On May 2, 2024 Delphia Therapeutics, Inc. (Delphia), reported its launch today to pioneer a new area of cancer biology – activation lethality – which targets cancer’s surprising vulnerability to oncogene overactivation (Press release, Delphia Therapeutics, MAY 2, 2024, View Source [SID1234642617]). Leveraging this next-generation approach, Delphia is advancing highly differentiated first-in-class targeted cancer medicines with the potential for significant anti-tumor activity and more durable patient benefit across multiple prevalent cancer types. Delphia completed a $67 million Series A financing led by premier early life sciences investors including GV (Google Ventures), Nextech Invest, Polaris Innovation Fund and Alexandria Venture Investments.

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"Despite dramatic advances in the understanding and drugging of key driver mutations and oncogenic pathways, cancer remains a tremendous global health challenge, as tumors rapidly develop resistance to targeted therapy in the vast majority of patients," said Kevin Marks, Ph.D., co-founder, president and CEO of Delphia. "Our activation lethality platform offers the potential for new cancer medicines that are effective on their own while also combating the emergence of resistance to classic targeted therapies. These medicines hold the potential to address significant cancer patient populations and may mark a disruptive paradigm shift in how cancer is treated, leading to more sustained disease control and longer patient survival. We are thrilled to launch Delphia to lead this exciting new area of cancer biology."

Activation Lethality: Unlocking the Next Wave in Oncology Therapeutics

The problem of cancer drug resistance

Mutations in oncogenes drive cancer by boosting activity of key pathways that drive cell/tumor growth. Targeted therapies that inhibit oncogenes block pathway activity and typically lead to an initial response.
However, tumors are heterogeneous. Under the selective pressure of inhibitor therapy, drug resistance rapidly emerges – often pushing pathway activity even higher, leading to increased tumor growth and further disease progression.
Activation lethality

Breakthrough research led by Delphia’s founders has revealed that many oncogenic pathways are also highly vulnerable to overactivation1. Oncogene overactivation leads to an overload on cell stress pathways and is selectively lethal to cancers with mutations that put them close to the upper bounds of tolerable pathway activity (‘activation lethality’).
Activation lethal medicines

Critical cellular pathways have multiple layers of regulation to ensure optimal activity. Oncogenic mutations boost pathway activity and disable much of this regulation. In cells with oncogenic mutations, the remaining regulators are vulnerable – a ‘last line of defense’ from overactivation.
These key, vulnerable regulatory nodes represent unique therapeutic targets to drive overactivation and selective killing of tumor cells.
Delphia’s next-generation platform

Delphia integrates tumor genetics, novel functional genomic approaches, and studies of inhibitor drug resistance to identify targets that drive activation lethality.
Through its activation lethality platform, Delphia is advancing a pipeline of first-in-class cancer medicines that aim to better control oncogenic pathways.
"Delphia is advancing multiple strategies to hyperactivate oncogene pathways; I am enthusiastic about the potential of this new class of medicines, which also may open up avenues to alternate between pathway activation and inhibition as a way to durably keep tumor growth in check," said Bill Sellers, M.D., director of the cancer program of the Broad Institute of MIT and Harvard and co-founder and board member of Delphia. "I am excited to work alongside the Delphia team to leverage the company’s activation lethality platform to advance potential paradigm-shifting cancer medicines."

Delphia Co-Founders

Delphia was founded by industry leading oncology drug developers who have collectively been involved in the discovery, development and commercialization of more than 15 approved drugs.

Bill Sellers, M.D., director of the cancer program of the Broad Institute of MIT and Harvard
Mike Dillon, Ph.D., former chief scientific officer of IDEAYA Biosciences and former global head of discovery chemistry for oncology at Novartis Institutes for BioMedical Research (NIBR)
Kevin Marks, Ph.D., president and CEO of Delphia, entrepreneur-in-residence at GV, and former oncology drug discovery site head at NIBR
"Delphia’s activation lethality platform is one of the most innovative approaches in cancer drug development and offers an excellent foundation to build a differentiated oncology company," said David Schenkein, M.D., general partner and co-lead of the life sciences team at GV and Delphia board observer. "This opens up a new category of cancer genetics and therapeutic targets that have the potential to lead to better medicines for patients. We are thrilled to continue supporting Dr. Kevin Marks and the Delphia team after the company was incubated at GV through our entrepreneur-in-residence program, and we are excited to see this team of experienced cancer drug developers make major impacts on the lives of cancer patients."

On May 2, 2024 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended March 31, 2024 (Press release, NovoCure, MAY 2, 2024, View Source [SID1234642616]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"The first quarter was a period of strong execution," said William Doyle, Novocure’s Executive Chairman. "In Q1, GBM active patients grew 11%, we announced the METIS Phase 3 clinical trial met its primary endpoint, and we met with the U.S. Food and Drug Administration (FDA) in a Day-100 meeting for the LUNAR PMA application. We have multiple milestones ahead of us in 2024, and I remain grateful for our teams’ dedication and hard work."

Financial updates for the first quarter ended March 31, 2024:

Total net revenues for the quarter were $138.5 million, an increase of 13% compared to the same period in 2023. This increase was primarily driven by our successful launch in France and improved U.S. approval rates.
The United States, Germany and Japan contributed $90.5 million, $15.7 million and $7.8 million, respectively, with other active markets contributing $19.5 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million.
Gross margin for the quarter was 76%.
Research, development, and clinical studies expenses for the quarter were $51.6 million, a decrease of 14% from the same period in 2023. This primarily reflects decreased personnel expenses and reduced direct clinical trial expenses driven by the timing of activities within the clinical trial portfolio.
Sales and marketing expenses for the quarter were $55.2 million, an increase of 8% compared to the same period in 2023. This primarily reflects sales force expansion and increased marketing activities in anticipation of our potential launch in non-small cell lung cancer.
General and administrative expenses for the quarter were $39.5 million, a decrease of 6% compared to the same period in 2023. This primarily reflects lower personnel expenses.
Net loss for the quarter was $38.8 million with loss per share of $0.36.
Adjusted EBITDA* for the quarter was $(4.6) million.
Cash, cash equivalents and short-term investments were $870 million as of March 31, 2024.
In May, we entered into a new five-year senior secured credit facility agreement with affiliates of Pharmakon Advisors for up to $400 million, drawn across up to four tranches of $100 million. This non-dilutive, multi-tranche, delayed-draw, debt facility strengthens our cash position and further solidifies our balance sheet while providing valuable flexibility as we invest in our future.
Operational updates for the first quarter ended March 31, 2024:

1,643 prescriptions were received in the quarter, an increase of 10% compared to the same period in 2023. Prescriptions from the United States, Germany and Japan contributed 990, 206 and 91 prescriptions, respectively, with the remaining 356 prescriptions received in other active markets.
As of March 31, 2024, there were 3,845 active patients on therapy. Active patients from the United States, Germany and Japan contributed 2,137, 540 and 379 active patients, respectively, with the remaining 789 active patients contributed by other active markets.
Quarterly updates and achievements:

In April, we met with the FDA in a Day-100 meeting for the PMA application for Optune Lua in non-small cell lung cancer (NSCLC). The meeting was productive with no indication that the PMA will be referred to an advisory panel. We continue to anticipate the PMA decision in the second half of 2024.
In March 2024, we announced the METIS Phase 3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in time to intracranial progression for patients with brain metastases from NSCLC. The METIS trial data will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) scientific congress in June.
In March, the FDA approved the Investigational New Drug (IND) application for the randomized, Phase 3 KEYNOTE D58 trial. KEYNOTE D58 will explore the use of TTFields therapy together with temozolomide and the immunotherapy pembrolizumab for the treatment of newly diagnosed glioblastoma.
In March, an exploratory subgroup analysis of the randomized, Phase 3 INNOVATE-3 trial was selected as a Best Oral Presentation at the European Society of Gynaecological Oncology 2024 Congress. The exploratory analysis found that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel exhibited median overall survival of 16.0 months compared to 11.7 months in PLD-naïve patients treated with paclitaxel alone.
Anticipated 2024 clinical milestones:

Top-line data from Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, May 2, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On May 2, 2024 Novocure (NASDAQ: NVCR) reported that it has entered into a new five-year up to $400 million committed senior secured credit facility with funds managed by Pharmakon Advisors, LP. The committed capital will be available to Novocure in four tranches of $100 million (Press release, NovoCure, MAY 2, 2024, View Source [SID1234642615]). The first $100 million was issued at closing, and the second $100 million will be issued by June 30, 2025. An additional $200 million is available to be drawn across two tranches, at Novocure’s discretion and subject to certain milestones, through March 31, 2026. The proceeds will be used to fund working capital needs stemming from Novocure’s anticipated launch in non-small cell lung cancer and settle, upon maturity, Novocure’s convertible notes. Additional information on the agreement will be filed with the U.S. Securities and Exchange Commission as a Current Report on Form 10-Q.

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"As we look ahead to multiple milestones on the horizon for Novocure, we have strengthened our cash position with non-dilutive capital and further solidified our balance sheet," said Ashley Cordova, Novocure’s Chief Financial Officer. "This multi-tranche, delayed-draw, debt facility provides us with the flexibility and financial stability to invest in future growth, specifically in non-small cell lung cancer, as we execute our objectives and advance our clinical pipeline. We are pleased to again partner with Pharmakon on this transaction."

Pharmakon Advisors, LP is a leading investor in non-dilutive debt for the life sciences industry and is the investment manager of the BioPharma Credit funds. Established in 2009, funds managed by Pharmakon Advisors, LP have committed $8.2 billion across 52 investments.

On May 2, 2024 Kelonia Therapeutics, Inc., a biotech company revolutionizing in vivo gene delivery, reported preclinical data from its lead in vivo CAR-T cell therapeutic candidate KLN-1010 in multiple myeloma that will be highlighted at two upcoming scientific conferences – the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting, taking place on May 7-11, 2024, in Baltimore, Maryland, and the Protein Engineering Summit (PEGS) Boston Summit 2024, taking place on May 13-17, 2024, in Boston (Press release, Kelonia Therapeutics, MAY 2, 2024, View Source [SID1234642614]).

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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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"Preclinical data continues to demonstrate exquisite T cell specificity and profound CAR T cell activity with low dose levels of our in vivo Gene Placement System (iGPS)," said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. "Combining this platform with our proprietary, fully-human, and highly active BCMA CAR candidate creates a medicine with the potential to transform the treatment of multiple myeloma. With KLN-1010 poised to be the first in vivo CAR-T cell therapy for multiple myeloma, we aim to provide a potentially life-changing solution for patients that need it most. We’re excited to share our latest data at these upcoming conferences, as we continue to advance toward the clinic."

Details for the panel discussion and presentations are as follows:

ASGCT 27th Annual Meeting – Scientific Symposium
Panel Session: Moving from Ex Vivo to In Vivo: Challenges and advances in in vivo gene therapy for hematological disorders
Presentation Title: In vivo generation of anti-BCMA CAR T cells for the treatment of multiple myeloma
Panelist: Shannon Grande Contrastano, Ph.D., Vice President of Research at Kelonia
Date and Time: Saturday, May 11, 2024 at 8:00 – 9:45 a.m. ET

PEGS Boston Summit – Therapeutics: In Vivo Cell and Gene Engineering
Discussion Session: In Vivo Engineering of Cells Using Viral Vectors
Presentation Title: In Vivo Engineering Using iGPS Technology
Presenter: Emily Beura, Ph.D., Director of Research at Kelonia
Date and Time: Friday, May 17, 2024 at 9:30 – 10:00 a.m. ET

On May 2, 2024 City of Hope, one of the largest cancer research and treatment organizations in the United States, reported that it will present new findings and offer expert perspectives on leading-edge cancer research and treatment development at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024, which will take place in Chicago from May 31 to June 4 (Press release, City of Hope, MAY 2, 2024, View Source [SID1234642613]).

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In total, City of Hope experts will present at 64 sessions, including oral abstracts, rapid oral abstracts, clinical science symposiums and education sessions.

ORAL AND RAPID ORAL ABSTRACT SESSIONS

"Overall survival (OS) of phase 3 CodeBreaK 300 study of sotorasib plus panitumumab (soto+pani) versus investigator’s choice of therapy for KRAS G12C-mutated metastatic colorectal cancer (mCRC)"
Session LBA 3510 presenting Monday, June 3, from 1:21 to 1:27 p.m. CT
Session title: Gastrointestinal Cancer—Colorectal and Anal
Presenter: Marwan G. Fakih, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research
"Post-transplant cyclophosphamide-based graft-versus-host disease prophylaxis following mismatched unrelated donor peripheral blood stem cell (PBSC) transplantation"
Session 6503 presenting on Friday, May 31, from 3:45 to 3:57 p.m. CT
Session title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenter: Monzr M. Al Malki, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation
"Glofitamab monotherapy in patients with heavily pretreated relapsed/refractory (R/R) mantle cell lymphoma (MCL): Updated analysis from a phase I/II study"
Session 7008 presenting on Saturday, June 1, from 5:24 to 5:36 p.m. CT
Session title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Tycel Phillips, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation
"Preliminary safety, pharmacokinetics and clinical activity of DFF332, an oral HIF2α inhibitor, as monotherapy in a phase 1 dose escalation study in patients with advanced clear cell renal cell carcinoma"
Session 4513 presenting Saturday, June 1, from 8:30 to 8:36 a.m. CT
Session title: Genitourinary Cancer—Kidney and Bladder
Presenter: Sumanta Kumar Pal, M.D., FASCO, City of Hope professor, Department of Medical Oncology & Therapeutics Research
CLINICAL SCIENCE SYMPOSIUMS

"Geriatric assessment-directed supportive care intervention (GAIN-S)-implementation via telehealth in a lower-resourced community"
Session 1510 presenting Saturday, June 1, from 1:39 to 1:51 p.m. CT
Session title: Patient-Centered Care for Older Adults With Cancer
Presenter: Tanyanika Phillips, M.D., M.P.H., City of Hope assistant clinical professor, Department of Medical Oncology & Therapeutics Research
Senior author: William Dale, M.D., Ph.D., FASCO, City of Hope professor, Department of Supportive Care Medicine
"Quality of life for older patients with metastatic cancer in Brazil: A telehealth-based geriatric assessment and supportive care intervention (GAIN-S)"
Session 1514 presenting Sunday, June 2, from 11:54 a.m. to 12:06 p.m. CT
Presenter: Cristiane Decat Bergerot, Ph.D.
Senior author: William Dale, M.D., Ph.D., FASCO, City of Hope professor, Department of Supportive Care Medicine
POSTER ABSTRACT SESSION

"A phase I/II trial of palbociclib, pembrolizumab, and endocrine therapy for patients with HR+/HER2- locally advanced or metastatic breast cancer (MBC): Clinical outcomes and stool microbial profiling"*
Session 1038 on Sunday, June 2, from 9 a.m. to noon CT
Session Title: Breast Cancer—Metastatic
Presenter: Alexis LeVee, M.D., City of Hope Hematology & Medical Oncology Chief Fellow
* Conquer Cancer, the ASCO (Free ASCO Whitepaper) Foundation, awarded LeVee a 2024 ASCO (Free ASCO Whitepaper) Annual Meeting Merit Award, which supports students and trainees who are first authors on abstracts selected for presentation.
At the meeting, ASCO (Free ASCO Whitepaper) will recognize researchers who have reshaped cancer care. City of Hope’s William Dale, M.D., Ph.D., FASCO, is the recipient of this year’s B.J. Kennedy Geriatric Oncology Award, which honors geriatric oncologists who have demonstrated outstanding leadership and achievement in the field of geriatric oncology. Dale is the first non-oncologist recipient in the history of the award. Of note, Dale is first author of ASCO (Free ASCO Whitepaper)’s recent cancer and aging guideline update.

Online on-demand award lecture on Friday, May 31, from 1 to 1:45 p.m. CT
Presenter: William Dale, the George Tsai Family Chair in Geriatric Oncology and vice chair for academic affairs in the Department of Supportive Care Medicine at City of Hope
EDUCATION SESSIONS

"Evidence Evaluating Cannabis’ Efficacy Across the Cancer Care Continuum"
Monday, June 3, from 8:30 to 8:45 a.m. CT
Session title: Evidence-Based Integrative Oncology: Guideline Insights for Comprehensive Care
Presenter: Richard T. Lee, M.D., FASCO, City of Hope clinical professor, Supportive and Integrative Medicine Program; Cherng Family Director’s Chair for the Center for Integrative Oncology
"Tissue-Based Molecular Testing and the Role of Artificial Intelligence"
Monday, June 3, from 10 to 10:15 a.m. CT
Session title: Should I Order the Test? Expanding the Array of Emerging Diagnostics in Breast Cancer
Presenter: Daniel Schmolze, M.D., City of Hope associate clinical professor, Department of Pathology
"What Is Variant Histology Renal Cell Cancer and What Are the Available Treatment Options?"
Monday, June 3, from 3:15 to 3:30 p.m. CT
Session title: Managing Variant Histologies in Urothelial and Renal Cell Cancers
Presenter: Sumanta Kumar Pal, M.D., FASCO, City of Hope professor, Department of Medical Oncology & Therapeutics Research