On September 11, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Joseph Romanelli, president, Human Health International, is scheduled to participate in a fireside chat at the Bank of America 2024 Global Healthcare Conference on Wednesday, Sept. 18, 2024, at 6:40 a.m. EDT / 11:40 a.m. BST (Press release, Merck & Co, SEP 11, 2024, View Source [SID1234646512]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

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.

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 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 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held in Barcelona, Spain on 13-17 September (Press release, Astellas, SEP 11, 2024, View Source [SID1234646508]). Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas’ commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts include data spanning prostate, urothelial, gastric and gastroesophageal junction (GEJ), and pancreatic cancers. Two abstracts feature Phase 1 data presented for the first time from immuno-oncology and targeted protein degradation assets.

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Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:
"The data presented at ESMO (Free ESMO Whitepaper) are an exciting demonstration of the strength of our portfolio and the transformative potential of our pipeline to help deliver outcomes that matter for patients. Astellas has made a long-term commitment to helping people living with hard-to-treat cancers by both investing in next-generation modalities like targeted protein degradation and immuno-oncology, and by maximizing the number of patients that could benefit from our approved medicines."

Highlights at the ESMO (Free ESMO Whitepaper) Congress 2024 include:

Data from the Phase 3 EV-302 study, evaluating Nectin-4 expression and response to first-line treatment of enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression.
Five-year follow-up data from the Phase 1/2b EV-103 DE/A study, analyzing durable responses and meaningful survival to enfortumab vedotin in combination with pembrolizumab in patients with first-line cis-ineligible la/mUC. These results further support the broad suitability, regardless of cis-eligibility, and long-term benefits of this regimen in la/mUC.
Final pooled overall survival data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab plus chemotherapy as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
Updates involving a Phase 2 trial in progress assessing zolbetuximab in combination with gemcitabine and nab-paclitaxel (GN) versus GN monotherapy as first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer.
Phase 3 EMBARK post-hoc analyses, evaluating enzalutamide in combination with leuprolide and as monotherapy versus leuprolide alone in patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer. These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years.
Clinical data from lead pipeline assets: Phase 1 data from ASP3082, the first protein degrader targeting KRAS G12D mutant to enter clinical trials, in patients with advanced pancreatic, colorectal, and non-small cell lung cancer; and preclinical, translational/early clinical data from ASP1570, a novel DGKζ inhibitor, in patients with advanced solid tumors. The results support continued study of these investigational therapies for the treatment of various cancer types.

Astellas Presentations at 2024 ESMO (Free ESMO Whitepaper) Congress

Enfortumab vedotin

Presentation title

Speaker

Presentation details

EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or

Metastatic Urothelial Cancer (la/mUC)

T. Powles

Type: Mini Oral Session
Abstract Number: 1966MO
Date: September 15

Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L)

Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally

Advanced Or Metastatic Urothelial Carcinoma (la/mUC)

J. Rosenberg

Type: Poster
Abstract Number: 1968P
Date: September 15

Epidemiology and treatment patterns of patients with locally advanced or metastatic

urothelial cancer in France: a non-interventional database study

F. Joly

Type: Poster
Abstract Number: 2001P
Date: September 15

Zolbetuximab

Presentation title

Speaker

Presentation details

First-line (1L) zolbetuximab + chemotherapy in patients (pts) with claudin 18.2 (CLDN18.2) +, HER2–, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: A pooled final analysis of SPOTLIGHT + GLOW

Y-K Kang

Type: Poster
Abstract Number: 1438P
Date: September 16

Zolbetuximab With Gemcitabine + Nab-Paclitaxel (GN) in First-Line Treatment of Claudin 18.2–Positive Metastatic Pancreatic Cancer (mPC): Phase 2, Open-Label, Randomized Study

W. Park

Type: Poster
Abstract Number: 1532TiP
Date: September 16

Enzalutamide

Presentation title

Speaker

Presentation details

Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post-hoc analysis by age

N. D. Shore

Type: Poster
Abstract Number: 1638P
Date: September 15

Pipeline

Presentation title

Speaker

Presentation details

Phase 1/2 Trial of ASP1570, a Novel Diacylglycerol Kinase ζ Inhibitor, in Patients With Advanced Solid Tumors

D. Olsen

Type: Poster
Abstract Number: 1004P
Date: September 14

Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)

W. Park

Type: Proffered Paper Session
Abstract Number: 608O
Date: September 15