On June 26, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that it has agreed to sell approximately 12.1 million shares of its common stock (or pre-funded warrants in lieu thereof) to a select group of institutional and accredited healthcare specialist investors in a private placement, at a price per share of $7.00, representing a premium of approximately 15% to ORIC’s 30-day volume-weighted average price and approximately 8% to the closing price on June 23, 2023 (Press release, ORIC Pharmaceuticals, JUN 26, 2023, View Source [SID1234632901]). The pre-funded warrants will have an exercise price of $0.0001 per share of common stock, will be immediately exercisable, and will remain exercisable until exercised in full. The financing is expected to close on June 27, 2023, subject to customary closing conditions. ORIC anticipates the gross proceeds from the private placement to be approximately $85 million, before deducting any offering related expenses.

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The financing includes participation from new and existing institutional investors and is being led by Nextech1 with participation from EcoR1 Capital, Frazier Life Sciences, Venrock Healthcare Capital Partners, and Boxer Capital. Participating investors entered into confidentiality agreements and executed lock-up agreements with ORIC to restrict their ability to sell ORIC shares.

"As the competitive profiles of multiple of our clinical programs begin to emerge with respect to internally generated data and competitor updates, the added financial firepower provided by this blue-chip syndicate of investors, both new and existing and with whom we’ve had longstanding relationships, allows us to aggressively advance our pipeline for the benefit of patients," said Jacob M. Chacko, MD, chief executive officer. "The extended cash runway positions us well, and we look forward to presenting initial clinical data from our three clinical programs over the coming quarters while continuing to advance our mission of overcoming resistance in cancer."

"We are thrilled to become long-term partners to ORIC’s ambitious management team at this critical inflection point as they look to accelerate the development of their pipeline of differentiated programs with clinical profiles that are now emerging," said Kanishka Pothula, Partner at Nextech. "We believe that this team’s broad capabilities spanning discovery research, translational expertise, thoughtfully-designed clinical trials, and strong business development networks, combined with their data driven decision-making and financial discipline, uniquely position ORIC to achieve meaningful impact on patients’ lives."

ORIC anticipates the following upcoming milestones:

ORIC-114: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with EGFR/HER2-mutated cancers in the second half of 2023.
ORIC-533: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with multiple myeloma in the second half of 2023.
ORIC-944: Report initial safety, PK/PD, and preliminary antitumor activity data from ongoing single agent Phase 1b study in patients with prostate cancer in the first quarter of 2024.
ORIC intends to use the net proceeds from the proposed financing to fund research and development of its clinical-stage product candidates and research programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash, cash equivalents and marketable securities, is expected to be sufficient to fund the current operating plan into late 2025.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. ORIC has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock and the shares of common stock issuable upon exercise of the pre-funded warrants issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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

On June 26, 2023 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported that it will host a conference call on Tuesday, June 27, 2023 at 8:00 a.m. ET to review updated clinical data from the ongoing clinical trial of NKX101, its allogeneic, off-the-shelf CAR NK cell therapy candidate engineered to target NKG2D ligands on cancer cells (Press release, Nkarta, JUN 26, 2023, https://ir.nkartatx.com/news-releases/news-release-details/nkarta-host-conference-call-discuss-updated-clinical-data-nkx101 [SID1234632900]).

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Conference Call and Webcast
To access the conference call, please register through this link: View Source

Accompanying slides will also be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. NKX101 is also engineered with a membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

On June 26, 2023 Marker Therapeutics, Inc. (Nasdaq: MRKR) (Marker or the Company), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported non-clinical data on its lead multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, which showed increased anti-tumor activity against an acute myeloid leukemia (AML) cell line after treatment with hypomethylating agents (HMA) (Press release, Marker Therapeutics, JUN 26, 2023, View Source [SID1234632899]). Marker further announces that the Company has been awarded a $2 million grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program to support the development of MT-401 for the treatment of patients with AML after hematopoietic stem cell transplant (HSCT).

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The multiTAA-specific T cell technology from Marker uses a novel non-genetically modified T cell therapy approach that recognizes multiple antigens expressed on tumor cells, thereby designed to minimize tumor escape. MT-401 was designed to specifically target four different antigens (Survivin, PRAME, WT-1 and NY-ESO-1), which are upregulated in AML but have limited expression on normal cells.

In March 2023, Marker reported clinical updates from the Company sponsored ARTEMIS clinical trial (clinicaltrials.gov identifier: NCT04511130) highlighting the potential benefit of MT-401 in patients with AML who have measurable residual disease (MRD+) after HSCT. Given the promising responses in patients who are MRD+, Marker has been investigating clinical opportunities to further improve AML patient outcomes.

One such opportunity is to combine multiTAA-specific T cell therapy with agents that make cancer cells more visible to cancer killing cells. This opportunity has practical merit because HMAs that do this, such as 5’-Azacytidine and Decitabine, are commonly used as therapies for AML. It also has scientific merit because these agents inhibit DNA methylation, a process which regulates gene expression. By reducing DNA methylation, HMAs can restore physiological gene expression patterns, including the upregulation of tumor suppressor genes, and the inhibition of oncogenes. HMAs have also been found to upregulate the expression of tumor antigens, including MT-401-specific tumor antigens, previously silenced by DNA methylation (Wong et al, Front Oncol, 2021).

Due to this mechanism of action, Laura S. Angelo, Ph.D., and her team at Marker investigated in a set of in vitro experiments, the capacity of MT-401 to inhibit or kill THP-1 cells, an aggressive treatment-resistant AML cell line, after the cells were exposed to HMA. The results of this non-clinical study have been posted on the Investor Relations section of the Marker website, and highlights are briefly summarized below:

· In this in vitro model of treatment resistant AML, tumor cells exposed to HMA for 72 hours upregulated tumor-associated antigen targets of MT-401, including Survivin.

· The THP-1 cell line was bioluminescent modified to allow real-time long-term assessment of cancer cell growth.

· THP-1 cells continued to grow both in the absence and presence of DMSO, the vehicle used to dissolve 5’-Azacytidine.

· The growth of THP-1 cells was reduced in the presence of 5’-Azacytidine (after exposure to the drug for 72 hours).

· The growth of THP-1 cells was also reduced in the presence of MT-401 (manufactured from donors that were partially HLA-matched to THP-1 cells).

· THP-1 cell growth, however, was significantly decreased when MT-401 was added after exposure to 5’-Azacytidine compared to MT-401 or 5’-Azacytidine administration alone, suggesting a synergistic effect between the two agents.

· These in vitro data demonstrate that administration of MT-401 following HMA infusion enhanced AML cell killing and could offer a new therapeutic option for AML patients post-HSCT.

"These non-clinical findings highlight that the potential for treatment of AML cells with HMA to upregulate expression of specific tumor antigens and increase tumor inhibition and killing. These benefits could therefore significantly enhance the potential clinical outcome of our multiTAA-specific T cell product," said Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "In light of these encouraging results we are planning to incorporate these findings into our current AML clinical study to improve and empower our multiTAA-specific T cell outcomes. Details about the revised clinical study design will be announced in Q3 of 2023."

Based on this non-clinical data, Marker received a $2 million grant from the NIH. The awarded SBIR grant will support a nationwide multi-center Phase 2b clinical trial in AML patients following HSCT to evaluate the effect of MT-401 administered after pre-treatment with HMAs. This proposed Phase 2b study includes evaluation of efficacy and safety of MT-401, as well as immune monitoring of patient samples. AML is considered an orphan indication and in 2020, MT-401 was granted orphan designation by the U.S. Food and Drug Administration for treatment of patients with acute myeloid leukemia (orphan drug designation number DRU-2020-7363).

"We are pleased to receive the SBIR grant from the NIH to support our clinical Phase 2b study in AML patients, a rare disease with limited treatment options after a stem cell transplant," said Dr. Angelo, PI of the study.

"We previously observed promising results in our Phase 2 ARTEMIS trial for patients with AML who are MRD+ post-transplant, suggesting that MT-401 can effectively positively impact this patient population before relapse. The SBIR grant will greatly contribute to further advance our clinical trial and to investigate the benefit of HMA administration before MT-401 therapy in patients after HSCT, and for whom no treatments have been approved," concluded Dr. Vera.

About the NIH SBIR Program

The NIH Small Business Innovation Research (SBIR) Program sets aside more than $1.2 billion from its Research & Development Funding to specifically support early-stage small businesses throughout the United States. Many companies leverage the NIH SBIR funding to attract the partners and investors needed to take an innovation to market. The Small Business program focuses on a variety of high-impact technologies including research tools, diagnostics, digital health, drugs, and medical devices, and can provide the seed funding needed to bring scientific innovations from bench to bedside.

About multiTAA-specific T cells

The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 180 patients with various hematological malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated, demonstrated durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables the potential contribution to a lasting anti-tumor effect. Unlike other cell therapies which require hospitalization and close monitoring, multiTAA-specific T cells are designed to be administered in an outpatient setting.

On June 26, 2023 Lipocine presented its corporate presentation (Presentation, Lipocine, JUN 26, 2023, View Source [SID1234632898]).

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On June 26, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported an update on key corporate and clinical initiatives and release a new investor presentation (Press release, Kazia Therapeutics, JUN 26, 2023, View Source [SID1234632897]).

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Key points
•
Dr John Friend completes transition into the CEO role, including a full portfolio review.

•
Final data anticipated from GBM AGILE pivotal study of paxalisib in glioblastoma in 2H CY2023.

•
Interim data from phase II Pacific Pediatric NeuroOncology Consortium study in diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs) now expected to be available in July or August 2023.

•
Phase I expansion cohort is enrolling for brain metastases study sponsored by Memorial Sloan Kettering Cancer Center. Two other preeminent cancer centres have joined the study. Preliminary data from expansion cohort is anticipated by 1Q24.

Following his appointment as CEO on 1 May 2023, Dr John Friend has completed his transition into the role. He commented, "In the weeks since my appointment, I’ve worked with the team to review the full set of assets and clinical trials within the Kazia portfolio and the process has strongly reinforced my conviction in the opportunities ahead of us."

"We believe substantial potential exists across our pipeline and in particular, across three key pillars of development for paxalisib—adult brain cancer, paediatric brain cancer and brain metastases. We are keen to explore paxalisib’s use in patient populations that may have the greatest benefit from a PI3K/AKT/mTOR targeted therapeutic candidate."

"As we move toward the second half of 2023, critical milestones are approaching for both paxalisib and EVT-801. We look forward to keeping investors updated across our progress on these important programs."

Clinical programs update

11 clinical trials are currently in progress or in planning for Kazia’s two assets, paxalisib and EVT-801, and Kazia continues to execute across all programs. Current program highlights are set out in brief below. Refer to the appended corporate presentation for more detail:

Paxalisib

Kazia’s lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in various brain cancers.

GBM AGILE Pivotal study

Final data are expected from the GBM AGILE pivotal study of paxalisib in glioblastoma in 2H CY2023. Depending on the results of the study, Kazia may use such data to support submission of a new drug application for marketing authorisation to the FDA.

PNOC022 phase II study

Paxalisib is being studied as an investigational drug for the treatment of the paediatric brain cancers DIPG and other DMGs in a study sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC).

The study team at PNOC has been diligently collecting and preparing the data for interim analysis. At this point, Kazia expects that the data will be available in July or August 2023.

LUMOS2 phase II study

On 8 June 2023, Kazia announced that it is supporting the University of Sydney on a molecularly-guided phase II clinical study evaluating paxalisib in adult patients with recurrent/progressive isocitrate dehydrogenase (IDH) mutant grade 2 and 3 gliomas (G2/3 gliomas).

The study, named LUMOS2, will be sponsored by the University of Sydney, and coordinated by NHMRC Clinical Trials Centre, University of Sydney, in collaboration with COGNO (CoOperative Trials Group for Neuro-Oncology). LUMOS2, an umbrella study with multiple arms, is expected to enroll up to 76 patients and will be a multi-centre study at several Australian sites, with the potential to expand internationally. We anticipate enrollment to commence in 4Q23.

MSKCC phase I clinical study

Paxalisib is the subject of an ongoing phase I clinical study in combination with radiotherapy for the treatment of brain metastases, sponsored by Memorial Sloan Kettering Cancer Center in New York, NY.

Kazia is pleased to confirm that the phase I expansion cohort is enrolling. Two world-renowned cancer centres have joined MSKCC in this study: Miami Cancer Institute and Fred Hutch Cancer Center in Seattle, WA. Preliminary data from the expansion cohort is anticipated by 1Q24.

EVT-801

Phase I study

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data showed EVT801 to be active against a broad range of tumour types and has shown evidence of synergy with immuno-oncology agents. A phase I study commenced recruitment in November 2021.

EVT-801 continues to enroll in the phase I dose finding study. Kazia anticipates stage 1 data in 2H23, which we believe will enable identification of the recommended dose for subsequent phase II trials. Kazia also anticipates reporting preliminary biomarker data focused on high-grade, serous ovarian cancer as part of this data update.