On March 28, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported it has reached agreement on the terms of a transfer of the entire issued and to be issued share capital of Acacia Pharma Group plc ("Acacia Pharma") (EURONEXT: ACPH) to Eagle by way of a scheme of arrangement under Part 26 of the United Kingdom’s Companies Act 2006 (the "Scheme") (Press release, Eagle Pharmaceuticals, MAR 28, 2022, View Source [SID1234611031]).

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The terms of the proposed transaction value Acacia Pharma’s existing issued and to be issued share capital at approximately €94,700,000, or the equivalent of €0.90 per share. Each shareholder of Acacia Pharma would receive, as consideration for each share of Acacia Pharma held by such shareholder, €0.68 in cash and 0.0049 shares of common stock of Eagle. The terms of the proposed transaction also provide for Eagle to guarantee approximately €25.0 million of debt within the Acacia Pharma group. In connection with the proposed transaction, (i) the Company and Acacia Pharma entered into a co-operation agreement (the "Cooperation Agreement") on March 27, 2022 and (ii) certain shareholders and directors owning shares in the capital of Acacia delivered to the Company and Acacia deeds of irrevocable undertaking.

The proposed transaction has been approved by the boards of directors of both companies and is expected to close in late Q2 2022, subject to approval by Acacia Pharma’s shareholders and the sanction of the High Court of England and Wales and customary closing conditions for transactions of this type. There is no assurance that the proposed transaction will be consummated on the proposed terms or timing or at all.

1 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.

The proposed transaction is expected to provide Eagle with two currently marketed, acute care, hospital products with the potential to disrupt the marketplace:

·BARHEMSYS is the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting (PONV) despite prophylaxis. Eagle currently calls on healthcare providers and institutions representing over 70% of the expected BARHEMSYS addressable market opportunity.
·BARHEMSYS is also approved for the treatment of PONV in patients who have not received prophylaxis and for the prevention of PONV. The total estimated annual U.S. addressable market for prophylaxis and rescue is $2.7 billion, and
·BYFAVO is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, with an estimated total addressable market in procedural sedation of more than $0.4 billion per year in the U.S.2

"We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia Pharma. This will be a very important acquisition for us, both financially and strategically. In recent years, the pharmaceutical industry has witnessed slower uptake of new products and longer ramp periods. In the face of further challenges brought about by the COVID-19 pandemic, many smaller underfunded companies experienced significant hurdles launching products. We therefore believe that Eagle is well suited to drive uptake of these two new products, building from Acacia Pharma’s established foundation since its launch, through our experienced and specialized hospital-based sales organization with minimal additional infrastructure," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"We have been extremely disciplined in managing our balance sheet over the years, and we believe that the proposed acquisition is a wise use of the cash we have generated. With these two products, together with landiolol, which is on track for an NDA submission to the FDA in May of this year, Eagle will potentially have three NCEs going into their launch phase. We believe these efforts will strengthen our leadership position in the hospital and oncology space and establish a strong foundation for sustainable long-term growth and bring value to our shareholders," concluded Tarriff.

"We believe that BARHEMSYS and BYFAVO address unmet clinical needs and are nearing usage inflection points, with strong formulary acceptance, and that with our longstanding relationships in the hospital space, we can accelerate uptake and capture the commercial potential of these assets. In doing so, we strive to impact and improve the care of patients undergoing medical treatments such as surgery and invasive procedures. Additionally, their value to anesthesia providers, who are key users, is important, facilitating precision medicine for patients. We see our sales infrastructure as a strategic asset, and as we add to our commercial product portfolio going forward, we plan to expand the size of our salesforce over the next two years," stated Michael Moran, Executive Vice President and Chief Commercial Officer of Eagle Pharmaceuticals.

2 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.

Proposed Transaction Rationale

·Opportunity for Eagle’s highly skilled hospital-based salesforce to integrate and promote BYFAVO and BARHEMSYS and to leverage longstanding relationships to realize the full potential of these assets.
·Anticipated strong synergistic fit with Eagle’s current and expanding portfolio of hospital products and other expected cost synergies.
·Attractive opportunity to accelerate Eagle’s existing growth strategy and further its advantage in acute care.
·Commercial stage, NCE products with long patent duration through 2031 would add complementary and diversified revenue streams to Eagle.
·Eagle’s strong financial position enables it to invest in this opportunity for potential significant value creation.
·Compelling commercial opportunity in both FDA-approved products:
oBARHEMSYS is the first and only antiemetic approved for rescue treatment of PONV despite prophylaxis and offers the potential for savings to hospitals and ambulatory centers.
oBYFAVO addresses an unmet need in procedural sedation by offering a fast-acting agent with a favorable safety profile versus other current treatments.
·Expected to be earnings accretive in 2024.

Product Descriptions and Potential Commercial Opportunity

BARHEMSYS (amisulpride for injection)3 is the first and only FDA-approved product for PONV rescue after failed prophylaxis4. It is a selective dopamine D2 /D3 antagonist with a broad, differentiated label. PONV is a common complication of surgery, occurring in approximately 30% of all surgical patients and 80% of high-risk patients. PONV is associated with the use of anesthetic gases and opioid painkillers and is particularly common following gynecological, abdominal, breast, eye, and ear operations, especially those lasting an hour or more. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to the hospital, all of which can result in significantly increased healthcare costs.

By reducing these risks, BARHEMSYS offers the potential for significant economic savings to hospitals and ambulatory centers. Approximately 70 million invasive surgical patients receive antiemetic prophylaxis annually in the U.S. Approximately 10 million of these patients per year require PONV rescue treatment. BARHEMSYS is the only drug with an FDA-approved indication to treat patients who have failed PONV prophylaxis. It has an established safety profile and efficacy demonstrated in controlled clinical studies. BARHEMSYS is nonsedating, a common complaint of standard antiemetic agents. Patients experiencing PONV who were treated in a pivotal clinical trial and failed prophylaxis were treated with BARHEMSYS. These patients were observed to have shorter post-anesthesia care (PACU) and hospital stays then patients who were not. Please see Important Safety Information for BARHEMSYS, below.

3 View Source

4 FDA labels for other recommended treatments do not include treatment after failed prophylaxis.

BYFAVO (remimazolam for injection)5 is a rapid onset/offset procedural sedative with an established safety and efficacy profile. Additional benefits include predictability and a readily available reversal agent. Please see Important Safety Information, including boxed warning, below.

BYFAVO has a compelling commercial opportunity, addressing a clear unmet need. There has been no innovation in the sedation space for over 20 years. Customers seek a fast onset, titratability, and rapid recovery for quick discharge, and shorter procedure times allow for increased procedural volumes. BYFAVO has a broad label and potential health economic benefits and may enable shorter procedure times and greater patient throughput. It is indicated for procedural sedation in adults in procedures lasting 30 minutes or less and has a substantial clinical data package demonstrating efficacy and safety in colonoscopies and bronchoscopies, including the most challenging patients.

Terms of the Proposed Transaction and Financing

The terms of the proposed transaction value Acacia Pharma’s existing issued and to be issued share capital at approximately €94.7 million. The cash consideration payable by Eagle under the terms of the transaction would be approximately €71.6 million. The cash consideration payable by Eagle under the terms of the proposed transaction is expected to be financed by existing cash resources of Eagle. The remaining approximately €23.2 million consideration payable by Eagle is expected to be paid in shares of Eagle common stock. The terms of the proposed transaction also provide for Eagle to guarantee approximately €25.0 million of debt within the Acacia Pharma group

Conditions to Closing and Anticipated Timing

The Scheme is expected to become effective between the middle of May 2022 and June 30th, 2022, and is subject to closing conditions including, among other things, obtaining the requisite approval of Acacia Pharma’s shareholders and the sanction of the High Court of England and Wales by June 30, 2022, which date may be extended by mutual agreement of the parties. There is no assurance that the proposed transaction will be consummated on the proposed terms or timing or at all.

Advisors

Cooley (UK) LLP is acting as legal advisor and William Blair & Company, L.L.C. is acting as exclusive financial advisor to Eagle Pharmaceuticals in connection with the proposed transaction. Locust Walk served as a transaction advisor to Eagle Pharmaceuticals. NautaDutilh BV is acting as legal advisor to Eagle Pharmaceuticals in connection with Belgian law. Sullivan & Cromwell LLP is acting as legal advisor and Greenhill & Co. International LLP and Jefferies International Limited are acting as co-financial advisors to Acacia Pharma in connection with the proposed transaction. Eubelius CVBA is acting as legal advisor to Acacia Pharma in connection with Belgian law and its listing on Euronext Brussels.

On March 28, 2022 Acacia Pharma Group PLC reported that proposed Transaction with Eagle Pharmaceuticals PLC (Press release, Acacia Pharma, MAR 28, 2022, View Source [SID1234611029])

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Key highlights

Acacia Pharma Group PLC ("Acacia") met its formulary goals for both Barhemsys and Byfavo in FY2021 and continues to be encouraged that feedback for both products is indicative of significant future commercial potential.
However, Acacia’s standalone financial condition has been negatively impacted by physical access limitations caused by the global COVID-19 pandemic, and a significant latency of demand due to postponement of surgical procedures. Accordingly, Acacia expects it would require a minimum of approximately US$115m of additional cash to fund operations to break-even (based on projections assuming break-even by early FY2025).
As a result, the Acacia Board appointed Greenhill to undertake a comprehensive review of strategic alternatives available to maximise value for Acacia Shareholders. The review included consideration of options to raise additional capital, but found that the terms on which such capital was likely to be available would have led to significant dilution and potential destruction of value for Acacia Shareholders.
Following this comprehensive exploration and assessment of all strategic alternatives, the board of directors of Acacia and the board of directors of Eagle Pharmaceuticals, Inc. ("Eagle") hereby announce that they have reached agreement on the terms of a transfer of the entire issued and to be issued share capital of Acacia to Eagle by way of a scheme of arrangement under Part 26 of the Companies Act 2006 (the "Proposed Transaction").
Under the terms of the Proposed Transaction, each Scheme Shareholder will receive as consideration (the "Consideration"):
for each Scheme Share, €0.68 in cash and 0.0049 New Eagle Shares

The Proposed Transaction values Acacia’s existing issued and to be issued share capital at approximately €94.7 million on a fully diluted basis.
The cash portion of the Consideration represents approximately 75 per cent. of the total Consideration, and the New Eagle Shares that Acacia Shareholders would receive represent approximately 25 per cent. of the total Consideration, which represents approximately 3.8 per cent. of the enlarged Eagle share capital in issue immediately following completion of the Scheme. The total Consideration equates to €0.90 for each Scheme Share.
The Consideration provides Acacia Shareholders with both up-front cash and, through the New Eagle Shares to be acquired by Acacia Shareholders, equity participation in the value creation potential for the enlarged business through de-risked funding requirements, enlarged group synergies, and being part of a well-funded entity with shares trading on a liquid exchange.
Having considered all of the available alternatives as part of its strategic review, the Acacia Board believes that the Proposed Transaction represents the best option for Acacia Shareholders to maximise the value of their shares, and therefore unanimously recommends the Proposed Transaction.
Furthermore, the Acacia Board considers that there is a significant risk that if the Scheme is not approved by the necessary number of Acacia Shareholders, this could lead to a very material reduction in the value attributable to Acacia Shares and/or an insolvency procedure relating to the Acacia Group, which could in turn result in negligible (if any) value being attributable to Acacia Shares.
In making its recommendation, the board of Acacia has considered the financial position of Acacia given the significant operational challenges as a result of the limited physical access to institutions resulting from the global COVID-19 pandemic, as well as the significant latency of demand due to the postponement of non-essential surgical procedures, as a result of which the Acacia Group has experienced a significant reduction in its available liquidity as the net revenue in 2021 and so far in 2022 continues to lag behind expectations.
Recommendation, irrevocable undertakings and shareholder support for the Proposed Transaction

The Acacia Directors consider the Proposed Transaction to be the best available option for Acacia Shareholders. In making this assessment, the Acacia Directors have received financial advice from Greenhill who, in providing its financial advice, has taken into account the commercial assessments of the Acacia Directors. Accordingly, the Acacia Directors intend unanimously to recommend that Acacia Shareholders vote in favour of the Scheme at the Court Meeting and the Resolutions to be proposed at the General Meeting, as the Acacia Directors have irrevocably undertaken to do in respect of the 217,543 Acacia Shares which they hold and which they control (or can procure the control of) the voting rights, representing approximately 0.22 per cent. of the issued share capital of Acacia on 25 March 2022, being the last business day before this announcement.
In addition to the irrevocable undertakings referred to above, Eagle has also received irrevocable undertakings from the three largest shareholders of Acacia to vote in favour of the Scheme at the Court Meeting and the Resolutions to be proposed at the General Meeting in respect of the 49,012,875 Acacia Shares which they hold and which they control (or can procure the control of) the voting rights, representing approximately 48.56 per cent. of the issued share capital of Acacia on 25 March 2022, being the last business day before this announcement.
Therefore, Eagle has received irrevocable undertakings representing, in aggregate, 49,230,418 Acacia Shares representing approximately 48.78 per cent. of the issued share capital of Acacia.
Further details of these irrevocable undertakings, including the circumstances in which they cease to be binding, are set out in Appendix 3 to this announcement.
Information on Eagle

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialised products include vasopressin injection, PEMFEXY, RYANODEX, BENDEKA, BELRAPZO, TREAKISYM (Japan), and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.
Eagle is listed with shares of its common stock publicly traded on Nasdaq under the trading symbol "EGRX" and has a market capitalisation of approximately US$615 million as at 25 March 2022, being the last business day before this announcement.
Comments on the Proposed Transaction

Commenting on the Proposed Transaction, Scott Byrd, Chairman of Acacia, said:
"I am proud of the progress that Acacia has achieved in bringing Barhemsys through clinical trials to the market and in the progress it has subsequently made in launching both this product and Byfavo in the US. Both products are designed to address clear and important hospital needs and to date have received positive feedback from customers and strong formulary acceptance, positioning them well for future success. However, the global COVID-19 pandemic has resulted in significant and sustained challenges that have significantly disrupted hospital operations, limited access, and dramatically increased the time and investment required for product launches.

The Acacia Board believes this Proposed Transaction represents an opportunity for Acacia shareholders to realise value for their investment in cash and, through Eagle, retain an interest in the future value that may be generated from Barhemsys and Byfavo being part of a larger portfolio of hospital products, in the hands of a well-capitalised company. We are therefore unanimously recommending this Proposed Transaction to our shareholders."

Commenting on the Proposed Transaction, Scott Tarriff, President and Chief Executive Officer of Eagle, said:
"We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia. This will be a very important acquisition for us, both financially and strategically. In recent years, the pharmaceutical industry has witnessed slower uptake of new products and longer ramp periods. In the face of further challenges brought about by the COVID-19 pandemic, many smaller underfunded companies experienced significant hurdles launching products. We therefore believe that Eagle is well suited to drive uptake of these two new products, building from Acacia’s established foundation since its launch, through our experienced and specialised hospital-based sales organisation with minimal additional infrastructure."

Timetable

The Proposed Transaction will be implemented by means of a Court-sanctioned scheme of arrangement between Acacia and the Scheme Shareholders under Part 26 of the Companies Act.
he Scheme Document, containing further information about the Proposed Transaction and notices of the Court Meeting and General Meeting, together with the Forms of Proxy, will be sent to Acacia Shareholders and (for information only) participants in the Acacia Share Schemes as soon as reasonably practicable. An expected timetable of principal events will be included in the Scheme Document.
The Scheme is expected to become effective between the middle of May 2022 and 30 June 2022, subject to the satisfaction (or, where applicable, waiver) of the terms set out in Appendix 1 to this announcement.
This summary should be read in conjunction with, and is subject to, the full text of the following announcement (including its Appendices). The Proposed Transaction will be subject to the terms set out in Appendix 1 and to the full terms and conditions to be set out in the Scheme Document. Appendix 2 contains the sources and bases of certain information contained in this summary and the following announcement. Appendix 3 contains details of the irrevocable undertakings received by Eagle. Appendix 4 contains the definitions of certain terms used in this summary and the following announcement.

On March 28, 2022 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported it will report its full year 2021 financial results on March 31, 2022 after market close. Investors and analysts are invited to join a webcast presentation of the 2021 financial results conducted by CEO Michael Engsig and other members of management on April 1, 2022, at 11.30 a.m. CET / 5.30 a.m. ET.

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An updated corporate presentation will be available in the Investors section of the Company’s website at 7:00 a.m. CET on April 1 at www.nykode.com/investors. The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website here.

On March 28, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that the diagnostic 64Cu SAR-bisPSMA trial (COBRA NCT052491271) for patients with prostate cancer is open for recruitment (Press release, Clarity Pharmaceuticals, MAR 28, 2022, View Source [SID1234611025]).

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COBRA (COpper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in up to 50 participants. The primary objectives of the trial are to investigate safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to commence recruitment into the COBRA study with our first trial site, Urology Cancer Center and GU Research Network (GURN) in Omaha, Nebraska, actively recruiting patients just a few weeks after receiving the FDA Study May Proceed letter. The pace with which Clarity is able to open and progress the new trials of our optimised SAR-bisPSMA agent is indicative of the interest among the clinicians in the U.S. for this product and the benefits it could deliver to the patients and their treating staff."

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program where COBRA is one of the four clinical trials employing the SAR-bisPSMA agent. Most recently, Clarity announced a collaboration with GURN on a diagnostic 64Cu SAR-bisPSMA investigator-initiated trial (IIT), X-Calibur (NCT05286840)2, sponsored by Dr Luke Nordquist. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)3, has been able to successfully image patients with metastatic castrate resistant prostate cancer from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)4, is well underway, with over 50% of participants recruited in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy). Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Neal Shore MD, FACS (CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre), Lead Principal Investigator in the COBRA trial, commented, "We are very excited to initiate patient accrual for the COBRA trial which will explore and validate the clinical benefits associated with the novel SAR-bisPSMA agent. The preliminary data from Clarity’s SECuRE and PROPELLER trials as well as preclinical data, indicate high uptake of Copper-64 SAR-bisPSMA, which suggests improved prostate cancer detection, inclusive of very low volume disease, which is especially important for patients with suspected disease recurrence. Importantly, the logistical advantages of central manufacture and the on-demand delivery of this novel imaging agent will provide enhanced accessibility to treatment facilities in the U.S. I look forward to expanding the trial U.S. sites and generating additional data for this next-generation technology which could ensure both ease of access and improved diagnostic accuracy for BCR patients."

Dr Taylor said, "Opening the recruitment into the COBRA trial is an exciting step in our prostate cancer program as it signifies the growing appetite for novel radiopharmaceutical treatments that can replicate the "big pharma" centralised manufacture model in the oncology field. TCT products can be delivered to clinical trial cancer patients and their treating staff on time and at a convenient location, with minimal delays and in sufficient quantities to meet the demand and address the backlog of patients waiting for these important diagnostic radiopharmaceuticals. We look forward to imaging prostate cancer patients in the COBRA trial and gathering further evidence of the clinical and logistical benefits of our optimised SAR-bisPSMA agent in pursuit of our ultimate goal of improving treatment outcomes for cancer patients."

This announcement has been authorised for release by the Executive Chairman.

On March 28, 2022 AstraZeneca reported that it will present new data underscoring the breadth of the Company’s early oncology portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, 8 to 13 April 2022 (Press release, AstraZeneca, MAR 28, 2022, View Source [SID1234611023]).

Data from 60 presentations, including 5 oral and 3 mini-oral presentations, will feature the Company’s next wave of potential cancer medicines spanning its immuno-oncology (IO), DNA Damage Response (DDR) and Antibody Drug Conjugate (ADC) scientific platforms. This includes key data shared from three potential new medicines that illustrate the Company’s innovative approach to designing molecules that address key challenges in treating cancer, including the ability to target different, complementary mechanisms.

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Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are serious about leading a revolution in oncology, which is why we continue to pioneer new ways to target cancer earlier and with greater precision, for the benefit of patients. Our data at AACR (Free AACR Whitepaper) from next-wave Immuno-Oncology medicines, PARP inhibitors and antibody drug conjugates demonstrate the potential of our diverse portfolio and reflect our vision to target cancer from every angle."

Introducing the next wave of IO therapies
The first clinical results will be shared for MEDI5752, a novel bispecific antibody, that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4, in solid tumours. Bispecific antibodies are a promising IO approach that combines the potential benefits of two medicines in one. MEDI5752 was engineered to achieve combined blockade of CTLA-4 and PD-1, to improve the therapeutic index when compared to targeting these proteins using two separate medicines.

A presentation from the NeoCOAST randomised Phase II trial in resectable, early-stage non-small cell lung cancer will highlight improved disease responses with novel Imfinzi (durvalumab) combinations including with oleclumab, an anti-CD73 monoclonal antibody, and with monalizumab1, an anti-NKG2A checkpoint inhibitor, when compared to Imfinzi alone.

Additionally, four presentations will describe novel molecules targeting interleukin-12 (IL-12) and leukaemia inhibitor factor (LIF) and illustrate the potential of targeting non-redundant mechanisms to modulate the immune tumour microenvironment.

Building the next generation of PARP inhibitors
The first data will be presented from the PETRA Phase I clinical trial investigating AZD5305, a next-generation PARP1-selective inhibitor, in patients with tumours harbouring specific homologous recombination repair gene mutations. AZD5305 is designed to selectively target PARP1, killing cancer cells by targeting tumour cell DNA damage repair mechanisms. This approach could allow PARP inhibitors to expand into new settings and offer new opportunities for combinations with DNA damage pathway activating agents such as ADCs. Preclinical data will be presented that support this hypothesis showing the activity of Enhertu (trastuzumab deruxtecan) in combination with DDR agents including PARP1-selective inhibitors.

Additionally, four presentations will describe the discovery of AZD9574, a novel PARP1 selective inhibitor designed to cross the blood brain barrier to enable the targeting of primary and secondary brain malignancies.

Innovative approaches to deliver a next-wave ADC
The first preclinical data will be shared on AZD8205, a novel ADC targeting B7-H4, a protein overexpressed in a range of solid tumours. This molecule is the first ADC to incorporate AstraZeneca’s proprietary linker technology, demonstrating the Company’s progress in establishing in-house ADC expertise and building leadership in this field.

Key AstraZeneca presentations during AACR (Free AACR Whitepaper) 2022

Presenting author

Abstract title

Presentation details

IO
Tran, B

MEDI5752, a novel PD-1/CTLA-4 bispecific checkpoint inhibitor for advanced solid tumors: First-in-human study

Abstract #CT016

Oral

Session CTPL04 – Combination Immunotherapy Clinical Trials

12 April 2022

11:46 – 12:01 CDT

Cascone, T

NeoCOAST-2: a randomized, open-label, phase 2 study of neoadjuvant durvalumab plus novel immunotherapies and chemotherapy (CT) followed by adjuvant durvalumab plus novel agents, in patients with resectable non-small-cell lung cancer (NSCLC)

Abstract #CT124 / 6

Poster – Trial in progress (TiP)

Session PO.CT02.03 – Phase II Trials in Progress

11 April 2022

09:00 – 12:30 CDT

Cascone, T

NeoCOAST: open-label, randomized, phase 2, multidrug platform study of neoadjuvant durvalumab alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC)

Abstract #CT011

Oral

Session CTPL03 – Neoadjuvant and Perioperative Immunotherapy Clinical Trials

11 April 2022

11:16 – 11:31 CDT

Shrestha, P

Durvalumab (D) + platinum-etoposide (EP) in 1L extensive-stage small-cell lung cancer (ES-SCLC): Exploratory analysis of SCLC molecular subtypes in CASPIAN

Abstract #CT024

Mini-oral

Session CTMS01 – Biomarker Advances in Clinical Trials

10 April 2022

15:50 – 160:00 CDT

Reinmuth, N

Durvalumab (D) plus tremelimumab (T) in platinum-refractory/resistant extensive-stage small cell lung cancer (ES-SCLC): Efficacy, safety and ctDNA dynamics from Arm A of the phase 2 BALTIC study

Abstract #CT533

Poster – Clinical Trial

Session OPO.CT02.01 – Phase II Clinical Trials

8 April 2022

12:00 – 13:00 CDT

Fayette, J

INTERLINK-1: A phase 3, randomized, double-blind, placebo-controlled, multicenter, global study of monalizumab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with an immune checkpoint inhibitor

Abstract #CT236 / 7

Poster – TiP

Session PO.CT03.02 – Phase III Trials in Progress

12 April 2022

13:30 – 17:00 CDT

Carneiro, BA

First-in-human study of MEDI1191 (mRNA encoding IL-12) plus durvalumab in patients (pts) with advanced solid tumors

Abstract #CT183 / 8

Poster – Clinical Trial

Session PO.CT01.02 – Phase I Clinical Trials 2

12 April 2022

09:00 – 12:30 CDT

O’Kane, G

A phase 2 trial of first-line AZD0171 + durvalumab and chemotherapy (CT) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and CD8+ T cell infiltration

Abstract #CT126 / 9

Poster – TiP

Session PO.CT02.03 – Phase II Trials in Progress

11 April 2022

09:00 – 12:30 CDT

Purroy, N

First-in-human trial of intravenous MEDI9253, an oncolytic virus, in combination with durvalumab in patients with advanced solid tumors

Abstract #CT218 / 18

Poster – TiP

Session PO.CT01.03 – Phase I Trials in Progress 1

12 April 2022

09:00 – 12:30 CDT

Candido, J

AZD0171 (anti-LIF) combines productively with chemotherapy and anti-PD-L1 in mouse models of cancer

Abstract #1293 / 3

Poster

Session PO.IM02.08 – Immune Mechanisms Invoked by Other Therapies

11 April 2022

09:00 – 12:30 CDT

DDR
Yap, TA

PETRA: First in class, first in human trial of the next generation PARP1-selective inhibitor AZD5305 in patients (pts) with BRCA1/2, PALB2 or RAD51C/D mutations

Abstract #CT007

Oral

Session CTPL02 – Clinical Trials Targeting the DNA Damage Response and KRAS

10 April 2022

16:01 – 16:16 CDT

Pike, A

Evaluation of the CNS penetration of a next generation PARP inhibitor, AZD9574, in cynomolgus monkey using positron emission tomography

Abstract #5076

Poster

Session OPO.CH01.01 – Drug Discovery, Design, and Delivery

8 April 2022

12:00 – 13:00 CDT

Davies, BR

AZD9574 is a novel, brain penetrant PARP-1 selective inhibitor with activity in an orthotopic, intracranial xenograft model with aberrant DNA repair

Abstract #2609 / 22

Poster

Session PO.ET04.02 – DNA Damage Response and Repair

12 April 2022

09:00 – 12:30 CDT

Ghosh, A

Structure-based and property-based drug design of AZD9574, a CNS penetrant PARP1 selective inhibitor and trapper

Abstract #6302

Poster

Session OPO.CH01.01 – Drug Discovery, Design, and Delivery

8 April 2022

12:00 – 13:00 CDT

Schou, M

Discovery and preclinical validation of [11C]AZ3391: A first in class blood-brain barrier permeable, subtype selective PARP-1 PET radioligand

Abstract #5977

Poster

Session OPO.TB07.01 – In Vivo Imaging

8 April 2022

12:00 – 13:00 CDT

Shapiro, GI

Ceralasertib and olaparib in the treatment of homologous recombination repair (HRR)-deficient platinum-sensitive ovarian cancer after progression on PARP inhibitors

Abstract #CT201 / 1

Poster – TiP

Session PO.CT01.03 – Phase I Trials in Progress 1

12 April 2022

09:00 – 12:30 CDT

ADCs
Kinneer, K

Discovery and first disclosure of AZD8205, a B7-H4-targeted antibody-drug conjugate utilizing a novel topoisomerase I linker-warhead

Abstract #1765 / 17

Poster

Session PO.ET01.04 – Antibody-Drug Conjugates

11 April 2022

13:30 – 17:00 CDT

Wortmann, P

Development and implementation of image analysis-based Quantitative Continuous Score (QCS) for B7-H4 IHC to understand AZD8205 pharmacodynamics

Abstract #452 / 3

Poster

Session PO.BCS02.02 – Artificial Intelligence and Digital Pathology

10 April 2022

13:30 – 17:00 CDT

Wallez, Y

Activity and tolerability of combinations of trastuzumab deruxtecan (T-DXd) with inhibitors of the DNA damage response in preclinical models

Abstract #5298

Poster

Session OPO.ET07.01 – Biological Therapeutic Agents

8 April 2022

12:00 – 13:00 CDT

Mettetal, J

Activity and tolerability of combination of trastuzumab deruxtecan with the next generation PARP1-selective inhibitor AZD5305 in preclinical models

Abstract #1142 / 6

Poster

Session PO.ET05.02 – Preclinical and Clinical Pharmacology

11 April 2022

09:00 – 12:30 CDT

1AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.