On January 20, 2020 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) has granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT) (Press release, Genmab, JAN 20, 2020, View Source [SID1234553341]). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in December 2019. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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"With this approval, newly diagnosed patients with multiple myeloma who are eligible for ASCT may have the opportunity for treatment with a DARZALEX-containing regimen. We are extremely pleased that DARZALEX has received this latest approval and we look forward to the combination of DARZALEX plus bortezomib, thalidomide and dexamethasone being launched in Europe," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval was based on the Phase III CASSIOPEIA (MMY3006) study sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC. Data from this study was published in The Lancet and presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

About the CASSIOPEIA (MMY3006) study
This Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC, including 1,085 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or treatment with bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part 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 16,830 new patients were expected to be diagnosed with multiple myeloma and approximately 10,480 people were expected to die from the disease in the Western Europe 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 bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; 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 intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; 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 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 therapy6. 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 intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; 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 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 States, 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).5,6,7,8,9,10

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 January 19, 2020 Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, Republic of Korea, reported that the Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) has been cleared on January 18th (Press release, BridgeBio, JAN 19, 2020, View Source [SID1234553328]).

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BBT-176, a novel epidermal growth factor receptor – tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). In the pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations. Furthermore, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

Bridge Biotherapeutics will initiate a dose escalation study as the first part of the phase I/II study in Korea to find the maximum tolerated dose (MTD) and to observe safety, tolerability and anti-tumor efficacy of BBT-176 in the patient groups of advanced NSCLC. In the second part of the study, which will be a dose expansion study, the safety, tolerability and efficacy along with the best MTD of the drug candidate will be assessed in the U.S. and Korea.

"We are highly proud of the IND clearance of BBT-176, a novel EGFR-TKI inhibiting C797S mutations for NSCLC treatments, by the U.S. FDA," and "Bridge will take the best-efficient development practices for bringing new treatment options for patients with NSCLC in need of novel therapy," said James Lee, CEO of Bridge Biotherapeutics.

BBT-176 was discovered by Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute, and was licensed to Bridge Biotherapeutics in December 2018 for the worldwide exclusive right for further development.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. It is split into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers. Overall, across 8 major countries including the U.S., 5 EU countries, China and Japan, the total NSCLC population as of 2015 is assumed 2 million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025.i

On January 17, 2019 Seneca Biopharma, Inc. (Nasdaq:SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported the agreement by several accredited investors to exercise certain warrants to purchase up to an aggregate of 5,555,554 shares of common stock having an exercise price of $2.70 issued by the company on July 30, 2019, at a reduced exercise price of $1.36 per share, priced at-the-market under Nasdaq rules (Press release, Seneca Biopharma, JAN 17, 2020, View Source [SID1234553313]).

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The shares of common stock issuable upon exercise of the warrants are registered pursuant to a registration statement on Form S-1 (File No. 333-232273) which became effective by the Securities and Exchange Commission (SEC) on July 25, 2019. The gross proceeds to the company from the exercise of the warrants are expected to be approximately $7.55 million, prior to deducting placement agent fees and estimated offering expenses.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash, the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 5,555,554 shares of common stock, at an exercise price of $1.23 per share, 2,777,777 of which have a term of exercise equal to two years and 2,777,777 of which have a term of exercise equal to five years.

Seneca intends to use the net proceeds from the offering as working capital for general business purposes, including continued development of SNCA’s stem cell assets and seeking partnership opportunities, as well as pursuing the in-licensing or acquisition of new innovative medicines to strengthen SNCA’s pipeline.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On January 17, 2020 PANTHERx Rare Pharmacy reported that it has been selected by Blueprint Medicines Corporation as a very limited distribution partner for breakthrough drug AYVAKIT (avapritinib) (Press release, Blueprint Medicines, JAN 17, 2020, View Source [SID1234553314]). It has been approved for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. With nationwide distribution of AYVAKIT, PANTHERx establishes a formidable presence in the precision oncology space.

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"PANTHERx is thrilled to be chosen by Blueprint Medicines to collectively make historic strides in precision oncology," said Dr. Gordon Vanscoy, Chairman and CEO of PANTHERx. "As a partner, we are grateful to offer hope to a genomically defined population of patients with rare gastrointestinal stromal tumors. PANTHERx is proud to be part of an elite network advancing precision oncology and bringing new hope to rare cancer patients."

AYVAKIT is a potent and selective KIT and PDGFRA inhibitor. It is the only FDA-approved type 1 inhibitor for GIST that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. AYVAKIT has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies.

The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation and one for the treatment of advanced systemic mastocytosis (SM), including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

For more information about PANTHERx RxARECARE services for patients with GIST, contact us at 833-918-2015.

Gastrointestinal Stromal Tumors

Gastrointestinal Stromal Tumors (GISTs) are a rare form of cancer located in the gastrointestinal (GI) tract. More than half of GISTs start in the stomach although many start in the small intestine and other parts of the GI tract. Doctors will look at specific features of a GIST to help predict whether it is likely to grow and spread to other parts of the body. GISTs are evaluated based on the size of the tumor, where it is located in the GI tract, and how fast the tumor cells are dividing (mitotic rate).

The GIST tumors often grow into empty spaces inside the GI tract so they may not cause symptoms until they reach a certain size or are in a certain location. As a result, a small tumor may not cause any symptoms. Common symptoms of GISTs include: include throwing up bright red or dark blood, bleeding into the stool, abdominal pain, a noticeable mass or swelling in the abdomen, nausea or vomiting, loss of appetite and weight loss, and feeling full after eating small amounts of food.

Treatment options depend on a several factors, including the tumor size, the mitotic rate, where the tumor is located in the GI tract, the genetic makeup of the tumor, and if the tumor has spread to other parts of the body. Treatment options include surgery to remove the tumor and targeted therapies with tyrosine kinase inhibitors (TKIs).

For more information about the symptoms, diagnosis, and treatment of Gastrointestinal Stromal Tumors please click here (View Source).

About PANTHERx Rare Pharmacy

PANTHERx Rare Pharmacy, the nation’s only health entity with an Accredited Distinction (ACHC) in Rare Pharmacy, is headquartered in Pittsburgh, Pennsylvania. PANTHERx Rare’s mission is to transform lives by delivering medical breakthroughs, clinical excellence, and access solutions to patients afflicted with rare and devastating conditions. Every day we Define RxARE, by developing focused solutions, bold innovations, and novel clinical services associated with the life-transforming therapies that we deliver.

PANTHERx was awarded 2018 Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy. Zitter Health Insights awarded PANTHERx the Specialty Pharmacy Patient Choice Award winner for two consecutive years. As a quad-accredited pharmacy, PANTHERx holds accreditations from URAC, VIPPS, ACHC, and CPPA.

On January 17, 2020 Aethlon Medical, Inc. (Nasdaq:AEMD) (the "Company"), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported that it has entered into definitive agreements with certain institutional investors for the purchase in a registered direct offering of 1,885,378 shares of its common stock, at a purchase price per share of $2.00, priced at-the-market under Nasdaq rules (Press release, Aethlon Medical, JAN 17, 2020, View Source [SID1234553315]). Additionally, Aethlon has agreed to issue to the investors unregistered warrants to purchase up to 942,689 shares of common stock. The warrants have an exercise price of $2.75 per share of common stock, will be exercisable immediately and will expire five and one-half years from the issuance date.

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The closing of the offering is expected to occur on or about January 22, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Aethlon, before deducting placement agent fees and other offering expenses, are expected to be approximately $3.77 million. The Company intends to use the net proceeds from this offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Aethlon pursuant to a "shelf" registration statement on Form S-3 that was originally filed on May 10, 2019 and declared effective by the Securities and Exchange Commission ("SEC") on August 1, 2019 and the base prospectus contained therein (File No. 333-231397). The offering of the shares of common stock is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.