On June 28, 2023 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing Stealth Editors to perform in vivo gene editing without triggering the immune system, reported that it has entered into definitive agreements for the issuance and sale of an aggregate of 578,697 of its shares of common stock (or common stock equivalents) in a registered direct offering at a purchase price of $2.57 per share (or common stock equivalent) and associated unregistered warrants (Press release, NeuBase Therapeutics, JUN 28, 2023, View Source [SID1234632965]). In a concurrent private placement, NeuBase has also agreed to issue and sell an aggregate of 1,366,829 of its shares of common stock (or common stock equivalents), at the same purchase price of $2.57 per share (or common stock equivalent) and associated unregistered warrants as in the registered direct offering. In addition, the Company has agreed to issue in the offerings unregistered Series A warrants to purchase up to an aggregate of 1,945,526 shares of common stock and unregistered short-term Series B warrants to purchase up to an aggregate of 1,945,526 shares of common stock. The registered direct offering and the private placement were priced at-the-market under Nasdaq rules.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

Each series of unregistered warrants will have an exercise price $2.32 per share and become exercisable immediately upon issuance. The Series A warrants will have a term of five and one-half years from the date of issuance and the short-term Series B warrants will have a term of eighteen months from the date of issuance.

The offerings are expected to close on or about June 30, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the concurrent offerings are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by NeuBase. NeuBase currently intends to use the net proceeds from the offerings for working capital and general corporate purposes.

The securities offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the unregistered warrants issued in the registered direct offering) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-254980), including a base prospectus, previously filed with the Securities and Exchange Commission (the "SEC") on April 1, 2021 and declared effective by the SEC on April 14, 2021. The offering of the securities to be issued in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the securities in the private placement and the unregistered warrants described above are being made in transactions not involving a public offering and have not been registered pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement, the unregistered warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

NeuBase has agreed to file an initial registration statement with the SEC covering the resale of the securities to be issued in the private placement no later than 30 days following the date of the definitive agreement and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after the date of the definitive agreement in the event of a "full review" by the SEC.

On June 28, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the Company has been awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC) (Press release, Kintara Therapeutics, JUN 28, 2023, View Source [SID1234632964]).

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"We are delighted that the National Institutes of Health recognizes that Kintara’s REM-001 program shows an opportunity to address an unmet medical need by significantly improving the quality of life and reducing co-morbidities for patients with CMBC," said Robert E. Hoffman, President and CEO of Kintara. "The support from the NIH validates the potential of our program to help patients with metastatic breast cancer who have little or no treatment options for this devastating disease. We look forward to advancing our REM-001 program with this grant."

Funds from the NIH SBIR grant will enable Kintara to restart the REM-001 CMBC program and generate clinical evidence to demonstrate proof of concept for the photodynamic therapy platform in CMBC. Completion of this study is intended to aid in the design of a planned phase 3 registrational study.

A 2003 meta-analysis of over 20,000 cancer patients found that 24% of breast cancer patients included in the analysis had developed cutaneous metastases, which was the highest rate of any cancer type. According to the American Cancer Society’s estimates for 2021, it was projected that there would be approximately 281,550 new cases of invasive breast cancer diagnosed in women in the United States. Accordingly, the prevalence of CMBC may be in excess of 50,000 cases annually in the United States.

On June 28, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported the initiation of a pivotal Phase 3 clinical trial (XPORT-MF-034) (NCT04562389) to assess the efficacy and safety of once-weekly selinexor 60mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis (Press release, Karyopharm, JUN 28, 2023, View Source [SID1234632963]).

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The randomized, double-blind, placebo-controlled study is expected to enroll 306 JAKi-naive patients with intermediate or high-risk myelofibrosis. Patients will be randomized 2:1 to ruxolitinib plus selinexor 60mg or ruxolitinib plus placebo in 28-day cycles. Ruxolitinib dose will be determined by the investigators based on the patients’ baseline platelet count per the drug’s prescribing information. The co-primary endpoints of the study are spleen volume response rate of ≥ 35% (SVR35) and symptom improvement of ≥ 50% (TSS50) at week 24, with a key secondary endpoint of anemia response at week 24.

"Selinexor and ruxolitinib appear to work synergistically, resulting in meaningful improvements in spleen response and total symptom score for patients with myelofibrosis," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "We believe that an opportunity exists to expand upon the initial response, depth, and duration of JAK inhibitors to ultimately improve patient outcomes. This combination has the potential to become a cornerstone treatment in front-line myelofibrosis and we are excited to start this pivotal trial to deliver on our goal of bringing forward an innovative new approach for the treatment of myelofibrosis that can benefit MF patients."

"The substantial degree of spleen volume reduction observed across all subgroups with selinexor 60mg in combination with ruxolitinib is very encouraging. There is a significant unmet need in the treatment of patients with myelofibrosis, and these data demonstrate that the addition of XPO1 inhibition with selinexor with standard-of-care ruxolitinib has the potential to significantly improve outcomes for first-line myelofibrosis patients," said Dr. John Mascarenhas, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Center of Excellence for Blood Cancers and Myeloid Disorders. "As the principal investigator for the Phase 3 study, I look forward to defining a potential new standard of care for Jak naïve MF patients."

Updated data from the Phase 1 study recently presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 and European Hematology Association (EHA) (Free EHA Whitepaper) 2023 showed rapid, deep and sustained spleen responses and robust symptom improvement in patients treated with selinexor 60mg in combination with ruxolitinib as of the April 10, 2023 data cut-off date:

At week 24, 91.7% (11/12) of efficacy evaluable patients demonstrated SVR35 and 77.8% (7/9) achieved TSS50. The intent to treat population achieved a 78.6% (11/14) SVR35 and 58.3% (7/12) TSS50 respectively.
SVR35 responses were observed in 100% (12/12) of evaluable patients at any time and rates were consistent regardless of subgroups, including males and patients treated with low dose ruxolitinib.
Improvement in major spleen and cytokine-related symptoms were observed across all Myelofibrosis Symptom Assessment Form domains.
Selinexor was generally well tolerated with a manageable side effect profile, allowing most patients to remain on therapy, up to 74 weeks, as of the data cut-off date. The most common treatment emergent adverse events, regardless of grade, experienced with the 60mg selinexor dose, in combination with ruxolitinib were nausea (78.6%), anemia (64.3%), thrombocytopenia (64.3%) and fatigue (57.1%), and most common treatment emergent grade ≥3 adverse events experienced with the 60mg selinexor dose, in combination with ruxolitinib were anemia (42.9%), thrombocytopenia (28.6%) and back pain (14.3%)
75% of nausea events were grade 1, were mostly transient and did not lead to treatment-related discontinuations. Nausea rates and grades were reduced for patients who received prophylactic antiemetics. Meaningful weight gain was observed at week 24 despite the incidence of nausea and vomiting.
Further information about the Phase 3 study can be found at www.clinicaltrials.gov.

Karyopharm expects to present top-line data readout from this study in 2025. The company plans to expand its clinical development program in myelofibrosis by investigating selinexor in other front-line opportunities, such as novel combinations, to benefit the greatest number of myelofibrosis patients.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds to be approved for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with Velcade (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, China, South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by Karyopharm’s partners, Antengene, Menarini, Neopharm and FORUS, in China, South Korea, Singapore, Australia, Hong Kong, Germany, Austria, Israel and Canada.

Please refer to the local Prescribing Information for full details.

Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.

Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.

Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.

Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.

Serious Infection: Monitor for infection and treat promptly.

Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.

Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.

Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.

The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch.

On June 28, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Genentech, Inc’s Tecentriq in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment (Press release, Genprex, JUN 28, 2023, View Source [SID1234632962]).

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In the third quarter of 2023, Genprex expects to enroll the first patient in its Acclaim-3 clinical trial, which is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population. The Company has previously received two other FTDs for REQORSA, for REQORSA in combination with AstraZeneca PLC’s Tagrisso in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso, and for REQORSA in combination with Merck & Co’s Keytruda in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda.

"We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. "This is another exciting achievement in our REQORSA development program, which further validates REQORSA’s potential not only in NSCLC but also in SCLC. We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC."

Tumor suppressor genes are deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses a tumor suppressor gene named TUSC2. Virtually 100% of small cell lung cancers express descreased amounts of TUSC2 tumor suppressor protein, and 41% completely lack TUSC2 protein expression. ES-SCLC has a very poor prognosis, with a median progression free survival (PFS) of only 5.2 months. Importantly, median PFS for patients receiving Tecentriq as maintenance therapy is only 2.6 months from the start of maintenance treatment, so there is a great need for improvement in maintenance therapy.

"This Fast Track Designation for the Acclaim-3 patient population is another validation of REQORSA’s potential to treat lung cancer," said Mark Berger, MD, Chief Medical Officer at Genprex. "We are very excited to soon begin treating patients in the Acclaim-3 clinical trial, which positions REQORSA as a component of initial standard therapy for SCLC rather than as treatment for relapse. That will allow us to highlight the contribution of REQORSA to an earlier stage of treatment. Based on our experience in other REQORSA trials, we have reduced the Phase 1 portion of the study to two dose levels instead of the three dose levels in our Acclaim-1 and Acclaim-2 clinical trials. We believe this will shorten the Phase 1 portion of the trial. In addition, the median PFS of only 2.6 months seen with Tecentriq maintenance treatment will also shorten the time needed to evaluate the combination of REQORSA and Tecentriq as maintenance therapy for SCLC."

Patients in the Acclaim-3 clinical trial will be enrolled after receiving initial treatment with 3-4 cycles of carboplatin, etoposide, and Tecentriq, and achieving complete response, partial response or stable disease. They will then receive treatment with REQORSA and Tecentriq as maintenance therapy every 21 days until disease progression.

The Phase 1 dose escalation portion of the Acclaim-3 clinical trial is expected to enroll up to 12 patients at 3-5 U.S. clinical sites to determine the Maximum Tolerated Dose (MTD). If no dose limiting toxicities occur during Phase 1, then the highest dose evaluated will be the Recommended Phase 2 Dose. The Phase 2 portion of the study will then enroll approximately 50 patients at 5-10 sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The primary endpoint of the Phase 2 portion of the trial is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up.

FDA may award FTD if it determines that non-clinical or clinical data demonstrate the potential for a drug to address an unmet medical need for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of such drugs so that a product, if approved, can reach the market expeditiously.FTD recipients may also be eligible for accelerated approval or rolling review of the recipient’s Biologics License Application (BLA) if other qualifying criteria are met. In addition, Fast Track product candidates could be eligible for priority review if supported by clinical data at the time of BLA submission.

On June 28, 2023 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, reported data from the Phase 1 dose escalation safety study of FHD-286 in metastatic uveal melanoma (mUM) (Press release, Foghorn Therapeutics, JUN 28, 2023, View Source [SID1234632961]). These data reinforce the safety and tolerability profile of FHD-286. At this time, the company does not plan to advance FHD-286 in uveal melanoma.
"The clinical data further support the safety and tolerability of FHD-286 and build on the previously disclosed AML/MDS data. In the study, nine patients had stable disease and one patient had a durable partial response," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "However, Foghorn does not plan to pursue this indication on its own. We plan to initiate dosing the FHD-286 combination study in relapsed/refractory AML during the third quarter of 2023 and continue to invest in our promising pre-clinical programs such as Selective-BRM, CBP, EP300, and ARID1B."
FHD-286 Phase 1 Dose Escalation Study Data in Metastatic Uveal Melanoma

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The trial evaluated 73 metastatic uveal melanoma patients who had been treated with a median of two prior therapies across nine different cohorts. The doses evaluated included four continuous daily doses: 2.5mg (n=2), 5.0mg (n=12), 7.5mg (n=17), and 10.0mg (n=9); and five intermittent 1 week on/1 week off dose cohorts: 10.0mg (n=10), 15.0mg (n=9), 17.5mg (n=3), 20.0mg (n=5), and 22.5mg (n=6).
Clinical data seen in the Phase 1 dose escalation study reinforced the safety and tolerability profile of FHD-286. The most common treatment-related adverse events were dysgeusia, fatigue, AST increase, nausea/vomiting, dry mouth, and rash. The most common treatment-related grade 3 events or higher included anemia, asthenia, ALP increase, hypokalemia, muscular weakness, and rash.
Forty-seven of the 73 patients on study had target lesions for evaluation. One patient had a durable partial response and remained on treatment for over 16 months, and nine patients had stable disease. Tumor reductions in target lesions were also observed in eight patients. The clinical activity seen in the study was further supported by reductions in circulating tumor DNA (ctDNA). Preliminary data on immune modulation markers in the tumor microenvironment also support a combination path forward with checkpoint inhibitors.

The Company plans to present the full results at a future scientific meeting.

Foghorn plans to dose the first patient in a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.

About FHD-286
FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 (SMARCA4) and BRM (SMARCA2), two highly similar proteins that are the ATPases, or the catalytic engines of the BAF complex, one of the key regulators within the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors. FHD-286 is being developed for relapsed and/or refractory AML, and the company plans to commence a Phase 1 study, in combination with decitabine or cytarabine, in the third quarter of 2023.

About Uveal Melanoma
Uveal (intraocular) melanoma is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid, and is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years, however, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis. This press release refers to data gathered on an ongoing basis from our open-label Phase 1 trial in FHD-286 for uveal melanoma.

About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.