On January 26, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation (sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 4,190 million in 2020 (Press release, Genmab, JAN 26, 2021, View Source [SID1234574287]). Net trade sales were USD 2,232 million in the U.S. and USD 1,958 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX and DARZALEX FASPRO under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; 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.1 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 for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: 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 therapy2. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. 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 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 relapsed or refractory multiple myeloma. 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.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients 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.3 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

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).1,4,5,6,7

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 and T-cell acute lymphocytic leukemia (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 26, 2021 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies, reported the completion of its previously announced underwritten public offering of 14,285,714 shares of its common stock at a price to the public of $7.00 per share, with net proceeds to CytomX of approximately $93.6 million, after deducting underwriting discounts and commissions and estimated offering expenses (Press release, CytomX Therapeutics, JAN 26, 2021, View Source [SID1234574286]). All shares in the offering were sold by CytomX. In addition, CytomX has granted the underwriters of the offering a 30-day option to purchase up to an additional 2,142,857 shares of its common stock at the public offering price, on the same terms and conditions.

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J.P. Morgan Securities LLC, Cowen and Company, LLC and Piper Sandler are acting as joint bookrunning managers for the offering.

The securities described above were offered pursuant to a registration statement that was filed with the Securities and Exchange Commission ("SEC") on November 6, 2018, amended on February 6, 2019, and was declared effective on February 11, 2019. The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 21, 2021 and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204, or by emailing at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone: +1 (833) 297-2926, or via email: [email protected]; and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

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

On January 26, 2021 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical studies of Bicycle’s novel, fully synthetic Bicycle systemic immune cell agonists and tumor-targeted immune cell agonists (TICAs) was published in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, Bicycle Therapeutics, JAN 26, 2021, View Source [SID1234574285]). The article, titled "Anticancer immunity induced by a synthetic tumor-targeted CD137 agonist" is available online via this link.

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"The data published in JITC describe the application of Bicycle’s unique technology to produce a new class of potential immuno-oncology therapies: tumor-targeted immune cell agonists, or TICAs," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "In contrast to immune checkpoint inhibitors, the use of antibodies as agonists of immune costimulatory receptors as cancer therapeutics has largely failed. Here we demonstrate the discovery of small, chemically synthetic Bicycles that bind to key co-stimulatory receptors and that can be coupled in a modular manner to tumor antigen binding Bicycles to produce tumor localized receptor agonism. We look forward to initiating a clinical trial for our lead TICA program, BT7480, this year."

The article outlines the work Bicycle is undertaking to unlock a new method of cancer immunotherapy via small molecule agonism of TNF superfamily receptors. In the studies, TICAs were evaluated in a suite of in vitro and in vivo assays to characterize the pharmacology and mechanism of action. Results showed that by linking a costimulatory receptor (e.g., CD137) targeting Bicycle to a tumor antigen (e.g., EphA2), targeting Bicycle potent agonists were created, which activated the costimulatory receptor selectively in the presence of tumor cells expressing that antigen. An EphA2/CD137 TICA efficiently co-stimulated human peripheral blood mononuclear cells in vitro in the presence of EphA2-expressing tumor cell lines, as measured by an increased secretion of interferon γ and interleukin-2. Treatment of C57/Bl6 mice (transgenic for the human CD137 extracellular domain, huCD137) bearing EphA2-expressing MC38 tumors resulted in increased infiltration of CD8+ T cells, the elimination of tumors, and generation of immunological memory. Tumor target-dependent CD137 agonism using TICAs afforded elimination of tumors in preclinical models using only intermittent dosing, suggesting the potential for a wide therapeutic index in humans.

On January 26, 2021 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical studies of Bicycle’s novel, fully synthetic Bicycle systemic immune cell agonists and tumor-targeted immune cell agonists (TICAs) was published in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, Bicycle Therapeutics, JAN 26, 2021, View Source [SID1234574285]). The article, titled "Anticancer immunity induced by a synthetic tumor-targeted CD137 agonist" is available online via this link.

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"The data published in JITC describe the application of Bicycle’s unique technology to produce a new class of potential immuno-oncology therapies: tumor-targeted immune cell agonists, or TICAs," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "In contrast to immune checkpoint inhibitors, the use of antibodies as agonists of immune costimulatory receptors as cancer therapeutics has largely failed. Here we demonstrate the discovery of small, chemically synthetic Bicycles that bind to key co-stimulatory receptors and that can be coupled in a modular manner to tumor antigen binding Bicycles to produce tumor localized receptor agonism. We look forward to initiating a clinical trial for our lead TICA program, BT7480, this year."

The article outlines the work Bicycle is undertaking to unlock a new method of cancer immunotherapy via small molecule agonism of TNF superfamily receptors. In the studies, TICAs were evaluated in a suite of in vitro and in vivo assays to characterize the pharmacology and mechanism of action. Results showed that by linking a costimulatory receptor (e.g., CD137) targeting Bicycle to a tumor antigen (e.g., EphA2), targeting Bicycle potent agonists were created, which activated the costimulatory receptor selectively in the presence of tumor cells expressing that antigen. An EphA2/CD137 TICA efficiently co-stimulated human peripheral blood mononuclear cells in vitro in the presence of EphA2-expressing tumor cell lines, as measured by an increased secretion of interferon γ and interleukin-2. Treatment of C57/Bl6 mice (transgenic for the human CD137 extracellular domain, huCD137) bearing EphA2-expressing MC38 tumors resulted in increased infiltration of CD8+ T cells, the elimination of tumors, and generation of immunological memory. Tumor target-dependent CD137 agonism using TICAs afforded elimination of tumors in preclinical models using only intermittent dosing, suggesting the potential for a wide therapeutic index in humans.

On January 26, 2021 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric and orphan drugs reported that it has received the support from the region Île-de-France as part of the PM’up program to accelerate the development of the company in Europe and the US (Press release, ORPHELIA Pharma, JAN 26, 2021, View Source [SID1234574283]). ORPHELIA Pharma will receive a grant of 250 000 € aimed at supporting the international development of the company.

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"We are grateful to receive the support from region Île-de-France which will allow us to accelerate the development of our medicines portfolio worldwide. Our products address unmet medical needs of life-threatening paediatric diseases and our ambition is to make them available to all patients", comments Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma.

"We will use the proceeds to implement the marketing operations of Kigabeq in Europe and continue the efforts in finding partners for key territories elsewhere", states Hugues Bienaymé, General Manager. "This program will also support the preparation of the US dossier and the evaluation of the market access strategy of Kimozo, the first paediatric drinkable formulation of temozolomide currently under development for the treatment of relapsed or refractory neuroblastoma", he adds.

About PM’Up program

The Région Ile-de-France supports the development of Small and Medium-sized Enterprises by providing financial assistance to support their growth strategy. PM’up is a grant of up to 250 000 € to finance a 3-year development plan. For more information, please visit View Source