Immunome Announces Formation of Antibody-Drug Conjugate and T Cell Redirection Advisory Board

On February 8, 2023 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage biopharmaceutical company that discovers novel target-antibody pairs through its unbiased interrogation of the human immune response, reported the formation of an advisory board, comprised of Dr. John Lambert and Dr. Anthony Tolcher, to prioritize selection of novel targets for antibody drug conjugates (ADCs) and T cell redirection (TCR) modalities (Press release, Immunome, FEB 8, 2023, View Source [SID1234626982]).

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Antibody-drug conjugate and T cell redirection are two classes of treatment modalities that are gaining significant clinical and commercial importance, and require highly selective tumor targeting. Immunome’s Discovery Engine is highlighting novel target classes, such as proteins abnormally expressed on the cancer cell surface, that appear uniquely tumor selective.

"The level of tumor selective expression of the cancer targets is a critical aspect in the successful development of both antibody drug conjugates and T cell redirection," said John Lambert, Ph.D., former Chief Scientific Officer of ImmunoGen and ADC specialist. "To fully realize the value of recent developments in platforms related to both of those modalities will require identification of next-generation targets like those being found by Immunome’s Discovery Engine."

"There has been a sharp increase in the number of clinical studies evaluating ADC and TCR products in cancer, fueled by recent FDA approval of these modalities. I believe expanding the range of novel targets may offer benefits to a wider range of cancer types and patient populations," commented Anthony Tolcher, M.D., CEO and Founder, Director of Clinical Research at NEXT Oncology. "Based on my experience serving on Immunome’s oncology Scientific Advisory Board, I believe the platform has potential to yield targets suitable for these modalities. I am excited to assist Immunome in the development of new ADC and T cell engagers."

"Our Discovery Engine continues to generate novel insights into cancer biology including abnormally expressed targets, a unique class of targets that have potential for high tumor selectivity," said Matthew Robinson, Ph.D., Chief Technology Officer of Immunome. "We believe that this new advisory board will provide fundamental guidance on prioritizing amongst those targets for use in ADCs and TCR modalities."

John Lambert, Ph.D. has been in the antibody-drug conjugate field since joining ImmunoGen in 1987, serving as CSO from 2008-2015. During his tenure with ImmunoGen, the company invented the technology that led to the approved ADCs Kadcyla and Elahere, as well as many other candidates that entered clinical development. He has authored or co-authored over 120 scientific publications.

Anthony Tolcher, M.D. is a medical oncologist and key opinion leader in the field of developing and running early-stage clinical trials for oncology indications. He is a co-founder of NEXT Oncology and was previously a co-founder of South Texas Accelerated Research Therapeutics (START), both of which are clinical research organizations focused on first-in-human clinical trials. He is dedicated to the development of new anti-cancer agents for patients for whom current cancer therapies are no longer working.Immunome, Inc. (Nasdaq: IMNM), a clinical-stage biopharmaceutical company that discovers novel target-antibody pairs through its unbiased interrogation of the human immune response, reported the formation of an advisory board, comprised of Dr. John Lambert and Dr. Anthony Tolcher, to prioritize selection of novel targets for antibody drug conjugates (ADCs) and T cell redirection (TCR) modalities.

"Our Discovery Engine continues to generate novel insights into cancer biology including abnormally expressed targets, a unique class of targets that have potential for high tumor selectivity"

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Antibody-drug conjugate and T cell redirection are two classes of treatment modalities that are gaining significant clinical and commercial importance, and require highly selective tumor targeting. Immunome’s Discovery Engine is highlighting novel target classes, such as proteins abnormally expressed on the cancer cell surface, that appear uniquely tumor selective.

"The level of tumor selective expression of the cancer targets is a critical aspect in the successful development of both antibody drug conjugates and T cell redirection," said John Lambert, Ph.D., former Chief Scientific Officer of ImmunoGen and ADC specialist. "To fully realize the value of recent developments in platforms related to both of those modalities will require identification of next-generation targets like those being found by Immunome’s Discovery Engine."

"There has been a sharp increase in the number of clinical studies evaluating ADC and TCR products in cancer, fueled by recent FDA approval of these modalities. I believe expanding the range of novel targets may offer benefits to a wider range of cancer types and patient populations," commented Anthony Tolcher, M.D., CEO and Founder, Director of Clinical Research at NEXT Oncology. "Based on my experience serving on Immunome’s oncology Scientific Advisory Board, I believe the platform has potential to yield targets suitable for these modalities. I am excited to assist Immunome in the development of new ADC and T cell engagers."

"Our Discovery Engine continues to generate novel insights into cancer biology including abnormally expressed targets, a unique class of targets that have potential for high tumor selectivity," said Matthew Robinson, Ph.D., Chief Technology Officer of Immunome. "We believe that this new advisory board will provide fundamental guidance on prioritizing amongst those targets for use in ADCs and TCR modalities."

John Lambert, Ph.D. has been in the antibody-drug conjugate field since joining ImmunoGen in 1987, serving as CSO from 2008-2015. During his tenure with ImmunoGen, the company invented the technology that led to the approved ADCs Kadcyla and Elahere, as well as many other candidates that entered clinical development. He has authored or co-authored over 120 scientific publications.

Anthony Tolcher, M.D. is a medical oncologist and key opinion leader in the field of developing and running early-stage clinical trials for oncology indications. He is a co-founder of NEXT Oncology and was previously a co-founder of South Texas Accelerated Research Therapeutics (START), both of which are clinical research organizations focused on first-in-human clinical trials. He is dedicated to the development of new anti-cancer agents for patients for whom current cancer therapies are no longer working.

Guardant Health receives coverage from UnitedHealthcare for Guardant360® CDx blood test as companion diagnostic in advanced lung and breast cancer

On February 8, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that UnitedHealthcare (UHC) now covers the Guardant360 CDx liquid biopsy test for patients enrolled in its commercial policies for all FDA-approved companion diagnostic indications (Press release, Guardant Health, FEB 8, 2023, View Source [SID1234626981]). The test is used by oncologists as a companion diagnostic to assess if patients are eligible for a targeted therapy for advanced or metastatic breast or non-small cell lung cancer (NSCLC).

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The Guardant360 CDx test was the first blood test approved by the FDA for comprehensive genomic profiling for all solid tumors, and it is now FDA-approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In December 2019, Guardant360 became the first liquid biopsy to be broadly covered by Medicare for use across the vast majority of advanced solid tumors. The new policy coverage by UnitedHealthcare is in addition to existing coverage of the Guardant360 CDx test under UHC Medicare Advantage policies for comprehensive genomic profiling of all solid tumors.

"We are pleased that UnitedHealthcare has taken this important step to make comprehensive genomic profiling more accessible to patients with advanced lung and breast cancer," said Helmy Eltoukhy, Guardant Health co-CEO. "The biomarker identification available through the Guardant360 CDx blood test can enable oncologists to quickly identify patients who may benefit from a therapy targeted to their specific type of mutation to help improve their outcomes. We believe this important decision will help expand patient access to genomic profiling across additional tumor types and healthcare plans in the coming years."

This year, an estimated 236,740 adults in the U.S. will be diagnosed with lung cancer, which is the leading cause of cancer death worldwide.1 Non-small cell lung cancer, the most common type in the U.S., represents about 82% of all lung cancer.2 Worldwide, female breast cancer has now surpassed lung cancer as the most commonly diagnosed cancer and is the fifth leading cause of death. This year, an estimated 287,850 women in the United States will be diagnosed with invasive breast cancer, and 51,400 women will be diagnosed with non-invasive (in situ) breast cancer.3 Due to the expanded coverage decision, the Guardant360 CDx test will now be covered for comprehensive genomic profiling for all lives covered by UnitedHealthcare, the largest U.S. national health insurer in commercial and Medicare Advantage markets.

Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary

On February 8, 2023 Takeda (TSE:4502/NYSE:TAK) reported that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. ("Lakshmi") from Nimbus Therapeutics, LLC ("Nimbus"), on February 8, 2023 (EST), as set forth in the share purchase agreement, following clearance from the United States Federal Trade Commission and a satisfaction of other closing conditions (Press release, Takeda, FEB 8, 2023, View Source [SID1234626980]). The agreement had been announced on December 13, 2022: "Takeda to Acquire 100% Ownership of Nimbus Therapeutics’ TYK2 Program Subsidiary".

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Following the completion of this transaction, Takeda has now acquired TAK-279, formerly known at Nimbus as NDI-034858. With Phase 2b data to be presented in Q4 FY2022 and Phase 3 study in psoriasis expected to start in 2023, TAK-279 has the potential to demonstrate best-in-class efficacy, safety and convenience in psoriasis as well as multiple other immune-mediated diseases, including inflammatory bowel disease, psoriatic arthritis and systemic lupus erythematosus. This acquisition strengthens Takeda’s growing late-stage pipeline and potentially expands its portfolio and patient impact across multiple indications, reinforcing Takeda’s ability to maintain strong growth globally in the mid- to long-term.

"With our plan to acquire announced in December, we are excited to have promptly added TAK-279, a highly selective oral TYK2 inhibitor with truly transformative potential for patients in multiple diseases, to our late-stage pipeline," said Ramona Sequeira, president, global portfolio division, at Takeda. "This program closely aligns with our strategy and expertise in immune-mediated diseases, and we look forward to sharing more details of our development plans soon."

Under the terms of the agreement and following the closing of the transaction, Takeda will pay Nimbus approximately 4 billion USD upfront, after adjusting items including closing indebtedness and closing account payable of Lakshmi. Takeda will also make two milestone payments to Nimbus of 1 billion USD each upon achieving annual net sales of 4 billion USD and 5 billion USD of products developed from the TAK-279 program.

Takeda expects that the financial impact on its consolidated operating results for the fiscal year ending March 31, 2023 (FY2022), as a result of the completion of the transaction, is immaterial. There is no change in Takeda’s FY2022 consolidated forecasts for operating results or the management guidance.

Elevation Oncology to Present at the SVB Securities Global Biopharma Conference

On February 8, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that Joseph Ferra, Interim Chief Executive Officer and Chief Financial Officer of Elevation Oncology, will present at SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 4:20 pm ET (Press release, Elevation Oncology, FEB 8, 2023, View Source [SID1234626979]).

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A live webcast and replay of the event will be available on the Events page of the Company’s Investor Relations website at View Source

Poseida Therapeutics to Host Third Annual Virtual R&D Day on February 22, 2023

On February 8, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company will host a virtual R&D Day at 10:00 am – 1:30 pm ET / 7:00 – 10:30 am PT on Wednesday, February 22, 2023 (Press release, Poseida Therapeutics, FEB 8, 2023, View Source [SID1234626978]).

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Poseida’s third-annual R&D Day will feature its executive leadership and scientists for a morning of presentations and fireside chats with special guest speakers exploring the future of cell and gene therapy. The program will highlight the Company’s proprietary genetic engineering platform technologies, differentiated allogeneic CAR-T programs, and novel approaches to gene therapy as well as ongoing collaborations with Roche and Takeda.

External speakers will include George M. Church, Ph.D., a pioneer in the fields of genetics and synthetic biology and Chair of Poseida’s Gene Therapy Scientific Advisory Board; Madhu Natarajan, Ph.D., Head of the Rare Diseases Drug Discovery Unit at Takeda; and Christine Brown, Ph.D., Professor, City of Hope, a CAR-T cell expert and member of Poseida’s Immuno-Oncology Scientific Advisory Board.

Registration for this virtual event and access to the live webcast will be available on the Investors & Media section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for 90 days following the presentation.