On April 7, 2020 ImaginAb Inc., a leading clinical stage immuno-oncology imaging company, and ARTMS Products Inc., the global leader in the development of novel technologies which enable the production of the world’s most-used diagnostic imaging isotopes, reported they have entered a multi-year non-exclusive partnership to explore a novel radiochemistry manufacture of ImaginAb’s lead asset 89Zr CD8 ImmunoPET (Press release, ImaginAb, APR 7, 2020, View Source;utm_medium=rss&utm_campaign=imaginab-and-artms-announce-strategic-partnership-for-innovative-manufacture-of-89zr-cd8-immunopet-agent [SID1234556191]).

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Under the terms of the agreement, ARTMS’ high-power technology will be deployed to enhance the manufacture of ImaginAb’s proprietary antibody 89Zr-Df-IAB22M2C (89Zr CD8 ImmunoPET).

The CD8 ImmunoPET minibody binds to the CD8 receptor on human T cells and is used for non-invasive PET (positron emission tomography) imaging of CD8 T cells in patients as a pharmacodynamic and predictive marker for immunotherapy. Due to the zirconium-89 (89Zr) labeling of the minibody it can be visualized by PET imaging. ARTMS’ flagship product, the QUANTM Irradiation SystemTM (QISTM), provides for cost-effective, decentralized, and local production of important medical isotopes, including 89Zr which is used for the labelling of ImaginAb’s CD8 ImmunoPET agent.

This pioneering methodology of radiochemistry manufacture represents an innovative way to generate 89Zr which will allow for the local manufacture of a significant commercial scale leading to an increase in 89Zr supply as well as potentially expanding ImaginAb’s supply sites. This new process of manufacturing 89Zr has the potential to be applied in the development of other assets in ImaginAb’s pipeline.

As part of the research collaboration, ARTMS will run pilot and optimization studies to assess radiolabelling of ImaginAb’s CD8 ImmunoPET minibody using this new methodology.

Commenting on the news, Ian Wilson, Chief Executive Officer of ImaginAb, said: "We are very excited to expand our manufacturing capabilities with ARTMS. ImaginAb’s CD8 ImmunoPET technology is the most advanced CD8 PET tracer under clinical development, and this new collaboration has the potential to increase access of our technology to patients and partners alike."

Charles S. Conroy, Chief Executive Officer of ARTMS, added: "We are very pleased to join ImaginAb in the search and establishment of a novel and more efficient manufacturing process. This collaboration fits ARTMS’ vision of being a leading manufacturer of the world’s most needed medical radioisotopes. Our state-of-the-art technology platform and robust global quality-supply network make us uniquely qualified to support ImaginAb. ARTMS and ImaginAb share the same patient-focused mindset and dedication to producing products of the highest quality for patients."

On April 7, 2020 Mersana Therapeutics, Inc. (Nasdaq: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it has raised gross proceeds of approximately $65 million through its At-the-Market (ATM) facility with participation based on interest received from Avoro Capital Advisors LLC, Bain Capital Life Sciences, Consonance Capital Investors and David Mott, Mersana’s Chairman of the Board (Press release, Mersana Therapeutics, APR 7, 2020, View Source [SID1234556208]). The Company sold approximately 8.9 million shares of the Company’s common stock at a purchase price of $5.59 and 2.0 million shares at the closing price of $7.74, in each case the market price at the time of sale. Cowen is acting as the sales agent for the ATM facility.

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The additional funds raised through the ATM strengthen the Company’s balance sheet and will be used to advance its pipeline, including the clinical development of XMT-1536 and XMT-1592, as well as for working capital and other general corporate purposes.

The shares of common stock described above were sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-226055), including a preliminary prospectus supplement, which was declared effective by the SEC on September 17, 2018. A final prospectus supplement will be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926. Electronic copies of the final prospectus supplement and the accompanying prospectus will also be available on the SEC’s website at View Source

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On April 7, 2020 Amphista Therapeutics, a biopharmaceutical company creating first-in-class cancer therapeutics that harness the body’s natural processes to selectively and efficiently degrade and remove disease causing proteins, reported the closing of a USD $7.5m Series A round, led by Advent Life Sciences (Press release, Amphista Therapeutics, APR 7, 2020, View Source [SID1234556189]). Seed round funders the Scottish Investment Bank, with backing from the Scottish Growth Scheme, and the European Investment Fund joined the round, along with new investor, US-based life sciences BioMotiv.

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Amphista’s CEO Nicola Thompson said, "This international financing provides Amphista with a firm foundation to underpin a Series B round to progress our oncology pipeline to the clinic. Our vision is to create a leading protein degradation company on the global stage that delivers ground-breaking new medicines to patients in areas of high unmet need."

Raj Parekh, General Partner at lead investor Advent Life Sciences said, "We are excited to support Amphista in its next stage of development. The Company has a potentially unique approach to targeted protein degradation when compared with traditional proteolysis targeting chimera (PROTAC) platforms. We believe that Amphista has great potential with its differentiated proprietary technology to address traditionally undruggable targets."

Satish Jindal, CEO of BioMotiv, and newly appointed Amphista Chairman, commented, "We are a mission-driven accelerator, and we are excited by Amphista’s focus to rapidly produce potent bifunctional small molecules to augment the body’s own processes to remove disease-associated proteins. We see huge potential to accelerate Amphista’s breakthrough technology platform into medicines."

Amphista’s scientific founder, Professor Alessio Ciulli, based at the University of Dundee, is an internationally renowned expert in the field of targeted protein degradation (TPD). "Highly specific TPD is a transformative new modality for tackling previously undruggable targets with high therapeutic value," said Ciulli.

Amphista’s TPD small molecules instruct the cell to degrade the target directly rather than activating or inhibiting the target protein function. As protein-protein interactions are involved in disease progression, removing the target protein provides a clear therapeutic advantage over simple inhibition. Specifically, Amphista’s platform is independent of traditional E3 ubiquitin ligases used by the field, potentially expanding the available target scope of TPD approaches and should overcome recently identified PROTAC resistance mechanisms.

On April 7, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has received approval from the Center for Drug Evaluation of the China National Medical Products Administration for the Phase Ib/II study of APG-2575, the company’s novel Bcl-2‒selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL) (Press release, Ascentage Pharma, APR 7, 2020, View Source;small-lymphocytic-lymphoma-in-china-301036549.html [SID1234556188]).

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This open-label, Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and preliminary anticancer activity of APG-2575 as a single agent or in combination therapies for the treatment of patients with r/r CLL/SLL in China.

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Recent studies have demonstrated that Bcl-2 inhibitors are effective in CLL/SLL, and Bcl-2 inhibitors in combination with Bruton tyrosine kinase inhibitors or CD20 monoclonal antibodies can deepen patient responses and prolong patient survival. These findings provide the rationale for investigating APG-2525 as a single agent or in combination therapies. The Phase I study of APG-2575 monotherapy, previously commenced in the US, Australia, and China, has shown a favorable safety profile and promising anticancer activity, and the preliminary data support the continued clinical investigation of APG-2575.

CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms, and it mainly affects middle-aged and elderly populations. The condition is characterized by accumulation of cancerous lymphocytes in peripheral blood, bone marrow, spleen, and lymph nodes. CLL/SLL is the most common type of adult leukemia in North America and Europe but is less common in Asian countries such as China and Japan. However, with an aging population, as well as dietary and lifestyle changes in China, CLL/SLL incidences have been increasing, and more patients develop the condition at younger ages and display greater disease progression. Despite significant initial responses to current first-line treatments, many patients with CLL/SLL need continued treatment to maintain these responses, and relapse often portends a poor prognosis. At present, there are even fewer treatment options for patients with CLL/SLL in China than in Europe or North America, hence representing an urgent clinical need for more effective and safe therapies.

"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis, and the first China-made Bcl-2‒selective inhibitor to enter clinical studies, with great potential as a monotherapy and in combination therapies in several hematologic malignancies. Upon receiving recent approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, we are now advancing its clinical development globally," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "There is an enormous unmet clinical need in the treatment of CLL/SLL globally. We will soon initiate this Phase Ib/II study of APG-2575 in China, which hopefully will provide a new treatment option to patients with CLL/SLL."

On April 7, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported to share positive interim data from its ongoing phase II study of paxalisib (formerly GDC-0084) in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, APR 7, 2020, View Source [SID1234556187]).

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Key Points

Interim analysis of Part A (escalation cohort) (n=9) showed median overall survival (OS) of 17.7 months, representing a clinically meaningful extension of life when compared to the 12.7 months associated with the existing standard of care, temozolomide
Interim analysis of all evaluable patients (Part A = 9; Part B = 21) shows median progression-free survival (PFS) of 8.5 months, broadly in line with previous analysis, and comparing favourably to the 5.3 months associated with temozolomide
The longest-treated patient remains progression-free 19 months after diagnosis
Approximately half the enrolled patients remain on drug and both OS and PFS figures may further improve as the trial progresses toward conclusion
Kazia expects to present further data in 2H CY2020 and final data in 1H CY2021
Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)

Temozolomide
(FDA-approved treatment)

Paxalisib

(interim phase II data)

Progression-Free Survival (PFS)

Measures ability of a drug to slow
growth of a tumour

5.3 months

8.5 months

Overall Survival (OS)

Measures ability of a drug to
prolong life

12.7 months

17.7 months

Kazia CEO, Dr James Garner, commented, "This is an excellent result, and we are delighted with the emerging data. The ‘gold standard’ for any new cancer treatment is the ability to extend life – an especially challenging goal in a disease such as glioblastoma – and this data provides our first evidence that paxalisib may achieve this objective in a very challenging patient population."

He continued, "There have not been any new drug treatments for newly-diagnosed glioblastoma patients for over twenty years, and we aspire to change that situation. We believe that paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this very challenging disease and we will be working strenuously to make it available to patients as quickly and efficiently as possible. The study continues to follow a number of patients who remain on treatment, and we currently expect to report a further data read-out in the second half of the year."

Background

The reported overall survival (OS) figure of 17.7 months represents a strong signal of clinical efficacy. The existing, FDA-approved standard of care, temozolomide, is associated with an OS of 12.7 months in this patient population[1]. Comparison between different studies is always imprecise, but the magnitude of the numerical difference provides powerful evidence that treatment with paxalisib may extend life in this patient group.

The reported progression-free survival (PFS) figure of 8.5 months is slightly better than the figure of 8.4 months previously reported in November 2019. Temozolomide is associated with a PFS of 5.3 months in this patient population.

Before losing patent protection, temozolomide achieved peak sales in excess of US$ 1 billion per annum, which provides an indication of the commercial opportunity associated with a new treatment for glioblastoma.

Thirty patients were enrolled to this study, comprising 9 in Part A, and 21 in Part B. Data reported here are provisional figures from Part A (for OS) and from the entire study population (for PFS), but may change as ongoing patients proceed through the study. The study has been conducted at leading centers of excellence in the United States.

The safety of paxalisib remained broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and low-grade rash among the most common drug-related toxicities.

In addition to this phase II study in glioblastoma, four other studies are underway with paxalisib in different forms of brain cancer, and it is anticipated that several of these will provide initial efficacy data during CY 2020.

This data had been accepted for presentation at the annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in San Diego, CA from 24 -29 April 2020. However, given the cancellation of the AACR (Free AACR Whitepaper) meeting due to the COVID-19 outbreak, Kazia has determined to provide an update to investors via this ASX announcement.

Next Steps

The phase II study remains ongoing, with approximately half of the total enrolled patient population still receiving drug at the time of analysis and a number of additional patients still in follow-up. At this stage, Kazia expects to present further data in 2H CY2020, and final data in 1H CY2021.