On May 22, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that the United States Food and Drug Administration (FDA) approved the Company’s investigational device exemption (IDE) application for its NanoKnife Irreversible Electroporation pilot study for the ablation of prostate cancer tissue in low-risk patients (Press release, AngioDynamics, MAY 22, 2019, View Source [SID1234536531]).

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The prospective, non-randomized pilot study includes six subjects at up to three clinical sites. The pilot study is intended to inform the design of a pivotal clinical study in the United States to support the approval of a future Premarket Approval Application (PMA).

"On the heels of our first patient enrollment in our Stage III pancreatic cancer IDE, we are excited to receive approval to conduct a separate pilot IDE for the treatment of prostate cancer," said Brent Boucher, AngioDynamics Senior Vice President and General Manager of Oncology. "This pilot study represents the next step in our comprehensive approach to establish NanoKnife as a platform technology to treat numerous cancers and conditions."

Prostate cancer is the second leading cause of cancer death in American men1. Approximately one man out of every nine will be diagnosed with prostate cancer during his lifetime1. Traditional treatment options have focused on standard whole-gland therapies, such as active surveillance, radical prostatectomy, and external beam radiation2. However, over the last decade, focal therapy has been evaluated as an alternative for select patients diagnosed with localized prostate cancer in order to minimize treatment-related toxicity2.

The NanoKnife System is a unique, minimally invasive technique that has been used to successfully treat focal prostate lesions through irreversible electroporation.

On May 22, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported a presentation at TIDES: Oligonucleotide and Peptide Therapeutics, the world’s largest meeting to accelerate oligonucleotide and peptide products from early discovery to late-stage development and commercialization (Press release, Exicure, MAY 22, 2019, View Source [SID1234536530]).

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The talk, "Preclinical and Clinical Development of AST-008, A Toll-like Receptor Agonist 9 Spherical Nucleic Acid for Immuno-oncology Applications," will be presented by Weston Daniel, Exicure Senior Director of Program Management, at the conference, May 20-23 at Manchester Grand Hyatt in San Diego.

Presentation Date/Time: Wednesday, May 22, 12:45 – 4:35 p.m. PT
Room: Seaport A
Session: Oligonucleotide Discovery, Preclinical and Clinical

On May 22, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a late-stage cancer biotechnology company developing gene-based intratumoral immunotherapies, reported interim data from KEYNOTE-890, an ongoing Phase 2 study of TAVO (intratumoral IL-12) in combination with KEYTRUDA in patients with heavily pretreated, metastatic, chemotherapy refractory triple negative breast cancer (mTNBC) (Press release, OncoSec Medical, MAY 22, 2019, View Source [SID1234536528]). Patients who previously failed an average of 3.5 prior lines of chemotherapy were enrolled in KEYNOTE-890 to evaluate if the addition of TAVO (IL-12) could provide meaningful clinical activity when combined with KEYTRUDA, an anti-PD-1 checkpoint inhibitor.

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Heavily pretreated patients with refractory mTNBC (average of 3.5 prior lines of chemotherapy) showed a rapid tumor reduction of 20% or greater at the initial 3-month evaluation in the first five of 10 patients. Two patients had a partial response, one with a 66% tumor reduction, including a significant reduction of liver lesions, and four patients had stable disease, three of which reported a 20% or greater tumor reduction. These preliminary findings, when compared to the results of KEYNOTE-086, which demonstrated a 5.3% response rate in mTNBC patients treated with KEYTRUDA monotherapy1, suggest TAVO’s ability to unlock KEYTRUDA’s potential anti-cancer efficacy in this very difficult to treat patient population. Four of the six patients who experienced tumor reductions have an ongoing response as of May 9, 2019.

"These interim data are impressive, especially when considering that all of the patients received numerous prior rounds of chemo/radiation with no success, and the safety profile associated with this platform continues to be unparalleled. Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," explained Alain Algazi, M.D., Associate Professor of Clinical Medicine at UCSF and Clinical Strategic Advisor to OncoSec. "Therefore, the marked synergy shown in these patients adds even more support for our earlier findings demonstrating that TAVO primes the tumor microenvironment, dramatically improving the clinical results that would have been anticipated with PD-1/PD-L1 checkpoint treatment alone. The combination of TAVO and KEYTRUDA represents a highly promising new therapeutic approach for TNBC and warrants expedited evaluation."

Of the four patients who progressed following treatment, two received only one cycle of combination treatment prior to rapid clinical deterioration. Importantly, treatment was very well-tolerated, with only three patients reporting Grade 1 TAVO-related adverse events (AE’s). No TAVO-related Grade 2 or above AE’s/SAE’s were reported.

Patients demonstrated encouraging immunological responses in tumor and blood consistent with an IL-12-associated mechanism of action, including on-treatment reduction of the peripheral gMDSC suppressors, which aligns with observed clinical responses. Biomarker analysis of patient tumor and blood samples are ongoing.

The Company has enrolled over half of the targeted enrollment of 25 patients, and expects to complete enrollment and present the clinical data at the San Antonio Breast Cancer Symposium later this year.

Additional details can also be found at www.clinicaltrials.gov here.

To learn more about the trial, visit www.oncosec.com.

About Triple Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three. As a result, TNBC does not respond to therapies targeting these markers, making it more difficult to treat. Approximately 10-20% of patients with breast cancer are diagnosed with TNBC.

About KEYNOTE-890

KEYNOTE-890 is designed as a multicenter Phase 2 open-label trial focusing on patients with a histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. 25 patients are expected to be enrolled. Each patient will undergo 3-week treatment cycles with pembrolizumab administered as a 30-minute IV infusion day 1 of every cycle (flat dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every six weeks.

On May 22, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported a plan to focus its research and development investments on advancing on-going and previously announced clinical trials for its innate cell engager candidates, AFM13 and AFM24 (Press release, Affimed, MAY 22, 2019, View Source [SID1234536527]). As part of the strategic plan, Affimed will terminate the Phase 1 clinical program of AFM11, a CD19/CD3-targeting bispecific T cell engager. The Company also provided an update on recent operational progress and reported financial results for the quarter ended March 31, 2019.

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"We are focused on advancing our CD16A-targeting innate cell engager product candidates as we progress through 2019, with the goals of initiating a market registration-directed study of AFM13 and entering the clinic with AFM24," said Dr. Adi Hoess, Affimed’s CEO. "We strongly believe our innate cell engagers could enhance current immuno-oncology approaches and address unmet patient needs in treating hematologic and solid tumor malignancies. We have determined that the optimal use of our resources at this time is to advance our innate cell engagers, focusing their development on indications with high unmet need and the potential for a rapid path to regulatory approval. In addition to advancing our current clinical product candidates, we are working toward expanding our early clinical stage pipeline and exploring rational combinations of our innate cell engagers with other therapeutic modalities such as adoptive NK cell therapies."

Corporate Updates
Affimed received a milestone payment from Genentech, a member of the Roche Group, triggered by the achievement of a preclinical milestone under its research collaboration with Genentech to develop and commercialize novel natural killer (NK) cell engager-based immunotherapeutics based on Affimed’s ROCK platform to treat multiple cancers.
Dr. Martin Treder has informed Affimed that he intends to step down from his position as Chief Scientific Officer to pursue new opportunities. Dr. Treder will continue as a consultant to the Company.
Dr. Hoess commented, "Martin oversaw the development of Affimed’s ROCK platform. We thank Martin for his many contributions to Affimed during his tenure as CSO, and wish him success in his future endeavors."

Pipeline Updates and Upcoming Clinical Plans
CD16A innate cell engager programs

AFM13 (CD30/CD16A)

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Affimed together with its collaboration partners from Washington University School of Medicine, St. Louis, MO, presented data that describe functional responses of conventional and cytokine-induced memory-like (CIML) NK cells in the presence or absence of AFM13. In a poster titled, "The CD30/CD16A bispecific innate immune cell engager AFM13 elicits heterogeneous single cell NK cell responses and effectively triggers memory like (ML) NK cells," preclinical data showed that AFM13 significantly enhanced NK cell recognition of CD30-positive tumor cells and this enhanced tumor recognition correlated with superior NK cell activation. In the study, the combination of CIML NK cells with AFM13 potentiated cytokine secretion and cytotoxicity towards tumor target cells, further demonstrating the rationale for combining AFM13 with adoptive NK cell-based therapies as a promising therapeutic approach for treating CD30-positive malignancies.
Abstracts providing updates on AFM13 clinical studies have been accepted for oral and poster presentations at the 15th International Conference on Malignant Lymphoma (ICML), to be held from June 18-22, 2019, in Lugano, Switzerland. The oral presentation includes updated data from the combination study of AFM13 with Merck’s Keytruda (pembrolizumab) in patients with relapsed or refractory Hodgkin lymphoma (HL). In addition, a poster presentation will highlight data from the investigator-sponsored study of AFM13 as monotherapy in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestations. Details on these presentations are expected to be available in mid-June through the ICML meeting website at www.lymphcon.ch.
Affimed filed with U.S. Food and Drug Administration (FDA) the full study protocol for the Company’s Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with peripheral T cell lymphoma (PTCL) and transformed mycosis fungoides, a subset of cutaneous T cell lymphoma. The study commencement is targeted for the second half of 2019 pending agreement with the FDA on the final study protocol.
An investigator-sponsored study directed towards development of an off-the-shelf adoptive immunotherapy comprised of AFM13 pre-mixed with expanded cord blood-derived allogeneic NK cells in patients with relapsed/refractory CD30-positive malignancies is planned by The University of Texas MD Anderson Cancer Center (MDACC) with the support of Affimed.
AFM24 (EGFR/CD16A)

At the AACR (Free AACR Whitepaper) Annual Meeting 2019, a poster titled, "Preclinical characterization of the bispecific EGFR/CD16A innate immune cell engager AFM24 for the treatment of EGFR-expressing solid tumors," highlighted potentially differentiating features of AFM24 versus standard of care anti-EGFR therapies, such as the monoclonal antibody cetuximab. AFM24 demonstrated the ability to bridge NK cells and macrophages to EGFR expressing tumor cell lines, and induced lysis through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively, which was independent of RAS mutational status. AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. Importantly, AFM24 showed reduced inhibition of EGFR phosphorylation relative to the standard of care, cetuximab. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when treated at high dose levels, demonstrating AFM24’s potential to have significantly lower toxicities in humans compared to standard of care.
Affimed currently anticipates completing investigational new drug (IND)-enabling studies of AFM24 by mid-year 2019 to support the initiation of the first-in-human study of AFM24 in the second half of 2019.
Financial Highlights
(Figures for the first quarter of 2019 and for the first quarter 2018 are unaudited.)

Pro-forma cash, cash equivalents and short-term deposits, including the milestone payment under the Genentech collaboration that the Company received in April 2019, totaled €100.4 million or approximately $113 million, as of March 31, 2019. Cash, cash equivalents and short-term deposits on December 31, 2018 were €108.8 million. Based on its current operating and budget assumptions, Affimed anticipates that its cash, cash equivalents and short-term deposits as of March 31, 2019 will enable the Company to fund its planned clinical development and early development activities into 2021.

Net cash used in operating activities was €13.4 million for the three months ended March 31, 2019 compared to net cash used in operating activities of €6.9 million for the three months ended March 31, 2018. Total revenue was €11.4 million for the three months ended March 31, 2019 compared to €0.5 million for the three months ended March 31, 2018. The increase in revenue is primarily attributable to the recognition of €10.6 million as revenue from the Genentech collaboration in the first quarter of 2019.

Research and development (R&D) expenses for the first quarter of 2019 were €8.0 million compared to €6.4 million for the first quarter of 2018. The increase was primarily related to higher expenses related to clinical study startup activities for the AFM13 registration study in PTCL, as well as early stage development and discovery activities.

General and administrative (G&A) expenses for the first quarter of 2019 were higher at €2.4 million compared to €2.0 million for the first quarter of 2018. This increase was primarily related to higher personnel expenses. Net income was €1.9 million, or €0.03 per common share, for the first quarter of 2019, compared to a net loss of €8.2 million, or €0.15 per common share, for the first quarter of 2018. Net income was primarily related to significantly increased revenue, partially offset by higher R&D and G&A expenses.

Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Wednesday, May 22, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 1083705 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.

On May 22, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results and business progress for the first three months of 2019 (Press release, Bavarian Nordic, MAY 22, 2019, View Source [SID1234536526]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "As outlined in our strategy, 2019 and 2020 will be transitional years for Bavarian Nordic with significant investments in R&D and our new fill and finish facility, all with the objective to secure future revenue, growth and profitability. We have prepared for an eventful year, and while we have already shared several news during the first quarter, there are more exciting news to come, including the anticipated first U.S. approval, which will solidify our position as the global leader in the smallpox vaccine space and create new commercial opportunities ahead. Also, the approval will trigger the award of a Priority Review Voucher which, when sold, will contribute to maintaining a strong financial position. We also look forward to presenting a finalized plan for Phase 3 development of our RSV vaccine, and to report Phase 2 data from our immuno-oncology programs later this year. So, we are moving forward within all four strategic pillars of the company as planned and are reporting a first quarter fully in line with our expectations and guidance, both financially and operationally."

OPERATIONAL HIGHLIGHTS

Delivering our strategy

Our strategy is four-fold, and aims to secure and reinforce a sustainable foundation, while also expanding the commercial opportunities:

MAINTAIN global leadership of our smallpox vaccine business
EXPAND and rapidly ADVANCE the pipeline of infectious disease programs
ESTABLISH a broad and deep cancer immunotherapy portfolio
EXPAND the commercial footprint and capabilities
Smallpox

We have seen continued strong progress for our smallpox vaccine program, reinforcing our global leadership position.
The approval of the liquid-frozen formulation and award of a Priority Review Voucher are anticipated in September of 2019.
We have continued manufacturing for the ongoing contract for freeze-dried MVA-BN and will have produced bulk vaccine worth USD 333 million by year-end, of which USD 50 million are part of our 2019 revenues.
In January, we were awarded USD 44 million by the U.S. Government for qualification of our new fill and finish facility, as well as for transfer and validation of the production process for freeze-dried MVA-BN, which are all activities that will occur during 2020 before starting production of the current order (conversion of bulk vaccine to approx. 13 million final vaccine doses).
The pivotal Phase 3 lot consistency trial of the freeze-dried formulation of MVA-BN is planned to initiate in the second quarter of 2019. Based on the successful completion of this trial, we expect to submit a BLA supplement in 2021 with anticipated approval in 2022 of freeze-dried MVA-BN.
Infectious diseases

We remain at the forefront of RSV vaccine development with our differentiated, broad-spectrum vaccine candidate, which has successfully concluded Phase 2 development in elderly. We are currently in discussions with U.S. regulatory authorities on licensure requirements and expect to outline the Phase 3 development plan around mid-2019.
In February, our partner Janssen initiated a Phase 1/2a of the therapeutic HPV vaccine regimen. This is the first of three commercial programs under our partnership to initiate clinical trials. The second program, HIV, is also expected to initiate clinical trials later this year. Collectively, these programs, along with our Ebola collaboration represent USD 1 billion in potential future milestone payments, in addition to royalties on future sales.
Our partnership with the U.S. Department of Defense on the development of a prophylactic vaccine against the equine encephalitis virus – a rare, but potentially deadly illness – further evolved, as we received funding to support a Phase 1 clinical trial, which we expect to initiate later this year. Successful trial results could lead to additional funding of clinical development towards licensure.
Cancer immunotherapy

In January, our pivotal Phase 2 trial of BN-Brachyury for the treatment of chordoma completed the recruitment of patients for the first stage ahead of schedule. The first results from this study are expected by the end of this year.
Our other immune-oncology candidate, CV301, is currently subject of three Phase 2 trials in multiple cancers, where the vaccine is combined with different immune checkpoint inhibitors. The first results from one of these trials, where CV301 is combined with atezolizumab in bladder cancer, is expected to become available later in 2019.
Both vaccine candidates will be employed in new trials later this year to investigate new routes of administration as part of our strategy to further enhance our immuno-oncology platform.
Commercial

Construction of our fill and finish facility is progressing according to plan, and we expect the building to be completed by end of 2019, which is also the peak investment year with approximately DKK 270 million in total investments. Subsequently, qualification and validation activities will begin and continue into late 2020 before initiating production.
FINANCIALS AND OUTLOOK

Financial results for the first quarter in line with expectations

Revenue generated for the three months ending March 31, 2019 was DKK 127 million/USD 19 million (DKK 11 million/USD 2 million in the first three months of 2018).
The income before interest and tax (EBIT) was a loss of DKK 104 million/USD 16 million (loss of DKK 173 million/USD 26 million in the first three months of 2018.
As of March 31, 2019, the Group’s cash preparedness was DKK 2,172 million/USD 327 million (DKK 2,314 million/USD 327 million as of December 31, 2018), including unutilized credit lines of DKK 244 million/USD 37 million (DKK 244 million/USD 37 million as of December 31, 2018).
Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.64 per 1.00 USD, which was the exchange rate as of March 31, 2019.

Outlook for 2019 maintained

We maintain our financial expectations for 2019 as announced on March 21, 2019 with revenues of approximately DKK 600 million/USD 92 million for the full year, a loss before interest and tax (EBIT) of approximately DKK 360 million/USD 55 million and a cash preparedness at year-end of approximately DKK 1,600 million/USD 246 million.

While the Company anticipates the award of a Priority Review Voucher upon the expected approval of MVA-BN smallpox vaccine by the FDA in 2019, income from the sale of this voucher has not been included in the guidance.

The financial expectations are based on an exchange rate of DKK 6.50 per 1.00 USD. For further details regarding assumptions behind the guidance see the Annual Report 2018.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (8 am EST) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 3096344.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Graham Morrell
Paddock Circle Advisors (US)
[email protected]
Tel: +1 781 686 9600

Company Announcement no. 08 / 2019