On June 13, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell $100,000,000 of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) (Press release, Kura Oncology, JUN 13, 2023, View Source [SID1234632663]). In connection with the offering, Kura expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the securities offered in the public offering. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be offered by Kura. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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BofA Securities, Jefferies and SVB Securities are acting as joint bookrunning managers in the offering. Cantor and BTIG, LLC are acting as lead managers in the offering. JMP Securities, a Citizens Company, and H.C. Wainwright & Co. are acting as co-managers in the offering.

The securities described above are being offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura and became effective by rule of the Securities and Exchange Commission (the "SEC") on December 7, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; and SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On June 13, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that the first patient has been dosed in the investigator-led Phase 2 IMpress clinical trial evaluating imetelstat, the Company’s first-in-class telomerase inhibitor, in patients with acute myeloid leukemia (AM)L, or higher risk myelodysplastic syndromes (MDS), who are relapsed/refractory/intolerant to hypomethylating agents (HMAs) (Press release, Geron, JUN 13, 2023, View Source [SID1234632658]).

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"This trial is based on multiple preclinical publications that describe the role of telomerase in AML, which have reported that inhibiting telomerase in both mouse and human AML models targets and potentially depletes leukemic stem cells and impairs their leukemic progression," said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. "We are delighted that the first patient has been dosed in the investigator-led IMpress Phase 2 study, an important first step to understanding the potential impact of imetelstat in relapsed/refractory AML and higher risk MDS."

"Despite some recent advances in the treatment of AML and higher risk MDS, there is still a tremendous unmet need for new agents, especially in the relapsed/refractory setting," said Uwe Platzbecker, M.D., Department of Hematology, Cellular Therapy and Hemostaseology, Leipzig University Hospital, Leipzig, Germany, and Principal Investigator of IMpress. "With the first patient dosed and several in screening, we are pleased that IMpress Phase 2 is underway and look forward to understanding more about the potential efficacy of imetelstat in this rather frail and elderly patient population."

About IMpress Phase 2

IMpress Phase 2 (NCT05583552) is an open-label, single-arm, multicenter study aiming to enroll approximately 45 patients AML and higher risk MDS patients who are relapsed, refractory, or intolerant to HMAs. The objective of this trial is to evaluate the efficacy, in terms of hematologic improvement, of imetelstat in this patient population. The primary endpoint of this trial is overall response rate. The combined response assessment criteria for MDS and AML based on IWG 2018 criteria (MDS) and the criteria of the European LeukemiaNet (AML) will be used to define responders. Study sites will be located in Australia, France and Germany.

IMpress Phase 2 is an investigator-led study being led by The European Myelodysplastic Neoplasms Cooperative Group (EMSCO) and Australasian Leukaemia & Lymphoma Group (ALLG).

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 plans to submit a New Drug Application (NDA) in the U.S. in June 2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication.

On June 13, 2023 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in a fireside chat at the 44th Annual Goldman Sachs Global Healthcare Conference being held from June 12th- 15th, 2023 (Press release, CRISPR Therapeutics, JUN 13, 2023, View Source [SID1234632653]).

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Fireside Chat
Presenter: Sam Kulkarni, Ph.D., Chief Executive Officer
Date: Wednesday, June 14, 2023
Time: 10:00 a.m. PT

A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On June 13, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported an update for its iopofosine I 131 clinical program and guidance related to its Waldenstrom’s macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to its proprietary phospholipid ether drug conjugate platform (Press release, Cellectar Biosciences, JUN 13, 2023, View Source [SID1234632651]).

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WM CLOVER-WaM pivotal trial

The company now expects to release top-line data from the WM CLOVER-WaM trial in the second half of 2023 and assuming NDA approval, remains on target for a 2024 product launch. Cellectar experienced delays with trial start-up activities, such as site contracting and country regulatory responses, which slowed the initial pace of site initiations resulting in lower-than-expected patient enrollment. The company now has all 49 sites up and running and patient enrollment rates have accelerated. As has been previously reported, and in agreement with the FDA, WM CLOVER-WaM is a single arm, open label trial with a target enrollment of 50 patients.

"Although we are disappointed with the delay in the study’s completion, our ongoing commercial preparations have compressed timelines and support a 2024 launch. Trial activations at high patient volume sites over recent quarters have increased the enrollment trend giving us confidence in our ability to complete the WM CLOVER-WaM study in the second half of 2023," said Dr. Andrei Shustov, Cellectar’s senior vice president, medical. "Iopofosine I 131 demonstrated a 100% overall response rate, an 83.3% major response rate and a 16.7% complete response rate in our Phase 2a study of six WM relapsed/refractory patients. In addition to these impressive response rates, iopofosine I 131’s fixed, short-duration therapy removes the need for the indefinite or prolonged maintenance treatment that is currently required for other therapies."

Phase 1b study in pediatric high-grade gliomas

With the support of a $2 million grant from the National Institute of Health’s National Cancer Institute (NCI) the company plans to initiate a Phase 1b study in pediatric high-grade gliomas (pHGGs) in the third quarter of 2023. The study objective is to identify the recommended iopofosine I 131 Phase 2 dose in pHGG patients. The NCI grant was in part driven by the Phase 1a trial data demonstrating a near tripling of the progression free survival typically observed in relapsed/refractory patients.

Central nervous system lymphoma

Iopofosine I 131’s ability to cross the blood-brain barrier and recently demonstrated activity in central nervous system lymphoma (CNSL) provides further rationale for treatment of WM patients with CNSL involvement, also known as Bing-Neel syndrome.

Based upon achieving a complete response in a CNSL patient treated as part of its Phase 2a trial, the company expanded the CNSL cohort to further evaluate iopofosine I 131 in this indication. Currently, there are no approved therapies available to CNSL patients.

Multiple myeloma

Iopofosine I 131 has been evaluated in over 125 multiple myeloma patients including triple class refractory, quad/penta refractory, high-risk and post-BCMA patients with response rates ranging from 40 to 62%. The company’s recently published post BCMA response rate of 50% prompted expansion of this cohort in our ongoing Phase 2a trial.

The company’s COO, Jarrod Longcor, will deliver an oral presentation of iopofosine I 131 in multiple myeloma at the Society of Nuclear Medicine and Molecular Imaging Annual Conference. The presentation is on June 26th (#P1243, Using targeted radiotherapy in highly refractory multiple myeloma).

Phospholipid ether cancer targeting platform

Development of the company’s phospholipid ether cancer targeting platform continues to demonstrate its broad utility to provide targeted intracellular delivery of multiple cancer treatment modalities. Preclinical data recently presented at several conferences demonstrate the broad utility of the platform, including:

· multiple alpha-emitter radiotherapeutic programs targeting solid tumors;
· the activity of multiple cytotoxic small molecule payloads in triple negative breast cancer mouse models including eradication of the tumors with no subsequent regrowth;
· the successful delivery, uptake, and gene knockdown in a mouse model of pancreatic cancer with siRNA-phospholipid ether when given intravenously; and,
· the conjugation and use of peptides against intracellular targets where small molecules may not be effective.

James Caruso, president and CEO of Cellectar said, "The company’s priority remains the near-term completion of our WM pivotal study. Iopofosine I 131’s Fast Track Designation allows for a six-month FDA review of our submission. In parallel, we continue to advance the clinical development of iopofosine I 131 for both adult and pediatric indications while efficiently executing on potentially value-creating research to best understand the wide-ranging capacity of our proprietary delivery platform."

On June 13, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported that, in the second quarter of 2024, it expects to report topline overall survival data from its ongoing, open-label, phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor treatment (ICI) in patients with non-resectable, stage III/IV non-small cell lung cancer (NSCLC) who progressed while on treatment with PD-(L)1 ienhibitor therapy (Cohort 2) (Press release, Candel Therapeutics, JUN 13, 2023, View Source [SID1234632650]).

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"As we approach full enrollment of a cohort of approximately 40 patients with documented radiographic progression on PD-(L)1 inhibitor treatment, we expect that we will be able to report topline overall survival data for this cohort in the second quarter of 2024," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "In conjunction with this topline data, we will assess whether the effect on tumor biology previously reported could translate into improved survival, which we believe is what matters to patients and regulators. We remain optimistic that this expected dataset could help initiate discussions with regulators about a future potentially registrational clinical trial in this indication of serious unmet disease."

Dr. Tak continued, "In the near-term, we continue to expect to present additional clinical and immunological biomarker activity data from this clinical trial in the third quarter of this year. To date, we have reported mechanistic evidence that CAN-2409 plus valacyclovir can induce a systemic anti-tumor response in ICI inadequate responders, which had shown improvement of injected and uninjected tumor size and an overall beneficial effect on tumor growth over time."

In 2022, the Company presented preliminary evidence that CAN-2409 plus valacyclovir, when added to first line PD-(L)1 inhibitor therapy, in late-stage NSCLC patients showing

radiographic progression despite at least 18 weeks of ICI treatment, is able to 1) induce local and systemic reduction in the size of tumor lesions, with an abscopal effect in uninjected lesions (Aggarwal C et al. J Clin Oncol 2022;40(16) Suppl:9037 [ASCO abstract]), and 2) change the tumor growth trajectory after follow up, and significantly decrease the monthly rate of tumor growth (Aggarwal C et al. Virtual R&D Day, December 2022). These data supported the application for Fast Track designation, granted by the U.S. Food and Drug Administration for this program in April 2023. The Company remains on target to present additional clinical and immunological biomarker activity data in the third quarter of 2023. Based on enrollment rates and duration of follow-up in Cohort 2, the Company expects to present top line data for overall survival in this Cohort, a key clinical endpoint of interest to regulatory bodies in this patient population, in the second quarter of 2024.

CAN-2409 is an investigational off-the-shelf viral immunotherapy designed to induce an individualized, systemic immune response against the patient’s specific tumor. CAN-2409 plus valacyclovir in combination with continued PD-(L)1 inhibitors is being evaluated in an ongoing, open-label phase 2 clinical trial (NCT04495153) in patients with non-resectable, stage III/IV NSCLC and an inadequate response to ICI treatment.