On February 8, 2023 Akiram Therapeutics, spin-out from SciLifeLab, reported that raised 68 MSEK and is heading for clinical trials in 2024 (Press release, Akiram Therapeutics, FEB 8, 2023, View Source [SID1234628975]).

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With the goal to enable personalized medicine, the idea was to evaluate the use of tailored molecular radiotherapy as treatment for advanced thyroid cancer, for which there is currently no effective treatment available. Since the exit, Marika Nestor and colleagues from Uppsala University have started a company – Akiram Therapeutics – to further develop the candidate drug for clinical use. The drug is a novel antibody-based radiopharmaceutical, which has potential to be broadly used in several other cancer indications.

"Marika’s project represented an ideal case for the SciLifeLab DDD model. In short, that means that we get innovative ideas from academic researchers around Sweden and use our technical infrastructure and drug discovery knowledge to develop prototype drugs, while the academic research group continues to develop the biological understanding", says Per Arvidsson, Director Drug Discovery & Development Platform, SciLifeLab.

In January 2023, Akiram Therapeutics secured investments of 68 MSEK from Sciety Venture Partners and Linc AB, in a venture capital round led by Sciety.

"The support and knowhow from SciLifeLab’s Drug Discovery and Development Platform has been instrumental for the development of the drug that is the basis for the company. The focus on bringing basic research from academia into applied science for the benefit of society, combined with the idea that the researchers behind an innovation continue to own their intellectual property rights, is a motivational force to take the step from lab to business, says Marika Nestor, Department of Immunology, Genetics and Pathology, Uppsala University.

Based on 20 years of work in the target protein, Marika realized that a subgroup of thyroid cancer patients, that does not respond to current treatment, has a specific protein expressed on the cancer cells. She approached the SciLifeLab DDD platform for help in developing an antibody that could carry a radioactive payload to the tumor to selectively expose it to cell killing radiation while sparing normal tissue.

"We used our expertise at the Drug Discovery and Development Platform in production of a suitable antigen and selected for human antibody binders in our in-house developed phage-display libraries. We characterized several lead antibodies at DDD, while Marika’s team, operated by co-Principal Investigator Anja Mortensen, was working on labeling the best leads and could demonstrate that they did indeed bind selectively to the target – both on cells and later in animal models. The lead antibodies were further engineered for optimal properties, such as isoform selection, binding affinity, biophysical properties, etc. Marika was able to demonstrate a good efficacy in killing cancer cells, while sparing normal cells and tissue. DDD also supported with bioanalysis and calculations of pharmacokinetic and pharmacodynamic response", says Per Arvidsson.

Until the financing round, the research behind Akiram Therapeutics has been carried out at Uppsala University with funding from among others from SciLifeLab, VINNOVA and the Swedish Cancer Society.

"Akiram Therapeutics is a great example of a company that bring together the best of academia and industry to advance breakthrough innovations. The collaboration between Akiram Therapeutics and SciLifeLab, coupled with the promising preclinical data and experienced team, made it a compelling investment opportunity for us. The DDD model is a critical component in the life science ecosystem, and we are proud to support projects like Akiram that are working towards finding solutions for unmet medical needs", says Andreas Lindblom, Managing Parter at Sciety.

"For us, the collaborative environment where we alternated work in the lab with the preclinical models that SciLifeLab have, were very successful. Without the support from SciLifeLab for pre-clinical proof of concept, and Testa Center, where we could optimize the production of the antibody, we would not have started the company. Now, with the financing, our mission to contribute to meet the therapeutic need of a group of cancer patients is about to be realized", finishes Marika Nestor.

On February 9, 2023 Moleculin presented its corporate presentation (Presentation, Moleculin, FEB 8, 2023, View Source [SID1234626999]).

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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.