On September 2, 2021 Abbott (NYSE: ABT) reported that it has acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots (Press release, Abbott, SEP 2, 2021, View Source,-LLC [SID1234587224]). Walk Vascular’s peripheral thrombectomy systems will be incorporated into Abbott’s existing endovascular product portfolio. Financial terms were not disclosed.

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"The acquisition of Walk Vascular fits well into our leading vascular device offerings and further drives Abbott’s ability to provide one-of-a-kind endovascular therapy solutions to improve patient care," said Julie Tyler, senior vice president of Abbott’s vascular business. "Walk Vascular’s technology provides physicians with tools to efficiently remove dangerous clots from blood vessels to improve patient care."

Walk Vascular’s JETi Peripheral Thrombectomy System and next-generation JETi AIO (All In One) Peripheral Thrombectomy System are unique aspiration systems for the removal of intravascular clots, known as thrombus, that can reduce blood flow and lead to serious complications for patients. The innovative JETi systems are designed to break-up and remove clots from the peripheral vascular system while reducing the risk of dislodged clots. The systems are backed by real-world clinical experiences, and Walk is currently enrolling up to 250 patients in the United States and Europe in the JETi Registry.

Both the JETi Peripheral Thrombectomy Systems have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the aspiration and breaking up of soft emboli and thrombus from the peripheral vasculature, as well as CE Mark in Europe and approvals in other countries.

On September 2, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that it has entered into an agreement with RadioMedix, Inc. (RadioMedix) for the commercial production of the Company’s radiopharmaceuticals (Press release, Cytori Therapeutics, SEP 2, 2021, View Source [SID1234587154]).

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"RadioMedix is a global leader in the development and production of GMP radiopharmaceutical products," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "This strategic partnership substantially supports our efforts to have fully compliant 186RNL available by mid-2022 for a potential Phase 2/3 clinical study in adults with recurrent glioblastoma (GBM)."

"We are very excited to be the GMP manufacturing arm of Plus Therapeutics and participate in the development of 186RNL, a promising radiotherapeutic for central nervous system tumors. Our investment in state-of-the-art facilities for radiopharmaceutical manufacturing and highly trained experts emphasizes our commitment to delivering positive customer experiences across all phases of radiopharmaceutical development and commercial manufacturing," said Ebrahim S. Delpassand, M.D., Chairman and Chief Executive Officer of RadioMedix.

Under the agreement, RadioMedix will produce cGMP drug product meeting all applicable requirements of the U.S. Food and Drug Administration (FDA) and similar global regulatory entities. This strategic partnership further secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.

186RNL is being developed to treat recurrent GBM, leptomeningeal metastases, and pediatric brain cancer. It has been designed to safely, effectively and conveniently deliver high doses of radiation to rare and central nervous system tumors. Plus Therapeutics is currently enrolling patients with recurrent GBM in the U.S. NIH-supported multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial.

On September 2, 2021 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported business highlights and financial results for the second quarter of 2021 (Press release, Caribou Biosciences, SEP 2, 2021, View Source [SID1234587171]).

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"2021 has been a transformational year for Caribou, and we believe that our highly successful IPO speaks to the enormous potential of the company’s chRDNA technology to deliver innovative, transformative therapies for patients with devastating diseases," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "In July, we announced the dosing of the first patient in our ANTLER Phase 1 clinical trial evaluating our lead product candidate, CB-010, in relapsed or refractory B cell non-Hodgkin lymphoma. In addition to this program, we have three other wholly-owned allogeneic cell therapy product candidates in our pipeline, and we are collaborating with AbbVie to research and develop two additional allogeneic CAR-T programs for AbbVie using our Cas12a chRDNA technology."

Business Highlights

Dosed the first patient in Phase 1 clinical trial of CB-010. In July 2021, Caribou reported dosing the first patient in its ANTLER Phase 1 clinical trial of CB-010. The ANTLER trial is evaluating CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), and initial data from the trial are expected in 2022.

Completed upsized IPO raising $349.6 million in gross proceeds. In July 2021, Caribou completed its IPO, selling 19,000,000 shares of its common stock at a price to the public of $16.00 per share, for gross proceeds of $304.0 million. In August 2021, the underwriters fully exercised their option to purchase an additional 2,850,000 shares of common stock at the IPO price, increasing the total number of shares sold by Caribou in the IPO to 21,850,000 shares and the aggregate gross proceeds to $349.6 million. Aggregate net proceeds from the IPO, after deducting underwriting discounts and commissions and other offering expenses payable by Caribou, were $321.0 million.

Expanded Caribou’s board of directors. In August 2021, Nancy Whiting, Pharm.D., was appointed to Caribou’s board of directors. Dr. Whiting, who most recently served as executive vice president, corporate strategy, alliances and communication of Seagen, Inc., brings over 17 years of biotechnology industry expertise in drug and portfolio development as well as significant strategic leadership experience. Dr. Whiting joins Scott Braunstein, M.D., Andrew Guggenhime, Rachel Haurwitz, Ph.D., and Natalie Sacks, M.D., on Caribou’s board of directors. In July 2021, Mr. Guggenhime assumed the roles of chair of the board of directors and chair of the audit committee.

Published data demonstrating the significantly improved specificity of Caribou’s proprietary CRISPR hybrid RNA-DNA (chRDNA) guide technology compared to all-RNA guides. In September 2021, Caribou and its collaborators published studies in an article entitled, "Conformational control of Cas9 by CRISPR hybrid RNA-DNA guides mitigates off-target activity in T cells," in the journal Molecular Cell.

Upcoming Milestones

CB-010: Caribou expects initial data from the ongoing ANTLER Phase 1 trial in patients with relapsed or refractory B-NHL in 2022. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy derived from healthy donor T cells engineered using Cas9 chRDNA technology to introduce a CD19-specific CAR into the TRAC gene locus, thus eliminating expression of the T cell receptor to reduce the risk of graft versus host disease. The T cells are further modified to knock out the PDCD1 gene, preventing the expression of the PD-1 protein, to boost the persistence of CAR-T cell antitumor activity.

CB-011: Caribou expects to file an Investigational New Drug (IND) application for its CB-011 program in 2022. CB-011 is an allogeneic anti-BCMA CAR-T cell therapy derived from healthy donor T cells that is being developed as a potential treatment for relapsed or refractory multiple myeloma. Caribou is engineering healthy donor T cells using its proprietary Cas12a chRDNA technology to introduce a BCMA-specific CAR into the TRAC gene locus. In addition, Caribou utilizes an immune cloaking strategy designed to prevent rapid immune rejection of CB-011. This strategy comprises two edits: knockout of the endogenous B2M gene and site-specific insertion of a B2M–HLA-E fusion gene into the T cell genome.

CB-012: Caribou expects to file an IND application for its CB-012 program in 2023. CB-012 is an allogeneic anti-CD371 CAR-T cell therapy derived from healthy donor T cells for the potential treatment of relapsed or refractory acute myeloid leukemia. CB-012 cells are engineered using Caribou’s proprietary Cas12a chRDNA technology to introduce a fully-human CD371-specific CAR into the TRAC locus and to armor the cells to promote persistence.

CB-020: Caribou expects to announce target selection for its CB-020 program in 2022. CB-020, a CAR-NK product candidate, is the lead program in Caribou’s proprietary genome-edited iPSC-derived natural killer (iNK) cell therapy platform. Multiplex-edited CAR-NKs hold significant potential for treating a variety of solid tumor types.

Second Quarter 2021 Financial Results

Cash and cash equivalents: Caribou finished the second quarter of 2021 with cash and cash equivalents of $129.5 million. Cash and cash equivalents as of June 30, 2021, do not include $321.0 million in aggregate net proceeds from the company’s IPO completed in July and August of 2021.

Licensing and collaboration revenue: Revenue generated from Caribou’s licensing and collaboration agreements was $1.5 million for the second quarter of 2021, compared to $8.5 million for the second quarter of 2020. The decrease was primarily due to revenues recognized pursuant to an exclusive license agreement the company entered into during the second quarter of 2020.

R&D expenses: Research and development expenses increased by $4.7 million to $12.3 million in the second quarter of 2021, up from $7.6 million in the second quarter of 2020. The increase in research and development expenses was primarily due to an increase in costs associated with intellectual property license and assignment agreements, costs associated with pre-clinical programs, an increase in payroll and related expenses, an increase in the fair value of the Memorial Sloan Kettering Cancer Center (MSKCC) success payments liability, and an increase in facilities and other allocated expenses.

G&A expenses: General and administrative expenses increased by $2.0 million to $5.1 million in the second quarter of 2021, up from $3.2 million in the second quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in recruiting and personnel costs, legal and accounting services, and facilities and maintenance expenses.

Net loss: Caribou reported a net loss of $14.3 million in the second quarter of 2021, compared with a net loss of $1.9 million for the second quarter of 2020.

On September 2, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will participate in three upcoming virtual investor conferences (Press release, Autolus, SEP 2, 2021, View Source [SID1234587189]). An audio webcast of any presentations will be available live. You can access the webcasts via the Events section of the Autolus website. An archived version will also be available through the Company’s website for a limited time following the conference.

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On September 2, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2021 (Press release, MEI Pharma, SEP 2, 2021, View Source [SID1234587206]).

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"Fiscal year 2021 was very successful for MEI; it was highlighted by multiple data updates that continue to support the potential of the unique intermittent dosing therapy schedule we designed for zandelisib, both as a monotherapy and in combination with other therapies across a range of B-cell malignances. To that end, we are continuing to expand the clinical program with studies designed to broaden zandelisib’s potential, like the Phase 3 COASTAL study in second line or later follicular lymphoma and the planned start of a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "As we expect to report top-line data from the potentially registrational Phase 2 TIDAL study by the end of the calendar year, we are diligently advancing our pre-commercialization activities, including the building out of our commercial infrastructure, in preparation for the potential commercialization of zandelisib."

Dr. Gold continued: "In addition to advancing zandelisib clinical development, this past year also brought other exciting pipeline developments supporting new clinical development plans for voruciclib, our oral CDK9 inhibitor, to explore its potential to synergize with KRAS inhibitors, and plans for a Phase 2 study of ME-344 plus bevacizumab evaluating patients with colorectal cancer. We are proud of our progress over the last fiscal year and committed to maintaining our overall focus on the development and commercialization of novel, best-in-class, cancer therapies intended to improve outcomes for patients."

Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Report topline data from the Phase 2 TIDAL study in the fourth quarter from the follicular lymphoma primary efficacy population. The complete data from the follicular lymphoma arm of the Phase 2 TIDAL study data are intended to be submitted to the U.S. Food and Drug Administration (FDA) to support an accelerated approval marketing application.
Initiation of a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia.
Updates from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib, including in expansion cohorts enrolling patients with relapsed or refractory mantle cell and follicular lymphomas.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Program updates, including data from the monotherapy portion of the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor

Initiation of a Phase 2 study of ME-344 in relapsed colorectal cancer in the mid calendar year 2022.
Fiscal Year 2021 and Recent Select Drug Candidate Pipeline Highlights

Zandelisib

Completed enrollment in the follicular lymphoma primary efficacy population of 91 patients, and enrollment in the complete study population of 120 patients, of the global Phase 2 TIDAL study. Topline data from the study is expected to be reported in the fourth quarter of the calendar year. If successful, the complete Phase 2 TIDAL study data are intended to be submitted to the U.S. FDA to support accelerated approval applications under 21 CFR Part 314.500, Subpart H.
Initiated COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
The dosing of the first patient in the global Phase 3 COASTAL study evaluating zandelisib in combination with rituximab, announced in August 2021, triggered a $10,000,000 milestone payment payable to MEI from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies. Receipt of the milestone payment is expected in the quarter ending September 30, 2021.
Initiated a second arm in the Phase 2 TIDAL study evaluating zandelisib as a monotherapy for the treatment of adults with relapsed and refractory marginal zone lymphoma. Subject to results from TIDAL, data from the study are intended to support accelerated approval applications with the FDA under 21 CFR Part 314.500, Subpart H.
Presented clinical data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress from a Phase 1b study of zandelisib in combination with zanubrutinib (marketed as BRUKINSA), an inhibitor of Bruton’s tyrosine kinase developed by BeiGene, Ltd., in patients with relapsed or refractory B-cell malignancies. The data demonstrated that the combination was generally well tolerated in the 20 patients enrolled in the safety evaluation cohort. The combination administered on an optimized dosing regimen did not result in additive toxicity to each agent alone. Further, 100% of patients (n=16) with r/r indolent B-cell malignancies and chronic lymphocytic leukemia (CLL) achieved an objective response.
Presented clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 and the 16th Annual International Conference on Malignant Lymphoma from a Phase 1b study of zandelisib as a monotherapy or plus rituximab demonstrating a 95% overall response rate (ORR) with rituximab and a 78% ORR as a monotherapy in patients with relapsed or refractory follicular lymphoma. Data presented also demonstrated that a median duration of response was not reached. Zandelisib was generally well-tolerated, demonstrating an 8% discontinuation rate due to any treatment emergent adverse event.
Initiated a pivotal Phase 2 study by Kyowa Kirin of zandelisib in patients with indolent B-cell non-Hodgkin’s lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma and Waldenström’s macroglobulinemia in Japan.
Voruciclib

Reported preclinical data demonstrating that voruciclib is potent against CDK9, has single agent activity against multiple KRAS-mutant cancer cell lines and synergistically inhibits growth of KRAS mutant cancers in combination with KRAS inhibitors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. MEI is now expanding the clinical development of voruciclib into KRAS-mutated cancers, adding to the ongoing program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
Fiscal Year 2021 and Recent Corporate Highlights

During fiscal year 2021, MEI announced changes to its management team. In August 2021, MEI announced the planned transition and retirement of Brian Drazba as chief financial officer. The company initiated a search for a new chief financial officer. In July 2021, MEI appointed Tina C. Beamon, J.D. as chief compliance officer. In April 2021, MEI announced the retirement of Robert Mass and the promotion of Robert Ghalie as chief medical officer. In September 2020, MEI appointed Brian T. Powl as senior vice president, marketing.
Fiscal Year 2021 Financial Results

As of June 30, 2021, MEI had $153.4 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the year ended June 30, 2021, net cash used in operations was $52.4 million, compared to $45.3 million for 2020, excluding upfront cash payments from Kyowa Kirin. The increase primarily relates to increased costs associated with our clinical development programs.
Research and development expenses were $69.4 million for the year ended June 30, 2021, compared to $34.1 million for 2020. The increase was primarily related to increased development costs associated with zandelisib, including start-up costs related to the Phase 3 COASTAL study, increased drug manufacturing costs, and increased consulting fees to support clinical trial activities.
General and administrative expenses were $24.4 million for the year ended June 30, 2021, compared to $16.7 million for 2020. The increase primarily relates to increased professional services costs, increased personnel costs associated with increased headcount to support our activities, including preparation for commercial launch of zandelisib, and general corporate expenses incurred during 2021.
MEI recognized revenues of $25.5 million for the year ended June 30, 2021, compared to $28.9 million for 2020. The decrease in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations. Revenue also includes recognition of fees allocated to performance obligations in accordance with the Helsinn License Agreement.
Net loss was $50.6 million, or $0.45 per share, for the year ended June 30, 2021, compared to net loss of $46.0 million, or $0.51 per share for 2020. The Company had 112,614,643 shares of common stock outstanding as of June 30, 2021, compared with 111,513,689 shares as of June 30, 2020.
The adjusted net loss for the year ended June 30, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $68.7 million, compared to an adjusted net loss of $23.1 million for 2020.
Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, September 2, 2021, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI Pharma earnings call.

The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.