On December 13, 2021 APS reported the application for clinical trial of APS second generation RET inhibitor APS03118 without cancer limitation was accepted by the United States Food and Drug Administration (FDA) (Press release, Applied Pharmaceutical Science, DEC 13, 2021, View Source [SID1234613104]). APS03118 is an oral second-generation RET kinase inhibitor independently developed by APS. Preclinical studies indicated that APS03118 could effectively inhibit solvent frontier RET G810R/S mutation and was expected to overcome drug resistance of existing selective RET inhibitors.

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The approval of selective RET inhibitors brings significant improvements to the treatment of aberrant RET positive patients, including non-small cell lung cancer and thyroid cancer. However, the drug resistance of these first-generation selective RET inhibitors was reported recently. Compared with EGFR, ALK and other targets, there are no drugs targeting RET resistant mutations, and patients usually have disease progression again after experiencing effective treatment. The reported drug resistance mechanism is the on target mutation represented by the RET G810R/S solvent frontier mutations, which hinders the binding of first-generation RET inhibitors to the target and finally results in drug resistance. APS03118, with unique structural advantages, can effectively inhibit RET solvent frontier mutations and displays remarkable anti-tumor effect in multiple mouse models with good tolerance.

On December 13, 2021 Brenus Pharma reported that it will be attenting the #JPMweek2022 from January 10 to 12 in San Francisco; We are proud to be part of the 2022 French delegation of this major networking event for the healthcare ecosystem (Press release, Brenus Pharma, DEC 13, 2021, View Source [SID1234598462]). This JP Morgan week is an opportunity to meet investors, business partners and make new connections. Follow us, and contact us to learn and see more !!

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On December 13, 2021 Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapies and vaccines, reported that it has acquired US-based Avidea Technologies, Inc. ("Avidea") (Press release, Vaccitech, DEC 13, 2021, View Source [SID1234597263]).

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The consideration to Avidea’s existing shareholders is $40 million (comprised of approximately $12.5 million in cash and $27.5 million in Vaccitech American Depository Shares) in addition to potential future payments that are conditioned upon the achievement of certain development milestones.

The acquisition of Avidea strengthens Vaccitech’s position as a leader in immunotherapies and vaccines.

Product candidates: Avidea’s existing product candidates are based on its SNAPvaxTM platform. As reported in several recent high-profile publications, Nature Biotechnology and Nature Immunology, the SNAPvaxTM platform uses self-assembly to co-deliver multiple antigens and immunomodulators in nanoparticles of precise, programmable size and composition, thereby enabling immunotherapy product candidates with tighter control over immune responses. The SNAPvaxTM platform can be configured either to induce high magnitude cytotoxic T cells for treating cancer and chronic infections or to induce regulatory T cells for treating autoimmunity and allergies.

Within oncology, Avidea’s platform will expand Vaccitech’s pool of target antigens and can be used to augment Vaccitech’s heterologous prime-boost vaccines, thereby increasing the probability of therapeutic success in this highly competitive area. The ability to induce antigen-specific regulatory CD4+ T cells with SNAPvaxTM also broadens the range of therapeutic areas that Vaccitech can pursue to include allergies and autoimmune diseases, each with significant market potential.

In both therapeutic areas, Avidea’s product candidates have been validated in rigorous preclinical (in vivo) proof of concept studies and are within approximately 12 months of IND filing.

A platform and discovery engine: Avidea was founded in 2016 to develop next generation T cell immunotherapies and draws on its founders’ research at several of the world’s leading institutions, including the Vaccine Research Center at the National Institutes of Health (NIH), the Johns Hopkins University, and the University of Oxford.

Avidea’s co-founders – Geoffrey Lynn, Ph.D., and Andrew Ishizuka, Ph.D. – will both join Vaccitech to continue to drive development of SNAPvaxTM product candidates and expand Vaccitech’s U.S. operational presence. The deep R&D capabilities of the combined teams will ensure the full potential of the technology platforms can be realized to fuel a more diverse and resilient pipeline of product candidates.

"Avidea’s technologies are complementary to our own ChAdOx-MVA prime-boost platform and create a powerful opportunity to accelerate the development of novel product candidates for exciting new disease areas," said Bill Enright, Chief Executive Officer of Vaccitech. "This is a timely and synergistic acquisition which also grows our operational and R&D presence in the United States."

Thomas Evans, M.D., Chief Scientific Officer of Vaccitech, said "Avidea’s SNAPvaxTM platform is designed to address key limitations of competing approaches and offers an innovative means for developing more effective immunotherapies for oncology, infectious diseases and now autoimmunity. There is potential to mix platforms, such as a ChAdOx and SNAPvax in prime-boost combinations, which may provide advantages in terms of safety, manufacturability, and efficacy for expanding our pipeline. In addition, we have a common heritage: both of our companies emerged from leading vaccine centers, including the University of Oxford, with a common objective to harness the immune system to treat and cure serious diseases."

"We are excited to become part of Vaccitech and have a shared vision for advancing the next generation of immunotherapies. Vaccitech is a perfect fit for the Avidea team and technology. Our teams are both expert in immunotherapies leveraging T cell and antibody immunity, but we have unique and complementary approaches that we expect will lead to immense synergies. The Vaccitech team has also built an impressive infrastructure and capabilities that will help realize the full potential of Avidea’s technologies and accelerate the development of promising immunotherapy product candidates to patients who need them. Their commitment to R&D also provides an ideal setting to advance several other promising early-stage assets in Avidea’s pipeline, including our programs in RNA delivery" said Geoffrey Lynn, Ph.D., Chief Executive Officer of Avidea.

Conference call and webcast information

Vaccitech will host a live conference call and webcast today, December 14, 2021 at 8:30 a.m. EST. Listeners may access the live webcast by visiting the Company’s website at View Source Investors may participate in the conference call by dialing (866) 966-1396 in the U.S., or +44 (0) 2071 928000 outside the U.S., and entering passcode 6917947. An archived version of the webcast will be available for 12 months at View Source

On December 13, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that the company, in collaboration with Dr. Geoffrey Greene from the University of Chicago, presented compelling new data in a poster at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Press release, Sermonix Pharmaceuticals, DEC 13, 2021, View Source [SID1234597212]). The symposium was held December 7-10 at the Henry B. Gonzalez Convention Center in San Antonio.

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The poster describes results from a pre-clinical study demonstrating that lasofoxifene alone or in combination with a CDK inhibitor may limit tumor progression in AI resistant tumors that are characterized by low levels of estrogen receptor (ESR1), elevated HER2 and genetic modifications other than activating ESR1 mutations.

Sermonix’s fully enrolled, ongoing Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies include the randomized ELAINE 1 study of lasofoxifene versus fulvestrant and the ELAINE 2 combination study of lasofoxifene with abemaciclib. The program aims to evaluate the safety and efficacy of lasofoxifene as a treatment option for breast cancer patients who develop AI resistance due to ESR1 mutations.

"These new pre-clinical data presented at this year’s SABCS move our development program a step further and suggest that lasofoxifene may have activity in non-ESR1-driven mechanisms of resistance as well," said David Portman, M.D., Sermonix founder and chief executive officer. "We intend to further evaluate a possible path forward in AI resistance not due to ESR1 mutations to complement our existing ESR1 mutation-focused programs."

"Widespread aromatase inhibitor use and selective pressure in the metastatic setting have together dramatically increased the incidence of endocrine therapy resistance, leading to deteriorating prognosis among these patients," said Dr. Geoffrey Greene. "These data, together with Sermonix’s current development program in AI resistance conferred by ESR1 mutations, suggest that lasofoxifene may have broad clinical utility across a number of resistance mechanisms. If proven in rigorously designed clinical trials, this could represent a significant leap forward in the treatment of metastatic breast cancer."

Poster details:

Title: Lasofoxifene as a Potential Treatment for Aromatase Inhibitor Resistant ER Positive Breast Cancer
Summary: First line treatment of breast cancer is primarily a long-term regimen with an aromatase inhibitor (AI), which is now also combined with a CDK 4/6 inhibitor. Treatment resistance is a relatively common result signaled by tumor progression and metastatic disease. Resistance in approximately 20-40% of those in treatment is associated with activating mutations of the estrogen receptor (ESR1) where we have shown in preclinical models that lasofoxifene more effectively inhibits these tumors’ proliferation and metastases compared to fulvestrant. However, treatment resistance may not be confined to those with ESR1 activating mutations. This study, performed by Dr. Geoffrey Greene’s research group at the University of Chicago, employed a model utilizing a metastatic cell line expressing low levels of ESR1 (MCF-7 LTLT-1) which are resistant to AI treatment, but not as a function of an ESR1 mutation. Lasofoxifene +/- palbociclib was significantly more effective than fulvestrant +/- palbociclib at inhibiting tumor progression, and all treatment combinations inhibited bone metastases except for fulvestrant alone.
Conclusion: These data support the hypothesis that lasofoxifene or lasofoxifene in combination with a CDK 4/6 inhibitor may effectively limit tumor progression and metastases in AI resistant tumors not resistant due to an ESR1 mutation.
The poster can be found on the Sermonix website here.

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and 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 potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On December 13, 2021 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported it has entered into a licensing agreement with Hansoh (Shanghai) Healthtech Company Limited ("Hansoh"), a subsidiary of Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma"), a leading R&D driven biopharmaceutical company in China (Press release, Keros Therapeutics, DEC 13, 2021, View Source [SID1234597182]). Under the terms of the agreement, Hansoh will obtain an exclusive license from Keros to develop, manufacture and commercialize KER-050 within the territories of mainland China, Hong Kong, and Macau.

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"We look forward to working with Hansoh in China, to unlock the potential of KER-050 for patients in China," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "This agreement enables us to strategically expand our program, subsidized by non-dilutive capital, while also gaining access to one of the largest pharmaceutical markets globally."

Yuan Sun, Executive Director of Hansoh Pharma, added, "We are excited to partner with Keros, a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins. We believe in the potential of KER-050 as a treatment for diseases associated with ineffective hematopoiesis, such as myelodysplastic syndromes and other hematologic disorders, and we believe that our extensive clinical development and commercialization experience in China can help to bring this differentiated product candidate to benefit patients across China."

Under the terms of the agreement, Hansoh is responsible for the development, regulatory approval and commercialization of KER-050 in mainland China, Hong Kong, and Macau. Keros will receive a $20 million upfront payment and will also be eligible to receive up to $170.5 million in development and commercial milestones, plus tiered royalties on net product sales ranging from the low double digit to high teens.

About KER-050

Keros’ lead protein therapeutic product candidate, KER-050, is an engineered ligand trap comprised of a modified ligand-binding domain of the Transforming Growth Factor-Beta receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. KER-050 is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes, or MDS, and in patients with myelofibrosis.