On August 21, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported a manufacturing agreement with Gilead for the supply of GS-1423, a bi-functional molecule licensed to Gilead (Press release, Agenus, AUG 21, 2019, View Source [SID1234538899]). This supply represents a second clinical batch for an ongoing Phase 1 clinical trial of GS-1423. Agenus is providing clinical supply at standard industry rates.

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"Our state-of-the-art facility in Berkeley, California and experienced staff have delivered more than 50 antibodies into the clinic2," said Al Dadson, Chief Manufacturing Officer of Agenus. "In the last 18-20 months, we have set path-breaking records with the development and manufacture of 8 compounds including two bi-specific compounds with 7 accepted INDs and one pending acceptance."

The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received $150 million in an upfront cash payment and equity investment and is eligible for approximately $1.7 billion in potential future fees and milestones.

GS-1423 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.

On August 21, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that the Company will participate in the following upcoming investor conferences (Press release, Arcus Biosciences, AUG 21, 2019, View Source [SID1234538915]):

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Citi’s 14th Annual Biotech Conference on Wednesday, September 4, 2019, at 9:30 am Eastern Time in Boston. Terry Rosen, Ph.D., Chief Executive Officer, will participate in a panel discussion entitled, "New Targets in Cancer Immunotherapy and the Tumor Microenvironment."
Morgan Stanley 17th Annual Global Healthcare Conference on Tuesday, September 10, 2019, at 11:10 am Eastern Time in New York. Terry Rosen, Ph.D., Chief Executive Officer, will participate in a fireside chat.
A live audio webcast of each presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcasts will be available for 30 days following the live event.

On August 21, 2019 AstraZeneca reported final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients (Press release, AstraZeneca, AUG 21, 2019, View Source [SID1234538900]). The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumour mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumour, and tumours with high levels of TMB may be more visible to the immune system.1,2

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In the primary analysis population of patients whose blood TMB was 20 or more mutations per megabase (mut/Mb), the combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving OS compared to SoC chemotherapy. The safety and tolerability profile for the combination of Imfinzi and tremelimumab was consistent with previous trials.

José Baselga, Executive Vice President, Oncology R&D said: "We are fully committed to a deep analysis of the vast clinical and biomarker data from this trial to gain further insights to improve Immuno-Oncology approaches for patients with metastatic non-small cell lung cancer."

AstraZeneca will submit the full results for presentation at a forthcoming medical meeting.

Imfinzi is also being tested as monotherapy in the Phase III PEARL trial, and in combination with chemotherapy with or without tremelimumab in the Phase III POSEIDON trial as part of an extensive late-stage Immuno-Oncology programme in Stage IV NSCLC.

About NEPTUNE
The NEPTUNE trial is a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi in combination with tremelimumab vs. SoC platinum-based chemotherapy in the 1st-line treatment of patients with Stage IV (metastatic) NSCLC. The trial population included patients with non-squamous or squamous histologies, no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation and the full range of PD-L1 expression levels. The primary endpoint was OS in patients with high blood TMB defined as ≥ 20 mut/Mb.

The trial is being conducted in more than 200 centres across 29 countries, including the US, Europe, South and Central America, the Middle East and Asia.

About Stage IV NSCLC
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.3 Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.4 Stage IV is the most advanced form of lung cancer and is often referred to as metastatic disease.5 Lung cancer patients are most commonly diagnosed after the tumour has spread outside of the lung.6 For these patients with metastatic disease, prognosis is particularly poor, as only 1 in 10 will be alive five years after diagnosis.7

About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III NSCLC in 49 countries including the US, Japan, and across the EU, based on the Phase III PACIFIC trial. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Australia, Israel, India, United Arab Emirates, Qatar, Macau and Hong Kong.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small-cell lung cancer (SCLC), bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumours.

About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers.

About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso (osimertinib), and ongoing Phase III trials ADAURA, LAURA, FLAURA and FLAURA2 as well as the Phase II combination trials SAVANNAH and ORCHARD.8-10

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents approximately three-quarters of all patients with lung cancer.11 Imfinzi (durvalumab), an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials NEPTUNE, POSEIDON, PEARL, and CASPIAN) and for patients in earlier stages of disease including potentially-curative settings (Phase III trials AEGEAN, PACIFIC-2, ADRIATIC, ADJUVANT BR.31, PACIFIC-4, and PACIFIC-5) both as monotherapy and in combination with tremelimumab and/or chemotherapy.

About AstraZeneca’s approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. Our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with radiation, chemotherapy, small targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On August 21, 2019 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a private placement financing of 13,725,000 units of the Company and the disposition of a 25% stake of its wholly-owned Polish subsidiary for aggregate gross proceeds of CAD $7,000,005 (Press release, Helix BioPharma, AUG 21, 2019, View Source [SID1234538933]).

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The terms of the placement are for the purchase of units at $0.455 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $0.72 and have an expiry of five years from the date of issuance. In addition, the terms of the private placement also include the disposition by the Company of shares of its Polish subsidiary, Helix Immuno-Oncology S.A. ("HIO"), representing 25% of the outstanding shares of HIO.

Mr. Jerzy Wilczewski ("Mr. Wilczewski"), acquired 13,725,500 units of Helix in the private placement. Following closing, Mr. Wilczewski’s holdings, including previously held common shares and common share purchase warrants of the Company ("Warrants"), represent approximately 15.70% of the issued and outstanding common shares of the Company on a non-diluted basis and 26.14% on a partially diluted basis, assuming the full exercise of all Warrants that Mr. Wilczewski beneficially owns or exercises control or direction over.

"My family wants to contribute to cancer research development," said Mr. Wilczewski. "I decided to make this sizeable investment in Helix because I believe in the social objective and the uniqueness of the Company’s technology. An additional motivation for me is the ongoing research and development work that the Company is carrying on in Poland."

"On behalf of Helix, I thank Mr. Wilczewski for his confidence and contribution," said Dr. Heman Chao, Helix’s Chief Executive Officer.

The issuance of the units under the private placement would ordinarily require shareholder approval under the requirements of the Toronto Stock Exchange (the "TSX"), since the aggregate number of common shares issuable (including through the exercise of Warrants) in successive private placements within the last three months exceeds 25% of the issued and outstanding common shares of the Company prior to the first such placement and since Mr. Wilczewski would potentially become a "control person" of the Company on exercise of the Warrants. However, Mr. Wilczewski has undertaken not to exercise any Warrants where the exercise would result in him owning 20% or more of Helix’s outstanding common shares unless disinterested shareholder approval, or the approval of the TSX, has been obtained.

The Company intends to seek shareholder approval for the creation of Mr. Wilczewski as a control person at its annual general meeting to be held later this year. 2 The Company intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

On August 20, 2019 Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) reported results and corporate updates for the second quarter 2009 (Press release, Evotec, AUG 20, 2019, View Source;announcements/press-releases/p/evotec-announces-strong-second-quarter-financial-results-4440 [SID1234538881]).

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Recent Highlights:
Strong quarterly performance leads to 46% revenue growth and 29% improvement of operating result
Further milestone payment received in drug discovery collaboration with Boehringer Ingelheim (after period-end)
Royalty income earned from DeveloGen
Several new discovery contracts signed
Failure of EVT 302 in smoking cessation; positive Phase I results with EVT 401; alliance with Roche on EVT 100 compound family
Execution of restructuring program "Evotec 2012 – Action Plan to Focus and Grow" yields" first results
Acquisition of Indian RSIPL to strategically leverage Discovery Alliance Business and create a global leader in drug discovery and development services (after period-end)
Revenue guidance increased; all other financial projections confirmed despite the acquisition of RSIPL

1. Operational performance

Strong quarterly performance leads to 46% revenue growth and 29% improvement of operating result
Evotec’s revenues for the second quarter 2009 grew strongly by 46% to EUR 10.5 million (Q2 2008: EUR 7.2 million). This is mainly the result of strong underlying revenues from Evotec’s Discovery Alliances Business, of a portion of the upfront payment for the EVT 100 compound family from Roche (EUR 0.9 million) as well as of license and royalty income totaling EUR 1.8 million from Roche and DeveloGen. Gross margin improved strongly to 38.8% (Q2 2008: 20.8%)
Evotec’s operating loss for the second quarter 2009 improved by 29% to EUR 8.9 million (Q2 2008: EUR 12.5 million) despite restructuring expenses in the amount of EUR 2.7 million. This improvement is a result of the Company’s strong top-line performance and its cost reductions in SG&A and R&D following the implementation of "Evotec 2012 – Action Plan to Focus and Grow".
Net loss for the second quarter 2009 amounted to EUR 8.6 million (Q2 2008: EUR 12.0 million).
Liquidity, which includes cash and cash equivalents (EUR 38.4 million), short-term investments (EUR 25.2 million) and auction rate securities (EUR 9.1 million), at the end of June 2009 amounted to EUR 72.7 million (December 31, 2008: EUR 92.4 million).

Royalty income earned from DeveloGen
The royalty income from DeveloGen was a result of the upfront payment DeveloGen received in its collaboration with Boehringer Ingelheim (published on May 13, 2009) on a target addressing insulin resistance. The target formed part of the Joint Venture between Evotec and DeveloGen which ended in 2005. As part of the agreement, DeveloGen maintained certain IP rights including those for the insulin target, and Evotec retained participation right on all future income DeveloGen might generate from the target. Under the terms of the agreement with Boehringer Ingelheim, DeveloGen received an upfront payment of EUR 7 million, and has the opportunity to earn potential additional milestone payments as well as tiered sales performance payments.

Further milestone payment received in drug discovery collaboration with Boehringer Ingelheim
On July 29, 2009, Evotec announced that a further research milestone, leading to payments to Evotec, has been successfully achieved in its drug discovery collaboration with Boehringer Ingelheim. The milestone was achieved for the identification and selection of a second compound to be advanced into preclinical development within an existing program. This represents the sixth milestone achieved in this multi-year, multi-target collaboration and is the second compound selected for pre-development in the last twelve months.

Several new discovery contracts signed
In July 2009, Evotec announced a significant research collaboration with Cubist Pharmaceuticals utilizing Evotec’s world-leading fragment-based drug discovery platform and a high-throughput screening collaboration with Alios Biopharma. In addition, Evotec-RSIL extended its library synthesis collaboration with Ferrer Grupo.

2. Status of clinical programs and partnering of assets

Failure of EVT 302 in smoking cessation; positive Phase I results with EVT 401; alliance with Roche on EVT 100 compound family
In April 2009, Evotec reported that the Phase II smoking cessation study of its MAO-B inhibitor EVT 302 failed to meet its clinical endpoints and Evotec subsequently stopped the development of the compound in this indication. All other clinical pipeline projects developed on track during the second quarter. On June 29, 2009, Evotec announced the successful completion of the first Phase I study with EVT 401, a potential novel oral treatment for inflammatory conditions such as Rheumatoid Arthritis. The compound was safe and well tolerated and demonstrated the desired pharmacodynamic activity in healthy volunteers. Evotec is now focusing its efforts on optimizing the oral dose formulation, completing the Phase I studies, and preparing for Phase II studies in Rheumatoid Arthritis.
Preparations of the Phase II clinical study for EVT 101 in treatment-resistant depression and a Phase I program for EVT 103 are on track to start in the second half of 2009. In March 2009, Evotec signed a partnership with Roche for the development of the EVT 100 compound family with total potential payments exceeding $300 million.

3. Update on Evotec 2012 Action Plan and cost reductions

Execution of restructuring program "Evotec 2012 – Action Plan to Focus and Grow" yields first results
Based on the "Evotec 2012 – Action Plan to Focus and Grow" Evotec implemented strict restructuring measures during the course of the second quarter. Evotec initiated headcount reductions in administrative functions by 20% and, following the setback in the progress of Evotec’s clinical pipeline, headcount reductions in the clinical development group by approximately 50%. In addition, the Company re-engineered its drug discovery and development operations to more efficiently leverage its research and development infrastructure. All proprietary programs are now managed through Evotec’s European operations and the Company is on course to finally close its US operations in South San Francisco, California, by the end of the third quarter.
As a consequence of these measures, as compared to the prior year, Evotec’s headcount as of June 30, 2009 decreased by 60 people to 370; R&D expenses were down 35% and SG&A expenses were down 11% in the second quarter, despite the fact that in the same quarter last year, the US research and developments programs were consolidated into European operations only after May 2. Expenses are expected to further decline and the full impact of Evotec’s restructuring will be reflected in the financial results for the second half of 2009.

4. Acquisitions

Acquisition of Indian RSIPL to strategically leverage DAB and create a global leader in drug discovery and development services
On August 6, 2009, Evotec announced the acquisition of a controlling majority shareholding of the Indian organization Research Support International Private Limited (RSIPL) for approximately EUR 2.8 million in cash, a portion of which includes a potential earn-out. With this acquisition Evotec expands its chemistry capacity by approximately 160 scientists and delivers on its strategy as described in the "Evotec 2012 – Action Plan to Focus and Grow" to create the global partner of choice for the pharmaceutical and biotechnology industries in discovery and early development services. This transaction adds a complementary drug discovery operation and capability in a cost-effective location to Evotec’s already world-leading discovery platform and efficiently increases its ability to deliver high quality drug discovery and development services to its partners.
On May 7, 2009, Evotec also acquired the zebrafish screening operations of Summit Corporation plc to further strengthen its state-of-the-art technology platform. These strategic technology and capacity additions further validate Evotec’s goal to become the number one global provider of discovery and development services.

5. Guidance

Revenue guidance increased; all other financial targets confirmed despite the acquisition of RSIPL
The Company increases its 2009 revenue guidance to above EUR 40 million (previously above EUR 35 million) and confirms all other financial targets for the fiscal year 2009 published in March despite the acquisition of RSIPL. Liquidity at the end of June 2009 is at EUR 72.7 million. With the contribution of milestone receipts from research collaborations and the full impact of Evotec’s restructuring measures, cash consumption is expected to be reduced considerably in the second half of the year. On this basis, Evotec remains confident to deliver on its liquidity guidance of above EUR 65 million by the end of 2009.

Conference Call
The Company is going to hold a conference call to discuss the results:

Conference call details
Date: Friday, August 7, 2009
Time: 09.30 a.m. CEST
08.30 a.m. BST
03.30 a.m. US time (East Coast)

From Europe: +49.(0)69.5007 1308 (Germany)
+44.(0)20.7806 1956 (UK)
From the US: +1.718.354 1388
Access Code: 8676443

A simultaneous slide presentation for participants dialing in via phone is available at www.equitystory.com, password: evotec0809.

Webcast details
To join the audio webcast and to access the presentation slides you will find a link on our home page www.evotec.com shortly before the event.

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialing +49.(0)69.22222 0418 (Germany) or +44.(0)20.7806 1970 (UK) and in the US by +1.718.354 1112. The access code is 8676443#. The on-demand version of the webcast will be available on our website: www.evotec.com – Investors – Financial Reports.