On January 4, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2022 (Press release, Personalis, JAN 4, 2023, View Source [SID1234625818]).

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Personalis estimates revenue of approximately $16.7 million for the fourth quarter of 2022 and approximately $65.0 million for the full year of 2022, which exceeds the company’s previous full year guidance range of $63.0 to $64.0 million.

Fourth Quarter Highlights

Preliminary revenue from biopharma and other customers is estimated to be $15.8 million in the fourth quarter of 2022 compared with $15.4 million in the fourth quarter of 2021, and preliminary revenue from biopharma and other customers includes estimated revenue from Natera at $8.2 million in the fourth quarter of 2022

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Preliminary revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) is estimated to be $0.9 million in the fourth quarter of 2022, which is initial revenue from the new contract for up to five-years awarded in September 2022, compared with $5.3 million in the fourth quarter of 2021

Preliminary cash, cash equivalents, and short-term investments is estimated to be $167.0 million as of December 31, 2022

Full Year 2022 Revenue

Preliminary revenue from biopharma and other customers is estimated to be $56.6 million for the full year of 2022 compared with $39.8 million for the full year of 2021, a 42% increase; preliminary revenue from biopharma and other customers includes estimated revenue from Natera at $26.5 million for the full year of 2022

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Preliminary revenue from the VA MVP is estimated to be $8.4 million for the full year of 2022, which includes $0.9 million from the new contract for up to five-years awarded in September 2022, compared with $45.7 million for the full year of 2021, a decrease of 82%; VA MVP unfulfilled orders were approximately $9.1 million as of December 31, 2022 and remaining unfulfilled orders are expected to be recognized as revenue in the first-half of 2023, depending upon sample receipt volume and timing from the VA MVP

"We ended 2022 by exceeding our previous full year guidance range, driven by oncology revenue growth of 42% for the fiscal year," said Aaron Tachibana, Interim Chief Executive Officer and Chief Financial Officer. "We will be providing details in the coming weeks about extending our cash runway while focusing on our key product opportunities."

The above information is preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2022, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

On January 4, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate at the 41st Annual J.P. Morgan Healthcare Conference in a podium presentation on Wednesday, January 11 at 10:30 a.m. PT, followed by a question-and-answer breakout session at 10:50 a.m. PT (Press release, Karyopharm, JAN 4, 2023, View Source [SID1234625813]).

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A live webcast of the presentation, along with accompanying slides, can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay for 30 days following the event.

On January 4, 2023 ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies, reported that Cancer Focus Fund is investing $5 million in funding to support ISA103, ISA’s PRAME-targeting immunotherapy, in a first-in-human study for the treatment of uveal melanoma, a rare ocular cancer (Press release, ISA Pharmaceuticals, JAN 4, 2023, View Source [SID1234625811]).

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ISA103 immunotherapy targets PRAME (PReferentially expressed Antigen in MElanoma), a cancer testis antigen that is overexpressed in various solid and liquid cancers. It plays a crucial role in tumor survival and spread. ISA103 was developed using the company’s proprietary Synthetic Long Peptide (SLP) technology, designed to fully harness and direct the body’s defense mechanisms towards fighting the disease. It contains multiple long peptides spanning the most immunogenic regions of the PRAME protein.

"At ISA we believe that our rationally designed immunotherapies have the potential to produce improved outcomes for cancer patients," said Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals. "We have already achieved proof-of-concept successes with our lead product ISA101b in HPV-induced cancers, and we view PRAME-positive tumors as another promising target for our unique approach. We believe this investment from the Cancer Focus Fund and the clinical expertise provided by MD Anderson will significantly advance ISA103 as an immunotherapy with the potential to combat this rare but debilitating malignancy."

"Cancer Focus Fund is committed to using its investments to support the clinical development of truly innovative cancer therapies," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "ISA’s multi-pronged approach to the design and development of fully synthetic novel immunotherapeutics has great potential and importantly, has already demonstrated early success in its initial programs. Our distinctive investment model is continuing to resonate globally, with another of our portfolio programs now based outside the U.S., and we are pleased to be collaborating in this effort with ISA and MD Anderson."

PRAME expression is common in uveal melanoma and is associated with poor disease outcome. In the two-part open label Phase 1b/2 trial, ISA103 will be tested in combination with standard of care checkpoint blocker immunotherapies. An initial dose-finding phase will be followed by an expansion cohort using the optimal dose. Study endpoints will include safety, immunogenicity and signs of efficacy (response rates and survival indicators). A total of 90 patients will be enrolled in the trial. The trial will be conducted at MD Anderson under the direction of Principal Investigator Sapna Patel, M.D., Associate Professor of Melanoma Medical Oncology and Director of MD Anderson’s Uveal Melanoma Program.

About ISA103 and PRAME

PRAME (PReferentially expressed Antigen in MElanoma) is a protein that is expressed on various types of tumors, including lung, breast, head & neck and kidney cancers, as well as melanoma and neuroblastoma, while there is minimal expression in heathy tissue. There appears to be a functional association of PRAME expression and tumorigenesis. Overexpression of PRAME is associated with poor disease prognosis. ISA103 is designed to create a strong and specific T cell immune response against PRAME. It consists of multiple Synthetic Long Peptides (SLP) spanning the most immunogenic regions of the PRAME protein. ISA103 is under investigation as a potential treatment for PRAME expressing cancers.

About ISA’s SLP Technology

ISA’s SLP immunotherapeutics are easy-to-manufacture synthetic peptides. They cover the most immunogenic regions of the therapeutic target and contain epitopes for the efficient induction of both CD4 and CD8 T cell responses by the patient, regardless of the individual’s HLA type. SLP-based immunotherapeutics overcome central tolerance, cover a broad range of HLA restricted epitopes to induce strong and lasting specific T cell responses, and are complementary to standard of care therapy, including, in the case of cancer, chemotherapy and immunomodulators like anti-PD1 antibodies.

About Cancer Focus Fund
The Cancer Focus Fund LP is a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center. The fund provides investment support to advance promising cancer therapies that are close to being tested in humans or are in early clinical development, as well as the clinical trial expertise and infrastructure of MD Anderson and strategic partners Ochsner Health System Precision Cancer Therapies Program New Orleans and the LSU Feist Weiller Cancer Center Shreveport. The Fund’s objective is to leverage this unique combination to provide investors with superior risk-adjusted returns. In collaboration with partner MD Anderson, the Cancer Focus Fund provides both capital and translational research expertise with the goal of accelerating the development of novel cancer therapies that result in better outcomes for patients while generating returns for investors.

Disclosures

The University of Texas MD Anderson Cancer Center’s relationship with Cancer Focus Fund, and all research conducted at MD Anderson related to Cancer Focus Fund, has been identified as an institutional financial conflict of interest by MD Anderson’s Institutional Conflict of Interest Committee and therefore is managed under an Institutional Conflict of Interest Management and Monitoring Plan.

On January 4, 2023 Invitae (NYSE: NVTA), a leading medical genetics company, reported that Ken Knight, president & chief executive officer, will present at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023, at 12:00 p.m. Eastern / 9:00 a.m. Pacific (Press release, Invitae, JAN 4, 2023, View Source [SID1234625810]).

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The live audio webcast of the presentation may be accessed by visiting the investors section of the company website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the presentation.

On January 4, 2023 Invectys, Inc. and CTMC, a joint venture between MD Anderson Cancer Center and National Resilience, Inc., reported Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 1/2a clinical study of IVS-3001, Invectys’s lead engineered human leukocyte antigen A (HLA-G) targeting chimeric antigen receptor (CAR) T cell therapy for the treatment of solid tumors (Press release, Invectys, JAN 4, 2023, View Source [SID1234625809]).

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IVS-3001 has been developed in collaboration with CTMC as part of an agreement announced in 2022, and it will now move forward through an MD Anderson-sponsored trial led by principal investigator (PI) Aung Naing, M.D., professor of Investigational Cancer Therapeutics at MD Anderson and co-PI Samer Srour, M.D., assistant professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The planned first-in-human, single-arm, open-label, Phase 1/2a study will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of IVS-3001 in patients with histologically or pathologically confirmed diagnosis of a locally advanced unresectable or metastatic HLA-G+ select solid tumor malignancy who failed or was intolerant to standard of care therapies known to confer clinical benefit per treating physician.

IVS-3001 may be administered to up to a total of 117 patients under approved protocol. Up to 24 may be treated in Phase 1 Dose Escalation and up to 93 may be treated in Phase 2a. All participants will be asked to enter the long-term follow up (LTFU) study as per FDA standard requirement for all gene and cell therapies. The IVS-3001 therapy for the Phase I trial will be manufactured by CTMC, which was launched to speed the development and manufacturing of innovative cell therapies for patients with cancer.

"CTMC was created to accelerate impactful cell therapies reaching patients, » said Jason Bock, CEO of CTMC. "We are excited to partner with Invectys to move the HLA-G CAR-T from contract execution to IND safe-to-proceed, in less than a year."

"The FDA clearance of the IND application for IVS-3001 represents an important milestone for Invectys and our colleagues at CTMC, and it is the result of years of commitment to developing a novel class of engineered CAR-T therapy," said Praveen Tyle, Ph.D., CEO of Invectys. "We believe IVS-3001 therapy has the potential to significantly transform the treatment landscape for cancer patients and the potential to achieve improved clinical outcomes."

About IVS–3001

IVS-3001 is an HLA-G-targeting chimeric antigen receptor (CAR) T cell therapy. HLA-G is not only an immune checkpoint but also a tumor-specific antigen. The CAR construct consists of the HLA-G antigen-targeting domain fused to intracellular signaling domains. The CAR allows IVS-3001 to recognize and kill target cells which express HLA-G on the cell surface. Antigen-specific activation of IVS-3001 results in CAR-T cell proliferation, cytokine secretion, and subsequent cytolytic killing of HLA-G-expressing cells.

IVS-3001 preclinical studies have generated adequate data to support efficacy and safety of the CAR-T therapy leading to IND clearance and initiation of First-in-Human clinical trial.