Fresenius Kabi launches IV Drug in the U.S.

On July 29, 2022 Fresenius Kabi reported that Thiotepa Injection, a cancer therapeutic, is now available in the United States (Press release, Fresenius, JUL 29, 2022, View Source [SID1234617133]). It has multiple indications, including for the treatment of patients with adenocarcinoma of the breast or ovary. This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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Anaveon to present new data from the Phase I/II study of ANV419 at the ESMO Congress 2022

On July 29, 2022 Anaveon reported that it will present new clinical data from the ongoing Phase I/II study of ANV419 in patients with solid tumors, as well as new pre-clinical data further elucidating the mode of action of this powerful and selective interleukin-2 (IL-2) agonist, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, taking place in Paris, September 9 – 13, 2022 (Press release, Anaveon, JUL 29, 2022, View Source [SID1234617132]). Abstracts will be available online starting 00.05 CEST on Monday, September 5, 2022.

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Details of the poster presentations are:

Abstract Title: "ANV419, a selective IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, in patients with advanced solid tumors, a phase I/II study"

Presentation Number: 479P
Location: Poster Area Hall 4

Authors: H. Läubli, G. Alonso, J. Lopez, E. Calvo, M. Jörger, V. Sanchez, D. Di Blasi, A. Nair, K. Richter, Ch Huber, J Mouton, S. Costanzo, S. Jethwa, Ch Bucher and E. Garralda
Date/Time: 12 September 2022 at 9:00 CEST – 18:30 CEST

Abstract Title: "ANV419 is a novel CD122-biased IL-2/anti-IL-2 fusion protein with potent CD8 T cell and NK cell stimulating capacity that shows additive efficacy in combination with checkpoint inhibitors and treatments acting through antibody dependent cellular cytotoxicity"

Presentation Number: 39P
Location: Poster Area Hall 4

Authors: K. Richter, N. Egli, L. Petersen, P. Murer, A. Katopodis and Ch. Huber
Date/Time: 11 September 2022 at 9:00 CEST – 18:30 CEST

Please visit the ESMO (Free ESMO Whitepaper) website here for more information.

Anaveon is undertaking a Phase I/II study to evaluate the safety, dosing and clinical activity of its lead program, ANV419, a powerful and selective interleukin-2 (IL-2) agonist in patients with solid tumors. The Company is pursuing multiple parallel Phase II programs in order to explore the full therapeutic potential of ANV419. In addition, Anaveon continues its work in developing follow-on compounds to expand on the success of ANV419 by delivering the IL-2 agonist to tumor fighting cells and thus expand the therapeutic potential into less immunogenic tumors. Alongside this, the Company is building on its cytokine engineering expertise with preclinical-stage programs harnessing the power of cytokines for therapeutic purposes.

New NSF awards will advance theoretical foundations of data science research through interdisciplinary collaborations

On July 29, 2022 National Science Foundation reported that Data science is an expanding field that requires the expertise of computer scientists, engineers, mathematicians, and statisticians to handle the complex analysis of ever-larger data sets (Press release, National Science Foundation, JUL 29, 2022, View Source [SID1234617130]). Data affect how industry, academia and government operate. The U.S. National Science Foundation is committed to leading the nation in foundational data science research.

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As part of this effort, NSF announces two new Transdisciplinary Research in Principles of Data Science, or TRIPODS, Phase II awards totaling $20 million that bring together scientists and engineers from different research communities to further the theoretical foundations of data science through integrated research and training activities. TRIPODS is tied to NSF’s Harnessing the Data Revolution Big Idea, which aims to accelerate discovery and innovation in data science algorithms, data infrastructure, and education and workforce development.

Phase II of the program will continue to support the development of collaborative institutes to delve deeper into foundational issues in data science, such as design of algorithms for analyzing large, complex, noisy and changing data sets; data that includes historical biases and elements influenced by self-interested and possibly malicious parties; and the need for fair, ethical and understandable results from complex data-driven decision-making processes.

"The NSF TRIPODS Institutes will bring advances in data science theory that improve health care, manufacturing, and many other applications and industries that use data for decision-making," said NSF Division Director for Electrical, Communications and Cyber Systems Shekhar Bhansali.

TRIPODS awards aim to achieve these goals and other long-term major impacts in areas ranging from basic science to commerce and law by bringing together electrical engineering, mathematics, statistics, and theoretical computer science communities in synergistic and mutually beneficial ways to develop a unified foundation for data science.

NSF is supporting two new teams over five years focused on these topics, bringing the total number of TRIPODS Phase II Institutes to four. Previous TRIPODS Institutes were announced in 2020.

The Institute for Emerging CORE Methods in Data Science, or EnCORE, is led by the University of California San Diego in collaboration with the University of California, Los Angeles; University of Pennsylvania; and The University of Texas at Austin. EnCORE brings together scientists from multiple disciplines such as statistics, mathematics, electrical engineering, theoretical computer science, machine learning and health science, among others.

EnCORE’s team will focus on the four CORE pillars of data science: C for complexities of data, O for optimization, R for responsible learning, and E for education and engagement. The institute is fostering a plan for outreach and broadening participation by engaging students of diverse backgrounds at all levels, from K-12 to postdocs and junior faculty. The project aims to reach a wide demography of students by offering collaborative courses across its partner universities and a flexible co-mentorship plan for multidisciplinary research.

To bring theoretical development into practice, EnCORE will work with industry partners and domain scientists and will forge strong connections with other NSF Harnessing the Data Revolution Institutes across the nation.

Institute for Emerging CORE Methods in Data Science awards: UC San Diego, UCLA, University of Pennsylvania, and The University of Texas at Austin.

The Institute for Data, Econometrics, Algorithms, and Learning, or IDEAL, is a multi-institution and transdisciplinary institute led by the University of Illinois Chicago in collaboration with Northwestern University; Toyota Technological Institute at Chicago; the University of Chicago; and Illinois Institute of Technology, in partnership with members of the Learning Theory team at Google. The institute involves more than 50 researchers working on key aspects of the foundations of data science across computer science, electrical engineering, mathematics, statistics, and fields such as economics, operations research and law.

Research will center around the foundations of machine learning, high-dimensional data analysis and inference, and data science and society. Topics include foundations of deep learning, reinforcement learning, machine learning and logic, network inference, high-dimensional data analysis, trustworthiness and reliability, fairness, and data science with strategic agents.

The institute will broaden research and education participation from underrepresented groups by organizing activities that engage diverse communities of students at all levels, including high school and undergraduate students, as well as teachers (through a partnership with Math Circles of Chicago) and the public (via lectures in partnership with the Museum of Science and Industry).

Institute for Data, Econometrics, Algorithms, and Learning awards: UIC, Toyota Technological Institute, The University of Chicago, IIT, Northwestern University.

"The new 2022 TRIPODS awards address foundational challenges in data science at the core of data-driven discovery and decision making," said NSF Division Director for Computing and Communication Foundations (CCF) Dilma Da Silva. "CCF is pleased to be able to support these impactful projects."

Lexicon Pharmaceuticals to Host Second Quarter 2022 Financial Results Conference Call and Webcast on August 2, 2022

On July 29, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its second quarter 2022 financial results on Tuesday, August 2, 2022 after the markets close (Press release, Lexicon Pharmaceuticals, JUL 29, 2022, View Source [SID1234617127]). Management will conduct a conference call and live webcast at 5:00 p.m. ET / 4:00 p.m. CT that day to discuss its financial and operating results and to provide a general business update.

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The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

ImmunoGen Reports Recent Progress and Second Quarter 2022 Financial Results

On July 29, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended June 30, 2022 (Press release, ImmunoGen, JUL 29, 2022, View Source [SID1234617125]).

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"With the BLA for MIRV accepted and receiving Priority Review designation from FDA, we have taken a significant step closer to bringing this important new therapy to ovarian cancer patients this year," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer, "We are pleased with the positive reception our data received at ASCO (Free ASCO Whitepaper) and are focused on building our commercial and medical infrastructure to support a successful launch to establish MIRV as the new standard of care for patients with folate receptor alpha positive disease."

Enyedy continued, "We have also completed accrual in MIRASOL and expect to report data from this confirmatory study early next year. In support of moving MIRV into broader patient populations, we are expanding our development program and are in the process of initiating the GLORIOSA and Trial 0420 studies. Turning to our second pivotal program, PVEK, we expect to report preliminary efficacy data from our pivotal CADENZA study in BPDCN this year and plan to present initial data from our triplet expansion cohort in AML at ASH (Free ASH Whitepaper). We have had a productive first half of the year, and with key regulatory and clinical milestones anticipated before year-end, we are well positioned to create meaningful value for both patients and shareholders."

RECENT PROGRESS

Announced that the U.S. Food and Drug Administration (FDA) accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with one to three prior systemic treatments with Priority Review designation.
Completed enrollment in the confirmatory MIRASOL study.
Presented additional efficacy data from the pivotal SORAYA study and an integrated safety summary of single-agent mirvetuximab across multiple studies enrolling almost 500 patients with FRα-positive recurrent ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Advanced accrual in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer.
Supported investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Progressed the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued enrollment in expansion cohorts in the Phase 1b/2 study evaluating pivekimab, Vidaza (azacitidine), and Venclexta (venetoclax) in both R/R and frontline unfit acute myeloid leukemia (AML) patients.
Advanced dose escalation and opened additional sites in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed the generation of supplemental chemistry, manufacturing, and controls (CMC) information for submission to the FDA to support the investigational new drug (IND) application for IMGN151.
Announced a multi-year collaboration to research novel, first-in-class ADCs with Oxford BioTherapeutics (OBT) utilizing ImmunoGen’s proprietary linker-payload technology directed to novel targets identified via OBT’s proprietary OGAP discovery platform.
ANTICIPATED UPCOMING EVENTS

Potential FDA approval of mirvetuximab as a monotherapy in patients with FRα-high platinum-resistant ovarian cancer by the Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.
Generate top-line data for MIRASOL in early 2023.
Enroll the first patients in two combination studies for mirvetuximab in platinum-sensitive ovarian cancer: Trial 0420, a single-arm Phase 2 trial of mirvetuximab in combination with carboplatin followed by mirvetuximab continuation in FRα-low, medium, and high patients; and GLORIOSA, a randomized Phase 3 trial of mirvetuximab in combination with bevacizumab maintenance in FRα-high recurrent second-line platinum-sensitive ovarian cancer.
Present additional data from the mirvetuximab program at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and the 2022 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS) in September.
Report preliminary efficacy data from the pivotal CADENZA study of pivekimab in BPDCN before year-end.
Present pivekimab efficacy data for genetic sub-types of AML at the Society of Hematologic Oncology (SOHO) in September, and initial data from frontline and R/R AML expansion cohorts combining pivekimab, azacitidine, and venetoclax at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end.
Begin enrollment in the Phase 1 study of IMGN151 following the submission of supplemental CMC information to the FDA.
FINANCIAL RESULTS
Total revenues were $14.2 million for the quarter ended June 30, 2022 compared to $16.9 million for the quarter ended June 30, 2021. The decrease was driven by lower non-cash royalty revenue due to the completion of the first tranche of payments under the 2015 KADCYLA royalty agreement in the second quarter of 2021, partially offset by greater license and milestone fee revenue driven by the recognition of $6.9 million of fees previously received and deferred pursuant to the Company’s collaboration agreement with Huadong Medicine.

Operating expenses for the quarter ended June 30, 2022 were $75.2 million, compared with $44.3 million for the same quarter in 2021. Research and development expenses rose to $51.4 million for the quarter ended June 30, 2022 compared to $34.6 million for the quarter ended June 30, 2021, driven by increases in clinical trial costs, personnel and temporary staffing costs, and research expenses to further build our ADC pipeline, which includes a $7.5 million upfront fee paid to Oxford BioTherapeutics. Selling, general and administrative expenses increased to $23.8 million for the quarter ended June 30, 2022 compared to $9.7 million for the quarter ended June 30, 2021, due primarily to building commercial capabilities, including the hiring of personnel, in anticipation of a potential U.S. launch of mirvetuximab in the fourth quarter of 2022.

Net loss for the second quarter of 2022 was $62.0 million, or $0.24 per basic and diluted share, compared to a net loss of $30.7 million, or $0.15 per basic and diluted share, for the second quarter of 2021. Weighted average shares outstanding increased to 253.3 million for the 2022 period from 199.9 million in the prior year.

ImmunoGen had $373.9 million in cash and cash equivalents as of June 30, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $105.4 million for the first six months of 2022, compared with cash used in operations of $88.5 million for the same period in 2021, with the current period benefiting from a $13.0 million upfront license payment received from Lilly. Capital expenditures were $0.5 million and $0.9 million for the first six months of 2022 and 2021, respectively.

FINANCIAL GUIDANCE
ImmunoGen’s financial guidance for 2022 remains unchanged; the Company continues to expect:

revenues between $75 million and $85 million;
operating expenses between $285 million and $295 million; and
cash and cash equivalents at December 31, 2022 to be between $245 million and $255 million.
Given the range in timing for potential approval, revenue guidance does not reflect potential product sales from mirvetuximab.

ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.