On April 20, 2021 Luye Pharma Group reported that the marketing authorization application for the company’s oncology product, LY01008 (Bevacizumab injection), has been accepted by the China Center for Drug Evaluation of National Medical Products Administration (Press release, Luye Pharma, APR 20, 2021, View Source [SID1234595091]). LY01008 is a biosimilar of Avastin indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer .

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A leading anti-angiogenic oncology drug, Bevacizumab is a standard therapy recommended by global guidelines for treating multiple malignant cancers and also ranks as one of the top 10 best-selling drugs in the world. According to public financial reports, Avastin achieved sales of 7.07 billion Swiss francs globally in 2019, while according to IQVIA its 2019 sales in China were RMB2.88 billion.

The application for LY01008 was based on clinical data generated from two clinical comparative studies with Avastin, the first a pharmacokinetics ("PK") study in healthy subjects, the second a comparative study of efficacy and safety in metastatic or recurrent non-squamous non-small-cell lung cancer patients. Both studies met pre-defined primary endpoints, demonstrating that LY01008 and Avastin are similar in terms of PK and equivalent in efficacy.

LY01008 is indicated for advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer. Patient numbers show that lung cancer and colorectal cancer are the most common and the third most common cancers in China. There were about 774,000 new lung cancer cases in China in 2018. Non-small-cell lung cancer accounts for approximately 85% of all lung cancers. Colorectal cancer is the third most common cancer in China after lung cancer and gastric cancer, with 429,000 estimated new cases and 281,000 deaths in 2018. Due to the huge and rapidly increasing number of patients, medications available to treat this disease rank far short of those required.

LY01008 has stolen a march on the competition by filing the marketing authorization application in China. With an expected increase in market players to come, the size of the market for the biosimilars of Bevacizumab will grow steadily in China—this will also help to alleviate the financial pressure on patients. According to a report by Frost & Sullivan , with the ongoing launch of biosimilars and the use of Bevacizumab in combination with other drugs, the size of the Chinese market for Bevacizumab is expected to reach RMB 17.7 billion by 2030.

As a broad-spectrum monoclonal anticancer drug, Bevacizumab has a unique advantage when being used in combination with other drugs. It can be used in combination with paclitaxel-based chemotherapy drugs including paclitaxel liposome, and multiple related indications have been approved in China and abroad. A Luye Pharma Group management representative said: "We will actively drive the launch and commercialization of LY01008. The company will employ its strength in marketing and its wide market coverage in oncology therapy to support the future launch of LY01008, and build a powerful synergy with existing products."

In addition to LY01008, Luye Pharma also has a series of antibody drugs under development, including both biosimilars and innovative biological drugs. In China, LY06006 (a biosimilar of Prolia) is under Phase III clinical trials, and both LY09004 (a biosimilar of Eylea) and LY01011 (a biosimilar of Xgeva) are under Phase I clinical trials. In addition, Luye Pharma is also using its in-house antibody development platforms such as the "human antibody transgenic mouse" and collaborating with multiple cutting-edge overseas biotech companies to develop the next-generation innovative antibodies in immuno-oncology and increase the pipeline and supply of new biologics. Currently, Luye Pharma has established a complete industry chain covering R&D, manufacturing and commercialization in the biopharmaceutical field.

On April 20, 2021 Forbion, a leading European life sciences venture capital firm, reported the final close of its Forbion Growth Opportunities Fund I ("Forbion Growth I") at the hard cap amount of EUR 360 million (USD 428 million) (Press release, Forbion Capital Partners, APR 20, 2021, View Source [SID1234578235]). Forbion Growth I is focused on investing in late-stage European life sciences companies.

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Pantheon, Eli Lilly and Company, Horizon Therapeutics plc (Nasdaq: HZNP), the Belgian Growth Fund, New Waves Investments, Wealth Management Partners, KfW Capital and the European Investment Fund (EIF) are part of a strong base of institutional LPs that supported the fund. Forbion Growth I concentrates on later-stage investments, particularly in European biotech companies that develop novel therapies for areas of high medical need.

The Fund targets this market segment using three distinct strategies that provide: private growth capital for clinical stage development assets, cross-over capital to companies aiming to pursue a public listing in the near-term, as well as capital injections that support existing under-valued public companies. In all cases, Forbion Growth I aims to take leading positions with an investment size of up to EUR 35 million per deal.

In executing its strategy, Forbion Growth I is working closely with its Advisory Group, consisting of CEOs from Europe’s leading BioPharma companies, comprising Jan van de Winkel (CEO Genmab), Tim van Hauwermeiren (CEO ArgenX), Werner Lanthaler (CEO Evotec), Onno van de Stolpe (CEO Galapagos), and Maarten de Jong, a leading Life Sciences banker with Moelis & Co.

Forbion Growth I will aim to build a portfolio of 10-12 investments in the most promising European late-stage life sciences companies. Thus far, the Fund has already made three investments: SynOx Therapeutics (Ireland), New Amsterdam Pharma (Netherlands), and Gyroscope Therapeutics (UK).

Sander Slootweg, Managing Partner and co-founder of Forbion said:

"We were very pleased to see Forbion Growth I reach its final close at the hard cap amount, well exceeding our original target size of EUR 250 million. Since launching the fund, it has become even clearer that this European market segment of late-stage life sciences companies with de-risked assets is rapidly maturing, but remains under-served. Forbion Growth I and its specialized team positions us well to enable the most innovative of these companies to bring new, impactful treatments and therapies to market."

Dirk Kersten, General Partner of Forbion Growth I said:

"The successful close of Forbion Growth I allows us to become a preferred partner for the most promising European biotech companies and ambitious management teams, and be an anchor investor in the final private financing round before an M&A or IPO exit. We are looking to expand our current portfolio of three investments with new opportunities that can deliver meaningful benefits to patients whilst providing strong financial returns. To be optimally positioned to execute this strategy, we will be further expanding our team of key investment professionals with new hires expected to join by mid 2021."

With well over EUR 1.8 billion of assets under management, Forbion has been ranked "…#1 most consistently performing VC Manager in Europe.." by Preqin’s fund performance database in 2019. Forbion’s investment team has built an impressive performance track record with over 70 investments in both the EU and North America over the past 15 years.

Forbion has led the first institutional rounds of several of Europe’s leading biotech companies such as Argenx (ARGX; market cap USD 15 billion), Replimune (REPL; market cap of USD 1.4 billion) Uniqure (QURE; market cap USD 1.5 billion), and Dyne Therapeutics (DYN; market cap 815 million), as well as clinical-stage companies such as Promedior (acquired by Roche for up to EUR 1.4 billion), Dezima Pharma (acquired by Amgen for up to EUR 1.55 billion) and KandY Therapeutics (acquired by Bayer for an upfront payment of EUR 378 million and an undisclosed total deal value), and Achilles Therapeutics (ACHL; market cap USD 612 million).

On April 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its first quarter 2021 financial results on Tuesday, May 4, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, APR 20, 2021, View Source [SID1234578251]).

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To access the conference call and webcast, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].

On April 20, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported a new supply agreement with Israel for 2022 (Press release, Moderna Therapeutics, APR 20, 2021, View Source [SID1234578267]). Under the terms of this agreement, Israel also retains an option to purchase doses of one of Moderna’s variant-specific vaccine candidates subject to regulatory approval. Today’s announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine Moderna. The Israeli Ministry of Health authorized COVID-19 Vaccine Moderna for use on January 4, 2021.

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"We appreciate the continued confidence and collaboration with the Israel Ministry of Health with this new agreement," said Stéphane Bancel, Chief Executive Officer of Moderna. "This is an important moment for our company as the first firm order for 2022 supply and for the supply of our variant-specific booster vaccine candidates against COVID-19, currently being studied in human clinical trials. Recent preclinical results have shown that our variant-specific booster candidates were effective against COVID-19 variants of concerns, and we hope to continue to see positive results from the clinical studies."

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar and Taiwan. Additional authorizations are currently under review in other countries and by the World Health Organization.

Preclinical data on the Company’s variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication. These variant-specific vaccine candidates include mRNA-1273.351, which is more specifically targeted against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and a multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 (Moderna’s authorized vaccine against ancestral strains) and mRNA-1273.351 in a single vaccine. The Company’s Phase 2 study to evaluate three approaches to boosting is ongoing.

Authorized Use

Moderna has received approval to import and market COVID-19 Vaccine Moderna in Israel under Regulation 29 (A)(9). COVID-19 Vaccine Moderna is approved as a two-dose series for patients 18 years of age and older.

On April 20, 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 1,365 million in the first quarter of 2021 (Press release, Genmab, APR 20, 2021, View Source [SID1234578236]). Net trade sales were USD 691 million in the U.S. and USD 674 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. (Janssen) 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.