On February 9, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has extended and expanded its integrated multi-target drug discovery agreement with data-driven biotech creation firm, Related Sciences ("RS"), to continue to grow their joint portfolio of drug development candidates through 2030, leveraging Evotec’s industry-leading capabilities across the full R&D continuum (Press release, Evotec, FEB 8, 2023, View Source [SID1234626991]).

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Launched in early 2021, the Evotec-RS partnership brings together a unique set of complementary capabilities to efficiently select, discover, and develop new, precisely targeted medicines for unmet patient needs. By combining RS’ unique FacetsTM opportunity selection engine and decentralised team science model, with Evotec’s comprehensive platform of integrated drug discovery services and advanced A.I./M.L. capabilities, the parties jointly progress large portfolios of related programmes from target to clinic and then share the economic value created.

To bolster the growing portfolio of more than 15 discovery-stage assets, the partners are expanding the collaboration to include Evotec’s leading-edge capabilities in covalent inhibitor discovery, leveraging and building upon Evotec’s custom covalent libraries and novel screening approaches to discover an exciting new class of highly potent and selective covalent medicines for eligible targets.

In addition to substantial investment from RS and its companies to finance all Evotec-led research and discovery efforts across the portfolio of promising new drug programmes, Evotec is eligible to receive milestones, royalties, and a founding equity stake in all RS assets developed under the partnership.

Dr Craig Johnstone, Chief Operating Officer of Evotec, said: "We are delighted to expand and extend this unique and transformative partnership with Related Sciences. Through best-in-class, fully integrated interdisciplinary science, A.I./M.L.-enabled target selection and drug design, and joint project leadership and portfolio management, Evotec and Related Sciences are well positioned to generate novel, high quality treatments for patients with significant unmet medical needs."

Adam Kolom, Cofounder and CEO at Related Sciences, said: "Our unique data science, technology, and risk-optimization platforms at Related Sciences combine beautifully with Evotec’s best-in-class integrated drug discovery capabilities to create a powerful new model for hyper-efficient, scalable discovery of important new medicines for patients. We are excited to continue our collaborative work in this partnership, including adding new world-class capabilities for the discovery of covalent inhibitors to our growing, multi-modality portfolios."

No financial details of the collaboration were disclosed.

On February 8, 2023 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, reported that it had an abstract accepted as a Discussed E-poster Presentation at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2023 (Press release, Sermonix Pharmaceuticals, FEB 8, 2023, View Source [SID1234626964]). The conference takes place March 3-5 in St. Louis.

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The poster, "Vaginal/vulvar symptoms with lasofoxifene versus fulvestrant in ESR1-mutated, ER+/HER2- metastatic breast cancer patients," will be presented Saturday, March 4, at the Marriott St. Louis Grand. Presentation details are as follows:

Session: E-poster Session 10 – Cancer & Chronic Medical Illness
Date/time: Saturday, March 4, 2023; 2:50 p.m. – 3:20 p.m. CST
Presenter: Shari B. Goldfarb, M.D., Assistant Attending Physician, Memorial Sloan Kettering Cancer Center
The poster shares results from the open-label randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study, which began U.S. enrollment in September 2019. Top-line data were revealed in September at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. ELAINE 1 assessed the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

The objective of the abstract to be shared at the ISSWSH Annual Meeting was to evaluate an exploratory endpoint of patient-reported vaginal/vulvar symptoms with lasofoxifene versus fulvestrant in ELAINE 1 participants.

About Lasofoxifene

Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced HR+ breast cancer.

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.

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.

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.