On April 30, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, APR 30, 2021, View Source [SID1234584739]).

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"This latest approval is another meaningful extension of our bendamustine franchise. We believe this expanded label will significantly increase the market opportunity for TREAKISYM in Japan. Based on this additional indication, as well as the anticipated approval of the ten-minute RI liquid formulation, we are reiterating our belief that the combined royalty and milestones revenue from these products will generate $25 million at peak," stated Scott Tarriff, Chief Executive Officer.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

SymBio received approval for the TREAKISYM RTD (250 ml) liquid formulation in September 2020 and is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation, for which it plans to seek approval in the second half of 2022.

Key benefits to patients and healthcare providers of these products include eliminating the need for manual reconstitution and significantly reducing preparation time as compared to the lyophilized formulation.

On April 30, 2021 RemedyBio reported the success of the HEALED Consortium in securing DTIF support of €6.8M as part of a 3-year, €10.5M programme to develop new cell therapies for cancer (Press release, Remedy Biologics, APR 30, 2021, View Source [SID1234644112]). The consortium is comprised of RemedyBio as programme lead, aCGT Vector DAC, Trinity College Dublin & St James’s Hospital, and the NUIG’s Genomics Data Science Centre, bringing together deep capabilities in mass-scale functional biology, GMP clinical deployment, clinical and tumour microenvironment expertise in cancer, and molecular data analytics to create a world first in near-patient, personalised, functional cancer therapeutics. Our goal is to enable a new kind of revolutionary immunotherapy to cure incurable cancers. The Disruptive Technologies Innovation Fund (DTIF) is managed and funded through the Department of Enterprise and Innovation (DBEI) in Ireland.

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On April 30, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it has received exercise notices from Kreos Capital along with other historical investors who have converted warrants to shares (Press release, Noxxon, APR 30, 2021, View Source [SID1234578905]).

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A total of 3,768,449 new shares in NOXXON shall be issued consequently to the transaction, and NOXXON shall receive €1.2 million. This brings the total number of outstanding shares in NOXXON to 65,223,981. Following this warrant exercise, Kreos Capital holds 7.38% of outstanding shares in NOXXON.

The warrants were issued in connection with NOXXON’s €1 million private placement, Kreos Capital’s partial conversion of debt into equity and €10 million convertible notes with warrants on May 2, 2017. Details of the transaction can be found in the associated press release.

"We are pleased to exercise these warrants and increase our investment in NOXXON. We have been involved in NOXXON since 2014 and are confident the company has exciting long-term prospects, based on its differentiated technology, strong oncology-focused pipeline and the development strategy being implemented by management," said Aris Constantinides, General Partner at Kreos Capital.

"I would like to thank Kreos Capital for their ongoing long-term support of NOXXON. We look forward to working closely together as we continue to focus on improving cancer treatments by targeting the tumor microenvironment, including our lead candidate NOX-A12, which is progressing well in a Phase 1/2 brain cancer trial, with data read-outs expected in May and November 2021," said Aram Mangasarian, CEO of NOXXON.

On April 30, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that the first US patient has been enrolled into the fimaChem pivotal RELEASE study with registration intent in inoperable bile duct cancer patients (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585158]). The RELEASE study spans across Europe, USA and Asia, with patient enrolment initiated in all continents.

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Per Walday, CEO, said: "It is reassuring to see screening activity and enrolment picking up across the geographies of the RELEASE study, despite Covid-19 still having an impact on the healthcare systems. We are focused on optimal execution of the RELEASE study, to bring a new treatment option to a patient group with a high unmet medical need."

On April 30, 2021 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, and Cancer Focus Fund, LP, a unique venture capital fund established in collaboration with The University of Texas MD Anderson Cancer Center ("MD Anderson") to provide funding and clinical expertise to advance promising cancer therapies, reported a partnership to evaluate Mereo’s lead anti-TIGIT therapeutic antibody candidate, etigilimab, in clear cell ovarian cancer, a rare cancer that accounts for approximately 5–10% of all ovarian carcinomas in North America (Press release, Mereo BioPharma, APR 30, 2021, View Source [SID1234578872]).

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The Mereo and Cancer Focus Fund partnership will support a Phase 1b/2 clinical study of etigilimab in combination with an anti-PD-1 antibody in clear cell ovarian cancer, to be conducted at MD Anderson and led by Shannon Westin, MD, MPH, associate professor of Gynecologic Oncology and Reproductive Medicine. The study will be financed by Cancer Focus Fund, in exchange for upfront consideration of $1.5 million of Mereo shares and additional payments based on the achievement of certain milestones.

"We are honored to partner with Cancer Focus Fund on clinical studies of etigilimab in this rare and aggressive form of ovarian cancer," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "This program is the first investment made by Cancer Focus Fund since its inception. We believe that this speaks to the significant potential of etigilimab in the emerging TIGIT space. We look forward to working closely with the Cancer Focus Fund team and with Dr. Westin and her team at MD Anderson to design and execute the trial."

"Cancer Focus Fund is partnering with MD Anderson to help advance novel anticancer drug candidates through early clinical development, and we are delighted that our first investment is in support of Mereo’s anti-TIGIT antibody, etigilimab," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "The TIGIT immune receptor is a promising new target for cancer immunotherapy. We welcome the opportunity to collaborate with Mereo and MD Anderson to jumpstart the clinical assessment of etigilimab in clear cell ovarian cancer, which lacks effective treatment options once advanced."