On May 07, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the US and Canada) for CytomX’s first-in-human Phase 1 clinical trial assessing the clinical activity of CX-801, a dually-masked interferon-alpha2b cytokine in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) (Press release, CytomX Therapeutics, MAY 7, 2024, View Source [SID1234642768]).

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"Interferon-alpha-2b is a potent cytokine with demonstrated clinical activity against multiple cancer types, but its use has been limited by systemic toxicities. CX-801 is designed to overcome these limitations to unlock the full potential of interferon in activating the immune tumor microenvironment. With an improved therapeutic profile, our goal is to establish CX-801 as a cornerstone of immuno-oncology combination regimens, including in combination with checkpoint inhibitors such as Keytruda, for the treatment of a broad range of tumor types," said Wayne Chu, M.D., chief medical officer of CytomX Therapeutics.

"CytomX is excited to be entering into this agreement with Merck to utilize Keytruda in combination with CX-801. The product design principles behind CX-801 integrate over a decade of continuous innovation and experience at CytomX in masking potent biologic therapies. The mechanistic combination of CX-801 and Keytruda is compelling and has potential to be a highly effective regimen to significantly improve the outcomes of patients with cancer," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

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

About CX-801
Interferon-alpha 2b is an immunotherapeutic cytokine that has demonstrated clinical activity and gained regulatory approval previously in multiple cancer types. IFNα2b provides a potentially superior approach to activating anti-tumor immune responses compared to other cytokines. CX-801 is a dually masked, conditionally activated IFNα2b cytokine that has the potential to become a cornerstone of combination therapy for a wide range of tumor types, including in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. Phase 1 initiation for CX-801 solid tumors including melanoma, renal, and head and neck squamous cell carcinoma anticipated in the first half of 2024. Further details on the design and preclinical optimization of CX-801 can be found here:

Link to 2023 SITC (Free SITC Whitepaper) poster

On May 7, 2024 Curis, Inc., a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its business update and financial results for the first quarter ended March 31, 2024 (Press release, Curis, MAY 7, 2024, View Source [SID1234642767]).

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Operational Highlights

The Company will release a topline update of clinical data from the ongoing TakeAim Leukemia study of emavusertib monotherapy in patients with relapsed or refractory (R/R) Acute Myeloid Leukemia (AML), including separate readouts for the FLT3 mutation (mFLT3) and Splicing Factor mutation (mSF) cohorts, on Tuesday, May 14, 2024, in connection with the publication of accepted abstracts for the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Conference.

"We are very pleased to have several opportunities to present additional patient data in R/R AML patients with a targeted mutation (mFLT3 or mSF), as well as progress updates for our R/R PCNSL and AML frontline triplet studies, at these prestigious oncology meetings," said James Dentzer, President and CEO of Curis.

Upcoming Presentations

At the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences, Curis will update its current dataset of 5 targeted patients with R/R AML (3 mFLT3, 3 mSF – including 1 patient with both a FLT3 and SF mutation who is included in both populations). The clinical update will include data for 25 new patients, bringing the total to 30 targeted patients with R/R AML treated with emavusertib as a monotherapy. The mutation status for the 30 patients is: 12 mFLT3, 20 mSF – including 2 patients with both a FLT3 and SF mutation who are included in both populations.

The following abstracts have been accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (May 31 – June 4):

TakeAim Leukemia

Preliminary safety, efficacy and molecular characterization of emavusertib (CA-4948) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation (FLT3m).
Predictive biomarkers of response to the IRAK4/FLT3 inhibitor emavusertib in hematological malignancies.
TakeAim Lymphoma

Emavusertib (CA-4948) in combination with ibrutinib in patients with relapsed/refractory primary central nervous system lymphoma (R/R PCNSL).
AML Triplet

A phase 1 single-arm, open-label study of emavusertib (CA-4948) in combination with azacitidine and venetoclax in patients (pts) with acute myeloid leukemia (AML) in complete response (CR) with measurable residual disease (MRD).
The following abstract has been accepted for poster presentation at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Conference in Madrid (June 13 – 16):

TakeAim Leukemia

Preliminary safety, efficacy and molecular characterization relapsed/refractory acute myeloid leukemia patients with a FLT3 mutation treated with single agent emavusertib (CA-4948).
Upcoming Milestones

TakeAim Leukemia – updated clinical data from the on-going combination study of emavusertib monotherapy in patients with R/R AML in mid-year 2024 (at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) later this quarter).
TakeAim Lymphoma – updated clinical data from the on-going combination study of emavusertib with ibrutinib in patients with R/R PCNSL in late 2024.
Initial safety data from the frontline triplet combination study of emavusertib with azacitidine and venetoclax in patients with AML in late 2024.
First Quarter 2024 Financial Results

For the first quarter of 2024, Curis reported a net loss of $11.9 million or $2.05 per share on both a basic and diluted basis as compared to $11.6 million or $2.39 per share on both a basic and diluted basis, for the same period in 2023.

Revenues for the first quarter of 2024 were $2.1 million as compared to $2.3 million for the same period in 2023. Revenues for both periods consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $9.6 million for the first quarter of 2024, as compared to $9.1 million for the same period in 2023. The increase was primarily attributable to higher employee-related costs.

General and administrative expenses were $4.9 million for the first quarter of 2024, as compared to $4.8 million for the same period in 2023.

Other income, net was $0.6 million for the first quarter of 2024, as compared to $0.1 million for the same period in 2023. The increase was primarily attributable to a decrease in the non-cash expense related to the sale of future royalties.

Curis’s cash, cash equivalents and investments totaled $40.7 million as of March 31, 2024, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments will enable its planned operations into 2025.

Conference Call Information

Curis management will host a conference call today, May 7, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 800-836-8184 from the United States or 1-646-357-8785 from other locations, or login to View Source shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the ‘Investors’ section.

On May 07, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a business update and announced financial results for the first quarter ended March 31, 2024 (Press release, Cogent Biosciences, MAY 7, 2024, View Source [SID1234642766]).

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"Our team made important progress in the first quarter," said Andrew Robbins, the Company’s President and Chief Executive Officer. "Based on the emerging clinical results demonstrating the potential of bezuclastinib in both systemic mastocytosis and GIST patients, we have experienced very strong interest in our ongoing clinical trials from patients and investigators. We remain on track to complete enrollment in APEX and PEAK by the end of this year, and to complete enrollment in SUMMIT during 2Q 2025. This should allow us to report topline results from all three registration-directed trials during 2025. Following our successful financing in February, we are well positioned with a cash runway into 2027, allowing us to complete our ongoing studies while continuing to broaden our portfolio with a robust research pipeline of novel compounds."

Recent Business Highlights

Reported positive Part 1b data from the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting and initiated the registration-directed SUMMIT Part 2.
Selected the 100 mg once-daily recommended Phase 2 dose (RP2D) based on:
51% week 12 mean improvement in Total Symptom Score (TSS), including 70% of patients achieving ≥50% reduction in TSS at week 12
49% week 12 mean improvement in quality-of-life (MC-QoL)
Safety and tolerability profile generally similar to placebo with no grade 3/4 events, and no bleeding, edema or cognitive events, no dose reductions and no discontinuations
Presented preclinical data from the company’s ErbB2 candidate at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
The new preclinical data described CGT4255’s exceptional stability in human whole blood and liver cytosol fractions, high oral bioavailability and low clearance across preclinical species. CGT4255 also demonstrated 80% brain penetrance in mice and was well-tolerated at 10x maximally efficacious concentration, resulting in mouse tumor regression, suggesting potential best-in-class properties.
Completed oversubscribed private placement, resulting in $213.4 million net proceeds, extending the company’s cash runway into 2027.
Upcoming Milestones

Share updated clinical data from the lead-in portion of the PEAK trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place May 31-June 4, 2024. PEAK is the Company’s ongoing Phase 3 trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST). Cogent remains on track to complete enrollment in PEAK by the end of 2024 and report top-line results by the end of 2025.

ASCO Poster details
Title: Peak part 1 summary: A phase 3, randomized, open-label multicenter clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST)
Session Type and Title: Poster Session – Sarcoma
Session Date and Time: June 1, 2024, 1:30 PM-4:30 PM CDT
Complete enrollment in APEX in patients with advanced systemic mastocytosis (AdvSM) by the end of 2024 and report top-line results mid-2025.
Complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by the end of 2025.
First Quarter 2024 Financial Results

Cash and Cash Equivalents: As of March 31, 2024, cash, cash equivalents and marketable securities were $435.7 million as compared to $273.2 million as of December 31, 2023. Total cash spend in the quarter was $51.2 million, including a non-recurring payment of $8.6 million related to annual performance-based bonus compensation. Based on its current plans, the company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2027 and through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials.

R&D Expenses: Research and development expenses were $52.7 million for the first quarter of 2024 compared to $36.0 million for the first quarter of 2023. The increase was primarily due to costs associated with accelerating enrollment in both SUMMIT and PEAK clinical trials, on-going APEX costs and costs related to development of the research pipeline. R&D expenses include non-cash stock compensation expense of $4.4 million for the first quarter of 2024 as compared to $3.0 million for the first quarter of 2023.

G&A Expenses: General and administrative expenses were $9.7 million for the first quarter of 2024 compared to $7.2 million for the first quarter of 2023. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $5.0 million for the first quarter of 2024 as compared to $2.9 million for the first quarter of 2023.

Net Loss: Net loss was $58.3 million for the first quarter of 2024 compared to a net loss of $38.6 million for the first quarter of 2023.

On May 7, 2024 Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, and ImmunoAdoptive Cell Therapy (ImmunoACT), a Mumbai, India-based pioneering research and cell and gene therapy development company, reported an agreement to develop and commercialize a multi-targeted chimeric antigen receptor T-cell immunotherapy for leukemia and lymphoma (Press release, Caring Cross, MAY 7, 2024, View Source [SID1234642765]). The TriCAR-T immunotherapy is designed to address relapse that can occur when patients with Leukemia or Lymphoma are treated with a single targeting anti-CD19 CAR T-cell product. Under the terms of the agreement, Caring Cross will provide a TriCAR-T cell immunotherapy for clinical development, manufacturing, and commercialization at ImmunoACT’s facilities in India.

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ImmunoACT is developing an array of CAR-T therapeutic assets at various stages of clinical maturity to address oncological indications and autoimmune disorders. Its lead candidate, NexCAR19 (Actalycabtagene autoleucel), was recently approved as India’s first CAR-T cell therapy for the treatment of r/r B-cell lymphomas and leukemia by the Central Drugs Standard Control Organization (CDSCO). It is a first-of-its-kind product that has given patients in India access to this lifesaving, leading-edge therapy at an affordable price.

"We are pleased to form this commercial partnership with ImmunoACT, which is committed to providing affordable and accessible CAR-T cell therapies for serious diseases like leukemia and lymphoma," said Caring Cross Co-Founder and Executive Director Boro Dropulić, Ph.D. "Our global partnership model aims to improve access for CAR-T cell therapies by developing CAR-T cell manufacturing technologies and providing therapeutic candidates that are affordable in countries like India. We are excited to work with ImmunoACT to commercialize a dedicated proprietary TriCAR-T cell therapy in India, which we anticipate will decrease the rate of relapse seen with current single targeted anti-CD19 CAR-T cell therapies. We look forward to working closely with ImmunoACT to expand access to a commercial TriCAR-T cell therapy in India as part of our mission to further universal access and affordability of CAR-T therapies worldwide."

"We are delighted to work with Caring Cross to bring next generation CAR-T therapies to India, which will enable cost-effective local production and improved access to these advanced medicines " stated ImmunoACT’s Founder and Professor at IIT Bombay, Rahul Puwar, Ph.D. "ImmunoACT’s technical and commercial operations capabilities are well proven and with its network of partner hospitals across the country, this partnership has great potential to benefit thousands of patients in coming years."

On May 7, 2024 Bristol Myers Squibb reported that the company will participate in two upcoming investor conferences in May 2024 (Press release, Bristol-Myers Squibb, MAY 7, 2024, View Source [SID1234642764]).

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Ben Hickey, President, RayzeBio, Head of Mirati, will take part in a fireside chat at the Guggenheim Healthcare Talks Radiopharmaceuticals Day on Monday, May 13, 2024. He will answer questions about the company beginning at 11:00 a.m. ET.

David Elkins, Executive Vice President, Chief Financial Officer, will participate in a fireside chat at the 2024 Bank of America Global Healthcare Conference on Wednesday, May 15, 2024. He will answer questions about the company beginning at 11:20 a.m. PT/2:20 p.m. ET.

Investors and the general public are invited to listen to both sessions at their respective times by visiting View Source An archived edition of each session will be available following its conclusion.