OncoMyx Closes $50 Million Series B to Advance a Novel Immuno-Oncology Platform that Delivers Multiple Cancer-Killing Payloads

On December 8, 2021 OncoMyx Therapeutics, a privately-held immuno-oncology platform company, reported the closing of a $50 million Series B financing, co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and all Series A investors: Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison Partners (Press release, OncoMyx Therapeutics, DEC 8, 2021, View Source [SID1234596600]). In conjunction with the financing, Benjamin (Beni) Rovinski, Ph.D., Managing Director of Lumira Ventures and Widya Mulyasasmita, Ph.D., Senior Principal, Healthcare at B Capital Group will join the company’s Board of Directors. The proceeds of the financing will support the further development of OncoMyx’s pipeline of multi-armed myxoma immunotherapies for the treatment of solid tumors and hematological malignances and the advancement of the company’s lead candidate into clinical trials.

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OncoMyx has leveraged myxoma’s unique qualities to build an immunotherapy platform to deliver multiple cancer-killing payloads in one therapeutic. Myxoma is a natural oncolytic virus, selectively infecting and killing a wide range of cancer cell types. It is also inherently highly immuno-interactive, and as a large dsDNA poxvirus, is engineerable to express multiple payloads. OncoMyx’s multi-armed myxoma virus delivers different antitumor immunomodulatory proteins that hit critical points in the cancer immunity cycle to modulate the tumor microenvironment and stimulate a robust anti-tumor response. Because myxoma is not pathogenic to humans, it does not have to overcome pre-existing immunity and is highly amenable to IV and repeat dosing with a longer dosing window.

"OncoMyx builds on more than three decades of research into the myxoma virus, brings together the top team with experience developing targeted cancer treatments, immunotherapies, and virotherapies, and is fueled by a commitment to addressing unmet medical needs in patients with cancer," said Steve Potts, Ph.D., MBA, cofounder and CEO of OncoMyx. "The power of our myxoma platform is the potential to systemically deliver broad and selective targeting of cancer cells combined with robust activation of the cancer immunity cycle in a single therapeutic. With this financing, we plan to advance our lead multi-armed myxoma immunotherapy into clinical trials to demonstrate initial safety and efficacy of intravenous dosing."

"I have long been interested and was previously involved in the development and use of modified, recombinant viruses as immunotherapeutic agents. Oncolytic viruses in particular have shown clinical promise but a significant challenge has been the inability to engineer a safe and versatile oncolytic virus platform that is not restricted to local intratumoral delivery," said Dr. Rovinski. "The use of myxoma virus, which is not pathogenic to humans and can accommodate several insertions of heterologous therapeutic agents, as the backbone of OncoMyx’s immunotherapy platform, represents a uniquely differentiated feature that has the potential to overcome the well-known historical challenge of effectively delivering oncolytic viruses systemically for optimal dosing. We believe that OncoMyx’s myxoma-based oncolytic viruses may become best-in-class components of novel immunotherapeutic regimens, and we look forward to supporting the world class team at OncoMyx to bring these therapies to patients in need."

"We always seek to invest in companies with visionary founders and world-changing technology, and we saw the unmatched potential of OncoMyx’s myxoma platform to make a significant breakthrough in cancer immunotherapy by delivering multiple immune-activating and anti-tumor agents in one off-the-shelf package. We are impressed with the extensive preclinical data OncoMyx has generated demonstrating efficacy and safety of the myxoma platform across a broad range of cancers, from hematological malignancies to solid tumors," said Dr. Mulyasasmita. "OncoMyx has attracted an exceptionally experienced and talented team who are as committed as the founders about building the next great immuno-oncology company that delivers lifesaving medicines for many difficult-to-treat cancers. We couldn’t be more thrilled and honored to support their mission."

OncoMyx has presented preclinical safety and efficacy data at major scientific conferences demonstrating their myxoma immunotherapies stimulate anti-tumor immunity and produce anti-tumor efficacy in a wide range of models following IV or intratumoral administration. The data, along with previously published studies, support the advancement of these therapies into clinical development as a monotherapy and in combination with many cancer therapeutics and immunotherapies, including checkpoint inhibitors and chemotherapies. The company plans to advance its lead candidate into clinical trials next year to generate safety and efficacy data for IV dosing.

H3 Biomedicine Presents Investigational Data Update on H3B-6545 for Treatment of Locally Advanced or Metastatic Estrogen Receptor- positive, HER2-negative Breast Cancer at San Antonio Breast Cancer Symposium

On December 8, 2021 H3 Biomedicine Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the presentation of two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held in a hybrid format on December 7- 10, 2021 (Press release, H3 Biomedicine, DEC 8, 2021, View Source;positive-HER2-negative-Breast-Cancer-at-San-Antonio-Breast-Cancer-Symposium [SID1234596620]). The presentations include interim investigational data from H3’s ongoing clinical development program, H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer.

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"At H3, we are developing a pipeline of targeted medicines with the potential to impact the future of cancer treatment," said Ping Zhu, Ph.D., President and Chief Scientific Officer of H3. "Our ongoing clinical study of H3B-6545 is evaluating its potential to address current unmet medical needs in breast cancer either as a single agent or in combination with therapies such as palbociclib. We look forward to showcasing its progress at SABCS 2021."

H3B-6545 PRESENTATIONS

Abstract Number: 976

Title: H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist (SERCA), in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer – A Phase II Study
Program Number: P1-17-10
Poster Session: 1
Date and Time: Wednesday, December 8, 2021, 7:00am – 8:30am CT
Presenter: Erika P. Hamilton, Sarah Cannon Research Institute, Tennessee Oncology

Abstract Number: 1166
Title: H3B-6545 in Combination with Palbociclib in Women with Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer, Phase 1b Study
Program Number: P1-17-03
Poster Session: 1
Date and Time: Wednesday, December 8, 2021, 7:00am – 8:30am CT
Presenter: Stephen Johnston, Royal Marsden NHS FDN Trust, London, UK

About H3B-6545

Estrogen receptor alpha (ERα) plays an important oncogenic role in the genesis and progression of luminal breast cancers,1 and historically has been a target of endocrine therapies. However, recently, hotspot mutations in ERα have been detected in nearly 30% of endocrine-therapy resistant metastases. Functional studies have shown that these ERα mutations can confer ligand-independent activation of the ERα pathway and can promote partial resistance to existing classes of ER-directed therapies.2,3 H3B- 6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα.4 H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

Actinium Pharmaceuticals, Inc. Announces Participation in Two Panel Discussions at the 3rd Targeted Radiopharmaceuticals Summit

On December 8, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs reported its participation in the Targeted Radiopharmaceuticals Summit being held virtually December 7 – 9, 2021 (Press release, Actinium Pharmaceuticals, DEC 8, 2021, View Source [SID1234596585]). The Targeted Radiopharmaceuticals Summit brings together experts and thought leaders in the field with the goal to achieve meaningful clinical efficacy with theragnostic radionuclide therapies in a mono and combinatorial setting & deliver a robust, cGMP compliant manufacturing supply chain. Representatives from Actinium’s R&D and Clinical Development teams have been invited to participate as expert speakers in two panel presentations during the Targeted Radiopharmaceuticals Summit. The panel details are as follows:

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Panel: Review of the Last 12 Months of Development of Alpha Emitting Therapies

Session: Next Generation Alpha Emitter Based Therapeutics

Actinium Expert Speaker: Helen Kotanides, Ph.D., Vice President, Translational Research and Preclinical Development

Date and Time: December 9, 2021, 5:30 pm CET, 11:30 am EST

Panel: High Dose – Low Dose Therapeutic Strategy: Tailoring the Dose of Radiopharmaceuticals for Opportunity and Outcomes

Session: Optimizing Treatment Regimens

Actinium Expert Speaker: Mary Chen, M.D., Ph.D., Vice President, Clinical Development

Date and Time: December 9, 2021, 6:30 pm CET, 12:30 pm EST

Learn more about the Targeted Radiopharmaceuticals Summit at www.targeted-radiopharma.com.

New preclinical data confirm the ability of AsiDNA™ to tackle the drug-tolerant persister cells and prevent tumor resistance in several combination treatments

On December 8, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), reported the presentation of new preclinical data confirming the differentiated antitumoral properties of AsiDNA, its first-in-class DNA Damage Response (DDR) inhibitor, in poster and oral sessions during the EACR-AstraZeneca Virtual Conference organized by the European Association for Cancer Research and AstraZeneca on the theme of "Drug Tolerant Persister Cells" (7-8 December, 2021) (Press release, Onxeo, DEC 8, 2021, View Source [SID1234596601]).

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Several studies have shown that a small population of tumor cells, treated by targeted therapies, evade cell death by entering a reversible dormancy state known as the Drug-tolerant persister (DTP) state. These DTP cells are identified as major source of targeted therapy failures, thus leading to cancer relapse.

The data presented by Onxeo show that the addition of AsiDNA to targeted therapies prevents the regrowth of the DTP cells, thereby completely and irreversibly abolishing the emergence of resistance in tumor cells. The Company first discovered this unique property of AsiDNA in combination with PARPi (see Poster at AAC virtual meeting 2020). The most recent preclinical studies presented at EACR-AstraZeneca Virtual Conference, confirmed the prevention of resistance in other relevant tumor models where AsiDNA was combined with targeted therapies such as KRASi and EGFRi.

Judith Greciet, Chief Executive Officer of Onxeo, stated: "As already demonstrated in our previous studies, drug-tolerant persister cells are a well-established cause of resistance to targeted therapies such as TKIs and PARPi. Our new data provide further evidence that these cells are a major source of resistance to different cancer treatments, and that AsiDNA could be a therapeutic strategy of choice to specifically address this therapy failure. From a medical perspective, this is a major achievement as it paves the way for multiple combination strategies with our leading drug candidate in order to abolish tumor resistance. We are pleased that our pioneering approach has gained strong interest of the international medical and research community at the EACR-AstraZeneca Virtual Conference."

McKesson Investor Day to Highlight Progress Against Growth Strategies and Long-Term Financial Targets

On December 8, 2021 McKesson Corporation (NYSE: MCK) reported that it will host an Investor Day beginning at 1:00 p.m. ET, where executive leadership will provide an overview of the company’s progress towards its goal of delivering sustainable growth and details around the company’s long-term financial outlook (Press release, McKesson, DEC 8, 2021, View Source [SID1234596621]).

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The Investor Day event will showcase how McKesson will deliver long-term growth:

Highlighting significant progress in executing against its priorities by focusing on people and culture, sustainable core growth, streamlining the portfolio, and expanding its oncology and biopharma services ecosystems. The success is evidenced by its strong financial performance and outstanding operational excellence.
Reaffirming its commitment to the growth pillars of oncology and biopharma services. The company’s differentiated set of assets and capabilities uniquely positions the company to win in these growing markets and improve the health outcomes of patients.
Providing a financial overview and long-term outlook that highlights the focus on shareholder value creation and supports a compelling investment thesis.
Increasing fiscal 2022 Adjusted Earnings per Diluted Share guidance range to $22.35 to $22.95, from the previous range of $21.95 to $22.55, to reflect an additional $0.40 related to the U.S. government’s COVID-19 vaccine distribution program.
Announcing a new $4.0 billion increase to the share repurchase program authorized by the Board of Directors.
"We are excited to share our vision and strategy with the investment community. As we focus on the next chapter of growth and innovation, McKesson will leverage the breadth and depth of its core growth to further develop and build differentiated oncology and biopharma services ecosystems," said Brian Tyler, chief executive officer. "We remain committed to delivering superior shareholder returns through sustainable earnings growth and a disciplined approach to capital deployment."

Webcast and Presentations

The video webcast will be available live from 1:00 p.m. to 4:00 p.m. ET on Wednesday, December 8, 2021 at investor.mckesson.com/events-and-presentations. After the event, the archived video webcast will be available on McKesson’s Investor Relations website, along with the company’s slide presentation, at investor.mckesson.com.

Non-GAAP Financial Measure

This press release includes a forecast of Adjusted Earnings per Diluted Share, which is not a financial measure calculated in accordance with U.S. generally accepted accounting principles (GAAP). The company is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the equivalent forward-looking GAAP measure without unreasonable effort, because the company does not forecast GAAP earnings per share and cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially. Refer to investor.mckesson.com and the company’s slide presentation noted above for definitions and explanations of the Company’s Non-GAAP financial measures.