On September 29, 2020 The University Medical Center Groningen reported that ​​​​a pioneering new treatment for cancer, whereby a patient’s blood cells are currently sent to the United States to be genetically modified before being returned to the patient a few weeks later (Press release, The University Medical Center Groningen, SEP 29, 2020, View Source [SID1234567720]). It will no longer be necessary to send the blood to the USA, which will not only save time but will also improve the quality of the treatment and be considerably faster. Zorginstituut Nederland (The Dutch National Health Care Institute) and ZonMw (the Netherlands Organisation for Health Research and Development) have awarded a €30 million grant the research at the UMCG, which must now show whether this version of the treatment is as successful as the ‘USA route’ and does, indeed, generate the expected savings.

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Since the end of last year, patients with lymphoma, who have exhausted all other treatment options, have been successfully treated by having their own T cells genetically modified outside their body. At around €330,000 per patient, the treatment, available at a few UMCs in the Netherlands, is extremely expensive. This is because the process is lengthy and complicated.

T cells (a type of white blood cells) are extracted from the patient’s blood. These cells, which play an important role in the body’s natural resistance to cancer cells, are genetically engineered in a laboratory by adding a so-called CAR to the T cells. This CAR is an extra piece of DNA that allows the T cells (which are called CAR-T cells after the modification) to recognize and attack cancer cells. In other words, the patient’s own immune system is primed to eliminate the cancer cells.

The UMCG can now produce CAR (CAR stands for chimeric antigen receptor) in its own hospital pharmacy. This saves valuable time: at present, the entire procedure, including transport to and from America, takes an average of 4 to 6 weeks, time that many of these patients do not have. This can now be reduced to just under two weeks. As well as saving time, the researchers expect that the quality of the treatment will improve too. As the white blood cells can now be harvested and modified in the same place, work on fresh cells can begin immediately, dispensing with the need to freeze them for transport. The financial saving is also important: treatment with CAR-T cells produced in the UMC’s own laboratory is expected to cost around €80,000 per patient. This compares with €330,000 per patient for treatment with commercially produced CAR-T cells. The research is a joint project with Radboud University Medical Center, Erasmus Medical Center and Amsterdam UMC. Patients from Rotterdam and Amsterdam will also be treated with CAR-T cells from Groningen.

The head of the research programme, internist-haematologist Tom van Meerten from the Department of Haematology at the UMCG, describes the research as ‘A real game-changer. These are patients with no further treatment options, who will probably deteriorate during the waiting time. Around 40% of the patients who have received CAR-T cell therapy are still in remission two years later. This is a very long time, compared with other types of cancer and cancer treatments. If the teaching hospitals can produce their own CAR-T cells, the whole process will be much better and cheaper.’

Until recently, this was an experimental treatment. But it has proved so successful that, since early this year, it is given to all eligible patients with lymphoma. Nearly half of them are in remission. The treatment also seems to be promising for patients with other types of cancer but more studies are needed to prove this.​

The CAR-T cell therapy method is in its infancy. Only a few medical research centres worldwide are using and studying the method. More patients are expected to be eligible for this treatment in the future. In fact, it will possibly be the first option, and not only used if other treatment options (such as chemotherapy) fail. Research like this is very difficult to fund without a grant. The grant will cover the high costs of treatment while the long-term research is being carried out. This is usually the bottleneck in funding research into innovative care. The insurance companies will continue to pay for the standard treatment being used as a comparison in the research.

The six-year research programme is monitoring 299 patients. Once the programme has finished, the Zorginstituut will decide within six months whether the treatment has proved to be effective and whether it should be paid for via basic medical health insurance.

On September 29, 2020 ImmuPharma PLC (LSE:IMM), (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, reported that further to a subscription agreement entered into at the time of Incanthera’s IPO onto AQSE Growth Market* in February 2020, ImmuPharma has now executed its subscription agreement to subscribe £250,000 for 2,631,579 ordinary shares of 2p each at a subscription price equal to Incanthera’s IPO price of 9.5p each (Press release, ImmuPharma, SEP 29, 2020, View Source [SID1234567719]).

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Following this subscription, ImmuPharma will hold 9,904,319 shares in Incanthera, representing a 15.35% position in the enlarged share capital of Incanthera.

ImmuPharma notes two recent positive announcements from Incanthera regarding studies of its lead product Sol, a potentially innovative topical product for the treatment of solar keratosis and the prevention of skin cancers. These announcements can be viewed on Incanthera’s website:

On September 29, 2020 Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca, reported that the European Commission (EC) has granted the marketing authorization for Equidacent (Product Code: FKB238), the company’s biosimilar to Avastin (bevacizumab) (Press release, Kyowa Hakko Kirin, SEP 29, 2020, View Source [SID1234567718]).

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The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical, and immunogenicity data demonstrated biosimilarity with the reference product, Avastin.

The EC approval of Equidacent applies to 27 European Union (EU) member states, the United Kingdom (UK) and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein.

Equidacent is indicated for the following indications:
 Metastatic carcinoma of the colon or rectum
 metastatic breast cancer
 unresectable advanced, metastatic, or recurrent non-small cell lung cancer
 advanced and/or metastatic renal cell cancer
 epithelial ovarian, fallopian tube, or primary peritoneal cancer
 persistent, recurrent, or metastatic carcinoma of the cervix

Fujifilm Kyowa Kirin Biologics President and CEO Atsushi Matsumoto, Ph.D. commented, "We are proud that Centus received the approval of Equidacent from the European Commission. This demonstrates that Fujifilm Kyowa Kirin Biologics successfully utilized its deep scientific expertise needed to develop biosimilars in collaboration with AstraZeneca."

Centus was established in 2015 as a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca. Fujifilm Kyowa Kirin Biologics has granted an exclusive license to Centus for the development, manufacture, and commercialization of Equidacent on a worldwide basis. Centus has been proceeding with clinical development of Equidacent.

Data submitted to obtain the marketing authorization for Equidacent included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the bevacizumab reference product, Avastin. The phase 3 clinical study, AVANA, conducted by Centus, demonstrated no clinically meaningful differences in terms of safety, efficacy, and immunogenicity compared with the reference product, Avastin, in non-small cell lung cancer patients. About Bevacizumab Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). It reduces growth and metastasis of several solid tumors.

On September 28, 2020, Sorrento Therapeutics, Inc. (the "Company") and Fortis Advisors LLC, in its capacity as representative of the former holders of equity (the "Equityholders’ Representative") of Semnur Pharmaceuticals, Inc. ("Semnur"), reported that it entered into an amendment (the "Amendment") to that certain Exchange and Registration Rights Agreement, dated as of March 18, 2019, by and among the Company and the stockholders and stock option holders of Semnur, as set forth on Schedule A thereto (the "Original Exchange Agreement") (Filing, 8-K, Sorrento Therapeutics, SEP 28, 2020, View Source [SID1234567978]). The Original Exchange Agreement was entered into in connection with the Agreement and Plan of Merger entered into among the Company, Scilex Holding Company ("Scilex Holding"), Sigma Merger Sub, Inc. and the Equityholders’ Representative, as amended by that certain Amendment No. 1 to Agreement and Plan of Merger, dated August 7, 2019 (as amended, the "Merger Agreement"), pursuant to which Merger Sub merged with and into Semnur and Semnur became a wholly-owned subsidiary of the Company (the "Merger").

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Pursuant to the Original Exchange Agreement, if by September 18, 2020, 100% of the outstanding equity of Scilex Holding had not been acquired by a third party and Scilex Holding had not entered into a definitive agreement with respect to, or otherwise consummated a firmly underwritten offering of Scilex Holding capital stock on a major stock exchange that met certain requirements, then the former holders of Semnur capital stock and holders of options to purchase Semnur’s common stock (collectively, the "Semnur Equityholders") could elect to exchange, during the 60-day period commencing on September 18, 2020 (the "Share Exchange"), the shares of Scilex Holding issued to the Semnur Equityholders in the Merger (the "Stock Consideration") for shares of the Company’s common stock with a value of $55.0 million, based on a price per share of its common stock equal to the greater of (a) the 30-day trailing volume weighted average price of one share of its common stock as reported on The Nasdaq Stock Market LLC as of the consummation of the Share Exchange and (b) $5.55 (such greater price, the "Exchange Price").

The Amendment amends the Original Exchange Agreement to, among other things, provide that if the Company receives notice from the Semnur Equityholders that the Semnur Equityholders will proceed with the Share Exchange (an "Exchange Notice"), the Company may, in its sole discretion, elect, within seven days of receipt of an Exchange Notice, to exchange all the Stock Consideration and the rights to receive cash from Scilex Holding held by certain of the Semnur Equityholders under the Merger Agreement for an amount in cash equal to $55.0 million, in lieu of issuing $55.0 million of shares of the Company’s common stock at the Exchange Price.

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment filed herewith as Exhibit 10.1 and the full text of the Original Exchange Agreement that was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 22, 2019, each of which are incorporated by reference herein.

On September 28, 2020 Virogin Biotech reported the completion of its Series C round of financing for a total of $62 million USD on September 20, 2020 (Press release, Virogen, SEP 28, 2020, View Source [SID1234567955]).

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Virogin Biotech is an oncolytic virus company developing next-generation oncolytic virotherapies to enhance the systemic antitumor immunity in patients. The financing round was co-led by CMG-SDIC Capital and CDH Investments, with participation from Lingdao Capital, Panlin Capital, Korea Investment Partners, Guanghua Alumni Capital of Canada and Stream Holdings. The endorsement of new investors reflects continued and growing confidence in Virogins’ ongoing clinical development as well as discovery projects.

The proceeds from this round of financing will be used to continue the clinical development of Virogins’ lead asset – VG161 through to Phase II studies; completion of pre-clinical research and IND-enabling studies for Virogins’ next-generation oHSVs; continued expansion and optimization of research and further development and expansion of the company product pipeline.

"Despite all the challenges in 2020, we are extremely grateful for the strong level of support and dedication from our investors", said Mr. Chris Huang, CEO and co-founder of Virogin. "With these funds, Virogin will continue to be a leader in the oncolytic virotherapy field, while continuing to expand and develop effective drugs for patients. The continued support and belief from our investors allows us to carry forward our lead asset through to Phase II studies, and continue the research work required to take our next-generation virotherapies to the clinic, one step closer to helping cancer patients."

"Oncolytic virotherapy is a valuable investment opportunity in the emerging biotech space", said Hua Yi, Executive Director of CMG-SDIC Capital. "We are confident on its demand in immunotherapy, and, through the continued support of current and future investors, aim to grow the company into a world leader in oncolytic virotherapy."

Dan Liu, the Healthcare Executive Director at CDH Investments Venture and Growth Capital, added: "We have been following immuno-oncology therapeutics, especially innovative approaches that change the tumor microenvironment. Believing in the potential and the importance of oncolytic virotherapy in treating cold tumors, we conducted a global search for OV companies and have identified Virogin as the frontrunner for the competitiveness of its proprietary TTDR viral backbone and Synerlytic platform. We are very excited to work with existing shareholders to help Virogin become a global leader in the field of oncolytic virotherapy."