On September 11, 2024 Radiant Biotherapeutics, a preclinical biotechnology company developing an antibody platform to deliver transformative therapies for patients facing life-changing disease, reported it has closed a $35 million Series A financing (Press release, Radiant Biotherapeutics, SEP 11, 2024, View Source [SID1234646524]). The round is co-led by the Bill & Melinda Gates Foundation and Amplitude Ventures of Canada.

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Additional participants in the Series A include new investors BDC Capital, the investment arm of the Business Development Bank of Canada, through its Thrive Venture Fund, and abrdn, an investment fund managed by abrdn Inc.; and existing investors FACIT, Alexandria Venture Investments and Toronto Innovation Acceleration Partners (TIAP).

Radiant has built a best-in-class, proprietary, multi-valent, multi-specific antibody platform called Multabody. The funds will enable Radiant to further develop the company’s lead clinical candidate, 4-1BB, and move it towards clinical trials.

"These supportive investors share our vision of delivering powerful, multi-functional biologics with the potential to advance treatments for patients suffering from debilitating and life-threatening illnesses," said Arthur J. Fratamico, President and CEO of Radiant. "This investment enables us to further demonstrate the unique power and breadth of our platform across multiple therapeutic areas with a focus in oncology, inflammation and immunology, and global health and infectious disease including HIV."

Multabody therapeutics are able to overcome the shortcomings of existing antibody approaches by leveraging remarkable avidity, or binding strength, on their intended targets. Multabodies also exploit multi-specificity, enabling targeting of different disease-modifying proteins as well as multiple epitopes on the same target. Together, these qualities give Multabody therapeutics exceptional potency against both solid tumors and blood cancers, infectious disease pathogens, and other targets in multiple therapeutic areas.

"This financing will enable the next stage in Radiant’s growth and move the company towards the clinic as it continues to demonstrate the superiority of the Multabody platform against therapeutic targets that cannot be treated with traditional antibodies," said Bharat Srinivasa, Ph.D., principal at Amplitude Ventures. "We are investing to accelerate Radiant’s transition to clinical stage and to expand its pipeline in additional therapeutic areas."

Radiant Biotherapeutics was founded in 2020 and is built around foundational science developed at The Hospital for Sick Children (SickKids) in Toronto and the University of Toronto, based on and including work performed at the laboratories of Jean-Philippe Julien, Ph.D., senior scientist at SickKids and associate professor at University of Toronto’s Temerty Faculty of Medicine, and Bebhinn Treanor, Ph.D., a professor at the University of Toronto. The company emerged from stealth mode in 2023 following a seed investment led by Amplitude Ventures, FACIT, TIAP and Alexandria Venture Investments. Radiant maintains offices in Toronto and Philadelphia.

On September 11, 2024 HanX Biopharmaceuticals reported that HX044 had received clinical trial approval from the Bellberry Human Research Ethics Committee (HREC) in Australia (Press release, HanX Biopharmaceuticals, SEP 11, 2024, View Source [SID1234655962]). HanX’ application, which complies with the requirements of the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2023), approved the conduct of a Phase I clinical trial: HX044-I-01, A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies.

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HX044 is a first-in-class investigational bispecific antibody for cancer immunotherapy developed independently by Hans-Iitra. Preclinical studies have demonstrated enhanced potency and a wider therapeutic window compared to previous-generation immunotherapy inhibitors , while also demonstrating promising results in tumor models refractory to immunotherapy inhibitors ("cold tumors"). Hans-Iitra has completed all necessary preclinical development, including GMP manufacturing and GLP toxicology studies, and plans to initiate Phase I single-agent dose escalation trials in humans across various solid tumors in Australia and China.

Dr. Qixiang Li, CEO/Chief Scientific Officer of HansItai, said: "The approval of HX044 for clinical trials is a new important milestone for HansItai. H044 is a new type of cancer immunotherapy bispecific antibody that we independently developed from molecular design. Through the close cooperation and efforts of all departments of HansItai, HX044 was approved for clinical trials very smoothly, further strengthening the company’s clinical layout in the cancer immunotherapy pipeline, and fully demonstrating the company’s innovation and R&D strength in cancer immunotherapy. We will quickly advance this clinical trial and look forward to seeing the potential for efficacy as soon as possible and helping patients as soon as possible."

On September 11, 2024 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its first quarter of fiscal 2025, ended July 31, 2024 (Press release, Champions Oncology, SEP 11, 2024, View Source [SID1234646509]).

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First Quarter Highlights:

•Total revenue increased 12% to $14.1 million
•Margin improved to 50%
•Adjusted EBITDA of $2.0 million
•Net income of $1.3 million

Ronnie Morris, CEO of Champions, commented, "As outlined on our year-end earnings call, we’re cautiously optimistic that we’ve weathered the worst of the business downturn and we’re poised to emerge leaner and stronger. Our first quarter’s performance provided further evidence that we’re on a strategic course to more consistently deliver the results we have been striving to achieve." Morris added, "Our comprehensive platform, unique data, and strong team are the key ingredients for future growth that will drive long-term returns for our shareholders."

David Miller, CFO of Champions, added, "The first quarter saw a return to profitability as revenue increased 12% to $14.1 million while we reduced total costs by more than $2.0 million. The revenue increase, combined with mostly unchanged cost of oncology services, lifted our margin to 50%." Miller added, "While there will be some revenue and margin volatility over the coming quarters, our cost reductions should enable us to remain profitable on an adjusted EBITDA basis."

Exhibit 99.1
First Fiscal Quarter Financial Results

Total revenue for the first quarter of fiscal 2025 was $14.1 million compared to $12.6 million for the same period last year, an increase of 12%. Operational improvements and efficiencies implemented in the prior year led to an increase in our bookings to revenue conversion percentage contributing to the revenue growth. Total costs and operating expenses for the first quarter of fiscal 2025 were $12.7 million compared to $15.1 million for the first quarter of fiscal 2024, a decrease of $2.4 million or 15.8%.

For the first quarter of fiscal 2025, Champions reported income from operations of $1.3 million, including $258,000 in stock-based compensation and $449,000 in depreciation and amortization expenses, compared to a loss from operations of $2.6 million, inclusive of $423,000 in stock-based compensation and $445,000 in depreciation and amortization expenses, in the first quarter of fiscal 2024. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA income of $2.0 million for the first quarter of fiscal 2025 compared to an adjusted EBITDA loss of $1.7 million in the first quarter of fiscal 2024.

Cost of oncology services was $7.1 million for the three-months ended July 31, 2024, a decrease of $612,000, or 8.0% compared to $7.7 million for the three-months ended July 31, 2023. The decrease in cost of oncology services was primarily from a decline in outsourced lab services. For the three-months ended July 31, 2024, total margin was 49.7% compared to 38.8% for the three-months ended July 31, 2023. The improved margin resulted primarily from a combination of an increase in revenue on a lower cost base due to operational efficiencies implemented and other cost reduction initiatives.

Research and development expense for the three-months ended July 31, 2024 was $1.5 million, a decrease of $1.3 million or 47.9%, compared to $2.8 million for the three-months ended July 31, 2023. The decrease was primarily due to reduced investment in research and development, including our target discovery program. Sales and marketing expense for the three-months ended July 31, 2024 was $1.7 million, a slight decrease of $17,000, or 1.0%, compared to $1.7 million for the three-months ended July 31, 2023. General and administrative expense for the three-months ended July 31, 2024 was $2.5 million, a decrease of $413,000, or 14.0%, compared to $2.9 million for the three-months ended July 31, 2023. The decrease was primarily from a reduction in compensation and recruitment expenses.

Net cash provided by operating activities was approximately $311,000 for the three-months ended July 31, 2024 and was primarily due to our operational income, offset by net changes in our working capital accounts in the ordinary course of business. There were no investing activities for the first quarter of fiscal 2025. Net cash used in financing activities for the three-months ended July 31, 2024 was approximately $37,000 resulting from financing lease payments.

The Company ended the quarter with cash on hand of approximately $2.9 million. The Company has no debt.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its first quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 726315, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by or before September 16, 2024 in the Company’s Form 10-Q at www.championsoncology.com.

On September 11, 2024 Ichnos Glenmark Innovation (IGI), an alliance between Ichnos Sciences Inc., a global fully-integrated clinical-stage biotech company developing multispecifics in oncology, and Glenmark Pharmaceuticals Ltd., reported that Nature Cancer published a research article describing the preclinical development of ISB 2001, a first-in-class trispecific antibody targeting BCMA and CD38 on myeloma cells and CD3 on T cells (Press release, Ichnos Sciences, SEP 11, 2024, View Source;utm_medium=rss&utm_campaign=igi-announces-publication-in-nature-cancer-on-isb-2001-igis-innovative-trispecific-antibody-for-relapsed-refractory-multiple-myeloma [SID1234646510]). ISB 2001 is currently being investigated in a Phase 1 clinical study in relapsed/refractory multiple myeloma (r/r MM).

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"Despite advances with monoclonal antibodies and earlier-generation bispecifics, a high relapse rate and resistance to currently available therapeutics are persistent challenges in treating multiple myeloma," said Cyril Konto, M.D., President, Executive Director and CEO of IGI. "The publication of ISB 2001 preclinical data in Nature Cancer supports the differentiation and mechanism of action of IGI’s multispecific antibody. These comprehensive findings underscore the therapeutic potential of ISB 2001, now in Phase 1 clinical testing, and we look forward to sharing our continued progress."

Key findings of the Nature Cancer article, "ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells" include the following

The data demonstrate that ISB 2001 can overcome resistance mechanisms by dual tumor targeting via binding and cytotoxicity of tumor cells with low expression of CD38 or BCMA.
ISB 2001’s architecture is optimized to support robust killing of tumor cells while limiting CD38 on-target, off-tumor activity.
ISB 2001 demonstrated increased killing of tumor cells compared to BCMA-targeted T cell engagers in vitro, in vivo and ex vivo; induced complete tumor regression in humanized mouse models; and demonstrated superior potency compared to standard combination of therapies.
"We leveraged our proprietary BEAT platform to create a highly specific antibody that increases binding to MM cells while minimizing off-target activity," said Mario Perro, Ph.D., Head of Biologics Research at IGI. "These preclinical data demonstrate the potential of a trispecific approach to augment immune cell activation and achieve more precise tumor targeting and killing."
The paper can be found at View Source

ISB 2001 – Mechanism of Action
ISB 2001 is the first T cell-engaging antibody that simultaneously targets BCMA and CD38 on MM cells. It is a trispecific antibody based on BEAT (Bispecific Engagement by Antibodies based on the TCR) technology, a proprietary platform allowing maximal flexibility and manufacturability of full-length multispecific antibodies. ISB 2001 combines three proprietary antigen-binding arms, each targeting a different antigen, with one arm binding to the epsilon chain of CD3 on T cells, and the other two binding BCMA and CD38 on MM cells. Its fragment crystallizable (Fc) domain was fully silenced to suppress Fc effector functions. ISB 2001 redirects CD3+ T lymphocytes to kill tumor cells expressing BCMA and CD38. Targeting of two different tumor-associated antigens instead of one allows for avidity binding to MM cells expressing very low levels of BCMA and CD38.

On September 11, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported a corporate and REM-001 clinical study update (Press release, Kintara Therapeutics, SEP 11, 2024, View Source [SID1234646511]).

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Corporate Updates

In April 2024, Kintara and TuHURA Biosciences, Inc. ("TuHURA") entered into definitive merger agreement (the "Merger Agreement"), pursuant to which Kayak Mergeco, Inc., Kintara’s wholly-owned subsidiary, will merge with and into TuHURA, with TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary (the "Merger").

Kintara’s existing stockholders will own approximately 5.45% of combined company’s common stock at the closing of the proposed Merger on a pro forma fully diluted basis, inclusive of the contingent value rights ("CVRs") to receive shares of common stock of the combined company upon the achievement of enrollment of a minimum of 10 patients in the REM-001 study with such patients each completing 8 weeks of follow-up on or before December 31, 2025 (the "Milestone").

Special Meeting of Stockholders (the "Special Meeting") to obtain stockholder approval of the proposals set forth in Kintara’s proxy statement for the Special Meeting required to allow for completion of the proposed Merger with TuHURA will be held virtually on Friday, September 20, 2024, at 9:00 a.m., Eastern Time via live audio webcast. In order to attend, register in advance at www.viewproxy.com/kintarasm/2024 by 11:59 p.m., Eastern Time, on September 19, 2024. Kintara stockholders of record on August 14, 2024 (the "Record Date") are eligible to vote even if not a stockholder after the Record Date.

Stockholders immediately prior to the closing of the proposed Merger, even if not a stockholder on the Record Date, are eligible to receive CVRs, entitling such holders to receive shares of common stock of the combined company upon achievement of the Milestone.

Vote By Phone: Please call Alliance Advisors, Kintara’s proxy solicitor, toll-free, at (866) 619-8907, if in North America. International voters can call +1 (551) 210-9859. You can also contact Alliance Advisors if you have any questions about voting.

Vote By Internet: Vote at www.proxyvote.com using your control number by following the instructions shared by your broker, bank or other nominee.

If you are a Robinhood holder, proxy voting emails are sent by [email protected] and voting is hosted by Say Technologies. You will be able to vote and view materials directly from your email.
REM-001 Clinical Study Update

As of September 10, 2024, the REM-001 study in patients with cutaneous metastatic breast cancer (CMBC) has enrolled four of the 10 patients needed to reach the minimum patient enrollment to assess safety and appropriate Phase 3 dose with several other patients identified as study candidates at Kintara’s clinical sites, the Memorial Sloan Kettering Cancer Center and the Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine.

Consistent with REM-001’s safety profile, no treatment-related safety issues have been identified to-date, and assessment of the appropriate Phase 3 dose is ongoing.

CMBC represents an unmet medical need, as there currently are no approved or effective therapies. REM-001 may potentially offer these patients a much needed treatment option. The majority of the cost associated with the REM-001 study is being covered by a $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded previously from the National Institutes of Health.
Without the completion of the proposed Merger with TuHURA, Kintara may not have adequate financial resources to continue the REM-001 study or operate its business and may be required to seek the protection of the bankruptcy courts. Kintara stockholders are urged to vote their shares before the Special Meeting on September 20, 2024.