On March 31, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the company is entering into a financing of up to $3 million with an institutional investor, with an initial $450,000 of securities purchased at closing (Press release, Propanc, MAR 31, 2020, View Source [SID1234556039]). Funds raised will be used to undertake an engineering run and full scale GMP manufacture of PRP, the Company’s lead product candidate, as well as validation of the pharmacokinetics method to analyze the distribution of the drug in advanced cancer patients for a FIH study, which the Company intends to undertake at the Peter Mac Center in Melbourne, Australia.

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To complete the transaction, the Company entered into a Securities Purchase Agreement for the purchase of 11,250,000 shares of common stock and prefunded warrants issued at closing and 11,250,000 Series A warrants to purchase common stock at $0.20 per share. At closing, the investor was also issued 63,750,000 Series B warrants to purchase common stock at $0.04 per share (for an aggregate maximum exercise price of $2,550,000), and 63,750,000 Series C warrants to purchase common stock at $0.20 per share, which vest upon exercise of the Series B warrants on a ratable basis. Such warrants contain cashless exercise and other cashless conversion provisions. The Company has agreed to register for resale all shares of common stock issued, or underlying securities issued. The Company will provide further information regarding this financing in a Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission.

"The completion of this transaction is at a pivotal point for the Company, as we move towards commencing a FIH study for PRP," said James Nathanielsz, Propanc’s Chief Executive Officer. "Given the unique and challenging situation for humankind due to recent global events, the need to improve our standard of healthcare is ever more urgent. During this time, I am especially thinking of cancer sufferers, who may be exposed to standard treatments like radiation or chemotherapy, having a suppressed immune system and therefore exposure to infection like COVID-19 becomes an extremely high risk. Our goal is to improve quality of life, reduce side effects compared to standard treatments and extend life meaningfully. We are grateful to have a strategic institutional investor on board with us who is willing to support our vision."

On March 31, 2020 Driven by its Intelligent Cancer Care approach in developing new solutions that use advanced technologies like machine learning, Varian (NYSE: VAR), reported the newest release of its treatment planning system, Eclipse v16 (Press release, Varian Medical Systems, MAR 31, 2020, View Source [SID1234556038]). This new release includes intelligent features such as RapidPlan PT, the first clinical application of machine learning in proton treatment planning, and RT Peer Review, which is a collaborative workspace designed to streamline and accelerate the peer review process for radiotherapy treatment plans.

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Previously only available for photon-based radiotherapy treatment planning, RapidPlan is knowledge-based treatment planning software that enables clinicians to leverage knowledge and data from similar prior treatment plans to quickly develop high-quality personalized plans for patients. This knowledge-based planning software is now available for proton treatment planning with RapidPlan PT. The software also allows dose prediction with machine learning models that can be used as a decision support tool to determine which patients would be appropriate for proton or photon therapy. Varian is the first vendor in the industry to offer machine learning capability in both proton and photon treatment planning.

"With the number of operational proton treatment rooms continuing to increase, there is a need for experienced proton therapy clinicians," said Kolleen Kennedy, chief growth officer, president, Proton Solutions, Varian. "RapidPlan PT helps bridge the learning curve, allowing established centers to share their models and clinical experience. The machine learning in RapidPlan PT has the potential to reduce proton treatment plan optimization from a one to eight hour process, as reported by clinical proton centers, to less than 10 minutes, while also potentially improving plan quality."

In many radiotherapy departments, radiation therapy peer review meetings have been routinely integrated into the clinical QA process for safer healthcare delivery for the patient. Although the relevant patient information is manually retrievable from the clinical database, there is currently no efficient and effective platform to support these peer reviews. The RT Peer Review feature in Eclipse v16 is designed for the oncology community to seamlessly integrate this review process into their normal clinical workflow by automatically presenting the necessary information that is required for peer review.

On March 31, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the U.S. Food and Drug Administration (FDA ) granted Fast Track designation to ME-401, MEI’s investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta for the treatment of adult Patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies (Press release, MEI Pharma, MAR 31, 2020, View Source [SID1234556035]). MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.

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"We are pleased to report that we have received Fast Track designation for ME-401. This designation holds several important advantages to expedite the development and regulatory review of ME-401 as we work diligently to deliver it as a new potential treatment option for patients and their physicians," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain very encouraged by the maturing body of ME-401 clinical data, and we are excited to continue expanding the opportunity that ME-401 holds to provide a meaningful impact in the treatment of B-cell malignances."

About Fast Track

Fast Track is an FDA program intended to facilitate the development and review of new drugs to address unmet medical needs for the treatment of serious or life-threatening conditions so that a product may get approved and therefore can reach the market expeditiously.

To qualify for Fast Track designation, a drug must address an unmet medical need, demonstrated by nonclinical or clinical data, in a serious condition, and show some advantage over any available therapy, such as:

Having an improved effect on serious outcome(s) of the condition
Providing comparable efficacy while avoiding serious toxicity that occurs with the available therapy or avoiding less serious toxicity that is common and causes discontinuation of treatment of the serious condition
Features of fast track designation include:

Actions to expedite a drug’s development and review by frequent interactions with FDA
A rolling review process in which a Sponsor, in agreement with FDA, may submit portions of its New Drug Application (NDA) in advance of submission of a complete application. However, actual review of submitted portions may not commence until an application is complete. The FDA review clock starts upon receipt of a complete application.
Fast track designated products are eligible for consideration of priority review if supported by clinical data at the time of NDA submission.

About ME-401

ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. MEI owns worldwide rights in all geographies except Japan, which we licensed to Kyowa Kirin Company in 2018.

MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma ("FL") after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, we are planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H.

In addition to TIDAL, MEI is also conducting a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies such as Rituxan or agents such as Zanubrutinib in patients with relapsed or refractory B-cell malignancies.

On March 31, 2020 Cambrex, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported that Troy Player has been appointed as President, Early Stage Development and Testing (ESDT) (Press release, Cambrex, MAR 31, 2020, View Source [SID1234556034]). In his new role, he has responsibility for operations at the Agawam, Massachusetts; Durham, North Carolina; Edinburgh, UK; High Point, North Carolina and Longmont, Colorado facilities.

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With more than 25 years’ experience in senior strategic and operational executive roles, Mr. Player has a proven track record of developing, driving and managing business improvement. He joins Cambrex from West Pharmaceuticals where he spent 17 years and was most recently Vice President and General Manager of the Contract Manufacturing Business Unit where he oversaw six manufacturing locations and two engineering development centers. Prior to this he was Vice President and Managing Director for their Asia Pacific Region. He holds a Master of Business Administration from Francis Marion University, and a Bachelor of Science in Mechanical Engineering from the University of South Carolina.

"I am pleased to welcome an operational excellence and continuous improvement expert like Troy to our team," commented Shawn Cavanagh, President and Chief Operating Officer at Cambrex. "He is well-versed in leading cross-functional business improvement within commercial, manufacturing, customer service, business development, logistics/procurement, and product management/development environments, which makes him an invaluable asset to our team."

The ESD&T Business Unit was integrated into the Cambrex service portfolio following the acquisition of Avista Pharma Solutions in January 2019.

On March 31, 2020 Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) reported the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody (Press release, Bristol-Myers Squibb, MAR 31, 2020, View Source [SID1234556033]).

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The submission is based on results from the pivotal Phase 2 KarMMa study. The KarMMa study evaluated the efficacy and safety of ide-cel in heavily pre-treated patients with relapsed and refractory multiple myeloma. Topline data from KarMMa, reported in December 2019, indicated the study met its primary endpoint of overall response rate, and the key secondary endpoint of complete response rate in this patient population treated with ide-cel. The safety results were consistent with those observed in the supportive Phase 1 CRB-401 study, which evaluated the preliminary safety and efficacy of ide-cel. Comprehensive results of the KarMMa study will be presented at a future medical meeting.

BCMA is a protein that is nearly universally expressed on cancer cells in multiple myeloma, making it an important potential target for the treatment of this aggressive blood cancer. Ide-cel is the first CAR T cell therapy submitted for regulatory approval to target this antigen and for multiple myeloma.

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the FDA and PRIority MEdicines (PRIME) designation by the European Medicines Agency for relapsed and refractory multiple myeloma.

About Ide-cel

Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Bristol Myers Squibb and bluebird bio’s broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio.

Ide-cel is not approved for any indication in any geography.

About KarMMa

KarMMa (NCT03361748) is a pivotal, open-label, single-arm, multicenter, multinational, Phase 2 study evaluating the efficacy and safety of ide-cel in adult patients with relapsed and refractory multiple myeloma in North America and Europe. The primary endpoint of the study is overall response rate as assessed by an independent review committee (IRC) according to the International Myeloma Working Group (IMWG) criteria. Complete response rate is a key secondary endpoint. Other efficacy endpoints include time to response, duration of response, progression-free survival, overall survival, minimal residual disease evaluated by Next-Generation Sequencing (NGS) assay and safety. The study enrolled 140 patients, of whom 128 received ide-cel across the target dose levels of 150-450 x 106 CAR+ T cells after receiving lymphodepleting chemotherapy. All enrolled patients had received at least three prior treatment regimens, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and were refractory to their last regimen, defined as progression during or within 60 days of their last therapy.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase quality, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.