On February 14, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) (Press release, Oncolytics Biotech, FEB 14, 2024, View Source [SID1234640097]). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

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"These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer. The results reported at IMACC 2023 showed that the combination of pelareorep and atezolizumab provided a 37.5% objective response rate, including one patient with a long-lasting complete response, and good overall tolerability. These data represent a meaningful contrast to recent clinical trial results which show that patients with second-line or later anal carcinoma treated with checkpoint inhibitor therapy experienced response rates of 10-14%1-3," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics."

"We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer. There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment. Continued positive results could potentially expand the opportunity for pelareorep beyond the lead indications of breast cancer and pancreatic cancer and open the door to a rapid regulatory pathway in this rare and significantly under-served patient population," continued Dr. Coffey.

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, "One of the most difficult challenges in my practice is the limited number of treatment options that are available for patients with advanced anal cancer who have progressed on first-line therapy. I am enthusiastic about the expansion of this cohort because it will enable the continued evaluation of the pelareorep/atezolizumab combination and could provide important confirmatory data that may lead to better treatment options for patients with this late-stage disease."

"We look forward to building on the oncology community’s enthusiastic reception of the IMACC 2023 data by expanding enrollment in the anal carcinoma cohort and incorporating additional sites into the study," commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Careful consideration of recently published clinical trial results indicates that a modest expansion of fewer than 20 patients will be sufficient to solidify the efficacy signal we have observed to date and lay the groundwork for a potential future registrational study in this population. We look forward to continuing our excellent collaboration with the clinical sites and investigators at AIO and hope to report additional results in 2025."

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; and

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On February 14, 2024 Moleculin presented its corporate presentation (Presentation, Moleculin, FEB 14, 2024, View Source [SID1234640096]).

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On February 14, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported continued encouraging clinical findings from the most recent follow-up visit of the first patient enrolled in Deltacel-01, the Company’s Phase 1 clinical trial evaluating Deltacel for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, FEB 14, 2024, View Source [SID1234640095]). After stable disease and preliminary progression-free survival of one and a half months were reported six weeks post-treatment, the two-month follow-up PET/CT scan revealed that the patient’s tumor size was reduced by 6.6%, and no new disease sites (metastasis) were detected. In addition, a 20% decrease in the tumor lesion’s metabolism was noted.

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This patient, who was treated at the Beverly Hills Cancer Center (BHCC), continues to do well two months following treatment.

"We are proud and excited to report these highly promising early results showing tumor reduction in a patient population that has few treatment options available. When considering that the first patient enrolled in Deltacel-01 suffered from an actively progressing disease immediately prior to therapy, this is a remarkable finding. We look forward to advancing our trial and to treating additional patients," said Pietro Bersani, Chief Executive Officer of Kiromic.

Kiromic also reports that the second patient in the Deltacel-01 clinical trial has received the second and final infusion of Deltacel. Kiromic expects to report initial tolerability and safety data from this patient in early March, and preliminary efficacy results by the end of the first quarter.

Additionally, Kiromic reports that the third patient has been enrolled and is expected to complete treatment on February 21. Both the second and third patients are being treated at BHCC. The Deltacel-01 clinical trial is expected to start enrolling patients at two additional clinical trial sites in the first half of the year.

"The preliminary data from our first patient offers promising insights into the effectiveness of Gamma Delta T-cell therapy when used alongside low-dose radiation for this condition. We are encouraged by the preliminary data on the first patient and are optimistic about the outcomes of the subsequent patients in the study. We continue to evaluate safety and efficacy outcomes as this study progresses, and are pleased to have enrolled two additional patients in the Deltacel-01 study," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Principal Investigator at Beverly Hills Cancer Center.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the study is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On February 14, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal second quarter ended December 31, 2023, and provided a corporate update (Press release, Kintara Therapeutics, FEB 14, 2024, View Source [SID1234640094]).

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RECENT CORPORATE DEVELOPMENTS

Announced the initiation of an open label 15-patient study in cutaneous metastatic breast cancer (CMBC) patients which is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded from the National Institutes of Health (NIH). (February 2024)

Announced that Kintara’s Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value and has engaged Ladenburg Thalmann & Co. Inc. to act as financial advisor for this process. (December 2023)

Announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. These topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. As a result, Kintara terminated the development of VAL-083 and turned its focus to its REM-001 program. (October 2023)
"We are pleased to have recently initiated our 15 patient REM-001 study for cutaneous metastatic breast cancer, a disease with little or no current treatment options" commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "We have strengthened our balance sheet primarily with net proceeds from our at-the-market (ATM) facility and aggressive cost-cutting efforts. We continue to evaluate strategic options with the goal of maximizing shareholder value."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 SECOND QUARTER ENDED DECEMBER 31, 2023

As of December 31, 2023, Kintara had cash and cash equivalents of approximately $0.7 million. From January 1, 2024, to February 12, 2024, the Company has received net proceeds of approximately $6.1 million from the sale of common stock, primarily from its ATM facility.

For the three months ended December 31, 2023, Kintara reported a net loss of approximately $1.0 million, or $0.24 per share, compared to a net loss of approximately $3.5 million, or $2.10 per share, for the three months ended December 31, 2022. The decreased net loss for the three months ended December 31, 2023, compared to the three months ended December 31, 2022, was largely attributed to lower research and development expenses which was primarily due to lower clinical development costs. General and administrative costs were also lower during the same period primarily due to a reduction in personnel.

Selected Balance Sheet Data (in thousands)

December 31,
2023

June 30,
2023

$

$

Cash and cash equivalents

658

1,535

Working capital (deficiency)

(684)

188

Total assets

1,885

3,979

Total stockholders’ equity (deficiency)

(164)

731

Selected Statement of Operations Data (in thousands, except per share data)

For the three months ended

December 31,

December 31,

2023

2022

$

$

Research and development

111

2,059

General and administrative

908

1,440

Other loss (income)

4

(45)

Net loss for the period

(1,023)

(3,454)

Series A Preferred cash dividend

(2)

(2)

Net loss for the period attributable to common stockholders

(1,025)

(3,456)

Basic and fully diluted weighted average number of shares

4,337

1,643

Basic and fully diluted loss per share

(0.24)

(2.10)

For the six months ended

December 31,

December 31,

2023

2022

$

$

Research and development

1,970

5,230

General and administrative

2,011

2,915

Other loss (income)

4

(95)

Net loss for the period

(3,985)

(8,050)

Series A Preferred cash dividend

(4)

(4)

Series C Preferred stock dividend

(173)

(362)

Net loss for the period attributable to common stockholders

(4,162)

(8,416)

Basic and fully diluted weighted average number of shares

3,027

1,554

Basic and fully diluted loss per share

(1.37)

(5.42)

Kintara’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: View Source

On February 14, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that the Company will be attending and presenting at the following upcoming investors conferences (Press release, Kineta, FEB 14, 2024, View Source;utm_medium=rss&utm_campaign=kineta-to-present-at-upcoming-investor-conferences [SID1234640093]):

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BIO CEO and Investor Conference
Date: Monday, February 26, 2024
Time: 9:45 A.M.- 10:00 A.M. Eastern Time
Format: Presentation and 1:1 meetings
Location: The New York Marriott Marquis, Uris room

10th Annual Immuno-Oncology 360 Conference (IO360)
Date: February 27-29, 2024
Format: 1:1 meetings
Location: New York Marriott at the Brooklyn Bridge

Opal Group Family Office Winter Forum
Date: Monday, March 4, 2024
Time: 12:30 P.M.- 12:50 P.M. Eastern Time
Format: Presentation and 1:1 meetings
Location: etc.venues 360 Madison, New York, NY

The Company will be available for one-on-one meetings during the conferences. Interested investors should contact their respective representative at the sponsoring institutions to request meetings.