On April 30, 2021 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, reported that it has been highly commended in the "Life Science Company of the Year" category at the 4th Cambridge Independent Science and Technology Awards (Press release, Microbiotica, APR 30, 2021, View Source [SID1234583882]).

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The Company was recognised for its transformational technology and significant progress over the past year. Recent achievements include a key new strategic collaboration with Cancer Research UK and Cambridge University Hospitals, progressing lead programmes in ulcerative colitis and immuno-oncology towards the clinic, and moving into purpose-configured facilities at Chesterford Research Park.

Mike Romanos, CEO of Microbiotica, said: "We are proud to be recognised for the milestones we have achieved this past year. Despite challenging conditions, we have progressed our ongoing programmes, expanded and strengthened our team, signed a key strategic collaboration, and moved to our new facility in Chesterford Research Park, so we can now house all our scientists in the same building for the first time. I would like to congratulate all the winners and highly commended entries and thank the entire Microbiotica team for their continued efforts."

The Cambridge Independent Science and Technology Awards recognise outstanding life science and biotechnology companies in Cambridge. The ceremony took place virtually in a bespoke interactive environment, and was attended by leaders of businesses, organisations and research institutes across the Cambridge region on April 15, 2021.

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 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 [SID1234578901]).

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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 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, cross-modality medicines for unmet needs in cancer, reported the initiation of patient dosing in TWT-202, its Phase 1b/2 study to evaluate its CFI-400945, an oral, first-in-class inhibitor of Polo-like kinase 4 (PLK4) in patients with Leukemia as a monotherapy or in combination with hypomethylating agents (Press release, Tio Bioventures, APR 30, 2021, View Source [SID1234578817]). Dosing of the first patient in the trial commenced April 16th at the University of Texas MD Anderson Cancer Center, Houston, TX.

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"Oral PLK4 inhibition opens a completely new approach to target therapeutic vulnerability in high risk MDS and AML and is very amenable to combination with other effective therapeutic agents," said Principal Investigator, Dr. Gautam Borthukar, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center.

"We are excited about the initiation of TWT-202 with our highly potent PLK4 inhibitor," said Dr. Michael Tusche, Treadwell co-CEO. "Previous clinical studies have shown that CFI-400945 can lead to single agent complete remissions in high-risk refractory AML patients. We look forward to continuing the development of this agent with the goal of delivering first in class medicines to patients in need."

The Phase 1b/2 clinical trial of CFI-400945, is an open-label, multi-center, dose optimization study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-400945 as a single agent or in combination with azacytidine or decitabine in patients with acute myeloid leukemia, myelodysplastic syndrome or chronic myelomonocytic leukemia. The trial will enrol approximately 72 patients at up to 20 sites in North America and Asia. It will involve 3 arms including monotherapy and combination dose optimization and expansion, as well as a food effect study.

About CFI-400945

CFI-400945 is a highly potent and selective inhibitor of the serine/threonine kinase PLK4, a cell cycle kinase known to be the master upstream regulatory of centriole duplication and is critical for the maintenance of genomic integrity. PLK4 is overexpressed in a variety of solid tumors and elevated expression is associated with poor clinical outcomes. Depletion of PLK4 expression in cancer cells by RNA interference leads to mitotic defects and cell death. PLK4 was identified as a drug target based on functional screening to identify vulnerabilities of genomically unstable cancers. Anti-tumor activity of CFI-400945 has been shown in mice bearing human cancer xenografts, including robust tumor growth inhibition and durable tumor regression in primary tumor xenografts from breast cancer. CFI-400945 is a potent, selective, orally administered, first-in-class inhibitor of the serine/threonine kinase, polo-like kinase 4 (PLK4). CFI-400945 is currently in multiple investigator-initiated studies in solid and liquid malignancies,

On April 30, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported its national sponsorship of the American Academy of Dermatology’s (AAD) "Skin Cancer, Take a Hike!" steps challenge for Skin Cancer Awareness Month (Press release, Castle Biosciences, APR 30, 2021, View Source [SID1234578902]).

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"Skin Cancer, Take a Hike!" is a participant-driven fundraising event that has raised $1.5 million since its inaugural 2014 hike. By educating the public about skin cancer prevention and early detection, the AAD and its partners like Castle aim to drive sun-safety behaviors that can reduce skin cancer and ultimately save lives. "Skin Cancer, Take a Hike!" proceeds are dedicated to reducing the incidence of skin cancer through public education and access to life-saving programs and services, including free skin cancer screenings, permanent shade structures where children learn and play, and sunscreen dispensers in public areas, such as parks and pools.

At this year’s virtual event, held throughout May for Skin Cancer Awareness Month, hundreds of participants across the country will complete 9,500 miles in honor of the approximately 9,500 people diagnosed with skin cancer every day.

"We greatly appreciate the support of Castle Biosciences in our efforts to help the public prevent skin cancer and detect it early, when it’s most treatable," says dermatologist Kenneth J. Tomecki, M.D., FAAD, president of the AAD. "Skin cancer is the most common cancer in the U.S., and nearly 20 Americans die from melanoma, the deadliest form of skin cancer, every day. By working together to raise awareness through ‘Skin Cancer, Take a Hike!’, we want to remind the public that they can protect their skin from the sun and reduce their risk of skin cancer by seeking shade, wearing protective clothing — including a wide-brimmed hat and sunglasses with UV protection — and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all skin not covered by clothing."

"Skin Cancer, Take a Hike!" is part of the AAD’s SPOT Skin Cancer initiative to reduce skin cancer mortality and incidence through public awareness, community outreach programs and services, and advocacy that promotes the prevention, detection and treatment of skin cancer. Thanks to the campaign’s dedicated volunteers and donors, SPOT Skin Cancer has provided more than 2.8 million free skin cancer screenings and awarded 432 shade structure grants, which provide shade for nearly 3.5 million individuals daily.

"Among the viable techniques to mitigate harm caused by skin cancer, the importance of prevention and early detection cannot be overstated," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Castle’s primary focus is to improve the lives of patients with skin cancer. In addition to our suite of prognostic and diagnostic tests, we recognize that reducing sun exposure, wearing sunscreen and UV-blocking clothing and getting screened for cancer are critical for improving health outcomes. Often, the largest barriers to wide uptake of those measures include insufficient awareness and insufficient financial allocation to their distribution—two barriers that we are proud to confront alongside the AAD."

About the AAD

Headquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 20,000 physicians worldwide, the AAD is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow the AAD on Facebook (American Academy of Dermatology), Twitter (@AADskin), Instagram (@AADskin1), or YouTube (AcademyofDermatology).