On April 4, 2022 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd. focused on development of oncology, immunology, and critical care therapies, reported, in partnership with Foresee Pharmaceuticals Co., Ltd., the U.S. launch of CAMCEVI (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults (Press release, Foresee Pharmaceuticals, APR 4, 2022, View Source [SID1234611422]). The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. CAMCEVI 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.

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"The U.S. launch of CAMCEVI validates the importance of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology and is a monumental step toward fulfilling our mission of improving on a standard of care," said Dr. Ben Chien, founder and Chairman of Foresee. "We know that Accord BioPharma shares in that important goal."

CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.1 The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.1

"Accord Healthcare has been providing quality pharmaceutical products in the U.S. since the early 2000s. Through this partnership with Foresee on the launch of CAMCEVI, we are excited to formally launch Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.," said Binish Chudgar, Chairman, Accord Healthcare and Accord BioPharma.

"Foresee’s technology allows us to offer a therapy for advanced prostate cancer that is both effective and convenient for practitioners, with the pre-filled syringe providing simplified preparation that leads to an improved treatment experience for healthcare professionals," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "CAMCEVI marks an important example of our philosophy – going beyond biology – in action."

Important Safety Information: CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy. Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. Patients should be monitored for cardiovascular disease and according to current clinical practice. Androgen deprivation therapy may prolong the QT interval. Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Monitor serum levels of testosterone following injection of CAMCEVI. Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women. The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremities.

On April 4, 2022 MNM Bioscience, a technological start-up using genomic data and artificial intelligence algorithms to develop solutions for personalized medicine, reported that received an $800 000 grant from the Eureka’s Eurostars Programme (Press release, MNM Bioscience, APR 4, 2022, View Source [SID1234611421]). The program is a funding instrument dedicated for innovative SMEs, and will support the development of MNM’s unique patient stratification tool for ovarian cancer patients.

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This ambitious project will be realized in Consortium between MNM Bioscience and Macrogen Europe, a Dutch company focused on DNA sequencing and bioinformatics services.

The tool, named PARPiNDx (PARPindex), aims at better patient classification for the targeted anti-cancer therapy, increasing the chances to battle the disease through rapid implementation of the highly efficient drug. The tool selects patients who will respond to PARP inhibitors, a revolutionary drug family that is being successfully administered to patients with ovarian cancer, as well as several other cancer types, including pancreatic, breast and prostate cancers.

PARPiNDx is based on the genomic data derived from the whole genome sequencing data analyzed by AI-driven algorithms. PARPiNDx is not only selecting patients who will respond to PARPi, it is also identifying patients with intrinsic resistance to PARPi.

The consortium Agreement Was Signed 24th of March 2022.

On April 4, 2022 KIYATEC, the leader in clinically correlated, published functional precision oncology technology and the Adenoid Cystic Carcinoma Research Foundation (ACCRF) reported their jointly-authored abstract will be presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 10th, 2022 1:30pm – 5:00pm CST among the 3D Models and Microfluidics, Section 9 at the Ernest N. Morial Convention Center in New Orleans, Louisiana (Press release, KIYATEC, APR 4, 2022, View Source [SID1234611420]).

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The abstract, entitled "Ex vivo 3D culture of adenoid cystic carcinoma PDX models recapitulate disease biomarkers and predict drug response," evaluates drug response using KIYATEC’s validated 3D-XPDX adenoid cystic carcinoma (ACC) model based on the KIYA-PREDICT drug response platform. This ex vivo 3D cell culture approach provides a high-throughput, less costly and significantly faster platform for certain drug response studies in rare tumors challenged with scarcity of tumor tissue, as in ACC.

KIYATEC Chief Executive Officer Matt Gevaert, Ph.D., said, "We are honored to work with ACCRF for patients with this rare condition. Our collaboration represents the mission of KIYATEC – to disrupt and inform cancer treatment options by accurately predicting therapeutic tumor response."

Jeff Kaufman, Executive Director of ACCRF, said, "It has been a pleasure to partner with KIYATEC to develop ex vivo ACC models for drug development and screening. Rare tumor models that faithfully recapitulate the disease are an essential tool to bring better therapies to our patients."

About Adenoid Cystic Carcinoma

Adenoid cystic carcinoma is diagnosed in about 1,300 patients annually with approximately 11,000 living with an ACC diagnosis in the US. Approximately 80% of ACC patients are diagnosed with a primary (initial) tumor in the head and neck region, 12% in mammary (breast) glands, and the rest throughout the remainder of the body. Following treatment of the primary tumor, usually with surgery and radiation, approximately 80% of ACC patients will not develop a "local" recurrence near the site of the primary tumor. Although the statistics vary, about half of ACC patients eventually develop distant metastases. These metastases most often develop three to ten years after the initial diagnosis but have been known to develop even later, therefore requiring ACC patients to be monitored for life. The lungs are the most frequent site for ACC metastases; however, they sometimes spread to the liver, bone, and brain. Currently, there is no standard of care for recurrent/metastatic ACC patients, underscoring a substantial unmet clinical need.

On April 4, 2022 Teen Cancer America reported Advancements in liquid biopsies, enabling safer, easier and earlier detection of cancer, is the focus of the inaugural S.E.E. Summit, a virtual conference on April 21, 2022 (Press release, Teen Cancer America, APR 4, 2022, View Source [SID1234611419]). Convened by Teen Cancer America (TCA), the summit will feature presentations by the leading researchers and oncologists from biotechnology companies that are turning the game-changing promise of liquid biopsies into reality. The presentations will be followed by an open panel discussion.

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Liquid biopsies are blood tests designed to identify biomarkers in the blood that can detect cancer very early. Breakthroughs in genomics have accelerated the potential for liquid biopsies to change the paradigm for cancer screening, diagnosis and treatment as a non-invasive alternative to tissue biopsy.

The S.E.E. Summit is the first event to bring liquid biopsy out of stealth mode and begin a national dialogue about this technology’s potential for cancer patients.

The primary goal is to share information about this growing sector in a way that scientists appreciate but consumers, healthcare professionals, potential investors and the media can also understand. Presenters and panel discussion participants will include preeminent liquid biopsy experts from Caris Life Sciences, Exact Sciences/Thrive, Grail, Guardant, IV BioHoldings (IVBH), Natera, Pillar Biosciences and StageZero Life Sciences.

The online conference will feature pre-recorded presentations from the participating companies, followed by a live, independent panel of scientists, oncologists, patients, patient advocates and other stakeholders. The summit is produced by The Special Events Company, a world-class media group that has extensive experience in biotech and healthcare.

"Liquid biopsy research is aligned with President Biden’s ‘Moonshot’ cancer initiative which calls for a focus on prevention and early detection," said Simon Davies, Executive Director of TCA, the national non-profit co-founded by Roger Daltrey and Pete Townshend of the legendary rock band, The Who. "While our charity’s mission is to serve teens and young adults with cancer, where late detection and misdiagnosis is not uncommon, liquid biopsy is a major step forward in cancer detection among all age groups, and we are excited to shine a light on this important work."

Equity and access are primary objectives in the development of liquid biopsies. The American Cancer Society estimates there will be 1.9 million new cancer cases in the U.S. in 2022. Due to the pandemic, nearly 10 million cancer screenings were missed in 2020, disproportionately impacting individuals from marginalized populations, potentially leading to increased diagnoses of late-stage cancers.

Due to the lower cost, non-invasiveness and reduced time required for screenings, liquid biopsies can have a significant impact on cancer detection, early treatment and outcomes for at-risk populations.

"Liquid biopsies have reached a tipping point," said S.E.E. Summit co-creator Jamie Reno, an acclaimed journalist, bestselling author, patient advocate and three-time survivor of stage IV cancer. "There is still much work to be done in the lab, in clinical trials, and in the clinic, but the evidence overwhelmingly shows that this technology works. Once people understand how safe, easy and accurate these tests are becoming, then we will see the full potential of this new science."

According to Precedence Research, the liquid biopsy market, valued at $7.1 billion in 2020, is expected to grow at an annual rate of 14%, topping $26.2 billion by 2030.

The organizations participating in the S.E.E. Summit plan to extend the program into a series of educational media initiatives to educate and inform cancer patients, healthcare professionals, and the general public.

The event takes place on Thursday, April 21 beginning at 12 p.m. ET, 9 a.m. PT.

Online attendance is free, and registration is available at this LINK.

On April 4, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation (Fujifilm), has completed the acquisition of Atara’s cell therapy manufacturing facility in Thousand Oaks, California for USD 100 million upfront and the commencement of a long-term strategic supply agreement (Press release, Atara Biotherapeutics, APR 4, 2022, View Source [SID1234611418]). This partnership and acquisition was first announced in January 2022.

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With the closing of the transaction, FUJIFILM Diosynth Biotechnologies will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tabelecleucel (tab-cel), ATA188 for multiple sclerosis, and allogeneic CAR T therapies, ATA3271 and ATA3219.

FUJIFILM Diosynth Biotechnologies will also expand use of the Thousand Oaks site to manufacture a broader portfolio of cell therapies by leveraging the experience and expertise of the manufacturing and quality staff who transitioned to FUJIFILM Diosynth Biotechnologies.

Atara has retained a talented Technical Operations team who will continue to manage external manufacturing partnerships, manufacturing process science & development, quality assurance, supply chain, and logistics. Atara’s Thousand Oaks-based Atara Research Center (ARC) now houses Atara’s Pre-Clinical, Translational Sciences, Manufacturing Process Sciences, and Analytical Development teams to further drive innovation by leveraging the Company’s unique and differentiated allogeneic cell therapy platform.

The agreement is expected to reduce Atara’s planned operating expenses over the multiyear partnership period. The upfront consideration, along with the reduction in operating expenses, in addition to Atara’s existing cash, cash equivalents and short-term investments is expected to fund Atara’s planned operations into Q4 2023, beyond the anticipated completion of the randomized, placebo-controlled Phase 2 study of ATA188, the Company’s investigational off-the-shelf T-cell candidate that has the potential to reverse disability in progressive multiple sclerosis.