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OS Therapies Completes $6 Million Series A Funding Round

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.

Transcenta Received IND Clearance from US FDA for Initiating Phase I Clinical Trial for its Bi-functional Anti-PD-L1/TGF-β Antibody TST005

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]).

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."

Cancer Researchers Receive Grant to Study Indolent Neuroblastoma

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.

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."

Vanda Pharmaceuticals to Announce First Quarter 2021 Financial Results on May 5, 2021

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]).

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.

Ascentage Pharma to Announce Results from Four Clinical Studies at 2021 ASCO Annual Meeting, with Data of Its Drug Candidates Including Lisaftoclax (APG-2575) to Be Released in Oral Presentations for the First Time

On April 20, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that results from four clinical studies of the company’s three apoptosis-targeted drug candidates have been selected for presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ascentage Pharma, APR 20, 2021, View Source [SID1234578268]). These include two oral presentations: one based on a global Phase I clinical study of the Bcl-2 inhibitor lisaftoclax (APG-2575); and the other based on a global Phase II clinical trial of the MDM2-p53 inhibitor alrizomadlin (APG-115) in combination with the PD-1 checkpoint inhibitor pembrolizumab.

Convening on June 4 to 8, 2021, the ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and the most advanced cancer therapies, and is the world’s most influential and prominent scientific gathering of the clinical oncology community.

"This year marks the fourth consecutive year in which our clinical study results were selected for presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting, and we are pleased to have an opportunity to share multiple progress from our clinical development programs," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We are thrilled that the results from two of our clinical studies have been selected for oral presentations at the meeting this year. Through these oral presentations, we will release the data from the Phase I study of lisaftoclax at a prominent scientific event for the first time. This signifies the drug candidate’s therapeutic potential and the global research community’s strong interest in this novel therapeutic, and shows Ascentage Pharma’s capability in the global research and development of apoptosis-targeted cancer therapies. We look forward to sharing detailed results during the meeting. Moving forward, we will strive to accelerate our clinical development programs to hopefully soon provide cancer patients with more treatment options."

At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma will present results from four clinical studies of the company’s three apoptosis-targeted drug candidates as follows:

The novel Bcl-2 inhibitor lisaftoclax (APG-2575)

Lisaftoclax is a novel, orally administered small-molecule Bcl-2‒selective inhibitor being developed by Ascentage Pharma. Lisaftoclax is designed to treat hematologic malignancies and solid tumors by selectively blocking antiapoptotic protein Bcl-2 to restore the normal apoptosis process in cancer cells. Lisaftoclax is the first China-developed Bcl-2 inhibitor entering clinical development in China.

Selected study: A global Phase I clinical study of lisaftoclax, a novel Bcl-2 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and other hematologic malignancies (HMs)
Format: Oral Presentation
This global multi-center, single-agent, open-label Phase I clinical study is designed to assess the safety, pharmacokinetics (PK), pharmacodynamic (PD), and efficacy of lisaftoclax, and to determine its maximum tolerated dose (MTD)/recommended Phase II dose (RP2D) in patients with R/R CLL and other HMs.

In the preliminary data released by Ascentage Pharma in December 2020, lisaftoclax has demonstrated an objective response rate (ORR) of 70%, with favorable tolerability and manageable safety profiles in patients with R/R CLL. Detailed updated results will be released in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting during June 4 – 8, 2021.

The novel MDM2 inhibitor alrizomadlin (APG-115)

Being developed by Ascentage Pharma, alrizomadlin is an orally administered, selective, small-molecule inhibitor of the MDM2 protein. Alrizomadlin has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction. Alrizomadlin is the first MDM2-p53 inhibitor entering clinical development in China, and is currently being investigated in multiple Phase Ib/II clinical studies in solid tumors and HMs in China, Australia and the US.

Selected study: A Phase II study of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs
Format: Oral Presentation
This study is designed to evaluate the efficacy and safety of alrizomadlin in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic drugs.

The results of this Phase Ib study released at the 2020 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated that alrizomadlin in combination with pembrolizumab is well-tolerated, with preliminary antitumor activity in advanced solid tumors.

Selected study: A Phase I/II trial of alrizomadlin, with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma
Format: Poster Presentation
This multi-center, open-label Phase I/II study in the US is designed to evaluate the efficacy of alrizomadlin, with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma.

The Bcl-2/Bcl-xL inhibitor pelcitoclax (APG-1252)

Pelcitoclax is a novel, highly potent, small molecule drug designed to restore apoptosis through selective inhibition of Bcl-2 and Bcl-xL proteins.

Selected study: A multi-center Phase Ib/II study of pelcitoclax plus paclitaxel in patients with relapsed/refractory small-cell lung cancer (R/R SCLC)
Format: Poster Presentation
This multi-center, open-label Phase Ib/II study is designed to evaluate the safety and preliminary efficacy of combination therapy with pelcitoclax plus paclitaxel in patients with R/R SCLC.