On June 17, 2021 The Children’s Oncology Group (COG), the world’s largest organization devoted exclusively to childhood and adolescent cancer research, and Signify Health, Inc. (NYSE:SGFY), a leading platform that leverages advanced analytics, technology and nationwide healthcare provider networks, reported a partnership to facilitate clinical trial participation for pediatric patients through in-home clinical services (Press release, Children’s Oncology Group, JUN 17, 2021, View Source [SID1234584158]).

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Through this new collaboration, pediatric patients participating in COG Study AALL1731, a clinical trial for a therapy to treat B-cell acute lymphoblastic leukemia (B-ALL), now have expanded options to facilitate receipt of experimental treatment at home. Participating in clinical trials that involve infusion therapies can be challenging for families because infusions require a credentialed provider to administer them, and because home health agencies are unable to bill insurance for investigational therapies.

AALL1731 (NCT03914625) is sponsored by the National Cancer Institute under a Cooperative Research and Development Agreement (CRADA) with Amgen, and is currently open at 195 U.S. COG sites. This in-home infusion service is for the patients assigned to receive blinatumomab on AALL1731 who are unable to access outpatient pumps and homecare. Amgen has provided funding to NCI under the CRADA to support more pediatric patients to receive blinatumomab at home.

B-ALL is the most prevalent childhood cancer, representing 20% of diagnoses in children younger than 15 years old and is the leading disease-related cause of death for children ages one to 19. Although improved treatments have led to higher survival rates for children with B-ALL, approximately 15% of children will have their leukemia return after remission is achieved. More effective treatment is needed for these children. Promising new therapies have the potential to alter the course of disease progression and removing barriers to participating in clinical trial programs is a primary focus for researchers and drug sponsors.

"This collaboration to provide in-home clinical services will allow more children to spend time at home receiving the investigational therapy while enabling much-needed research to deliver safer, and hopefully more effective therapies," said Mignon Loh, M.D., Chair of the COG ALL Committee. "A decentralized clinical trial approach will relieve unnecessary stress on families who are struggling financially and emotionally from their child’s cancer diagnosis. We hope that home access to investigational agents will increase participation in these important clinical trials."

Signify Health’s home-based clinical support services can help patients initiate investigational and approved therapies faster, improve their adherence, and provide a better overall experience for patients and families. Signify Health’s national network of credentialed clinicians will provide in-home infusion pumps and infusion bag changes to pediatric patients who have requested the in-home alternative. Signify clinicians will document patient metrics in real-time and be on call for the first 24 hours after a bag change to address any potential pump malfunctions.

"There is no better use of our network than to help children with cancer access potentially life-changing therapies," said Kyle Armbrester, CEO of Signify Health. "By activating the home as an alternate site of care, we hope to alleviate some of the burden and stress for families so that they can spend more time and energy focusing on what matters most."

On June 17, 2021 Cothera Bioscience reported that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial for the treatment of high-grade B-cell lymphoma that is resistant or refractory to first-line and second-line treatments with PC-002, an inhibitor that targets MYC mutations (Press release, Cothera Bioscience, JUN 17, 2021, View Source [SID1234618852]).

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PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancer involving MYC dysregulation.

Dr. Alex Wu, Co-founder and CEO of Cothera Bioscience, said: "The FDA’s approval of PC-002 to initiate human phase 2 clinical trials is an important milestone for Cothera. I believe this is a good start, and the company will continue its effort to launch late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients."

On June 17, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the ONCOS-102 and durvalumab trial in patients with advanced peritoneal malignancies has completed enrollment in the colorectal cancer cohort(Press release, Targovax, JUN 17, 2021, View Source [SID1234584100]).

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This phase 1/2 trial investigates the safety, biologic and anti-tumor activity of ONCOS-102 in combination with Imfinzi (durvalumab, anti-PD-L1) in patients with advanced peritoneal malignancies who have failed prior standard chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial ovarian or colorectal cancer.

In October 2020, the pre-defined disease control efficacy threshold in part 1 in the colorectal cancer cohort was met, and this expansion cohort was opened for recruitment of the part 2 patients. The clinical and immune activation data are expected to be available first half of 2022.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very pleased to see that recruitment is completed into this trial. This population of metastatic CRC who have failed prior therapy with peritoneal metastases is a large patient group with no effective available treatment. We look forward to seeing the clinical and immune activation data from this novel combination of immunotherapies and hope that it can deliver benefit to the patients."

The trial is a collaboration between Targovax, AstraZeneca (LSE/STO/Nasdaq: AZN), Cancer Research Institute (CRI) and Ludwig Cancer Research.

On June 17, 2021 Vor Biopharma (Nasdaq: VOR or the Company) reported that it will build-out an in-house clinical manufacturing facility in Cambridge, Massachusetts to support its development of potentially transformative engineered hematopoietic stem cell (eHSC) and chimeric antigen receptor T-cell (CAR-T) therapeutic candidates for patients with hematological malignancies(Press release, Vor BioPharma, JUN 17, 2021, View Source [SID1234584120]). Vor anticipates that the facility, located in the same premises as Vor’s current headquarters, will be operational in 2022.

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"Vor’s novel approach to cancer treatment demands an equally novel approach to cell therapy manufacturing. We are thrilled to construct our own manufacturing facility in our existing location, which will give us end-to-end oversight over drug product for our planned clinical trials and nicely complement our global supply chain," said Sadik Kassim, Ph.D., Chief Technology Officer at Vor. "With this new facility, our manufacturing teams will be seamlessly integrated within our wider organization, a crucial component of our strategy as we begin treating patients living with devastating blood cancers."

The facility has been designed to support clinical manufacturing for Vor’s cell therapy programs, including both eHSCs and CAR-T therapeutic candidates, and to be current Good Manufacturing Practice (cGMP) compliant. By integrating its internal research, process development, analytical development, manufacturing, and quality control testing capabilities under one roof, Vor aims to achieve flexible manufacturing capacity and to reduce the time and cost required to manufacture complex cell therapy clinical candidates.

In addition to leveraging its experienced manufacturing team, Vor plans to hire additional employees over the next few years to support the new in-house manufacturing operations. The planned build-out is consistent with Vor’s strategic plan and does not impact cash runway, which Vor believes is still sufficient to fund operations at least into the first quarter of 2023.

The new clinical manufacturing facility is part of a recently expanded lease agreement with Longfellow that increases Vor’s growing footprint in Cambridge.

On June 17, 2021 PanTher Therapeutics (PanTher), a privately held oncology company revolutionizing the treatment of solid tumors through direct, localized, and sustained delivery of proven and novel therapeutic agents, reported that it has closed an oversubscribed $5.4M Series A round led by Catalyst Health Ventures (CHV), with participation by Angel Physicians Fund (APF) and other notable investors (Press release, PanTher Therapeutics, JUN 17, 2021, View Source [SID1234584159]). The Series A round brings the total amount raised by the company to $7.4M.

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Proceeds from the funding will go toward the company’s first-in-human clinical trial. The company also announced today the additions of Darshana Zaveri, Managing Partner at CHV, Manish Bhandari, Managing Partner at APF, and Maria Palasis, President and CEO of Lyra Therapeutics, to its board of directors.

PanTher’s novel approach empowers oncologists to treat patients with life-threatening cancers by unlocking a drug’s full potential through direct, sustained treatment at the tumor site. The company’s proprietary platform is based on technology that was developed at the Massachusetts Institute of Technology (MIT) and was subsequently in-licensed by PanTher.

PanTher’s lead candidate is designed to control tumor progression in pancreatic cancer and improve survival rates, and it is easily integrated into a commonly used, minimally invasive staging procedure. PanTher’s platform technology can be adapted to treat additional solid tumor indications.

"The close of this Series A further establishes PanTher’s growth to a clinical-stage company, and our new board members reinforce our depth of knowledge and experience as we continue to build a collaborative and results-oriented culture," said Laura Indolfi, CEO and Co-Founder of PanTher Therapeutics. "It also allows us to continue investigating the potential of using our highly adaptable platform to treat other indications and exploring optimal localized cancer therapies for each of those indications."

"PanTher represents a truly new therapeutic modality that has the potential to change the way we deliver lifesaving drugs to tumors," noted Zaveri. "There is a clear, identifiable, unmet need in the treatment paradigm for patients with solid tumors, including tumors associated with pancreatic cancer, which is one of the most lethal and hardest-to-treat cancers."

"It is exciting to be part of a company whose technology is designed to produce better outcomes for cancer patients," said Palasis. "I am looking forward to collaborating with such a talented team of experts to advance new ways to effectively target chemotherapeutic drug therapy and reduce the toxicity and debilitating side effects that chemotherapy agents can produce when administered through traditional systemic intravenous or oral routes."