On September 26, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported an Issue Notification for the Chinese patent 201980010826.7 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18-TETRAAZAICOSANE-6,15-DIOL" (Press release, Panbela Therapeutics, SEP 26, 2023, View Source [SID1234635415]). This patent, developed in collaboration with Syngene International Ltd., an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101 (ivospemin), a lead investigational product. The patent is valid until 2039.

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Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics, commented, "This expansion of coverage into China and Asia as a whole, is significant for our patent portfolio and aligns with our global clinical programs. With a shorter synthesis of SBP-101, there are several advantages including a more scalable, efficient, and costeffective manufacturing process. These benefits are essential for future efforts, as they can potentially reduce production costs and improve the overall competitiveness of SBP-101 in the market.

Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Ltd., said, "We are delighted with the continued success of our longstanding collaboration with Panbela. Our partnership with them dates back to 2013 and since then we have collaborated on multiple projects. In this case, streamlining the production process of an investigational product is a core expertise in our Development Services division. A simpler production process means that commercialization will be easier, and the drug will reach patients more quickly. The protection of SBP-101 production through patents in multiple markets and now in China are significant milestones."

Dr. Simpson added, "This achievement underscores the Company’s commitment to protecting its intellectual property, advancing it’s products on a global scale, which can potentially lead to a broader market access and increased opportunities for SBP-101’s success."

On September 26, 2023 In an effort to continue accelerating new treatment options for people with pancreatic cancer, the Pancreatic Cancer Action Network (PanCAN) reported Oncolytics Biotech, Inc. (NASDAQ: ONCY) (TSX: ONC) as the recipient of its second annual PanCAN Therapeutic Accelerator Award (Press release, Oncolytics Biotech, SEP 26, 2023, View Source [SID1234635414]). Oncolytics received this award in recognition of its promising work on pelareorep, an investigational immunotherapy treatment that introduces double-stranded RNA into cancer cells, which stimulates anticancer inflammatory effects, including innate and adaptive immune responses and the activation and recruitment of T cells into the tumor. This $5 million grant will enable Oncolytics to continue the next stage of its research focused on a clinical trial with Oncolytics’ proprietary reovirus pelareorep in combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. If results are encouraging, the treatment combination may be advanced to late-stage clinical development through the PanCAN Precision PromiseSM adaptive clinical trial platform.

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The combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab was granted Fast Track designation by the FDA last year and has already been selected for inclusion in the Precision PromiseSM clinical trial platform, which is anticipated to open in early 2024. Testing pelareorep in combination with FOLFIRINOX expands the approach so all patients with advanced pancreatic cancer could have the opportunity to benefit from this innovative immunotherapeutic approach.

The announcement of the Therapeutic Accelerator Award is being made in advance of PanCAN’s annual Scientific Summit in Boston, which brings together PanCAN’s Community for Progress, including research grant recipients, Scientific and Medical Advisors, industry partners and special guests to share ideas and build collaboration. Oncolytics was selected to receive the 2023 PanCAN Therapeutic Accelerator Award for $5 million through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

Pancreatic cancer is notoriously aggressive and hard to treat. Current estimates suggest that the disease will be the second leading cause of cancer-related deaths in the United States before 2030. Most people with pancreatic cancer are diagnosed at a late stage when their tumor is inoperable, leaving these patients with few treatment options. And because the disease is significantly more resistant to chemotherapy than other cancers, it can even be difficult to treat in its earliest stages. Despite the fact that there is an urgent need for better outcomes for pancreatic cancer, research is often not prioritized because pancreatic cancer affects a relatively small population compared to other cancers, and clinical research can be risky and expensive.

"Today’s five-year survival rate of 12% is too low and we need new treatment options now," said PanCAN Chief Science Officer Lynn Matrisian, PhD, MBA. "PanCAN launched our own clinical program to de-risk companies’ investment through both the Therapeutic Accelerator Award and the Precision Promise platform to facilitate rapid advances in this disease."

PanCAN continues to take bold actions to improve the lives of everyone impacted by pancreatic cancer, including the investment of more than $208 million since 2003 to advance scientific research. PanCAN created the multimillion-dollar Therapeutic Accelerator Award in 2022 as a research investment focused on supporting companies working on new pancreatic cancer therapies that plan to conduct early-stage (Phase 1 and 2) clinical trials for these therapies.

"Oncolytics is so pleased to receive this innovative award and have the opportunity to work with PanCAN," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting. By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."

Oncolytics plans to utilize the grant funding to study pelareorep in combination with modified FOLFIRINOX chemotherapy in patients with metastatic pancreatic cancer who have not received prior cancer treatment. In addition, a separate group of patients will receive this combination along with a checkpoint inhibitor to verify synergies previously observed in this patient population. The goal of this research is to evaluate the safety and efficacy of these combination therapies. Efficacy will be assessed by measuring the effect of the treatments on tumor size, progression-free survival, and overall survival. In addition, immune responses to treatment will be assessed.

The funding offered through the PanCAN Therapeutic Accelerator Award represents an innovative and groundbreaking way for a non-profit to accelerate drug development. If the result of the clinical trial is positive, the hope is that the selected investigational treatment combination will be incorporated into the PanCAN Precision Promise adaptive clinical trial. While Precision Promise provides an effective approach for late-stage research on new pancreatic cancer therapies, many companies are not investing in the early-stage research necessary for late-stage studies and potential drug approval in this disease.

On September 26, 2023 Omega therapeutics presented its corporate presentation (Presentation, Omega Therapeutics, SEP 26, 2023, View Source [SID1234635413]).

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On September 26, 2023 Mythic Therapeutics, a clinical-stage biotechnology company committed to the development of next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer (NSCLC) with cMET overexpression (Press release, Mythic Therapeutics, SEP 26, 2023, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-receives-fda-fast-track-designation-for-mytx-011-for-patients-with-non-small-cell-lung-cancer-nsclc-with-cmet-overexpression [SID1234635412]). This designation encompasses NSCLC patients with any level of cMET overexpression, including low and intermediate.

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"Receiving Fast Track designation from the FDA reinforces our focus on addressing the unmet need of patients living with cMET-positive NSCLC, who currently have few effective treatments," said Brian Fiske, PhD, Chief Scientific Officer and Co-Founder at Mythic Therapeutics. "We are proud of this significant milestone as it highlights the potential of MYTX-011, which is enabled by our FateControl platform, to expand ADC therapy to more NSCLC patients."

Fast Track designation is intended to aid the development and expedite the review of drugs to treat serious and life-threatening conditions with unmet medical needs, with the goal of reaching patients earlier. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s clinical trial designs and development plans.

"While a small fraction of NSCLC tumors highly express cMET, a much broader patient population have tumors which overexpress cMET, but at lower levels," said KisMET-01 study investigator Rebecca Heist, MD, MPH, Massachusetts General Hospital. "It’s important we continue investigating the potential of MYTX-011 for patients with NSCLC who need new approaches to treating their cancer as many either do not respond to, or develop resistance to, existing treatment options."

About MYTX-011

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

On September 26, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2023 (Press release, MEI Pharma, SEP 26, 2023, View Source [SID1234635411]).

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"Over just the next few quarters we look forward to data readouts from two ongoing clinical studies of voruciclib and ME-344, advancing our strategy of assessing drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs," said David M. Urso, president and chief executive officer of MEI Pharma. "Focusing on the execution of these two clinical studies – voruciclib evaluated in combination with Venclexta in acute myeloid leukemia and ME-344 in combination with Avastin in colorectal cancer – we expect data readouts beginning with voruciclib early in calendar 2024 and in the first half of 2024 for ME-344. Positive data from the studies would provide important support for the further development of these therapies to address significant unmet medical needs among patients with acute myeloid leukemia and colorectal cancer."

Fiscal Year 2023 and Recent Highlights

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In August 2023, MEI announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, inhibit energy production through glycolysis and, thereby, increase tumor reliance on mitochondrial energy production, providing an opportunity to evaluate a combination with ME-344 to inhibit energy production in tumor cells and induce an antitumor effect. The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.

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In July 2023, at the Company’s Special Meeting of Stockholders, MEI did not obtain the necessary stockholder votes to approve a merger agreement for an all-stock transaction pursuant to which Infinity Pharmaceuticals would have become a wholly-owned subsidiary of the Company. The certified results showed that 59.70% of outstanding shares were voted, of which 47.86% voted in favor of the proposed transaction, and 51.44% against. Accordingly, MEI terminated the merger agreement.

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In June 2023, in connection with the Company’s succession plan, David M. Urso was appointed president and chief executive officer and also joined the Company’s board of directors. Mr. Urso replaced Daniel P. Gold, Ph.D., president and chief Executive officer of MEI since 2010. Dr. Gold continues to serve on MEI’s board. In June 2023, also as part of the Company’s succession planning, it was announced that Jay File would be appointed chief financial officer, replacing Brian Drazba. Mr. File’s appointment became effective on August 1, 2023.
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In May 2023, MEI announced an update to the ongoing Phase 1 study evaluating voruciclib, its oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta), a BCL2 inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies. The Company announced that early results demonstrated that voruciclib alone or in combination with venetoclax was generally well tolerated with no significant myelosuppression. The results further demonstrated encouraging clinical activity in heavily pretreated patients administered with voruciclib alone and at the initial dose level in combination with venetoclax. These early results are consistent with the hypothesis that voruciclib may address a common venetoclax resistance mechanism by inhibiting MCL-1 via CDK9 inhibition.
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In May 2023, MEI regained compliance with the Nasdaq minimum bid requirement after the Company implemented a 1-for-20 reverse stock split in April 2023. The reverse stock split was approved by MEI’s stockholders on January 5, 2023.

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In March 2023, the Safety Review Committee of the Phase 1 study evaluating voruciclib plus venetoclax completed a safety assessment of the initial dose escalation cohort evaluating the combination in patients with AML and recommended opening the next cohort. The combination stage of the study started after completing the single-agent dose exploration stage of the Phase 1 study in patients with either AML or B-cell malignancies.

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In December 2022, MEI announced a realignment of its clinical development efforts following the discontinuation of zandelisib, its PI3K delta inhibitor drug candidate. As part of the realignment, the Company disclosed plans to streamline the organization towards the development of its two earlier clinical-stage assets, voruciclib and ME-344. We currently have 41 employees, which reflects a 61% reduction in full-time employees since our announcement in December 2022.

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In December 2022, after receiving new guidance in an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), MEI and Kyowa Kirin announced the discontinuation of global development of zandelisib outside of Japan. The two companies concluded that a clinical trial consistent with the new FDA guidance, including modification of the then ongoing Phase 3 COASTAL trial, would likely not be feasible to complete within a time period that would support further investment. Kyowa Kirin, after meeting with the Pharmaceuticals and Medical Devices Agency (PMDA), subsequently discontinued zandelisib development in Japan after determining that conducting a randomized study consistent with that agency’s guidance to support a marketing application would also likely not be feasible to complete within a time period that would support further investment. In July 2023, the Company and Kyowa Kirin mutually entered a termination agreement between the parties pursuant to which MEI regained full global rights to zandelisib, subject to Kyowa Kirin receiving some limited rights to use zandelisib for compassionate use.

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
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Report clinical data from the ongoing Phase 1 clinical trial evaluating voruciclib plus Venclexta (venetoclax) in patients with AML early in calendar 2024.

ME-344 – Mitochondrial inhibitor in Phase 1b Study

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Report clinical data from the Phase 1b clinical trial evaluating ME-344 plus Avastin (bevacizumab) in patients with relapsed colorectal cancer in the first half of calendar-year 2024.

Fiscal Year 2023 Financial Results

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As of June 30, 2023, MEI had $100.7 million in cash, cash equivalents, and short-term investments with no outstanding debt.

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For the year ended June 30, 2023, cash used in operations was $52.5 million, compared to $48.7 million during the year ended June 30, 2022. The increase in cash used in operations was primarily due to changes in working capital associated with the close down of zandelisib activities with Kyowa Kirin.

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Research and development expenses were $52.5 million for the year ended June 30, 2023, compared to $85.6 million for the year ended June 30, 2022. The decrease was primarily related to a reduction in zandelisib costs as we continued the close down of development activities announced in December 2022.

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General and administrative expenses increased by $2.6 million to $33.1 million for the year ended June 30, 2023, compared to $30.5 million for the year ended June 30, 2022. The net increase was primarily related to severance costs due to our staggered reductions in the workforce announced in December 2022 and higher external professional services offset by a decrease in noncash stock-based compensation.

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MEI recognized revenue of $48.8 million for the year ended June 30, 2023, compared to $40.7 million for the year ended June 30, 2022. The increase in revenue primarily results from the discontinuation of the zandelisib program in December 2022 under our global License, Development and Commercialization Agreement with Kyowa Kirin that resulted in the recognition of $16.6 million of previously deferred revenue related to performance obligations that are being closed and $8.6 million of previously deferred revenue related to performance obligations associated with clinical trials that have not commenced and will no longer be initiated.

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Net loss was $31.8 million, or $4.78 per share, for the year ended June 30, 2023, compared to net loss of $54.5 million, or $8.75 per share for the year ended June 30, 2022. The Company had 6,662,857 shares of common stock outstanding as of June 30, 2023, compared with 6,657,602 shares as of June 30, 2022.

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The adjusted net loss (a non-GAAP measure) for the year ended June 30, 2023 and 2022, excluding noncash gains recognized for changes in the fair value of warrants, was $33.4 million and $75.2 million, respectively

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.

Conference Call & Webcast Information

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When: September 26, 2023, 5:00 p.m. ET

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Dial-in: 1-833-974-2378 (United States) or 1-412-317-5771 (International)

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Please ask to join into the MEI Pharma earnings call

Please join the conference call at least 10 minutes early to register. You can access the live webcast here or under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived for at least 30 days after the call.