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.

On February 14, 2024 IN8bio, Inc. (NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported a publication in Frontiers in Immunology that reviews IN8bio’s novel approach for solid tumors, such as glioblastoma (GBM), an aggressive form of brain cancer (Press release, In8bio, FEB 14, 2024, View Source [SID1234640092]).

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Cellular therapies, particularly chimeric antigen receptor T cell therapies (CAR-T), have shown promise in hematologic malignancies but have faced significant challenges when applied to solid tumors like GBM. These obstacles include rapid tumor growth, antigen heterogeneity, and limited response to current therapies.

The publication, titled: "Adoptive cell therapy for high grade gliomas using simultaneous temozolomide and intracranial mgmt-modified γδ t cells following standard post-resection chemotherapy and radiotherapy: current strategy and future directions," explains the mechanism of action behind IN8bio’s novel therapeutic approach called DeltEx Drug Resistance Immunotherapy (DRI) and the current strategy and future directions for this treatment.

The INB-200 and INB-400 studies by IN8bio addresses the challenges towards targeting solid tumors by harnessing the innate immune functions of gamma-delta T cells. GBM cells constitutively express stress-associated NKG2D ligands (NKG2DL), which can be further upregulated through the DNA damage response (DDR) pathway triggered by alkylating agents like temozolomide (TMZ).

"We believe our results to date represent a significant advancement in the treatment of GBM. By combining standard chemotherapy with gamma-delta T cells genetically engineered to resist the lymphodepleting effects of chemotherapy, we are creating a synergistic effect that enhances the immune response against GBM while minimizing toxicity to healthy tissues," said Lawrence Lamb, Ph.D., Chief Scientific Officer and Co-Founder of IN8bio. "This new treatment may improve the survival and quality of life of patients with GBM by preventing tumor recurrence and enhancing the immune response to eliminate residual cancer cells."

The current standard of care for newly diagnosed GBM typically involves primary tumor resection followed by six weeks of chemoradiation therapy, succeeded by six cycles of monthly maintenance therapy with TMZ. This regimen typically yields a median progression-free survival (PFS) of 6 to 7 months and an overall survival (OS) ranging from 14 to 16 months. IN8bio‘s Phase 1 trial (INB-200) assessing the safety and efficacy of intracranial infusions of autologously derived DeltEx DRI gamma-delta T cells in addition to standard-of-care maintenance therapy suggests that the therapy is manageable with a possible improvement in PFS.

In the Phase 1 study, cells from the patient are isolated, expanded and modified prior to being delivered intracranially to the tumor cavity every month in combination with maintenance TMZ. The trial assesses three different dosing regimens from a single dose delivered on cycle 1, day 1 in Cohort 1, to three doses delivered on day 1 of cycles 1-3 in Cohort 2, to six doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients receive 1×107 cells per dose. The trial aims to improve PFS by targeting residual cancer cells. Of the eight patients who have completed scheduled dosing, all have exceeded the median PFS expected with standard-of-care therapy alone.

IN8bio is also conducting a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed GBM. The study will assess the safety, efficacy and tolerability of genetically modified DeltEx DRI cells at leading medical centers across the United States.

About INB-200
INB-200 is a genetically modified autologous DRI product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy-resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.

INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM.

About INB-400
INB-400 is IN8bio’s DeltEx autologous and allogeneic DRI technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic DeltEx DRI technology.