On October 8, 2024 Bayer and MOMA Therapeutics, Inc., a clinical-stage biopharmaceutical company discovering and developing a new generation of precision therapeutics, reported that they have entered into a collaboration, under an option and exclusive license agreement, to develop and commercialize a small molecule oncology program based on MOMA’s proprietary KNOMATIC platform (Press release, Bayer, OCT 8, 2024, View Source [SID1234647099]). Under the agreement, Bayer will be responsible for completing further preclinical, development and commercial activities.

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"We are excited to partner with MOMA Therapeutics to explore the untapped potential of highly dynamic proteins in oncology," said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. "This collaboration reinforces Bayer’s commitment to precision medicine while enhancing our ability to address significant unmet medical needs in cancer treatment. By leveraging MOMA’s cutting-edge technologies and our expertise, we aim to accelerate the development of innovative therapies that can make a meaningful difference in patients’ lives."

Under the agreement, Bayer will gain access to the program itself along with results generated via MOMA’s KNOMATIC platform. This platform integrates deep structural insights with advanced hit-finding technologies and computation-enabled lead optimization to accelerate the discovery of therapeutics that effectively target highly dynamic proteins. Dynamic proteins represent an emerging class of therapeutic targets that can play critical roles in disease progression. Targeting these proteins via a small molecule approach offers a largely untapped means of developing innovative cancer therapies.

"We are thrilled to be partnering with Bayer to drug this disease-relevant target," said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA. "Following our recent announcement highlighting the advancement of our wholly owned Pol theta and Werner programs, Bayer’s interest in this collaboration further highlights the power of our KNOMATIC platform and MOMA’s openness to creating win-win partnerships."

Under the terms of the agreement, MOMA will receive an upfront payment and collaboration fee and is eligible to receive additional payments based on the achievement of certain near-term discovery, development and commercial milestones, as well as tiered royalties on net sales.

Financial terms of the collaboration were not disclosed.

On October 8, 2024 Kineta, Inc. (OTC Pink: KANT) ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that it has completed the enrollment of new patients into the monotherapy arm of the VISTA-101 phase 1 clinical trial evaluating KVA12123, Kineta’s novel VISTA blocking immunotherapy, in patients with advanced solid tumors (Press release, Kineta, OCT 8, 2024, View Source;utm_medium=rss&utm_campaign=kineta-announces-completion-of-enrollment-in-the-monotherapy-arm-of-the-vista-101-phase-1-clinical-study-in-advanced-solid-tumors [SID1234647084]). The monotherapy portion of the trial enrolled patients in 6-dose cohorts ranging from 3mg to 1000mg every two weeks and no dose limiting toxicities or cytokine related adverse events have been observed in the study. The Company is continuing to enroll patients into cohorts evaluating KVA12123 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

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Initial results demonstrating partial response and stable disease in the cohorts evaluating KVA12123 in combination with pembrolizumab and durable stable disease in the monotherapy cohorts were reported earlier this year at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of CRS-associated cytokines at any dose level. "We are pleased to successfully complete patient enrollment in the monotherapy arm, and we remain on target for completing full enrollment into this study before year end," said Craig W. Philips, President of Kineta.

On July 8, 2024, Kineta announced that it had entered into an exclusivity and right of first offer agreement (the "Agreement") with TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a $5 million nonrefundable payment from TuHURA in July 2024. In August 2024, Kineta announced that in collaboration with TuHURA, it reopened enrollment in the VISTA-101 clinical trial. Kineta and TuHURA continue to collaborate on the ongoing Phase 1 clinical program in patients with advanced solid tumor cancer. On October 2, 2024, Kineta announced that TuHURA was exercising its right to extend their exclusivity and right of first offer pursuant to the terms of the Agreement.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On October 8, 2024 Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), reported it will present interim findings from three real-world studies in cutaneous T-cell lymphoma (CTCL) at the annual meeting of the European Organisation for Research and Treatment of Cancer’s Cutaneous Lymphoma Tumour Group (EORTC-CLTG), taking place from 9th–11th of October 2024 in Lausanne, Switzerland (Press release, Kyowa Hakko Kirin, OCT 8, 2024, View Source [SID1234647100]).

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The three studies include participants from Europe, the United States (US) and the United Arab Emirates (UAE), and aim to collect evidence in the real-world clinical setting for mogamulizumab. Mogamulizumab is a first-in-class humanised monoclonal antibody (mAb) therapy approved in Europe and the United Arab Emirates for the treatment of adult patients with MF or SS who have received at least one prior systemic therapy.1 In the United States and Switzerland, mogamulizumab is approved for the treatment of adult patients with relapsed or refractory MF or SS who have received at least one prior systemic therapy.2,3

"For most patients, treatment of CTCL aims to prolong time to disease progression, reduce the burden of disease and preserve or enhance quality of life," said Professor Emmanuella Guenova, chief physician of dermatology and venereology at Lausanne University Hospital and chair of the EORTC-CLTG 2024 Annual Meeting. "The real-world evidence being established by Kyowa Kirin is invaluable information for physicians to understand response to treatment in the real world as they determine the best path forwards for their patients."

This will be the second interim analyses from these studies:

MINT (Germany) and MIBERIC (Spain and Portugal) – study the effectiveness and tolerability of mogamulizumab in real-world clinical practices and are broadly in line with efficacy and safety data demonstrated in global clinical trials. Across both studies, no new safety signals were seen.
PROSPER (US, UAE, Spain, Italy, Netherlands, UK) – an ongoing study investigating the impact of mogamulizumab in patients with MF and SS from the patient perspective, assessing symptoms and health-related quality of life, as well as impact on their primary care partners, also in the real-world clinical setting. Patients receiving mogamulizumab experienced improvements in skin symptoms (pain, itch, flaking and redness), sleep problems and body temperature within four weeks and improvements in patient-reported fatigue and health-related quality of life within 24 weeks.
"The studies being presented at EORTC-CLTG build on our presentations at last year’s annual meeting and reinforce our commitment to providing the community with a wide breadth of real-world data to inform clinical decision-making and hopefully improve patient outcomes," said Dr Nicholas Kronfeld, Senior Vice President, Head of Medical Affairs, Kyowa Kirin International. "Our ongoing research programme in CTCL reinforces mogamulizumab’s clinical utility across a diverse range of patient profiles and healthcare systems."

Kyowa Kirin is committed to sharing scientific knowledge at EORTC-CTLG 2024, with three accepted abstracts to be presented.

Table 1. Overview of Kyowa Kirin presentations at EORTC-CTLG 2024 Annual Meeting

Trial Name and Presentation Type

Presenting author

Abstract Title

Timing

MINT (oral)

Prof. Chalid Assaf, Helios Hospital, Germany

Mogamulizumab in patients with mycosis fungoides or Sézary syndrome: Update on the German

non-interventional MINT study

18:30–19:30, Wednesday, October 9th

MIBERIC (oral)

Prof. Pablo Ortiz Romero, Hospital Universitario 12 de Octubre, Spain

Real-world effectiveness of mogamulizumab in Spain and Portugal: Second interim analysis of the

MIBERIC study

18:30–19:30, Wednesday, October 9th

PROSPER (oral)

Prof. Julia Scarisbrick, University Hospital Birmingham, United Kingdom

Patient-reported symptoms and HRQL of MF and SS patients receiving mogamulizumab

over 24 weeks: interim results from the PROSPER study

15:25–16:25, Thursday, October 10th

About Poteligeo (mogamulizumab)

Mogamulizumab is a first-in-class humanised monoclonal antibody directed against CC-chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS.4-6 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.7

About MF and SS

MF and SS are two subtypes of CTCL,8 which is itself a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin.9,10 CTCL is treatable, but is not generally considered to be curable, and there has been a clear unmet need for novel treatment options. As well as the obvious impact of symptoms upon patients, there can be significant erosions to quality of life for those caring for an individual living with CTCL.11

MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.12,13 These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin.4-6 When these cancerous T cells move to the skin, this results in the visible early skin symptoms of red patches or plaques which can resemble psoriasis or eczema in the early stages of the disease.4,12,14-17 Later, for some patients, skin involvement may evolve to include tumours or reddening of the majority of the skin’s surface (erythroderma).

MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs and is typically indolent,10 characterised by skin symptoms including patches or plaques, skin redness and tumours.18 SS is much rarer, accounting for around 5% of CTCLs,19 and is more aggressive,12 with high levels of blood involvement.20 It can cause severe itching, erythroderma, intense scaling of the skin and frequent hair loss.14,21 CTCL can take on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.

On October 8, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases (Press release, Bio-Path Holdings, OCT 8, 2024, View Source [SID1234647153]). This program marks the first application of DNAbilize technology for development of a non-cancer application, which highlights the broad therapeutic potential of this technology.

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The Company also reported completion of enrollment in the third dosing cohort of its ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients. The cohort enrolled more quickly than projected, which underscores the ongoing need for new treatment options for these relapsed/refractory patients.

"Initiating a DNAbilize development program for the treatment of obesity is an exciting expansion opportunity with the potential to treat a growing epidemic. Developing BP1001-A for the treatment of obesity should have a high probability of success as its mechanism of action has the potential to treat insulin resistance, which is the underpinning of obesity, Type 2 diabetes and other related diseases," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "We expect to initiate Investigational New Drug (IND)-enabling testing of BP1001-A in the fourth quarter of 2024."

"In addition, we are pleased to report enrollment for the third dosing cohort of the Phase 1/1b clinical trial of BP1002 in refractory/relapsed AML patients has completed faster than projected. AML patients who had relapsed from frontline venetoclax-based treatment and are refractory to salvage therapy face dire survival prospects and we believe that BP1002 therapy can help these patients," concluded Mr. Nielsen.

BP1001-A for Treatment of Obesity – The disease pathology leading to obesity suggests that BP1001-A, which suppresses the adaptor protein Grb2, has the potential to treat insulin resistance, a major contributor to obesity, Type 2 diabetes and other related metabolic diseases. Bio-Path expects downregulating Grb2 expression with BP1001-A will enhance insulin sensitivity. The Company expects to begin preclinical studies to confirm these assumptions in the fourth quarter of 2024. These studies are expected to provide crucial insights into the mechanism and efficacy of BP1001-A in enhancing insulin sensitivity and reveal its therapeutic potential for obesity and Type 2 diabetes. Following successful preclinical studies, Bio-Path anticipates that a Phase 1 clinical trial would follow.

Completion of Enrollment for Third Dosing Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed AML Patients – After the U.S. Food and Drug Administration (FDA) completed its review of data from the first two dosing cohorts in the Phase 1/1b clinical trial in refractory/relapsed AML patients, Bio-Path initiated enrollment for the third, higher-dosing cohort of 60 mg/m2. Enrollment was completed faster than projected within six weeks, which underscores the continuing need for new treatment options. By targeting the key protein involved in the venetoclax treatment at the mRNA level, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.

On October 8, 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 fourth quarter ended June 30, 2024, and provided a corporate update (Press release, Kintara Therapeutics, OCT 8, 2024, View Source [SID1234647085]).

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Recent Corporate Developments

As previously disclosed, in April 2024 Kintara entered into a definitive merger agreement (the "Merger Agreement") with TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kayak Mergeco, Inc., Kintara’s wholly-owned subsidiary, whereby Kayak Mergeco will merge with and into TuHURA with TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary (the "Merger").

At Kintara’s special meeting of stockholders held on October 4, 2024, Kintara’s stockholders approved the requisite proposals to effect the completion of the proposed Merger with TuHURA. The proposed Merger is expected to be consummated in mid-October 2024, subject to the satisfaction of the remaining closing conditions under the Merger Agreement.

As of October 7, 2024, four patients have been dosed in Kintara’s open label 15-patient REM-001 study (the "REM-001 Study") in cutaneous metastatic breast cancer (CMBC). The majority of the costs to run the REM-001 Study will be covered by the $2.0 million Small Business Innovation Research grant Kintara was awarded from the National Institutes of Health.
Summary of Financial Results for Fiscal Year 2024 Ended June 30, 2024

As of June 30, 2024, Kintara had cash and cash equivalents of approximately $4.9 million.

For the three months ended June 30, 2024, Kintara reported a net loss of approximately $2.3 million, or $0.04 per share, compared to a net loss of approximately $3.3 million, or $1.97 per share, for the three months ended June 30, 2023. The decreased net loss for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, was largely attributed to lower research and development expenses which was primarily due to lower clinical development costs. General and administrative costs were higher during the same period primarily due to an increase in professional fees related to the proposed transaction with TuHURA.