On August 22, 2019 Genmab A/S (Nasdaq: GMAB) reported that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, AUG 22, 2019, View Source [SID1234538928]). DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize the product. Genmab will receive a USD 7 million milestone payment from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label. The approval and related milestone do not impact the financial guidance issued by Genmab on August 14, 2019.

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"Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a DARZALEX containing regimen," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval is based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent in newly diagnosed ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and published in The New England Journal of Medicine in December 2017.

About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study that included 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), once every three weeks from cycles 2 to 9, once every four weeks from cycle 9 until disease progression. The primary endpoint of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 6,313 new patients were expected to be diagnosed with multiple myeloma and approximately 4,338 people were expected to die from the disease in Japan in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On August 22, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the second quarter and first half 2019 (Press release, Nordic Nanovector, AUG 22, 2019, View Source;results-for-the-second-quarter-and-first-half-2019-300905662.html [SID1234538916]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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Eduardo Bravo, CEO, commented: "We continue to progress our clinical development programmes with Betalutin in major NHL indications. In PARADIGME, we have reached our target range in terms of activated sites and while the recruitment rate has accelerated in recent months, this has not been at the rate we anticipated. This has led us to reassess the trial timelines and we now estimate to complete patient enrolment in 2H 2020 rather than 1H 2020 as previously guided. We would expect the data read-out from the trial a few months after the final patient has been dosed. As a one-off treatment, Betalutin has an exciting product profile, and we have been encouraged by the preliminary analysis of the extended median duration of response data that we have disclosed today. We remain focused on advancing PARADIGME and our other clinical programmes as quickly as possible given the clear benefits that Betalutin could deliver to NHL patients around the globe."

Highlights

Preliminary analysis shows median duration of response (mDoR) of 13.5 months (formerly 9.0 months in December 2018) for Phase 1/2a LYMRIT 37-01 trial of Betalutin in R/R FL
Pivotal Phase 2b PARADIGME trial of Betalutin in advanced recurrent follicular lymphoma (FL) progressing with 81 sites in 23 countries open for enrolment as of August 21st, 2019
Patient recruitment has accelerated in recent months but not at the rate anticipated
Full enrolment now expected 2H 2020 compared with 1H 2020 as previously guided
Phase 1b Archer-1 trial of Betalutin plus rituximab (RTX) in patients with relapsed/refractory (R/R) 2nd line FL advanced into second cohort
Global patent portfolio strengthened with grant of European patent covering the use of Betalutin (and other anti-CD37 targeting agents) in combination with anti-CD20 antibodies (including rituximab) for the treatment of non-Hodgkin’s lymphoma (NHL)
Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours presented at international scientific congresses (TAT11 and TRP19)
Recruitment completed for dose escalation phase of LYMRIT 37-05 trial of Betalutin in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – preliminary results expected in 2H 2019
Dr Lars Nieba appointed as Chief Technology Officer to drive the company’s CMC strategy
Financial Highlights Q2 and 1H’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the second quarter amounted to NOK 0.0 (NOK 0.0 million). Revenues for the first half of 2019 were NOK 0.0 (NOK 0.0 million).
Total operating expenses for the second quarter were NOK 111.0 million (NOK 84.5 million). Total operating expenses for the first half of 2019 amounted to NOK 200.9 million (NOK 166.8 million)
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 77 % of total operating expenses (72.2 %) for the first half of 2019.
Comprehensive loss for the second quarter amounted to NOK 110.4 million (loss of NOK 82.9 million). Comprehensive loss for the first half was NOK 202.0 million (loss of NOK 173.6 million)
Cash and cash equivalents amounted to NOK 443.5 million at the end of June 2019 (NOK 570.1 million at June 2018 and NOK 440.1 million at 31 December 2018)
Upcoming R&D Day

Nordic Nanovector is planning to host and R&D Day in September. During the event the senior management team and external speakers will provide updates and further information on the company’s key activities. The R&D Day will take place in Oslo and will also be webcast live. Details on the date and how to register to attend will be announced within the next two weeks.

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin in 3L R/R FL is underway. Patient enrolment is expected to be completed in the second half of 2020. A data read-out is expected a few months after the final patient is dosed enabling filing for marketing approval in the first half of 2021.

The company maintains its guidance that current cash resources are expected to be sufficient to reach mid-2020.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30am CEST at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019 from 7:00am CEST the same day.

On August 20, 2019, Trovagene, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement (the "Purchase Agreement") with Lincoln Park Capital Fund, LLC (the "Purchaser"), pursuant to which the Company agreed to offer, issue and sell to the Purchaser, (i) in a registered direct offering, an aggregate of (a) 271,744 shares (the "Shares") of common stock, par value $0.0001 per share ("Common Stock") and (b) Series E pre-funded warrants (the "Series E Pre-Funded Warrants") to purchase up to 456,058 shares (the "Series E Warrant Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), which will be exercisable immediately upon issuance for a period of five years after the date of issuance, and (ii) in a concurrent private placement, Series F warrants (the "Series F Warrants") to purchase up to 707,802 shares (the "Series F Warrant Shares") of Common Stock, for aggregate gross proceeds to the Company of approximately $1.5 million, before deducting estimated offering expenses payable by the Company (Filing, 8-K, Trovagene, AUG 21, 2019, View Source [SID1234551237]).

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The combined purchase price for each Share, together with one Series F Warrant, is $2.061 per Share/Series F Warrant. Each Series F Warrant shall be exercisable beginning on the six-month anniversary of the date of issuance and for a period of five years after such date (or five-and-a-half years after the issuance date), at an exercise price of $1.936 per Series F Warrant Share. The exercise price of the Series F Warrants and the shares of the Company’s Common Stock issuable upon the exercise of the Series F Warrants (the "Series F Warrant Shares") will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Series F Warrants.

The aggregate exercise price of the Series E Pre-Funded Warrants ($2.061 per Series E Warrant Share), except for a nominal exercise price of $0.01 per Series E Warrant Share, will be pre-funded to the Company on the date of issuance of the Series E Pre-Funded Warrants and, consequently, no additional consideration (other than the nominal exercise price of $0.01 per Series E Warrant Share) shall be required to be paid by the holder to effect any exercise of the Series E Pre-Funded Warrants. The Company shall not be required to return or refund any portion of such pre-paid aggregate exercise price of the Series E Pre-Funded Warrants for any reason, including in the event such Series E Pre-Funded Warrants shall not have been exercised prior to expiration. Each of the Series E Pre-Funded Warrants and the Series F Warrants may be exercised on a "cashless" basis under certain circumstances set forth in the warrants.

The Shares, Series E Pre_Funded Warrants and the Series E Warrant Shares issuable upon exercise of the Series E Pre-Funded Warrants are being offered by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on June 25, 2019, and was declared effective on July 1, 2019 (File No. 333-232321) (the "Registration Statement").

The Series F Warrants and the Series F Warrant Shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and are instead being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

Per the terms of the Purchase Agreement, the Company has agreed to certain restrictions on future stock offerings, including that during the 60-day period following the closing, the Company will not issue (or enter into any agreement to issue) any shares of Common Stock or Common Stock equivalents, subject to certain exceptions.

The closing of the offering described above is subject to satisfaction of specified customary closing conditions.

The foregoing summaries of the offerings, the securities to be issued in connection therewith, the Purchase Agreement, the Series E Pre-Funded Warrants and Series F Warrants do not purport to be complete and are qualified in their entirety by reference to the definitive transaction documents. Copies of the form of Purchase Agreement, the Form of Series E Pre-Funded Warrant and the Form of Series F Warrant are attached hereto as Exhibits 10.1, 10.2 and 10.3, respectively, and are incorporated herein by reference.

On August 21, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that the Biomedical Advanced Research and Development Authority (BARDA) is modifying its existing anthrax vaccine development contract with Altimmune by awarding an additional $3.7 million (Press release, Altimmune, AUG 21, 2019, View Source [SID1234551236]). The increase in funding is primarily directed toward a Phase 1b clinical trial of NasoShield to evaluate alternative methods of intranasal dosing in humans.

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In 2018, BARDA awarded Altimmune $2.5 million for further NasoShield development including a comparison of different methods of administration of the vaccine in preclinical models. The data from this study demonstrated that a simple modification to the method of intranasal dose administration had a dramatic impact on the resulting immunogenicity. These results suggest that the 2018 Phase 1 study of NasoShield in healthy adults might have shown a more robust immunogenic effect had a modified administration method been employed. The planned Phase 1b clinical trial will evaluate modified methods of intranasal dosing on NasoShield safety and immunogenicity and is expected to start in 2019.

"We are extremely pleased that BARDA has made this additional funding available for a clinical study to advance this potentially transformative anthrax vaccine," said Dr. Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "BARDA has been an outstanding partner for NasoShield and we are excited to continue its development with their support."

About NasoShield

In contrast to the currently licensed vaccine that requires three injected doses of vaccine over one month for protection, NasoShield is being developed as a single-dose, intranasal anthrax vaccine. The NasoShield product characteristics may also provide for greatly improved logistics in distribution and administration allowing it to be used more effectively than the currently approved vaccine in the event of an anthrax incident. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.

On August 21, 2019 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a private placement financing of 13,725,000 units of the Company and the disposition of a 25% stake of its wholly-owned Polish subsidiary for aggregate gross proceeds of CAD $7,000,005 (Press release, Helix BioPharma, AUG 21, 2019, View Source [SID1234538933]).

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The terms of the placement are for the purchase of units at $0.455 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $0.72 and have an expiry of five years from the date of issuance. In addition, the terms of the private placement also include the disposition by the Company of shares of its Polish subsidiary, Helix Immuno-Oncology S.A. ("HIO"), representing 25% of the outstanding shares of HIO.

Mr. Jerzy Wilczewski ("Mr. Wilczewski"), acquired 13,725,500 units of Helix in the private placement. Following closing, Mr. Wilczewski’s holdings, including previously held common shares and common share purchase warrants of the Company ("Warrants"), represent approximately 15.70% of the issued and outstanding common shares of the Company on a non-diluted basis and 26.14% on a partially diluted basis, assuming the full exercise of all Warrants that Mr. Wilczewski beneficially owns or exercises control or direction over.

"My family wants to contribute to cancer research development," said Mr. Wilczewski. "I decided to make this sizeable investment in Helix because I believe in the social objective and the uniqueness of the Company’s technology. An additional motivation for me is the ongoing research and development work that the Company is carrying on in Poland."

"On behalf of Helix, I thank Mr. Wilczewski for his confidence and contribution," said Dr. Heman Chao, Helix’s Chief Executive Officer.

The issuance of the units under the private placement would ordinarily require shareholder approval under the requirements of the Toronto Stock Exchange (the "TSX"), since the aggregate number of common shares issuable (including through the exercise of Warrants) in successive private placements within the last three months exceeds 25% of the issued and outstanding common shares of the Company prior to the first such placement and since Mr. Wilczewski would potentially become a "control person" of the Company on exercise of the Warrants. However, Mr. Wilczewski has undertaken not to exercise any Warrants where the exercise would result in him owning 20% or more of Helix’s outstanding common shares unless disinterested shareholder approval, or the approval of the TSX, has been obtained.

The Company intends to seek shareholder approval for the creation of Mr. Wilczewski as a control person at its annual general meeting to be held later this year. 2 The Company intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.