On June 20, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that it will effect a 10-for-1 reverse stock split of its issued and outstanding common stock, effective at 5PM ET on June 20, 2023 (Press release, Leap Therapeutics, JUN 20, 2023, View Source [SID1234632796]). Leap expects its common stock to begin trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on June 21, 2023.

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Leap’s stockholders approved the reverse stock split during its 2023 Annual Meeting of Stockholders on June 16, 2023, and granted the Board of Directors authorization to determine the final ratio for the split. The reverse stock split is being implemented to increase the per share trading price of the Company’s common stock to meet the minimum Nasdaq listing price per share requirements and to decrease the number of shares outstanding in order to facilitate the conversion of the Series X Non-Voting Convertible Preferred Stock into common stock at 5PM ET on June 21, 2023.

Leap’s common stock will continue to trade on the Nasdaq Capital Market under the symbol "LPTX" following the reverse stock split, with a new CUSIP number of 52187K 200. As a result of the reverse stock split, every 10 shares of Leap’s common stock issued and outstanding will be automatically reclassified into one new share of common stock. No fractional shares will be issued in connection with the reverse stock split, and shareholders who would otherwise be entitled to a fractional share will receive a proportional cash payment. The shares underlying the Company’s outstanding equity awards and warrants and the Series X Non-Voting Convertible Preferred Stock conversion ratio will be adjusted accordingly. The reverse stock split affects all shareholders uniformly and will not alter any shareholder’s percentage interest in the Company’s common stock, except for adjustments that may result from the treatment of fractional shares.

Continental Stock Transfer & Trust Company is acting as the exchange agent and transfer agent for the reverse stock split. Shareholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.

On June 20, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that it will host an investor conference call and webcast to discuss lifileucel TIL therapy and the emerging melanoma treatment landscape on June 26, 2023, at 5:00 p.m. ET (Press release, Iovance Biotherapeutics, JUN 20, 2023, View Source [SID1234632795]).

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During the one-hour event, the Iovance leadership team will provide a brief recap of the C-144-01 trial and clinical data, defined regulatory pathway, and pre-commercial activities for lifileucel in advanced post-anti-PD-1 melanoma. A multidisciplinary panel of key opinion leaders (KOLs) will discuss the disease burden and unmet needs for advanced melanoma patients within current treatment practices, perspectives on TIL therapy and the emerging landscape, and preparations for broad adoption of lifileucel and cell therapies within their treatment centers.

The KOL roundtable will be moderated by Dr. Brian Gastman, Executive Vice President, Medical Affairs at Iovance and a practicing surgeon who consults and operates on cancer patients at the Cleveland Clinic. Prior to his recent arrival at Iovance, Dr. Gastman led the melanoma clinical trials team, including as lead investigator on numerous trials of TIL and other cell therapies, as Co-Medical and Surgical Director of Cleveland Clinic and Taussig Cancer Center’s melanoma and high-risk skin cancer program.

To participate in the webcast Q&A, please register at https://register.vevent.com/register/BI5f5b5df5576e42d2bf3535abcc93c3df, or to view only register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will also be available for one year.

Virtual KOL Event Agenda
Introduction: Recap of Lifileucel TIL Therapy Development & Regulatory Pathway

Multidisciplinary KOL Roundtable:
Perspectives on Lifileucel and Advanced Melanoma Treatment Landscape

Participant Title TIL Experience
Brian Gastman, M.D. (moderator) EVP, Medical Affairs at Iovance Biotherapeutics and practicing surgeon at the Cleveland Clinic Lead investigator of TIL trials at Cleveland Clinic

Krishna Komanduri, M.D. Professor and Chief, Division of Hematology and Oncology, Dept. of Medicine; Physician-in-Chief, Helen Diller Family Comprehensive Cancer Center; Clinical Director, Living Therapeutics Initiative, University of California San Francisco (UCSF) Chair of TIL Working Group (TIL-WG), dedicated to educating healthcare practitioners about TIL therapy

Past President, American Society for Transplantation and Cellular Therapy (ASTCT)

Mario Sznol, M.D. Medical oncologist at Yale Medicine; co-director of the Cancer Immunology Program at Yale Cancer Center Iovance Scientific Advisory Board member

Live Audience Q&A Session

On June 20, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the submission to the United States Food and Drug Administration (FDA) of a New Drug Application (NDA) for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs) (Press release, Geron, JUN 20, 2023, View Source [SID1234632794]).

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"This pioneering achievement to submit the first New Drug Application to the FDA for a telomerase inhibitor reflects the dedication, commitment and teamwork of so many people who believed targeting telomerase could make a significant difference for patients," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are deeply committed to addressing the unmet needs for lower risk MDS patients, who often suffer from transfusion-dependent anemia."

The NDA submission is based on results from IMerge Phase 3, in which the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (P<0.001), with median TI duration approaching one year for imetelstat 8-week TI responders. Mean hemoglobin levels in imetelstat-treated patients increased significantly (P<0.001) over time compared to placebo patients. Further, statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups: ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category. Safety results were consistent with prior imetelstat clinical experience.

As allowed under imetelstat’s Fast Track designation in lower risk MDS, Geron has requested that the FDA grant Priority Review of the NDA. Under standard practice, Geron expects FDA communication in 60 days whether the NDA was accepted for review and the timeline of such review (i.e., priority or standard). Additionally, based on IMerge Phase 3, Geron expects to submit a Marketing Authorization Application (MAA) in the EU in the second half of 2023.

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion-dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion-dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron submitted a New Drug Application (NDA) in the U.S. in June 2023 and expects to submit a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication. Imetelstat is currently not approved by any regulatory authority.

On June 20, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported positive top-line results from the pivotal BLUE-C study (Press release, Exact Sciences, JUN 20, 2023, View Source [SID1234632793]). The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30 percent lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard.

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Madison Haag, clinical laboratory specialist, loads samples for one step of the Cologuard testing process at one of Exact Sciences’ Madison labs.

"Cologuard is a groundbreaking innovation in non-invasive cancer detection. Next-generation Cologuard will set a new performance standard," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are harnessing deep scientific insights, advanced technology, and over a decade of research and development to detect colorectal cancer with greater sensitivity and significantly improve the false positive rate. Once approved, next-generation Cologuard will meaningfully enhance the patient experience, and it comes at a critical time – when there are 60 million Americans not up to date with screening."

About the BLUE-C Study
BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design directly compares multiple screening tests, including next-generation Cologuard and a fecal immunochemical test (FIT). Blood samples were also collected for later evaluation of a blood-based screening test being developed by Exact Sciences. BLUE-C is one of the largest colorectal cancer screening trials ever conducted, and the study population reflects the racial and ethnic makeup of the United States according to the 2020 census.

"Accurate and early detection of colorectal cancer and precancerous lesions is critical for reducing incidence and preventing deaths from this disease," said Thomas F. Imperiale, MD, Professor of Medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for BLUE-C. "The results from this large study of a representative population provide affirmation that Exact Sciences continues at the forefront of non-invasive screening. These new results suggest improved performance of an mt-sDNA test, strengthening the case for molecular stool-based testing."

About Next-generation Cologuard
Developed in partnership with Mayo Clinic, next-generation Cologuard features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences’ lab and increase the valid result rate.

Cologuard revolutionized colorectal cancer screening by providing a convenient and accurate testing option for those at average risk. Nearly a decade later, Cologuard has been used to screen for colorectal cancer more than 12 million times.

In the coming months, Exact Sciences plans to release additional analyses of the BLUE-C data and complete its application to the FDA for approval of next-generation Cologuard.

About Cologuard
Results from Exact Sciences’ prospective, 90-site, point-in-time, 10,000-patient pivotal trial, DeeP-C, were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2023). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

On June 20, 2023 Eli Lilly and Company (NYSE: LLY) and DICE Therapeutics, Inc. (NASDAQ: DICE) reported a definitive agreement for Lilly to acquire DICE (Press release, Eli Lilly, JUN 20, 2023, View Source [SID1234632792]).

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DICE is a biopharmaceutical company that leverages its proprietary DELSCAPE technology platform to develop novel oral therapeutic candidates, including oral IL-17 inhibitors currently in clinical development, to treat chronic diseases in immunology.

"In combination with its novel technology and expertise in drug discovery, DICE’s talented workforce and passion for innovation will enhance our efforts to make life better for people living with devastating autoimmune diseases," said Patrik Jonsson, executive vice president, president of Lilly Immunology and Lilly USA, chief customer officer. "We welcome DICE colleagues to Lilly and, together, we can tackle the challenges ahead in finding new treatments for patients with significant unmet medical needs."

Kevin Judice, Ph.D., CEO of DICE Therapeutics, added: "We’re eager to see our pipeline, including our oral IL-17 inhibitors, DC-806 and DC-853, benefit from Lilly’s resources and global reach and I’m excited by the prospect of watching these two talented teams in a united quest for scientific innovation. Our novel approach to discovering and advancing oral, small molecules against validated protein-protein interaction targets has even greater potential with Lilly’s industry-leading clinical development capabilities to get these medicines to patients suffering from autoimmune diseases."

Terms of the Agreement
Lilly will commence a tender offer to acquire all outstanding shares of DICE for a purchase price of $48 per share in cash (an aggregate of approximately $2.4 billion) payable at closing. The transaction has been approved by the boards of directors of both companies.

The transaction is not subject to any financing condition and is expected to close in the third quarter of 2023, subject to customary closing conditions, including receipt of required antitrust clearance and the tender of a majority of the outstanding shares of DICE’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of DICE that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

The purchase price payable at closing represents a premium of approximately 40% to the 30-day volume-weighted average trading price of DICE’s common stock ended on June 16, 2023, the last trading day before the announcement of the transaction. DICE’s Board of Directors unanimously recommends that DICE’s stockholders tender their shares in the tender offer.

Lilly will determine the accounting treatment of this transaction as a business combination or an asset acquisition, including any related acquired in-process research and development charges, according to Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For DICE, Centerview Partners LLC is acting as exclusive financial advisor and Fenwick & West LLP as legal counsel.