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 Arovella Therapeutics, (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, reported that it has signed a global, exclusive licence agreement with The University of Texas MD Anderson Cancer Center for the patent rights to a novel mAb developed for cancer treatment (Press release, Arovella Therapeutics, DEC 13, 2021, View Source [SID1234629025]).

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This is the first monoclonal antibody directed against a DKK1 peptide found in complex with HLA-A2 on the surface of cancer cells (DKK1). DKK1 is a target that is found in many cancer types, including blood cancers and solid tumours and 40-50% of the population is HLA-A2 positive, meaning that this technology may be applicable across a wide spectrum of cancers that affect a significant proportion of the population.

Higher levels of DKK1 in cancer patients may serve as a prognostic biomarker for cancers such as Multiple Myeloma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma (PAAD), and Lung Squamous Cell Carcinoma (LUSC). Higher DKK1 production has been observed in bladder cancer and increased production of DKK1 may assist Non-small Cell Lung Carcinoma (NSCLC) cell invasion and migration. It has also been suggested that increased DKK1 levels may cause resistance to chemotherapy in cancers such as ovarian cancer.

Arovella’s CEO and MD, Dr Michael Baker, commented: "The data that we have seen for the DKK1- CAR is compelling. We see a lot of promise in combining DKK1-CAR with our iNKT cell therapy platform and expect synergistic effects for the treatment of certain cancers. The next steps are to confirm the specificity, safety and proof-of-concept data in animal models before advancing this into manufacturing."

Numerous studies have shown that multiple myeloma cells overproduce DKK1. It is also documented that multiple myeloma cells produce CD1d, which is recognised by invariant Natural Killer T (iNKT) cells, the core of Arovella’s iNKT cell therapy platform. Arovella expects that by combing the DKK1- CAR with its iNKT cell therapy platform, it will lead to a more effective product to treat multiple myeloma and potentially other cancers. To date, the DKK1 mAb has shown promise in treating multiple myeloma when used as a single agent in mouse models. The DKK1-CAR-T successfully eliminates cancer in numerous cancer models, including multiple myeloma, pancreatic cancer, lung cancer and triple negative breast cancer.

More than a decade of work has gone into the production and testing of the DKK1 mAb. Professor Qing Yi, now at Houston Methodist, developed the technology during his time at MD Anderson as a tenured Professor of Medicine. At Houston Methodist, Professor Yi has continued the research, assessing the potential of the DKK1-CAR. Professor Yi was recruited to Houston Methodist in 2018 through a US$6m Cancer Prevention and Research Institute of Texas (CPRIT) award.

Professor Yi commented: "We have been working on the role of DKK1 for more than a decade. To target a range of cancers, we knew we needed to target something unique on the surface of different cancer types. That is why we generated the DKK1-peptide targeting mAb and CAR, because the DKK1 peptide in complex with HLA-A2 is found on many cancers and as expected, we see robust data treating several cancer types."

Key terms of the Licence Agreement

Under the terms of the licence agreement, Arovella has secured the right to use the technology for the treatment of human disease, for which it has agreed to pay MD Anderson license fees, development milestones and single digit royalty payments based on net sales. Upfront fees associated with the license agreement will be funded entirely from existing cash reserves. The licence agreement commences with an effective date of 13 December 2021 and extends to the later of the expiration of applicable patent rights or agreed upon number of years.

Arovella’s role in the oncology market

The Licence Agreement involving the DKK1 mAb adds substantially to Arovella’s existing exposure to the immuno-oncology market. The Company acquired the licence for a novel iNKT cell therapy platform in June 2021 and is developing a CD19 targeting CAR to treat haematological malignancies.

Since acquiring the licence to the iNKT cell therapy platform, Arovella has added new members to its Board of Directors, its Scientific Advisory Board and its management team. Arovella believes that acquiring the licence to another CAR adds substantial value to its iNKT cell therapy platform.

On December 13, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported updated results from its Phase 2 trial evaluating eprenetapopt with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML at the 2021 ASH (Free ASH Whitepaper) Annual Meeting (Press release, Aprea, DEC 13, 2021, View Source [SID1234596907]).

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In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 60% and the median RFS was 12.5 months. The overall survival (OS) at 1 year post-transplant was 79%, with a median OS of 20.6 months. Published studies evaluating post-transplant outcomes in TP53 mutant MDS and AML patients have reported a 1-year post-transplant RFS of ~30% and a median OS of ~5-8 months. In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial. Given the encouraging data, the Company intends to explore opportunities to conduct future randomized clinical trials to further assess safety and efficacy of this combination in the post-transplant maintenance setting.

"This update of data at ASH (Free ASH Whitepaper), representing the primary analysis, highlights the very encouraging outcomes for these TP53 mutant MDS and AML patients who received eprenetapopt and azacitidine as post-transplant maintenance therapy," said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute. "As these patients characteristically have poor outcomes, even with transplantation, this post-transplant maintenance regimen is potentially paradigm-shifting and I look forward to investigating it further."

Slides for this presentation can be accessed from "Presentations" in the News and Events section of the Company’s website at Link.

On December 13, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA), a leader in full-service therapeutic antibody discovery and development, reported financial results for second quarter fiscal year 2022, which ended October 31, 2021 (Press release, ImmunoPrecise Antibodies, DEC 13, 2021, View Source [SID1234596924]).

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Second Quarter Fiscal Year 2022 Financial Summary*

The Company achieved revenues of $4.7 million, a decrease of $32,780 or (0.7%) from the same period last year**.
The Company, primarily through its subsidiary Talem Therapeutics LLC, invested $2.8 million in strategic research and development costs compared to $1.1 million in the same period last year.
The Company recorded a net loss of $5.0 million during the three months ended October 31, 2021, compared to net loss of $463,584 for the three months ended October 31, 2020.
Adjusted EBITDA*** was a loss of $2.9 million, as compared to positive EBITDA of $795,159 for the same period last year.
As of October 31, 2021, the Company held cash of $38.4 million.
*Expressed in Canadian dollars, unless otherwise indicated.
**Please see section titled Revenue below for additional information on stated revenue in fiscal year 2021.
***For additional information on Adjusted EBITDA (a non-IFRS measure), please see section entitled Forward-looking statements below.

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "We have been tactically investing in R&D to accelerate our Talem pipeline, expand our discovery and characterization platforms, invest in novel and expedited technologies for decoding and delivering next-generation therapeutics, as well as aligning early-stage proof of concept studies with the emerging and swiftly increasing promise of nucleic acid technologies."

"With our expanded European footprint and channel partnerships firmly in place, we have rapidly built the necessary infrastructure to make immediate inroads across the region. As such, we have grown our senior leadership team to manage the ramp-up in growth across the organization prudently. With bold marketing initiatives in place, including the revitalization of IPA’s brand architecture underway, we are well positioned to compete and win, while delivering measurable value creating catalysts to our shareholders. Our core focus continues to move our proprietary potential therapies in Talem Therapeutics forward, close on a broadening pipeline of new CRO business, while advancing our PolyTope Cocktail development program which has taken an even more pressing role in light of the unmet need and total addressable COVID-19 market which we believe we can fill," concluded Dr. Bath.

Recent Second Quarter Fiscal 2022 and Operational Highlights

IPA prepared a pre-investigational new drug (PIND) application and received feedback from the U.S. Food and Drug Administration (FDA).
The Company has initiated final IND-enabling studies and has received the initial data related to the safety and toxicity profile of its PolyTope cocktail.
Based on in silico sequence and structural analysis, the Company anticipates that IPA’s PolyTope will retain activity against Omicron (B.1.1.529), similar to what they have observed in in vitro models for other variants of concern identified previously.
IPA established a US $50 million at-the-market transaction utilizing H.C. Wainwright & Co. as the sole sales agent.
The Company established a multi-target research collaboration utilizing ImmunoPrecise’s powerful antibody discovery technologies in combination with the long-standing expertise of Pierre Fabre in immuno-oncology.
IPA Europe has been granted a three-year approval for the "Crédit d’Impôt Recherche" (CIR) from the French Ministry of Higher Education and Research. CIR is a French R&D tax credit initiative which will provide tax credits to eligible French companies when they engage IPA Europe, Oss, in qualified research and development activities.
The Company bolstered global senior leadership with Barry Duplantis, Ph.D., promoted to Vice President of Client Relations and the addition of Ms. Carla Dahl, Vice President of Marketing.
Financial Results

Revenue

The Company achieved revenues of $4.7 million during the three months ended October 31, 2021, compared to $4.8 million in fiscal 2021, a $32,780, or (0.7%), decrease. As previously reported, the implementation of a new ERP system, effective for fiscal year 2021, was complicated by travel restrictions due to COVID-19. These complications, along with the new processes and procedures, caused the Company to miscalculate eliminations of intercompany transactions during the first three quarters of fiscal year 2021, primarily related to internal research and development sales to Talem.

The miscalculation resulted in immaterial, but notable, variances in revenues for the first three quarters of fiscal year 2021. The effect of the miscalculation can be seen in Management’s Discussion and Analysis in the Summary of Quarterly Results. Taking into account the prior year miscalculation, total revenues for the three months ended October 31, 2021, would have reflected an increase of 15.5% over prior year. This growth was driven primarily by increased financial value of a partner contract related to protein manufacturing, along with a notable increase in the number of projects under contract utilizing the Company’s B cell Select platform.

Research & Development

Research and development increased to $2.8 million from $1.0 million in 2020, due to the strategic investment in research the Company is undertaking, including the Company’s SARS-CoV-2 PolyTope cocktail and other Talem research projects.

Net Loss

The Company recorded a net loss of $5.0 million during the three months ended October 31, 2021, compared to net loss of $463,584 for the three months ended October 31, 2020.

Financing Activities / Liquidity and Capital Resources

As of October 31, 2021, the Company held cash of $38.4 million and had working capital of $36.4 million.

On October 13, 2021, an at-the-market ("ATM") equity offering facility, was entered into with H.C. Wainwright & Co., LLC, as sole sales agent ("Agent"). The Company will be entitled, at its discretion and from time-to-time during the term of the ATM agreement. to sell through the Agent common shares of the Company having an aggregate gross sales price of up to US $50 million. As of October 31, 2021, US $50 million of the Company’s stock remained available for sale under the ATM facility.

On December 13, 2021 Targovax ASA reported that its CEO, Erik Digman Wiklund, is invited to present at DNB’s Nordic Healthcare Conference (Press release, Targovax, DEC 13, 2021, View Source [SID1234596944]).

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DNB’s 12th Nordic Healthcare Conference:
Date: 16 December 2021
Presenter: Erik Digman Wiklund (CEO)
Time: 09:50 CET