On April 20, 2021 Reify Health reported that AstraZeneca (LSE/STO/Nasdaq: AZN), a leading global biopharmaceutical company, has selected StudyTeam, a patient enrollment management platform, to accelerate clinical development across its breast cancer investigational therapy portfolio (Press release, AstraZeneca, APR 20, 2021, View Source [SID1234578273]). Reify Health’s leading cloud-based solutions connect and empower the clinical trial ecosystem, starting with effective patient recruitment and enrollment. With its use of StudyTeam, AstraZeneca reinforces its reputation as a global sponsor of choice at breast cancer research sites.

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Since 2019, AstraZeneca has deployed Reify Health’s StudyTeam across multiple large global oncology clinical trials. Sites using StudyTeam with AstraZeneca randomize more patients per site per month and provide overwhelmingly positive feedback; in fact, 100% of sites using StudyTeam in its trials choose to do so for subsequent studies. High site engagement, supercharged workflows, and more visibility and control went into AstraZeneca’s decision to expand usage of StudyTeam.

"We now use StudyTeam to track patient recruitment and patient enrollment for all of our studies," said Katherine Wall, senior data manager at clinical research site Redlands Hematology Oncology in Redlands, California. "StudyTeam is a huge game changer for us to track all our patients in the solid tumor and hematologic malignancy trials that we’re participating in, and we’re now able to be even more efficient with our prescreening, thanks to StudyTeam. We’re grateful for sponsors like AstraZeneca that focus on providing sites like ours the solutions we need to enroll effectively."

AstraZeneca will expand use of the StudyTeam platform, including deployment of the Smart Patient Discovery feature. Information from a sponsor’s protocol can now be used to suggest potential patients to any research site coordinator using the StudyTeam system, allowing sites to more effectively connect the right patient to the right trial.

"AstraZeneca is prioritizing the site experience and the patient experience in its breast cancer clinical research program," said Ralph Passarella, CEO and co-founder of Reify Health. "By empowering sites with easy-to-use technology that allows sites to manage patients across all trials, our technology enables AstraZeneca to overcome the traditional challenges of moving candidates effectively through the enrollment funnel. And as the sponsor, AstraZeneca is gaining real-time visibility into patient enrollment to make quick, informed decisions on key issues that reduce site burden, improve candidate identification, and ultimately accelerate enrollment timelines."

AstraZeneca and other top-20 global biopharma companies, including Amgen and Eli Lilly and Company, use Reify Health’s StudyTeam to work with over 3,000 research sites in over 100 countries.

On April 20, 2021 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in kids and adults including ovarian, esophageal, endometrial and lung cancers, reported the closing of a $6 million Series A round of funding (Press release, OS Therapies, APR 20, 2021, View Source [SID1234578272]).

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The company’s lead product is OST-HER2 targeting Osteosarcoma in kids, which is a listeria cancer vaccine intended to prevent metastasis, increasing overall survival.

"Our primary focus is to get this done: to ensure that this leading technology is employed in a clinical trial, in order to bring new treatments for the deadly disease of Osteosarcoma to market," said Dr. Robert Petit, CMO/CSO of OS Therapies. "The OST-HER2 treatment has been highly successful in multiple trials in canine osteosarcoma, demonstrating 3X improvement in Overall Survival and Disease Progression – we hope to see that it works as well–or even better–in kids."

The completed private placement will also support the advancement of preclinical and toxicology studies for OS Therapies’ second major platform technology OST-TDC: a next generation Drug Conjugate Technology targeting large solid tumors and potentially other diseases. "With the combination of the OST-HER2 late-stage development, and the significant potential of the OST-TDC technology, we believe OS Therapies has found a balanced approach to significant growth potential," said Nathan Cali, Managing Director of Noble Capital Markets.

OS Therapies Executive Chair Colin Goddard, PhD. pointed out: "This funding gives OS Therapies the opportunity to execute on their clinical plan, while opening up funding options for the future corporate structure of what could likely be a fully-integrated biopharmaceutical company."

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes radiation and chemotherapy, with a high recurrence rate and significantly poorer prognosis upon metastasis.

On April 20, 2021 Transcenta Holding Limited (Transcenta), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, reported that it has received clearance of its IND for TST005 from US FDA for initiating Phase I clinical trial of its bi-functional anti-PD-L1/TGF-β antibody (Press release, Transcenta, APR 20, 2021, View Source;antibody-tst005-301272664.html [SID1234578271]).

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TST005, is a bi-functional anti-PD-L1 and TGF-β trap fusion protein designed to simultaneously target two immuno-suppressive pathways, transforming growth factor -β (TGF-β) and programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system. TST005 consists of a high affinity PD-L1 antibody fused with an engineered TGF-β Receptor Type II protein in its C-terminal. TST005 lacks FcR binding activity and thus has reduced FcR mediated killing of PD-L1 expressing effector T cells. TST005’s high PD-L1 binding activity and enhanced TGF-β trap stability enables the targeted delivery of TGF-β trap into PD-L1 expressing tumors, thereby minimizing off-target toxicities of systemic inhibition of TGF-β signaling. TST005 displayed potent activity in vitro in reversing TGF-β induced T-cell suppression. In multiple syngeneic tumor models, TST005 induced significant increase of CD8 T-cell infiltration into PD-L1 expressing tumors and displayed dose-dependent tumor growth inhibition in tumor model with high level TGF-β. TST005 is well tolerated in non-human primates and displayed a linear PK profile. TST005 is a potential novel bi-functional immunotherapy candidate with improved therapeutic window.

"TST005 is one of the few leading PD-L1/TGF-β bi-functional antibody drug candidates currently in clinical development globally," said Dr. Michael Shi, Transcenta’s EVP, Head of Global R&D and CMO, "We plan to simultaneously develop TST005 both in China and the United States under the same Phase I protocol with an innovative basket trial design. With the IND Clearance for TST005 in the US, we will accelerate the clinical development globally by allowing Chinese patients dosed at the current dose level when joining the study upon Chinese IND clearance. Once safety and tolerability are established, we plan to further evaluate TST005 in multiple other pretreated tumor types globally, benefiting patients worldwide at an early date."

On April 20, 2021 A trans-Atlantic collaborative group of researchers led by Children’s Hospital of Philadelphia (CHOP) reported that it has received approximately $680,000 from a group of research charities led by Solving Kids’ Cancer UK to study slowly progressive, or "indolent," neuroblastoma, which does not respond to chemotherapy and lacks other treatment options (Press release, CHOP, APR 20, 2021, View Source [SID1234578270]). The grant will fund research that could ultimately lead to better diagnosis of this form of the disease, as well as targeted treatment options.

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The interdisciplinary group involves researchers from CHOP; the Icahn School of Medicine at Mount Sinai; The Institute of Cancer Research, London; Texas Tech University Health Sciences Center; and Seattle Children’s.

"This grant will allow us to make progress in diagnosing and treating so-called indolent neuroblastoma, which is currently fatal in most patients," said principal investigator John M. Maris, MD, pediatric oncologist at the Cancer Center at CHOP and Giulio D’Angio Chair in Neuroblastoma Research at CHOP. "If we can identify signatures that allow us to diagnose this form of neuroblastoma in patients early, we can avoid unnecessary chemotherapy, which is not effective in these patients, and instead work toward targeted treatments that could ultimately improve patient outcomes."

Neuroblastoma is a type of cancer that forms in developing nerve cells and can present differently depending on the form of the disease. Some types can spontaneously regress and become benign, whereas others progress steadily and are fatal. The rate of progression varies. While certain forms of the disease progress rapidly but can be treated effectively with chemotherapy, other forms, like indolent neuroblastoma, progress slowly and are resistant to chemotherapy. The latter form predominately affects older children, teenagers and adults, who have very little chance of surviving their disease.

Currently, researchers lack tools to identify patients with indolent neuroblastoma and therapies with which to cure them. The joint award from Zoé4Life, Joining Against Cancer in Kids (JACK), Merryn Lacy Trust, Oscar Knox Fund, Solving Kids’ Cancer (US) and Solving Kids’ Cancer UK will allow the trans-Atlantic group of researchers to validate a specific and sensitive molecular test in tumors, which will be further developed for use with patient blood, in order to reliably identify patients with slowly progressing disease, rather than waiting for chemotherapy to fail them. The research team will also create and validate robust laboratory models of indolent neuroblastoma, which they will use to test combinations of immunotherapy with targeted small molecular therapies. Ultimately, the researchers hope to rapidly move a completely new therapy to an international clinical trial.

"Putting your child through multiple rounds of chemotherapy and watching them suffer from horrible side-effects only to find it’s made no difference to their disease is a truly devastating blow for parents," said Nick Bird, Research Trustee at Solving Kids’ Cancer UK. "We have to identify these children at diagnosis so we can spare them from chemotherapy that doesn’t work, and then we have to find better ways to treat their disease instead."

On April 20, 2021 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported it will release results for the first quarter 2021 on Wednesday, May 5, 2021, after the market closes (Press release, Vanda Pharmaceuticals, APR 20, 2021, View Source [SID1234578269]).

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Vanda will host a conference call at 4:30 PM ET on Wednesday, May 5, 2021, during which management will discuss the first quarter 2021 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 5709209.

The conference call will be broadcast simultaneously and archived on Vanda’s website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

A replay of the call will be available on Wednesday, May 5, 2021, beginning at 7:30 PM ET and will be accessible until Wednesday, May 12, 2021, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 5709209.