On May 31, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported that it will host an investor meeting highlighting the latest developments in the Company’s Oncology programs, including clinical data updates and a review of clinical development strategy for the Company’s two immuno-oncology product candidates, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ (Press release, Ascendis Pharma, MAY 31, 2023, View Source [SID1234632258]). Both are designed to recruit innate and adaptive components of the immune system to maximize anti-cancer activity while reducing dose-limiting toxicities.

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"TransCon IL-2 β/γ was designed by applying the TransCon technology together with protein bioscience to solve problems with aldesleukin that have eluded industry for many decades – to create a well-tolerated IL-2 therapy that has the potential to effectively activate the immune system to drive anti-cancer activity without dosing complexity that limits aldesleukin use. Today we are reporting for the first-time clinical data supporting the successful design for TransCon IL-2 β/γ," said Jan Mikkelsen, Ascendis Pharma’s President and CEO.

"We are excited to highlight the progress we have made across our two immuno-oncology product candidate programs, TransCon IL-2 β/γ and TransCon TLR7/8 Agonist," said Stina Singel, M.D., Ph.D., Executive Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. "The clinical data shared today from both programs showed an acceptable safety profile and single-agent clinical activity. Data from indication-specific cohorts, including melanoma, head-and-neck, and non-small cell lung cancer are expected in 2024."

Today’s meeting highlights include:

TransCon IL-2 β/γ program update from the Phase 1/2 IL-Believe Trial

Phase 1 monotherapy dose escalation complete; 25 heavily pre-treated patients enrolled (median of 4 prior lines of systemic therapies).
120 µg/kg IV every three weeks selected as monotherapy recommended Phase 2 dose (RP2D).
Eight monotherapy patients dosed at RP2D; of the three efficacy evaluable patients to date, one partial response in a metastatic colorectal cancer patient, and one stable disease in a renal cell carcinoma patient (data cut April 28, 2023).
At RP2D, TransCon IL-2 β/γ was generally well-tolerated with no DLT observed, no vascular leak syndrome and no grade 3 or 4 cytokine release syndrome.
As designed, the non-alpha TransCon IL-2 β/γ expanded local and systemic cytotoxic immune effector cells (CD8+ T and NK cells) without clear effect on Tregs and eosinophils.
RP2D for combination therapy with checkpoint inhibitor dose escalation data expected in the third quarter of 2023 and will be presented at a scientific congress in the fourth quarter.
Enrollment continues in indication-specific cohorts for the Phase 2 portion of the IL-Believe trial.
TransCon TLR7/8 Agonist program update from the Phase 1/2 transcendIT-101 Trial

Additional follow-up indicates further clinical activity in patients receiving TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab. Results supporting selection of RP2D from transcendIT-101 were first reported at SITC (Free SITC Whitepaper) 2022 last November.
Preliminary results showed that TransCon TLR7/8 Agonist was well-tolerated both as a monotherapy and in combination with pembrolizumab.
Enrollment continues in the Phase 2 portion of transcendIT-101 at the RP2D of 0.5 mg/lesion for up to two lesions, which is being evaluated in four indication-specific cohorts.
TransCon IL-2 β/γ is an investigational long-acting prodrug with sustained release of an IL-2Rβ/γ-selective analog (IL-2 β/γ) designed to address the known limitations of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβ/γ with low Cmax.

TransCon TLR7/8 Agonist is an investigational long-acting prodrug designed to provide sustained, localized release over weeks of resiquimod (a potent immune response modifier with clinically demonstrated anti-tumor activity) with low systemic exposure.

Oncology Program Update Meeting Webcast Information
Ascendis’ 2023 Oncology Program Update Meeting will take place today starting at 10:00 am Eastern Time (ET). Those who would like to participate may access the live webcast here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.

On May 31, 2023 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that the Company will participate in a fireside chat at the Jefferies Healthcare Conference taking place in New York on Wednesday, June 7, 2023 at 9:30 am ET (Press release, Arbutus Biopharma, MAY 31, 2023, View Source [SID1234632257]).

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Presenters: William Collier, President & Chief Executive Officer; Dr. Michael Sofia, Chief Scientific Offer; and David Hastings, Chief Financial Officer.

A live webcast of the fireside chat can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com. An archived replay of the webcast will be available on the Arbutus website after the event.

On May 31, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported that the company management team will provide a clinical update on Saturday, June 10, 2023, at 12:00 PM EST / 6:00 PM CEST, in conjunction with EHA (Free EHA Whitepaper) 2023 International Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Frankfurt, Germany (Press release, Aptose Biosciences, MAY 31, 2023, View Source [SID1234632256]). The webcast event will include an interim review of Aptose’s lead compound tuspetinib, a myeloid kinase inhibitor, currently being tested as a monotherapy and in combination with venetoclax in the phase 1/2 APTIVATE trial.

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Tuspetinib, administered as a once-daily oral tablet, is a precision targeted kinase inhibitor designed to suppress a select handful of kinases known to drive proliferation of acute myeloid leukemia (AML) while maintaining a favorable safety profile. Aptose management will highlight additional insights from the completed Phase 1/2 dose escalation clinical trial of tuspetinib and review early trends from the ongoing APTIVATE trial.

Aptose Clinical Update Webcast Details

Date & Time: Saturday, June 10, 2023, 12:00 PM ET

Participant Webcast Link: Link

Participant Dial-in:

Toll Free Investors Dial: 1-877-407-9039

Toll/International Investors Dial: 1-201-689-8470

Conference ID: 13739137

The slides will be available on Aptose’s website here and the webcast of the presentation will be archived shortly after the conclusion of the event.

In addition, an abstract on tuspetinib was recently published in EHA (Free EHA Whitepaper)’s open access library here:

Abstract: PB1766

Title: IN VITRO ACQUIRED RESISTANCE TO THE ORAL MYELOID KINASE INHIBITOR TUSPETINIB CREATES SYNTHETIC LETHAL VULNERABILITY TO VENETOCLAX

Session Title: Acute myeloid leukemia – Biology & Translational Research

Tuspetinib (TUS) is a once daily, oral agent that potently inhibits JAK1/2, SYK, RSK1/2, wildtype and mutant forms of FLT3, and mutant forms of KIT kinases, thereby simultaneously suppressing multiple oncogenic signaling pathways that mediate resistance to various drugs. TUS as a single agent has generated complete remissions in relapsed/refractory (R/R) acute myeloid leukemia (AML) patients with diverse mutations and demonstrated favorable safety in a Phase 1 trial (NCT03850574). TUS is now in a Phase 1/2 expansion trial (APTIVATE) for R/R AML patients with high unmet need as a monotherapy and as a doublet in combination with venetoclax. The clinical activity against diverse mutational subpopulations led us to investigate alterations in AML cells that may give rise to TUS resistance, and to understand the sensitivity of resistant isolates to venetoclax and other agents used to treat AML.

Resistance to TUS in MOLM-14 cells required prolonged high-level drug exposure, but ultimately yielded a stable phenotype. Strikingly, acquired TUS resistance generated a synthetic lethal vulnerability in which the cells were unusually hypersensitive to venetoclax. This suggests that concurrent administration of TUS and venetoclax may be advantageous clinically as TUS and venetoclax could act in concert to discourage the emergence of drug resistance during treatment.

For full published abstract, please visit: View Source

On May 31, 2023 Anocca AB reported that the company has successfully raised SEK 400 million through an equity financing round led by AMF and Mellby Gård (Press release, Anocca, MAY 31, 2023, View Source [SID1234632255]). The capital injection will be used to further develop the company’s unique process that enables discovery and manufacture of next generation cell therapies for cancer on an industrial scale. The financing also allows Anocca to progress the company’s first products into clinical trials.

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The financing brings together a solid group of existing and new investors, including Mellby Gård, AMF, Michano, Swedbank Robur, Ramsbury, Nidoco and several well-known family offices and private investors.

"In recent years, we have made great progress in automating our research platform. In addition, our large-scale and precise analytical methods have allowed us to generate additional data that strengthens the first products that will enter clinical trials. The capital injection will fund the continued expansion of Anocca’s research, development, and manufacturing capabilities as well as the start of a first clinical trial which is planned to be initiated in 2024," says Reagan Jarvis, CEO of Anocca.

Anocca uses proprietary analytical methods to identify and produce a kind of immune cell, T-cells, that have the ability fight a specific tumour. These processes are unique and Anocca aims to be the first company that on an industrial scale can identify suitable targets on tumour cells and generate matching T-cell receptors (TCRs), a type of receptor that controls the activity of the immune system’s T-cells. Each active TCR identified by Anocca can be further developed into a highly specialised cancer treatment, or a "TCR-T" therapy.

"We appreciate the opportunity to invest in such an interesting and important Swedish research company as Anocca. The company operates at the forefront of cancer research and drug development, with its ability to create a broad range of therapies with high precision. They have an impressive capacity and position already today, and very interesting plans for future expansion and development. We look forward to being a part of Anocca’s future growth journey and believe that this will be an investment that will be beneficial for our pension holders, as well as for Sweden, Swedish research, and for patients that will have access to more effective treatments due to Anocca’s breakthrough solutions," says Anders Oscarsson, Head of Equities at AMF.

In recent years, cell therapies have shown enormous potential in the treatment of cancer. The cell therapies used in practice today, CAR-T, have revolutionised the treatment of some cancers but are effective in less than 10% of all tumours. Despite this, CAR-T has quickly created a multi-billion-dollar market. The next generation of cell therapies, TCR-T, unlike CAR-T, has the potential to target virtually all forms of cancers.

"Anocca’s unique process creates almost endless opportunities to generate new TCR-Ts on a continuous basis. This means that we now have the chance to establish a Swedish company as a global leader in future cancer treatments," says Hans Stråberg, Chairman of the Board of Anocca.

Anocca was founded in 2014 and currently has 100 employees. The company’s operations include both research and manufacturing and are located at former AstraZeneca facilities in Södertälje. In recent years, Anocca has focused on automating and expanding its platform to identify the right targets on tumour cells and matching TCRs, while preparing for regulatory approval of the manufacturing facility. Including the current capital raise, Anocca has received a total of SEK 1.3 billion in venture capital. In addition, in December 2022, Anocca was granted a venture debt facility from the European Investment Bank (EIB) of EUR 25 million.

Danske Bank acted as financial advisor to Anocca in the transaction.

On May 31, 2023 Alkermes plc (Nasdaq: ALKS) reported that management will participate in fireside chats at two upcoming investor conferences (Press release, Alkermes, MAY 31, 2023, View Source [SID1234632254]).

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Jefferies Healthcare Conference
Date/Time: Wednesday, June 7, 2023 at 10:00 a.m. EDT (3:00 p.m. BST)

Goldman Sachs 44th Annual Global Healthcare Conference
Date/Time: Monday, June 12, 2023 at 9:20 a.m. PDT (12:20 p.m. EDT/5:20 p.m. BST)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.