On November 18, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for MT-6402 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) expressing PD-L1 (Press release, Molecular Templates, NOV 18, 2021, View Source [SID1234595799]).

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"Fast Track Designation is an acknowledgement from the FDA of the potential of MT-6402 to address a significant unmet need in NSCLC," said Roger Waltzman, Molecular Templates’ Chief Medical Officer. "This designation will allow for continued contact with the FDA regarding the ongoing clinical program as well as future studies."

The Fast Track program is designed to accelerate the development and review of products such as MT-6402, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and may allow for further benefit from FDA accelerated programs such as priority review and/or rolling review.

MT-6402 is the first of MTEM’s third generation ETBs to enter the clinic. It was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies. MT-6402 is currently being evaluated in a multi-center, open-label, dose escalation and dose expansion Phase I trial in patients with solid tumors in the United States. Patient enrollment is currently ongoing. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and basket cohorts.

On November 18, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported positive topline results from the global pivotal QuANTUM-First phase 3 trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, NOV 18, 2021, View Source [SID1234595816]).1

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QuANTUM-First met its primary endpoint, demonstrating that patients who received quizartinib in combination with standard induction and consolidation chemotherapy and then continued with single agent quizartinib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to those who received standard treatment alone. The safety of quizartinib was shown to be manageable and consistent with the known safety profile.

AML is one of the most common forms of leukemia in adults, representing about one-third of all cases.2 The five-year survival rate of AML is about 29%, and patients with FLT3-ITD positive AML have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1,3 There remains a high unmet need to improve survival for the majority of patients with AML.4

"The results of the phase 3 QuANTUM-First trial showed that adding quizartinib, a potent and selective FLT3 inhibitor, to chemotherapy significantly prolonged overall survival in patients with newly diagnosed FLT3-ITD positive AML," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to sharing the QuANTUM-First data with the hematology community and will initiate discussions with global regulatory authorities."

Data from QuANTUM-First will be presented at an upcoming medical meeting and shared with regulatory authorities globally.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, multi-center global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (age 18 – 75) with newly diagnosed FLT3-ITD positive AML.

Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo in combination with standard anthracycline and cytarabine-based induction and consolidation regimens. Eligible patients, including those who underwent allogenic hematopoietic stem cell transplant (HSCT), continued with single agent quizartinib or placebo for up to 36 cycles.

The primary study endpoint is OS. Secondary endpoints include event-free survival (EFS), post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, were also evaluated.

QuANTUM-First enrolled 539 patients at approximately 200 study sites worldwide including in Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About Acute Myeloid Leukemia (AML)

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.5 AML is one of the most common types of leukemia in adults, representing about one-third of all cases.2 A heterogenous blood cancer, AML is characterized by a five-year survival rate of about 29%, the lowest by far among the major leukemia subtypes.6,7

Treatment guidelines for patients with newly diagnosed AML recommend a cytarabine-based chemotherapy regimen with or without a targeted therapy as determined by the presence of genetic mutations, age and other factors.8 Patients with newly diagnosed FLT3 mutated AML may receive a FLT3 inhibitor as part of their initial treatment regimen and/or subsequent regimens.8 While intensive chemotherapy and/or HSCT can improve chances for sustained remission in eligible patients, a substantial proportion of patients are not suitable for either intervention, and cure rates are particularly low for older patients.1,6 In recent years, new targeted treatments have increased options and improved outcomes for some patients with molecularly defined AML subtypes.6

About FLT3-ITD

FLT3 (FMS-like tyrosine kinase 3) is a transmembrane receptor tyrosine kinase protein normally expressed by hematopoietic stem cells; FLT3 plays an important role in cell development by promoting cell survival, growth and differentiation through various signaling pathways.1 Mutations of the FLT3 gene, which occur in approximately 30% of patients with AML, can drive oncogenic signaling.1 The most common type of FLT3 mutation is the FLT3-ITD (internal tandem duplication), which is present in about 25% of all AML patients and contributes to cancer cell proliferation.1 Patients with FLT3-ITD mutations have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1

About Quizartinib

Quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, is in phase 1/2 clinical development in pediatric and young adult patients with relapsed/refractory FLT3-ITD AML in Europe and North America.1 Several phase 1/2 combination studies with quizartinib are also underway at The University of Texas MD Anderson Cancer Center as part of a strategic research collaboration focused on accelerating development of Daiichi Sankyo pipeline therapies for AML.

Quizartinib is currently approved for use in Japan under the brand name VANFLYTA for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.

About Daiichi Sankyo Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

On November 18, 2021 Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation of previously approved drugs for neurological indications, reported that it has entered into an exclusive licensing agreement with Myung In Pharm Co. Ltd ("Myung In Pharm") to commercialize P2B001 for Parkinson’s disease (PD) in South Korea (Press release, Pharma Two B, NOV 18, 2021, View Source [SID1234595837]). In addition, Myung In Pharm invested $5 million of equity in Pharma Two B.

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P2B001 is a novel fixed-dose combination of low dose extended release (ER) formulations of pramipexole (dopamine agonist) and proprietary ER rasagiline (monoamine oxidase-B inhibitor), both widely-prescribed drugs for PD. Based on the potential synergism of these two ER drugs working through different mechanisms, P2B001 was designed to address an unmet medical need, being highly effective with minimal side effects, especially for early-stage patients. It has been formulated in a convenient, once-daily pill, with no titration required.

"We are extremely pleased to enter this licensing agreement for P2B001 and look forward to building a long-term relationship with Myung In Pharm in South Korea," said Dr. Sheila Oren, M.D., M.B.A., Chief Executive Officer of Pharma Two B. "Myung In Pharm has an excellent track record of successfully launching and marketing pharmaceutical products in South Korea, and has particular expertise in CNS products, including treatments for PD."

Under the terms of the agreement, Myung In Pharm will seek regulatory approval for P2B001 in South Korea and will manufacture, commercialize and distribute P2B001 in the region. Myung In Pharm will be responsible for all expenses related to the registration, sales, marketing and distribution of P2B001 in South Korea. In addition to the $5 million equity investment by Myung In Pharm, Pharma Two B is entitled to royalties on sales of P2B001 in the region.

Hang-Myung Lee, President of Myung In Pharm commented, "P2B001 has the potential to be a valuable new treatment for PD and the product is a strategic fit for Myung In Pharm. CNS is one of our core areas and we believe that P2B001 will strengthen our presence in the field, if approved. We look forward to working with Pharma Two B to bring this much needed treatment for PD patients in South Korea."

Pharma Two B recently completed its multinational Phase III study of P2B001 in early PD. The pivotal study was conducted at 70 sites in North America and the EU. Top line results are expected by the end of the fourth quarter of 2021. For more information, refer to ClinicalTrials.gov Identifier: NCT03329508.

On November 18, 2021 Oasmia reported that Interim report for the period January 1, 2021 – September 30, 2021
(Press release, Oasmia, NOV 18, 2021, View Source [SID1234595764])

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SIGNIFICANT EVENTS DURING THE THIRD QUARTER
In August, Oasmia strengthened its internal capabilities with the appointments of Kia Bengtsson as Head of Clinical Development and Johanna Röstin as Head of Regulatory Affairs with effect from October 1, 2021.
In September, Oasmia signed a license agreement with the Swiss-based FarmaMondo Group for the commercialization of Paclical (Apealea) in Russia and the Commonwealth of Independent States.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In October an Extraordinary General Meeting decided on adoption of a long-term incentive program based on employee stock options for senior executives in the company
In October Oasmia announced a global settlement of all disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement will result in a negative cashflow effect of MSEK 24.5 but with a positive earnings effect of MSEK 32.5.
THIRD QUARTER: JULY 1, 2021 – SEPTEMBER 30, 2021
Consolidated net sales amounted to TSEK 11,920 (154)
Operating profit/loss var TSEK -29,572 (-35,194)
Net profit/loss after tax amounted to TSEK -30,987 (-36,784)
Earnings per share amounted to SEK -0.07 (-0.08)
THE PERIOD: JANUARY 1, 2021 – SEPTEMBER 30, 2021
Consolidated net sales amounted to TSEK 16,553 (201,628)
Operating profit/loss var TSEK -126,579 (15,117)
Net profit/loss after tax amounted to TSEK -129,873 (7,832)
Earnings per share amounted to SEK -0.29 (0.02)
CEO REVIEW
Transforming a business requires sustained effort and focus. Since I joined Oasmia in March 2020 we have set out a clear path to future growth as a sustainable global oncology business.

We’ve done this by:

rightsizing the Company and terminating commercial drug production
putting our finances in order by eliminating unnecessary operating expenditure
building our in-house capabilities to make us an attractive partner for innovative assets and companies
reducing business risks, such as resolving inherited legal issues, eliminating these potential liabilities
Creating these solid foundations means we are now well placed to deliver on our string of pearls strategy, putting in place a diversified portfolio of innovative cancer therapies through in-licensing and M&A. Our ambition is to build a pipeline focused on hard-to-treat and late-stage cancers using different approaches and mechanisms of action which offer us multiple shots on goal, de-risking our portfolio significantly and therefore increasing our chances of success. During the third quarter we made steady progress towards achieving this vision.

Resolving outstanding legal disputes
Post period end, we announced the global settlement of all outstanding legal disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement will result in a negative cashflow of MSEK 24.5 but will result in a positive earnings effect of MSEK 32.5. Reported debt in relation to the MGC litigation of MSEK 80, as well as a receivable of MSEK 40, is settled as a result of the agreement, strengthening our financial position and eliminating borrowings on the balance sheet. This is excellent news and enables us to look forward rather than back.

Progressing our in-licensed and wholly-owned development-stage oncology assets
Cantrixil is the first product of our string of pearls strategy, in-licensed from Kazia Therapeutics in March. It targets a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells thought to be responsible for disease relapse. Patients with chemotherapy-resistant ovarian cancer have a very poor prognosis, and Cantrixil could offer a much-needed new therapeutic option. Positive Phase 1 results were presented at AACR (Free AACR Whitepaper) earlier this year and Phase 2 study preparations in advanced ovarian cancer are well underway. In September, our Scientific Advisory Board, composed of key opinion leaders in oncology, met in Stockholm for the first time. The Board is offering invaluable guidance on the design of the Cantrixil Phase 2 trial and the longer-term clinical and regulatory path. Securing drug product for the Phase 2 trial through manufacturing agreements with multiple parties is a complex process and initiation of the trial will be later than originally envisaged. We will communicate further on the proposed timetable for the Phase 2 study when we have clarity on the supply situation.

A Phase 1b trial of our second clinical-stage program, docetaxel micellar, in development for advanced prostate cancer, continued to recruit patients in Switzerland under the leadership of the Swiss Group for Clinical Cancer Research (SAKK). SAKK has made excellent progress, with three centers open and enrolment is still expected to be completed by the end of 2022.

Exploring the full potential of our technologies
We recently provided an update on our collaboration with the Karolinska Institutet in Sweden to explore the full potential of our XR-17 drug solubilization technology platform. Work on our line extension for XR-17, which we have named XR-18, is progressing well and is intended to offer expanded utility. We are also preparing to evaluate formulations of XR-17/18 with our licensed product candidate, Cantrixil.

Our recent research into XR-19, our dual encapsulation technology designed to encapsulate two active pharmaceutical ingredients (APIs) in one micelle, has yielded encouraging proof-of-concept data. However, we have assessed the commercial utility of this approach to be limited and have therefore decided not to develop new product candidates with this technology, focusing our resources on other development opportunities.

Organizational update
Having the right scientific, regulatory, development and commercial skills to make Oasmia an attractive business partner for oncology drugs and companies around the world is critical to our success. Over the past 18 months, we’ve built a first-class team in all these areas, and in August I was pleased to announce the appointments of Kia Bengtsson as Head of Clinical Development and Johanna Röstin as Head of Regulatory Affairs. Kia and Johanna significantly strengthen Oasmia’s internal drug development expertise, supporting our ability to move products through to commercialization and to evaluate new opportunities. Peter Selin has decided to step down as Chief Business Officer and the search for a replacement has been initiated. Peter will remain in his current role during his notice period.

Maximizing the potential from out-licensed products
Maximizing the potential of our partnered ovarian cancer therapy Apealea has been another important focus. In September, we signed a license agreement with the Swiss-based FarmaMondo Group for the commercialization of Apealea in Russia and the Commonwealth of Independent States, where it is known under the brand name Paclical. This agreement marks the completion of the out-licensing of Apealea globally and we anticipate the first royalties from partnerships during 2022.

Elevar has informed Oasmia that it is reviewing the clinical and regulatory pathway for Apealea in the US in order to maximize the product’s commercial potential. This may impact the clinical development timelines for Apealea in the US and Oasmia will update investors when firm information has been provided by Elevar.

Building the business through in-licensing and M&A
As well as driving our existing portfolio in Q3, we’ve made further progress in making Oasmia a more attractive partner for innovative therapies and companies, positioning ourselves to add value in the sweet spot of early-to-mid-stage product development, demonstrated by the in-licensing of Cantrixil.

I’m pleased to report that our continuing transformation and new capabilities has attracted interest from a number of parties and that we are currently evaluating several promising opportunities. I look forward to updating you on progress in due course.

I’d like to thank you all for your continued support at this exciting time for the business as we look ahead to completing our transition to become a global oncology business.

On November 18, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported that an abstract for SBP-101, a proprietary polyamine analogue, has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, which will be held January 20-22, 2022 (Press release, Panbela Therapeutics, NOV 18, 2021, View Source [SID1234595782]).

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Details of the presentation are as follows:

Poster Presentation

Title: Efficacy of SBP-101, a polyamine metabolic inhibitor, administered in combination with gemcitabine and nab-paclitaxel, as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.

Session Name: Poster Session B: Pancreas, Small Bowel, and Hepatobiliary Tract

Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website View Source The full abstract will be made available online via View Source at 5:00 PM (EST) on January 18, 2022.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .