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 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 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy therapeutics, reported that the first patient has been dosed in its STEALTH-001 study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, OCT 8, 2024, View Source [SID1234647098]). VET3-TGI is a novel oncolytic immunotherapy which is designed to target and selectively kill tumor cells while also expressing an immuno-stimulatory transgene payload consisting of interleukin-12 and a TGFbeta inhibitor.

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"The dosing of our first patient in the STEALTH-001 study marks a significant milestone for KaliVir and our innovative VET3-TGI program," said James Burke, M.D., Chief Medical Officer of KaliVir Immunotherapeutics. "The unique engineering of this platform to selectively target the tumor even in the face of anti-viral immunity holds great promise in delivering potent immune stimulatory cargo intravenously in patients with advanced solid tumors. Both VET3-TGI monotherapy and combination with checkpoint inhibition will be explored in this initial study."

About the STEALTH-001 Clinical Trial
STEALTH-001 (ClinicalTrials.gov No. NCT06444815) is a dose escalation and expansion study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation will determine the highest tolerated dose of VET3-TGI when injected directly into the tumor(s), given intravenously and when combined with the checkpoint blockade. Once the maximum tolerated dose is found for each of these groups, expansion cohorts will be initiated to further evaluate the safety and efficacy of VET3-TGI. The study is enrolling patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors.

"VET3-TGI has the potential to reshape our approach to treating advanced tumors and provide a new path forward for patients who urgently need better treatment options," said Jorge Nieva, M.D., Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and Section Head of Lung and Head/Neck Tumors at the Norris Comprehensive Cancer Center and a member of KaliVir’s Medical Advisory Board. "This is a pivotal milestone and I look forward to seeing the continued progress of VET3-TGI as a monotherapy and in combination with checkpoint inhibitor therapy."

On October 8, 2024 Aurigene Oncology Limited, a wholly-owned subsidiary of Dr. Reddy’s Laboratories Limited and a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer, reported the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study – India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma (Press release, Aurigene Discovery Technologies, OCT 8, 2024, View Source [SID1234647097]).

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The study reported initial results from the first 8 patients. All patients were heavily pre-treated with median of 5.5 previous lines of treatment. Most patients had also received transplant in the past and had disease progression post-transplant. All 8 patients (100%) achieved clinical response, with 5/8 (62.5%) having achieved stringent complete response. With respect to safety, there were no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity, in any of the patients.

After reviewing the Phase 1 data, the Indian Regulatory Agency i.e., Drugs Controller General of India (DCGI), has given the nod to commence Phase 2 part of the trial. These results of Phase 1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently.

"The results from the trial in heavily pre-treated relapsed refractory myeloma patients are very exciting for us in India. We are thrilled with the data, as the drug could be transformative for Indian patients with myeloma," commented Dr. Murali Ramachandra, CEO, Aurigene Oncology Limited.

Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology Limited, Bangalore.

On October 8, 2024 Scholar Rock Holding Corporation (Nasdaq: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, reported the pricing of an upsized underwritten public offering of 10,265,488 shares of its common stock at a public offering price of $28.25 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase 353,983 shares of common stock at a public offering price of $28.2499 per pre-funded warrant, which represents the per share public offering price for the shares of common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Scholar Rock, OCT 8, 2024, View Source [SID1234647096]). All of the shares and pre-funded warrants are being offered by Scholar Rock. The offering is expected to close on October 10, 2024, subject to the satisfaction of customary closing conditions. In addition, Scholar Rock has granted the underwriters a 30-day option to purchase up to an additional 1,592,920 shares of common stock at the public offering price, less the underwriting discounts and commissions.

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The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by Scholar Rock and assuming no exercise of the pre-funded warrants, are expected to be approximately $300 million. Scholar Rock intends to use the net proceeds from the offering to support commercialization of apitegromab, to advance its ongoing and future clinical programs, to further develop its technology platform to continue to advance its clinical and preclinical pipeline, and for working capital and other general corporate purposes.

J.P. Morgan Securities LLC, Jefferies and Piper Sandler & Co. are acting as joint book-running managers for the offering. BMO Capital Markets Corp., Wedbush Securities Inc. and Raymond James & Associates, Inc. are acting as co-managers for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on October 7, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC on October 7, 2024, and are available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924, or by email at [email protected].

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