdaq Listing

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].

Affimed Announces U.S. Registrational Pathway and Updated Clinical Development Plan for AFM13 at R&D Day

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]).

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.

Update on the Phase III EAGLE trial of Imfinzi and tremelimumab in advanced head and neck cancer

On December 7, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported overall survival (OS) results for the Phase III EAGLE trial. EAGLE is a randomised, open-label, multi-centre trial evaluating Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression following platinum-based chemotherapy, regardless of their PD-L1 tumour status (Press release, AstraZeneca, DEC 7, 2018, View Source [SID1234531946]).

Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy in these hard-to-treat patients. The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous experience.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "The prognosis for recurrent or metastatic head and neck squamous cell cancer is very poor and new treatments for this group of cancers are urgently needed. While these results are disappointing, we remain committed to evaluating the potential of Imfinzi and other innovative medicines for patients with head and neck cancer. We look forward to seeing the results of the Phase III KESTREL trial of Imfinzi and tremelimumab in patients who have not received prior chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma in the first half of 2019."

AstraZeneca will submit the results from the Phase III EAGLE trial for presentation at a forthcoming medical meeting.

About EAGLE
The EAGLE trial is a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab compared to standard-of-care chemotherapy in patients with recurrent or metastatic HNSCC who experienced progression following platinum-based chemotherapy, regardless of their PD-L1 tumour status.

The trial was conducted at 169 centres across 24 countries including the US, Europe, South America, Japan, Korea, Taiwan, Israel and Australia. The primary endpoint of the trial was OS, and secondary endpoints included progression-free survival, landmark OS, objective response rate and duration of response.

About HNSCC
Approximately 880,000 patients were diagnosed with head and neck cancer around the world in 2018. Two-thirds of patients diagnosed with head and neck cancer are in advanced stages (Stage III or IV), while the remaining one third are in the early stages of disease (Stage I or II). More than 90% of all head and neck cancers start in the squamous cells that line the mouth, nose and throat called head and neck squamous cell carcinomas (HNSCC).

About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III non-small cell lung cancer (NSCLC) in more than 40 countries including the US, EU, and Japan based on the Phase III PACIFIC trial. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Israel, India, United Arab Emirates, Australia and Hong Kong.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small-cell lung cancer (SCLC), bladder cancer, head and neck cancer and other solid tumours.

About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation and boosting the immune response to cancer. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and neck squamous cell carcinoma, liver cancer and blood cancers.

About AstraZeneca’s approach to immuno-oncology
IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumours.

Site Visit Planned for December 19, 2018 to Initiate Phase 2 Trial of ProscaVax for Early-Stage Prostate Cancer

On December 7, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, is reported to provide an update on the Phase 2 clinical trial of ProscaVax being hosted at Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University (Press release, Oncbiomune, DEC 7, 2018, View Source [SID1234531944]). In the clinical trial, ProscaVax, the Company’s lead immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), is being evaluated for safety and efficacy in patients with low-risk localized prostate cancer compared to patients in "Active Surveillance."

OncBioMune has confirmed that a site visit is scheduled for December 19, 2018. This is the check-off meeting before beginning enrollment in the clinical trial, which is expected to transpire in the coming weeks.

"I’m very pleased to say that we are now staring down a major milestone for our company with the site visit to be followed by patient enrollment," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Enrollment of the first patient in the study is not only a watershed moment for our company and stakeholders, but for the oncology community as a whole. This is the first Phase 2 clinical trial of its type evaluating a therapeutic immunotherapy vaccine in early stage prostate cancer, a stage in disease where patients are left with no options other than to wait for disease progression. We are optimistic that ProscaVax will demonstrate a meaningful benefit to these patients in great need and that ProscaVax will set a new benchmark as a front-line treatment for prostate cancer."

Pacira Pharmaceuticals to Present at the 2018 BMO Capital Markets Prescriptions for Success Healthcare Conference

On December 7, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported that it will present at the 2018 BMO Capital Markets Prescriptions for Success Healthcare Conference at 1:20 PM ET on Wednesday, December 12, 2018. Live audio of the presentation can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event (Press release, Pacira Pharmaceuticals, DEC 7, 2018, View Source;p=RssLanding&cat=news&id=2379929 [SID1234531942]).