On September 29, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting (Press release, Infinity Pharmaceuticals, SEP 29, 2020, View Source [SID1234567723]). Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq and Abraxane in TNBC. Earlier this year Infinity also received Fast Track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the company’s global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.

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"Fast Track designation is an exciting regulatory milestone that bolsters our momentum in TNBC," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "TNBC remains the deadliest form of breast cancer, and there is tremendous need to expedite the development of new treatments that have the potential to improve outcomes in these patients. We believe that adding eganelisib on top of standard of care in a novel triple combination front-line regimen with Tecentriq and Abraxane has the potential to provide meaningful benefits to patients and are particularly encouraged by the early signals of clinical activity we have seen in MARIO-3 to date. We look forward to presenting these important data later this year."

Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions while fulfilling an unmet medical need, enabling drugs to reach patients more rapidly. A drug or treatment regimen that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA on matters pertaining to the drug’s clinical development plan as well as eligibility for accelerated approval and priority review.

MARIO-3 is a Phase 2 study in collaboration with Roche/Genentech to evaluate the addition of eganelisib to standard of care treatment with Tecentriq and Abraxane in a novel triple combination front-line regimen in patients with locally advanced and/or metastatic TNBC. The study is designed to enroll approximately 60 patients across two cohorts, approximately 30 patients with programmed death-ligand 1 (PDL1) positive disease based on immunohistochemistry (IHC) and 30 patients with PDL1 negative disease based on IHC. The primary objective of the study is Complete Response (CR) rate as measured by RECIST v1.1 with assessments conducted through month 12. Secondary measures include objective response rate (ORR), time to complete remission (TTCR), time to response (TTR), duration of Complete Response (DOCR), duration of response (DOR), and progression-free survival (PFS).

On September 29, 2020 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that the Company has entered into a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, through a subsidiary (Press release, Celyad, SEP 29, 2020, View Source [SID1234567722]).

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Celyad Oncology will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy, with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease.

"We are extremely pleased to enter into this clinical collaboration with MSD, as we believe the mechanism of actions of CYAD-101 and KEYTRUDA are highly complementary and could help to drive meaningful clinical benefit in patients with advanced metastatic colorectal cancer, in particular with microsatellite stable disease where a high unmet medical need exists" said Filippo Petti, Chief Executive Officer of Celyad Oncology. "In addition, the collaboration with MSD adds an important dimension to our clinical program for CYAD-101 for the treatment of mCRC and provides us with the opportunity to build upon the encouraging clinical activity we’ve reported to date from the ongoing alloSHRINK trial."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CYAD-101

CYAD-101 is an investigational, non-gene edited, allogeneic (healthy donor derived) CAR T candidate engineered to co-express a chimeric antigen receptor based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands and the novel inhibitory peptide TIM (TCR Inhibitory Molecule). The expression of TIM reduces signaling of the TCR complex, which is responsible for graft-versus host disease.

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.