On April 20, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported the closing of the sale of Coherus common stock to Junshi Biosciences. Under the terms of the February 2, 2021 stock purchase agreement, Coherus has received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares at a price per share of $20.06 (Press release, Coherus Biosciences, APR 20, 2021, View Source [SID1234578234]). The collaboration agreement between the companies for the development and commercialization in the United States and Canada of toripalimab, Junshi Biosciences’ PD-1 antibody, became effective in March.

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"This collaboration is a tremendous opportunity for Junshi Biosciences given Coherus’ commercial expertise and track record in bringing affordable high-quality medicines to patients," said Dr. Ning LI, CEO of Junshi Biosciences. "Since the collaboration was announced two months ago, we have already made progress toward the introduction of toripalimab in the United States with the initiation of the rolling submission of the Biologics License Application (BLA) for treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)."

"It is an honor to welcome Junshi Biosciences as both collaborators and investors as we build on our oncology biosimilar success with the expansion of our mission into immuno-oncology. This investment speaks volumes about Junshi Biosciences’ commitment to our partnership," said Denny Lanfear, Chief Executive Officer of Coherus. "Our teams are already making excellent progress with the NPC BLA submission and are working together closely on the registration strategy for additional toripalimab indications."

About the Exclusive License and Commercialization Agreement
Under the terms of the collaboration agreement, Coherus paid $150 million upfront for exclusive rights to toripalimab in the United States and Canada, options in these territories to Junshi Biosciences’ anti-TIGIT antibody and next-generation engineered IL-2 cytokine, and certain negotiation rights to two undisclosed preclinical immuno-oncology drug candidates. Coherus will also pay Junshi Biosciences a 20% royalty on net sales of toripalimab and up to an aggregate $380 million in one-time payments for the achievement of various milestones. The option exercise fee for each of the anti-TIGIT antibody and the IL-2 cytokine is $35 million per program. Additionally, for each option program, Coherus will pay Junshi Biosciences an 18% royalty on net sales and up to an aggregate $255 million for the achievement of various milestones. The Companies will collaborate in the development of toripalimab and other licensed compounds, and Coherus will pay for a portion of these co-development activities up to a maximum of $25 million per licensed compound per year.

On April 20, 2021 Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) reported that the companies have amended their collaboration agreement to develop, manufacture and commercialize CTX001, an investigational CRISPR/Cas9-based gene editing therapy that is being developed as a potentially curative therapy for sickle cell disease (SCD) and transfusion-dependent beta-thalassemia (TDT) (Press release, CRISPR Therapeutics, APR 20, 2021, View Source [SID1234578250]). With this revised agreement, Vertex will deploy the breadth of its established global capabilities and proven experience in manufacturing, development, regulatory, and commercialization to maximize the potential for CTX001 to transform the lives of tens of thousands of patients in the U.S., Europe and other countries. CRISPR Therapeutics will continue to support the development of CTX001 and invest in further innovation to maximize its potential.

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Under the terms of the amended agreement, Vertex will lead global development, manufacturing and commercialization of CTX001 with support from CRISPR Therapeutics. Vertex will be responsible for 60% of program costs and will receive 60% of profits from future sales of CTX001 worldwide, representing a 10% increase in program economics compared to the previous agreement. CRISPR will be responsible for 40% of costs and will receive 40% of profits. Additionally, CRISPR will receive a $900 million upfront payment, with potential for a $200 million payment upon the first regulatory approval of CTX001.

"Cell and genetic therapies are key to our strategy of developing transformative therapies for serious diseases, and this agreement is an important next step in cementing our leadership in these modalities as we bring forward our broad gene and cell-based therapeutics portfolio. As we take the lead on CTX001, we want to acknowledge the foundational contributions by the team at CRISPR Therapeutics," said Jeffrey Leiden, M.D., Ph.D., Executive Chairman of Vertex. "Our increased investment in our partnership with CRISPR is based on the compelling clinical profile of CTX001, which shows its potential to be a durable cure for patients with SCD and TDT, and the rapid progress that we and our partners at CRISPR have made toward registration and commercialization. We see a significant commercial opportunity for CTX001, and we believe we will be able to further enhance that opportunity by fully leveraging the breadth of Vertex’s capabilities – including our established and proven R&D and commercialization expertise in serious diseases – to bring CTX001 to more patients around the world, more quickly."

"Working with Vertex, we have made tremendous progress with CTX001, the first CRISPR/Cas9-based therapy to demonstrate proof of concept in the clinic and together we have broken new ground in the treatment of genetic diseases. We have now dosed more than 30 patients with CTX001, with longest follow-up beyond two years, and we are on track to complete enrollment in both clinical trials this year," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Given the transformative results and momentum that we have generated with this program, we are adopting a new operating model to enable a globally coordinated launch of CTX001, leveraging Vertex’s best-in-class global capabilities and leadership in development, manufacturing, and commercialization to enable this medicine to reach all patients that can benefit from it as quickly as possible. We remain deeply committed to the Sickle Cell and Thalassemia patient communities and look forward to continued success in our partnership with Vertex."

The transaction is subject to customary closing conditions and clearances, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.

About CTX001
CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD, in which a patient’s hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for patients with TDT and reduce painful and debilitating sickle crises for patients with SCD.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. CTX001 has also been granted Orphan Drug Designation from the European Commission for both TDT and SCD, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for SCD.

Among gene-editing approaches being investigated/evaluated for TDT and SCD, CTX001 is the furthest advanced in clinical development.

About the CRISPR-Vertex Collaboration
CRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first potential treatment to emerge from the joint research program.

On April 20, 2021 The Jerome Canady Research Institute for Advanced Biological and Technological Sciences, LLC (JCRI-ABTS) and US Medical Innovations, LLC (USMI) reported that they have successfully completed Phase 1 in their Clinical Trial using Canady Helios Cold Plasma (CHCP) for the treatment of recurrent and stage 4 solid tumors (IDE #G190195) (Press release, JCRI-ABTS, APR 20, 2021, View Source [SID1234578266]). The medical centers involved in the study were Rush University Medical Center in Chicago, Illinois (Principal Investigator, Steven Gitelis, MD) and Sheba Medical Center, in Tel HaShomer, Israel (Principal Investigator, Aviram Nissan, MD).

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USMI is the first company in the world to integrate a high frequency electrosurgical generator and plasma gas to deliver a CHCP for the selective treatment of cancer. This novel non-thermal process (24-27o C) has been developed for treating solid cancerous tumors. After the surgeon removes the cancerous tumor during surgery, CHCP is subsequently sprayed at the surgical margins to target any remaining cancerous tissue or cells, thus reducing the chances of cancer recurrence.

According to Jerome Canady, MD and USMI’s CEO (Sponsor Investigator), "Our Primary Objective was to establish the safety and efficacy of our Canady Helios Cold Plasma (CHCP) on human neoplastic tissues."

"We are very happy to report that the first phase of the Clinical Trial has been successfully completed with no adverse effects and we expect this product to not only be proven safe, but also proven effective in ablating cancer cells in the surgical tumor margins and macroscopic tumor sites."

Dr. Canady continued, "Unlike Chemo and Radiation Therapy, the Canady Helios Cold Plasma Therapy has many advantages. It is performed during the surgical procedure. It is highly selective because it only targets cancer cells without damaging surrounding healthy tissue. And thirdly, CHCP is personalized for your specific cancer type."

Through 20 surgical cancer procedures, Canady Helios Cold Plasma has been used safely with no side effects and is expected to be one of the most promising cancer treatments developed in recent times.

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).