On August 23, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK) reported positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916) (Press release, GlaxoSmithKline, AUG 23, 2019, View Source [SID1234538956]).

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The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated a clinically meaningful overall response rate with belantamab mafodotin in the patient population. The safety and tolerability profile was consistent with that observed in DREAMM-1, the first time in human study of belantamab mafodotin.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease."

Data from the DREAMM-2 study will be the basis for regulatory filings starting later this year.

Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable[i]. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.

Safety and efficacy results from the DREAMM-2 study will be submitted for presentation at an upcoming scientific meeting. Additional ongoing studies are testing the effect of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma and as a combination treatment in the first and second line setting as part of the broader DREAMM clinical development programme.

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines[ii].

About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an immuno-conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using technology licensed from BioWa.

Belantamab mafodotin is currently being investigated in patients with multiple myeloma.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Active, not recruiting

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK285791) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495

Planned

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887

Planned

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in participants with relapsed/refractory multiple myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS / GSK Co-Sponsored Study

209418

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on maximizing patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On August 22, 2019 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the Company has recently received ethics approval from the Human Research Ethics Committee in Australia for the Phase I clinical trial of CS3002, and Australia’s Therapeutic Goods Administration (TGA) has acknowledged the electronic Clinical Trial Notification (eCTN) the Company submitted for the trial (Press release, CStone Pharmaceauticals, AUG 22, 2019, View Source [SID1234551374]). This clinical trial is an open-label, multi-dose, dose-escalation, and dose-expansion Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of CS3002 in patients with advanced solid tumors.

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Being developed by CStone, CS3002 is a selective inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6). Inducing cell cycle arrest of tumor cells through the selective inhibition of CDK4/6, CS3002 has demonstrated high therapeutic potential for combination with endocrine therapy or immune checkpoint inhibitor therapy in various solid tumors. At present, three CDK4/6 inhibitors have been approved by the U.S. FDA. However, in China, palbociclib is the only approved CDK4/6 inhibitor, indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.

Preclinical studies have revealed that CS3002’s in vivo and in vitro activities are comparable to that of palbociclib’s. In mouse models, CS3002 combined with PD-1 monoclonal antibody therapy or endocrine therapy has shown improved tumor suppressing activities compared to monotherapies. In addition, CS3002 has also demonstrated potentially favorable safety and tolerability profiles.

Dr. Frank Jiang, Chairman and CEO of CStone, commented: "Currently, there are several CDK4/6 inhibitors that are either approved or in clinical development in the world. However, options in this class of therapies available to Chinese patients remain very limited and no domestically developed CDK4/6 inhibitor has been approved. I am pleased that we are about to initiate the Phase I trial on CS3002 in Australia. We will accelerate our work in obtaining its clinical trial approval in China and actively explore CS3002’s application in the treatment of various tumor types and different combination therapies. We hope CS3002 will become a new effective treatment option benefiting Chinese patients."

Dr. Jon Wang, CStone’s Chief Scientific Officer, noted: "The aberrant activation CDK4/6 was observed across various tumor types, suggesting CS3002’s potential utility in the treatment of breast cancer and a variety of other solid tumors. Recent studies have shown that, in addition to inducing cell cycle arrests, CDK4/6 inhibitors also have the effects of strengthening anti-tumor immunity and modulating the tumor microenvironment. These discoveries provide the foundation for a new approach in cancer treatment, which is the combination of CDK4/6 inhibitors and immunotherapies. We are hopeful that the clinical trial on CS3002 in Australia will be carried out successfully."

About CS3002

CS3002 is a new generation of well-tolerated and highly selective CDK4/6 inhibitor developed by CStone.

CDK4/6 inhibitors are the cyclin-dependent kinases that play a crucial role in the regulation of cell cycle progression from the first Growth phase (G1 phase) to the Synthesis phase (S phase). Upon activation of the cell proliferation signal, cyclin D protein binds to CDK4/6. The cyclin D–CDK4/6 complex then phosphorylates downstream retinoblastoma (Rb) protein, resulting in the aberrant proliferative signaling in the CDK4/6 pathway that drives the cell cycle progression from the G1 phase to the S phase. Aberrant CDK activity is a common feature of most cancer types. CDK4/6 inhibitors could suppress the activities of CDK4/6 and the phosphorylation of Rb protein, thereby achieving the suppression of tumor cell growth by interrupting the cell cycle transition from the G1 phase to the S phase. The commonality of aberrant cyclin D–CDK4/6–INK4–Rb pathway signaling in a tumor cells suggests CDK4/6 inhibitors’ potential application in strengthening anti-tumor immunity, and CDK4/6 inhibitors’ promising potential for the treatment of various solid tumors and synergistic combination with immuno-oncology therapies.

On August 22, 2019 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported its consolidated financial results for the first half of 2019 and provided its second quarter business update (Press release, Celyad, AUG 22, 2019, View Source [SID1234538960]). The full interim financial report is available on Celyad’s website in the "Investors" section.

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Filippo Petti, CEO of Celyad commented"As we enter the second half of the year, we continue to execute on our strategic plan for becoming a leader in the field of CAR-T development. Over the past few months we have presented encouraging data from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of hematological malignancies and solid tumors. We also received positive feedback from the FDA regarding our proposal to utilize the OptimAb manufacturing process with CYAD-01 under the current IND. In addition, the FDA recently cleared the IND application for our next-generation NKG2D-based CAR-T candidate CYAD-02, another testiment of our team’s focus on operational excellence. We are excited about our recent achievements and look to build upon our momentum as we approach several clinical milestones expected over the next several months."

Second Quarter 2019 and Recent Business Highlights

In June, the Company announced a strategic update to its autologous relapse/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) program, including that the U.S. Food and Drug Administration (FDA) accepted the Company’s proposal to utilize the OptimAb manufacturing process with CYAD-01 under the current Investigational New Drug (IND) application.

The OptimAb manufacturing process utilizes a shortened eight-day cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype while maintaining the high level of manufacturing reliability required to support clinical development. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive AML model compared to CYAD-01 produced with the previous mAb manufacturing process.

Following additional assessment of the r/r AML and MDS program for CYAD-01, Celyad plans to treat the first patient using the recently accepted OptimAb manufacturing process for CYAD-01 in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial.

The Company also announced that the FDA accepted the IND application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate, and permitted it to go into effect. CYAD-02 incorporates short hairpin RNA (shRNA) technology to target the NKG2D ligands MICA and MICB. The single shRNA modulates the expression of both ligands, which translates to encouraging increases in in vitro proliferation, in vivo engraftment and anti-tumor activity in preclinical studies. CYAD-02 also incorporates the OptimAb manufacturing process.

Regulated Information

Pipeline Updates

CYAD-01 – Autologous NKG2D-based CAR-T

The Company’s lead asset, CYAD-01 continues to advance in the Phase 1 THINK and DEPLETHINK clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). In June, Celyad presented preliminary data at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting that demonstrated that a denser schedule of infusions of CYAD-01 without preconditioning in Cohort 10 (Schedule Optimization) of the THINK trial was well tolerated and led to better time-averaged engraftment of the CAR-T cells compared to biweekly injections of CYAD-01 without preconditioning. Also at EHA (Free EHA Whitepaper), the Company reported that a single infusion of low dose CYAD-01 (100 million cells) following preconditioning chemotherapy consisting of cyclophosphamide and fludarabine was well-tolerated and led to better time-averaged engraftment of the CAR-T cells compared to the dose-escalation segment of the THINK trial.

In July, the Company also provided an update on CYAD-01 for the treatment of patients with metastatic colorectal cancer (mCRC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) in Barcelona. Professor Dr. Eric Van Cutsem from the University Hospital of Leuven (Universitair Ziekenhuis Leuven, UZ Leuven) presented preliminary data from the ongoing Phase 1 SHRINK trial assessing safety and clinical activity of CYAD-01 infused concurrently with FOLFOX chemotherapy for the treatment of mCRC. Data from the trial showed the regimen to be generally well-tolerated and with initial observations of disease control.

CYAD-101 – Allogeneic NKG2D-based CAR-T

Celyad’s first-in-class, non-gene edited clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the 21st ESMO (Free ESMO Whitepaper)-WCGIC, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with relapsed or refractory mCRC. Preliminary data showed no clinical evidence of Graft-versus-Host Disease post-infusion of allogeneic candidate CYAD-101. In addition, the regimen demonstrated encouraging anti-tumor activity with one patient experiencing a partial response and three patients experiencing stable disease at the three-month assessment.

CYAD-200 Series – shRNA-based Allogeneic CAR-Ts

The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform and progress towards the IND applications for the CYAD-200 series of shRNA-based allogeneic CAR-T candidates, including CYAD-211, the Company’s CAR-T therapy targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.

Regulated Information

Key Upcoming Milestones

Treatment of the first patient with CYAD-01 (300 million cells) produced with the OptimAb manufacturing process in the Phase 1 DEPLETHINK trial is expected by the end of September

Results from Cohort 11 (Schedule Optimization) of THINK Phase 1 trial and Cohort 3 of DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the mAb manufacturing process for the treatment of r/r AML and MDS are anticipated by year-end 2019

Additional results from the dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 for the treatment of mCRC are anticipated by year-end 2019

Initiation of the Phase 1 dose-escalation trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020

Submission of IND application for CYAD-211 (shRNA-based allogeneic BCMA CAR-T candidate) for the treatment of patients with multiple myeloma is anticipated during first half 2020

First Half 2019 Financial Review

The Company ended the quarter with a treasury position of €33.7 million ($38.3 million). Net cash burn over the first half of 2019 amounted to €16.1 million, in line with our financial planning. The Company confirms its previous position that its treasury position should be sufficient, based on the current scope of activities, to fund operating and capital expenditure requirementsuntil mid-2020.

Key financial figures for the first six months of 2019 compared with the same period of the previous year are summarized below:

Treasury position’ is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS.

The Company’s license and collaboration agreements have generated no revenue in the first half of 2019 compared to €2.5 million during first half 2018. Research and Development expenses totalled €12.7 million during first half 2019, a €1.6 million increase compared to first half 2018, driven by increased spending related to our key clinical studies for CYAD-01 and CYAD-101 as well as an increased spending associated with the development of our allogeneic platform (CYAD-200 series). Over the same period, General and Administrative expenses were €4.5 million for first half 2019, a decrease of €1.0 million compared to first half 2018, driven primarily by the decrease of non-cash expense associated with the vesting of warrants and by lower consulting fees for the period.

www.celyad.com | 3

Press Release

22 August 2019

10:00 pm CEST

Regulated Information

The Company’s other income/other expenses mainly include non-cash expenses relating to liability reassessment required by International Financial Reporting Standards (IFRS) related to the advancement in the Company’s NKG2D-based CAR-T candidates. Overall, the Company has posted €0.4 million in net income for first half 2019, against a €3.9 million net loss for first half 2018.

Due to the increase in net income, the Company’s loss for the period decreased to €16.0 million for the first half 2019 compared to €18.5 million for the first half of 2018.

Net operational cash burn, which excludes non-cash effects, was €16.1 million for first half 2019, compared to €13.9 million for first half 2018, driven primarily by an increase in Research and Development spend as described above.

Conference Call and Webcast Details

Celyad will host a conference call on Friday, 23 August at 2:00 pm CEST / 8:00 am EDT accessible through the following numbers:

Belgium +32 (0) 24 01 70 35
France +33 (0)1 76 72 89 28
United States: +1 917 720 0181
International: +44 (0) 2071 928501
Conference ID: 3547725
The event will also be archived and available on the "Events & Webcasts" section of the Company’s website.

Financial Calendar

Third quarter 2019 business update November 19, 2019
Full-year results 2019 March 25, 2020
Annual shareholders meeting May 5, 2020

On August 22, 2019 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY), reported that it will publish its Half Year Results for 2019 on Thursday, August 29, 2019 (Press release, Vivoryon Therapeutics, AUG 22, 2019, View Source [SID1234538958]). The company will host a conference call and webcast (in English) open to the public. The Half Year 2019 Results will be available to download on the company website (www.vivoryon.com/investors-news/financial-information/)

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Conference call details

Date: Thursday, August 29, 2019
Time: 3:00 pm CEST /09:00 am EDT

Access Code: 67470409#

From Germany: +49 69 201 744 220
From UK: +44 203 009 2470
From USA: +1 877 423 0830

Webcast details

A live webcast and slides will be made available at: (www.vivoryon.com/investors-news/financial-information/)

For more information, please contact:

Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: [email protected]

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

On August 22, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that Samuel Agresta, M.D., will transition from his role as Chief Medical Officer to Infinity’s Board of Directors and Research and Development Committee (Press release, Infinity Pharmaceuticals, AUG 22, 2019, View Source [SID1234538955]).

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"I joined Infinity due to the incredible potential of IPI-549 and remain convinced of this potential due to our Phase 1 clinical and translational data, both as a monotherapy and in combination with Opdivo," said Dr. Agresta. "These data have enabled the advancement of IPI-549 into a comprehensive Phase 2 program with world class partners which includes a randomized global study in bladder cancer. It has been incredibly rewarding to work with the Infinity team in advancing IPI-549 through its clinical development, though I am now transitioning out of my CMO role to fulfill a career-long commitment to patients with soft tissue and bone sarcoma. My medical training and practice at Moffitt Cancer Center was dedicated to treating these patients, and I am now pursuing an opportunity at a private company focused on improving treatment options for sarcoma patients. I remain deeply committed to Infinity and the success of IPI-549 and will continue to be closely involved in the IPI-549 clinical program as a member of the Board of Directors and the Research and Development Committee."

Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals, commented, "I would like to thank Sam for his significant contributions and ongoing commitment to the development of IPI-549. Sam has been instrumental in moving IPI-549 into several important Phase 2 trials including MARIO-275, our randomized, global study in bladder cancer patients as well as front-line trials in triple combination treatment regimens. We support Sam and wish him well in fulfilling his dream to advance treatment options for sarcoma patients and are delighted to have his continued active engagement with Infinity as a member of our Board of Directors and the Research and Development Committee. We look forward to his continued expertise and guidance in clinical development, along with his unwavering passion for improving treatments for cancer patients."

About Infinity and IPI-549

Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing IPI-549, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-1 is an ongoing Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab) in approximately 225 patients with advanced solid tumors including patients refractory to anti-PD-1 therapy. Infinity has initiated MARIO-275, a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients. MARIO-3 is the first IPI-549 combination study in front-line advanced cancer patients and is evaluating IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. MARIO-3 will be initiated in Q3. With the addition of MARIO-275 and MARIO-3 to the ongoing MARIO-1 study, Infinity will be evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve and front-line settings. For more information on Infinity, please refer to Infinity’s website at www.infi.com.