On August 19, 2020 Takeda reported to divest its over-the-counter business operations and has struck a deal for its U.S. offerings with The Blackstone Group, a U.S.-based investment fund valued at $2.37 billion (Press release, Takeda, AUG 19, 2020, View Source [SID1234563886]).

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Over the past several months, Takeda has struck multiple deals for its over-the-counter offerings in different markets. Most recently, the Japan-based pharma giant struck a deal with Celltrion Inc. for its non-core assets, prescription and over-the-counter, sold in the Asia Pacific market. South Korea-based Celltrion paid $278 million for the portfolio that includes prescription drugs Nesina, a diabetes treatment, and hypertension drug Edarbi. The portfolio generated net sales of $140 million in 2018.

This morning, Reuters reported that Takeda reached an agreement with Blackstone for Takeda Consumer Healthcare and its portfolio, which includes the Alinamin line of energy drinks. Takeda, which placed the business unit up for sale earlier this Spring, has not confirmed the finalized sale, Reuters reported. Japanese media first broke the story. According to Nikkei Asian Review, Blackstone acquired Ayumi Pharmaceutical, the producer of painkiller Calonal, in 2019.

Takeda has been selling off non-core assets as it pares down debt from its $62 billion acquisition of Shire. The acquisition of Shire placed about $30 billion of debt on the back of Takeda. The company has been looking to pare down that debt as it adjusts to the new size and scope of its portfolio from the Shire deal. Since the Shire acquisition, Takeda has been looking to sell off about $10 billion worth of non-core assets.

As Takeda sheds those non-core assets and pares down its debt, the company will preserve funds to remain focused on its five key business areas of gastroenterology, rare diseases, plasma-derived therapies, oncology and neuroscience. The company has also been building its presence in the gene therapy space. In June, Takeda and Carmine Therapeutics inked a deal to develop and commercialize non-viral gene therapies for two rare diseases. In March, Takeda entered a multi-target partnership with Evox Therapeutics to develop protein replacement and mRNA therapies for rare diseases.

Last month, Takeda and Twist Bioscience forged an agreement to expand biologics discovery capabilities and discover, validate and optimize new antibody candidates for a number of different indications. Takeda will have access to Twist’s "Library of Libraries," a large phage display library created using precisely defined synthetic DNA sequences to discover unique antibodies to important therapeutic targets including GPCRs. Target indications include oncology, rare diseases, neuroscience and gastroenterology.

On August 19, 2020 Lannett Company, Inc. (NYSE: LCI) reported that it will report financial results for its fiscal 2020 fourth quarter and full year on Wednesday, August 26, 2020, after the market closes (Press release, Lannett, AUG 19, 2020, https://www.prnewswire.com/news-releases/lannett-to-report-fiscal-2020-fourth-quarter-full-year-financial-results-host-conference-call-on-wednesday-august-26-301114557.html [SID1234563882]). Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company’s performance and answer questions.

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The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49903262. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

On August 19, 2020 SimonMed Imaging reported that it has reached an agreement with CorTechs Labs to onboard RSI-MRI+ for Prostate across many of its North American imaging sites (Press release, SimonMed Imaging, AUG 19, 2020, View Source [SID1234563881]).

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SimonMed, one of the largest outpatient medical imaging providers and largest physician radiology practices in the United States, announced its implementation of RSI-MRI+ for Prostate to support improved detection of clinically significant prostate cancer (PCa) using an advanced diffusion MRI technique.

"The arrival of RSI-MRI+ for Prostate into the SimonMed network marks an important step in our ability to accurately detect prostate cancer using the latest AI capabilities," said Dr. John Simon, MD, Chief executive officer of SimonMed. "I expect RSI-MRI+ to become standard technology across U.S. imaging centers, and transform prostate cancer detection and patient care."

RSI-MRI+ for Prostate is FDA-cleared advanced imaging software that supports improved PCa detection for a more accurate diagnosis. Using a patented advanced diffusion MRI technique called Restriction Spectrum Imaging (RSI) and artificial intelligence, RSI-MRI+ for Prostate significantly improves standard prostate imaging methods for cancer detection by making it easier for radiologists to identify areas of restricted diffusion, a hallmark characteristic of aggressive cancer.

"This integration of our latest AI software expands the already-extensive deployment of our other AI solutions throughout the SimonMed network of imaging centers," said Chris Airriess, Ph.D., chief executive officer of CorTechs Labs. "This is a big milestone for CorTechs Labs as we continue to deploy new AI tools in the oncology market. We look forward to growing our role in helping physicians in the U.S. and worldwide gain access to cutting-edge technology that helps improve patient care."

According to research published in Prostate Cancer and Prostatic Diseases, RSI has demonstrated both superior differentiation of PCa from normal tissue and prediction of PCa aggressiveness, compared to conventional MRI. When put in the hands of radiologists, a follow-up study in the same journal demonstrated that RSI-MRI with mpMRI improves PCa detection (85% accuracy) compared to mpMRI alone (79% accuracy), and RSI-MRI with T2WI achieves similar PCa detection (80% accuracy) as mpMRI alone (79% accuracy), which exemplifies its potential to support bi-parametric imaging. That same study also demonstrated improved inter-reader agreement amongst radiologists when using RSI-MRI.

"I expect that RSI-MRI+ for Prostate will support more accurate detection of prostate cancer for our patients, and improve the PI-RADS workflow for our radiology staff," added Dr. Simon.

On August 19, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the publication of interim results from its Phase II CONTROL trial of neratinib in the September 2020 Issue (Volume 31, Issue 9) of Annals of Oncology (Press release, Puma Biotechnology, AUG 19, 2020, View Source [SID1234563879]). The publication entitled, "Improved Tolerability of Neratinib in Patients with HER2+ Early-Stage Breast Cancer: Diarrheal Toxicity in the CONTROL Trial," can also be accessed online here.

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Previous studies of neratinib in HER2-positive early stage breast cancer showed that diarrhea was the most common adverse event (AE) associated with neratinib treatment.

The international, open-label, sequential-cohort Phase II CONTROL trial is investigating several strategies to improve neratinib tolerability. Researchers used data on incidence, duration and onset of diarrhea in the pivotal, multi-center, randomized, double-blind, placebo-controlled Phase III ExteNET trial as a historical comparison. In the ExteNET trial, prophylactic use of anti-diarrheal medication was not mandatory.

The interim results of the CONTROL trial discussed in this publication demonstrate that neratinib tolerability can be significantly improved using a variety of anti-diarrheal strategies. The most significant impact was seen using a dose escalation strategy with loperamide as needed, which included utilizing a lower dose of neratinib during the first two weeks of a 52-week treatment period. In the dose escalation cohort, of which patients completed one year of treatment or had the highest median treatment duration compared to other cohorts, grade 3 diarrhea was reduced by over 60% (CONTROL 15% versus ExteNet 40%), discontinuations by over 80% (CONTROL 3% versus ExteNet 17%), the need to dose reduce by almost 90% (CONTROL 3% versus ExteNet 26%) and no patients were hospitalized.

"Achieving a balance between treatment benefit and adverse events is an important clinical consideration in breast cancer, and the CONTROL trial demonstrates that neratinib tolerability can be most optimally improved with dose escalation, which can ultimately improve patient adherence to treatment," said Carlos H. Barcenas, M.D., M.S., associate professor in the department of breast medical oncology at The University of Texas MD Anderson Cancer Center. "These results, and specifically the lessened discontinuation of patients in early neratinib treatment, suggest that managing diarrhea during neratinib treatment allows more patients to receive the potential efficacy benefits of extended adjuvant neratinib therapy."

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased with the marked reduction in both the incidence of grade 3 diarrhea and the decrease in discontinuation of therapy demonstrated in the dose-escalation cohort of the CONTROL trial. We believe these are important results and should lead to improved tolerability for neratinib in early stage breast cancer patients. We remain committed to the fight against breast cancer, both in the early stage as well as in the metastatic setting."

The CONTROL trial initially tested high-dose loperamide prophylaxis given for the first two cycles (56 days) of adjuvant treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL trial was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide, the second cohort received the combination of loperamide plus colestipol, the third cohort received colestipol plus loperamide as needed and the fourth cohort did not use any antidiarrheal drugs as mandatory prophylaxis but instead used a dose escalation schedule plus loperamide as needed during the first month of neratinib treatment. Budesonide is a locally acting corticosteroid that Puma believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea, and colestipol is a bile acid sequestrant that Puma believes targets potential bile acid malabsorption that could result from such inflammation. The dose escalation schedule involved treating with neratinib with loperamide as needed at 120 mg per day for the first week, 160 mg per day for the second week and 240 mg per day starting at week three and until the end of treatment.

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On August 19, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported the presentation of preclinical data from its lead COBRA programs, MVC-101 and MVC-280, at the 2nd Annual Cell Engager Summit taking place virtually from August 18 to August 20, 2020 (Press release, Maverick Therapeutics, AUG 19, 2020, View Source [SID1234563878]).

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Chad May Ph.D., Senior Vice President, Research & Development, Maverick Therapeutics, will reveal new preclinical data characterizing the conditional and potent activity of its second program candidate, MVC-280, a COBRA that targets B7H3, during a presentation titled "Protease Dependent COBRATM Activity Regresses Established Tumors in Mice." The preclinical data demonstrate that MVC-280 regresses established solid tumors in mice and increases tolerability relative to inherently active T cell engagers. Dr. May is also scheduled to participate in a panel discussion on the opportunities within the tumor microenvironment to widen the therapeutic index.

"The preclinical data from MVC-280 are extremely encouraging and highlight the therapeutic potential for COBRAs to pursue more broadly expressed and validated targets," said Chad May, Ph.D., Senior Vice President, Research & Development, Maverick Therapeutics. "The binding kinetics of the MVC-280 COBRA also gave us a unique opportunity to assess tolerability and efficacy within the same in vivo model and enabled the calculation of a therapeutic index, which we consider to be 30 to 100x greater than that of an inherently active T cell engager."

Highlights of the presentation include:

MVC-101 regressed established solid tumors expressing EGFR in mice
MVC-280 regressed established solid tumors expressing B7H3 in mice
Half-life extended COBRAs are cleared more rapidly after proteolytic activation
Regression of established solid tumors is dependent on tumor mediated linker cleavage and COBRA activation
The COBRA design increases the therapeutic window
Presentation Schedule

Panel Discussion:

Title: Exploiting the High Protease Concentration in the Tumor Microenvironment to Reduce Toxicity
Date & Time: Wednesday, August 19, 2020 at 11:30AM ET
Presentation:

Title: Protease Dependent COBRA Activity Regresses Established Tumors in Mice
Session: Analyzing Tumor Target Selection to Maximize Efficacy Whilst Minimizing Toxicity
Date & Time: Thursday, August 20, 2020 at 9:30AM ET
About the COBRA Platform

Maverick Therapeutics’ COBRA platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought trifecta in cancer care; high specificity, high potency and reduced toxicity.

About MVC-101

Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target the Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non-small cell lung cancers. Maverick expects to initiate a Phase 1/2, Open Label, Dose Escalation Study of MVC-101 in Q1 2021.

About MVC-280

Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1/2, Open Label, Dose Escalation Study of MVC-280 in H2 2021.