On March 21, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the pricing of its previously announced underwritten public offering of 16,666,668 shares of common stock, short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75 per share and accompanying warrants (Press release, Oragenics, MAR 21, 2019, View Source [SID1234534524]). Oragenics expects to receive gross proceeds of approximately $12.5 million from the offering. The offering is expected to close on or about March 25, 2019, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

Each short-term warrant will have an exercise price of $0.75 per share of common stock, will be immediately exercisable, and will expire on the earlier of (1) the eighteen month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant will have an exercise price of $0.90 per share of common stock, will be immediately exercisable and will expire five years following the date of issuance.

The Company has granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016. A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction

On March 21, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that its partner in cancer immunotherapy, Xiangxue Life Sciences (XLifeSc), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147), has received an allowance by China’s National Medical Products Administration (NMPA, formerly known as the China Food and Drug Administration) of its company-sponsored Investigational New Drug (IND) application to initiate registrational related clinical studies in China of T-cell receptor Affinity Enhanced Specific T-cell (TAEST) therapy in patients with solid tumors that are HLA-A*02:01 positive and NY-ESO-1 positive (Press release, Athenex, MAR 21, 2019, View Source;p=RssLanding&cat=news&id=2391974 [SID1234534543]). The cancer immunotherapy product, named TAEST16001 injection, is based on TAEST technology generated T-cells, with enhanced binding affinity, against the antigen NY-ESO-1 and is HLA-A*02:01 restricted.

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On October 15, 2018, Athenex and XLifeSc announced preliminary results of investigator-initiated pilot studies in China of patients receiving TAEST therapy which showed encouraging positive clinical safety and efficacy signals. Among six patients that received TAEST therapy after the standard lymphodepletion protocol, two patients showed partial response and four patients showed stable disease, with two of the stable disease patients showing significant tumor necrosis. In addition, the safety profile is believed to be within the range for cancer immunotherapy, with no CNS adverse events observed. Importantly, it was observed that TAEST technology generated T-cells persisted for several months in these patients, highlighting the potential long-term effects of this treatment. An abstract with more detailed data has been submitted for presentation to an international scientific meeting.

In July 2018, Athenex and XLifeSc entered into an agreement to establish a new joint venture named Axis Therapeutics Limited, which owns the global rights to the TAEST technology, excluding China (XLifeSc retains the mainland China rights), and in this territory Axis Therapeutics is leading the research, development and commercialization efforts of T-cell receptor-engineered T cells (TCR-T, including the TAEST technology), a form of cancer immunotherapy.

Mr. YongHui Wang, Chairman and Chief Executive Officer of Xiangxue Pharmaceutical and Chief Executive Officer of XLifeSc, commented, "We are excited with the quick allowance by China’s NMPA of our IND for TAEST16001 and are ready to initiate registrational related clinical studies. Athenex has been a great collaborative partner and the joint development team established will allow our joint venture to move forward with the development of TAEST16001 in other geographic regions."

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex and Chief Executive Officer of Axis Therapeutics, said, "We congratulate our partner, XLifeSc, and its parent company, Xiangxue Pharmaceutical, for obtaining the allowance of this company-sponsored IND to initiate their registrational related clinical studies. We are impressed by their scientific approach and pre-clinical data, and excited by the encouraging preliminary safety and efficacy results from the investigator-initiated pilot studies in China. Axis Therapeutics is also preparing an IND application to the U.S. Food and Drug Administration and we look forward to starting clinical studies in the U.S. in the near future. Our collaboration with XLifeSc and Xiangxue Pharmaceuticals has been extremely rewarding. Exploring the combination of this exciting approach in conjunction with select Athenex pipeline products may lead to the development of more effective therapies for cancer patients."

On March 21, 2019 Cellular Biomedicine Group, Inc. (Nasdaq: CBMG) (CBMG or the Company), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported the pricing of an underwritten public offering of 1,029,412 shares of its common stock at a public offering price of $17.00 per share (Press release, Cellular Biomedicine Group, MAR 21, 2019, View Source [SID1234534562]). In addition, the underwriters have been granted a 30-day option to purchase up to 154,411 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. Closing of the offering is expected to occur on or about March 25, 2019, subject to customary closing conditions. The gross proceeds to CBMG from this offering are expected to be approximately $17.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by CBMG. CBMG intends to use the net proceeds from this offering for preclinical studies, clinical trials, continued technology platform development, as well as for working capital and other general corporate purposes.

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Cantor Fitzgerald & Co. and Robert W. Baird & Co. Incorporated are acting as joint book-running managers for the offering.

The shares of common stock described above are being offered by CBMG pursuant to its shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (or SEC) and declared effective by the SEC on June 17, 2016. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, by sending a request to: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, Wisconsin 53202, or by email at [email protected].

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

On March 21, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on pioneering precision medicine in neuro-degenerative diseases, reported financial results for the year ended December 31, 2018, and provided a business and clinical update detailing its corporate progress and anticipated milestones (Press release, AC Immune, MAR 21, 2019, View Source [SID1234534526]).

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Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, have generated multiple product-candidates utilizing different approaches to treating neuro-degenerative diseases. We are advancing five of these through various stages of clinical testing and expect multiple developments in 2019, including data on ACI-24 in Down syndrome and the initiation of a Phase 1 trial of Tau MorphomerTM as we advance our new partnership with Eli Lilly."

"Our partnerships with the global leaders in neuro-degeneration are a testament to our approach and already have generated CHF 292 million in funds, not including potential future milestones and royalties. We are particularly pleased with the recent validation of the small molecule Morphomer discovery platform by Lilly, which licensed rights to Tau Morphomer in December in one of the biggest deals ever for such an early-stage asset. Our cash position, approximately CHF 300 million as of Q1 2019, funds the company through Q3 2023, allowing us to continue and accelerate implementation of our strategy."

Anticipated 2019 Research & Development Outlook

AC Immune’s external collaborations and broad, robust pipeline to treat neuro-degenerative diseases are driven by its proprietary technology platforms, which are fueling sustained growth. Successful delivery of external and internal research & development strategies are expected to produce multiple near-term catalysts in FY 2019-2020.

Data read-outs
ACI-24 Phase 1b in Down syndrome interim data in 2019 (low dose cohort) and H1 2019 (high dose cohort); potential decision to start Phase 2 ahead of plan
a-synuclein antibodies lead selection in 2019
TDP-43 antibodies lead selection in 2019
Anti-Tau antibody phase 2 read-out in 2020
Study initiations
Tau-PET tracer longitudinal study, Phase 2 in 2018
Second generation a-synuclein-PET tracer start of first-in-human trial in Q1 2019
Morphomer Tau Phase 1 expected start in Q2 2019 by Lilly
ACI-35 to start Phase 2 testing in H1 19
2019 Financial Guidance

For the full year 2019, the company expects total operating expenses to range between CHF 65−80 million, up from CHF 56.8 million in 2018.

Financial Highlights 2018

Enhanced cash position projected to be approximately CHF 300 million as of Q1 2019, following receipt of CHF 80 million upfront payment and USD 50 million convertible note as a result of license agreement with Lilly in December 2018. The Company’s cash position as of December 31, 2018 totaled CHF 186.5 million.
Completed follow-on offering of 10 million common shares in Q3 2018 which raised gross proceeds of USD 117.5 million (CHF 116.3 million).
Strategic R&D expenditures increased by CHF 11.6 million (+36%) supporting an ongoing ramp-up in R&D activities, primarily driven by investments in our AD and discovery programs as well as advancements in our proprietary and partnered key vaccine programs, most notably ACI-24.
Addition of 19 FTE’s in R&D (+29%).
IFRS net operating loss of CHF 50.9 million and Non-IFRS loss of CHF 47.2 million.
Research & Development Highlights 2018 and Beyond

License agreement signed with Lilly to research and develop Tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease and other neuro-degenerative diseases. The terms include upfront payment of CHF 80 million, USD 50 million convertible equity note, CHF 60 million in potential near-term milestones, as well as other milestones up to approximately CHF 1.68 billion, and tiered royalty payments in the low double digits.
Genentech, a member of Roche Group, commenced recruitment for a second Phase 2 trial of AC Immune’s anti-Tau monoclonal antibody, RG6100 (MTAAU9937A, RO7105705), in moderate AD supplementing a separate Phase 2 trial to evaluate its efficacy and safety in participants with prodromal to mild AD.
Roche discontinued CREAD 1 and CREAD 2 Phase 3 studies of crenezumab. Further update on the interim analysis CREAD studies will be presented by Roche at Alzheimer’s and Parkinson’s Diseases Congress (AD/PD) Lisbon, Portugal on March 27 at 4:20 – 4:35 PM WET.
The landmark Alzheimer’s Prevention Initiative trial of crenezumab, for which data are expected in 2021/22, is continuing in cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at high risk of developing familial AD.
Commenced a Phase 2 clinical trial with an adaptive design for evaluation of ACI-24 (anti-Abeta vaccine) in patients with mild AD.
Completed recruitment for the high-dose cohort of the ACI-24 Phase 1b study for the treatment of AD-like characteristics in adults with Down syndrome. Low-dose cohort was fully recruited in August 2017.
Awarded third follow-up grant from The Michael J. Fox Foundation for first-in-human study of a potential alpha-synuclein Positron Emission Tomography (PET) tracer for Parkinson’s disease anticipated to commence in H1 of 2019.
Hosted a Key Opinion Leader (KOL) event addressing Abeta oligomers in AD and other neuro-degenerative diseases with top-level insights from KOLs Professor Michael W. Weiner, University of California San Francisco School of Medicine and Professor John Q. Trojanowski, Perelman School of Medicine, University of Pennsylvania.
Established an exclusive strategic partnership with WuXi Biologics allowing ACIU to leverage WuXi Biologics’ capacities and capabilities in the manufacturing and supply of biologics for CNS disorders.
Announced appointments to ACIU executive management including Dr. Marie Kosco-Vilbois, as Chief Scientific Officer, Piergiorgio Donati as Head of Technical Operations and Program Management, and Dr. Sonia Poli as Head of Translational Science.
Analysis of Financial Statements for the 12 months ended December 31, 2018

Key Financial Results1

For the year ended December 31,
2018 2017 Change
(in CHF million except per share data)
Revenues 7.2 20.3 (13.1)

R&D expenses (44.3) (32.7) (11.6)
G&A expenses (12.5) (10.1) (2.4)

IFRS loss for the period (50.9) (26.4) (24.5)
IFRS EPS – basic and diluted (0.82) (0.46) (0.36)

Non-IFRS loss for the period1 (47.2) (20.6) (26.6)
Non-IFRS EPS – basic and diluted1 (0.76) (0.36) (0.40)
As of December 31,
2018 2017 Change
(in CHF million)
Cash and cash equivalents 156.5 124.4 32.1
Short-term financial assets 30.0 - 30.0
Total Liquidity2 186.5 124.4 62.1
Total shareholder’s equity 177.6 116.8 60.8
______________________
1 Non-IFRS (Loss) and Non-IFRS EPS are non-IFRS measures. See "Non-IFRS Financial Measures" below for further information
2 Liquidity is defined as the cash and cash equivalents plus short-term financial assets. These short-term financial assets are comprised of cash held in fixed-term deposits ranging in maturity from 3−12 months

Revenues

Revenues for the 12-month period decreased CHF 13.1 million (-64%) compared to 2017. Revenues fluctuate as a result of our collaborations with current and potentially new partners, the timing of milestone achievements and the size of each milestone payment.
CHF 14 million milestone payment received in 2017 for the Company’s anti-Tau antibody moving into a Phase 2 trial for AD as part of the Company’s collaboration with Genentech. No such milestone was received in in 2018.
Increase of CHF 0.9 million and CHF 0.1 million for Janssen and Biogen collaborations, respectively. For Janssen, this relates to an increase in cost sharing activities for the advancement of ACI-35 in the development plan.
The Company also recorded an increase of CHF 0.6 million in its collaboration with Essex as this collaboration was in effect for the full year 2018.
Research & Development (R&D) Expenses

Total R&D expenditures increased CHF 11.6 million (+36%) for the 12 months ended December 31, 2018 compared to 2017.
The Company increased investments in each of its respective development category, led by a CHF 3.6 million (+34%) and CHF 3.9 million (+50%) increase in Alzheimer’s disease and discovery programs, respectively.
Alzheimer’s disease expenses increased due to a CHF 3.0 million increase for investments related to the completion of the Phase 1b study for ACI-35 and advancement of the vaccine through the development plan. ACI-24 AD spend increased by CHF 1.4 million in set-up fees such as site selection, administration and related manufacturing costs associated with the Phase 2 study.
Increase in discovery programs was led by a CHF 1.5 million increase related to continued proof-of-concept and manufacturing activities for studies related to our lead compounds in the anti-Tau MorphomerTM program and investments in new therapeutic and preventive vaccine technology, CHF 0.5 million increase related to manufacturing activities in our vaccine technology program and a CHF 0.8 million for our anti-a-Synuclein antibody. The Company also increased its investment by CHF 0.7 million in the area of neuroinflammation driven by additional costs related to medicinal chemistry and preclinical evaluation of the compounds.
General & Administrative (G&A) Expenses

For the year ended December 31, 2018 G&A increased CHF 2.4 million (+23%) to CHF 12.5 million. Increase driven by personnel expenses including share-based compensation and professional services.
IFRS Loss for the period

AC Immune had a net loss after taxes of CHF 50.9 million in 2018 compared with net loss of CHF 26.4 million in 2017.
Balance Sheet

The Company had a total cash balance of CHF 186.5 million comprised of CHF 156.5 million in cash and cash equivalents and CHF 30.0 million short-term financial assets. This compares to CHF 124.4 million as of December 31, 2017. The increase of CHF 62.1 million is principally due to the follow-on financing in 2018 offset by the Company’s net loss. Further details are available in our Statements of Cash flows on the accompanying Form 20-F.
The Company’s strong cash balance provides enough capital resources to progress through at least Q3 2023, not considering any incoming milestones.
The total shareholders’ equity position increased year-over-year to CHF 177.6 million as of December 31, 2018 from CHF 116.8 million as of December 31, 2017. Further details are available in our corresponding Financial Statements filed on the accompanying Form 20-F.
Non-IFRS Financial Measures

The Company’s operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, we use non-IFRS Loss and non-IFRS Loss per share when monitoring and evaluating our operational performance. Non-IFRS Loss is defined as loss for the relevant period, as adjusted for certain items that we believe are not indicative of our ongoing operating performance. Non-IFRS Loss per share is defined as non-IFRS Loss for the relevant period divided by the weighted-average number of shares for such period.

The Company believes that these measures assist shareholders because they enhance comparability and provide more useful insight into operational results for the period. The Company’s executive management uses these non-IFRS measures to evaluate operational performance. These non-IFRS financial measures are not meant to be considered alone or substitute for IFRS financial measures and should be read in conjunction with AC Immune’s financial statements prepared in accordance with IFRS. The most directly comparable IFRS measure to these non-IFRS measures is net loss and loss per share. The following table reconciles IFRS net loss and IFRS loss per share to non-IFRS net loss and non-IFRS net loss per share for the periods presented:

Reconciliation of Loss to Adjusted Loss and Loss per Share to Adjusted Loss per Share (unaudited)

For the year ended
December 31 Change
2018 2017 CHF
(in CHF millions except per share data)
IFRS loss (50.9) (26.4) (24.5)
Adjustments:
Non-Cash share-based compensation 2.5 1.6 (0.9)
Foreign currency remeasurement losses 1.2 4.2 3.0
Non-IFRS loss (47.2) (20.6) (26.6)

IFRS EPS – basic and diluted (0.82) (0.46) (0.36)
Adjustment to EPS – basic and diluted 0.06 0.10 (0.04)
Non-IFRS EPS – basic and diluted (0.76) (0.36) (0.40)
Weighted-average number of shares used to compute Adjusted Earnings (Loss) per share – basic and diluted 61,838,228 57,084,295 4,753,933
Non-IFRS Expenditures

Adjustments for the years ended December 31, 2018 and 2017 were CHF 3.7 million and CHF 5.8 million in net losses, respectively. These were largely due to foreign currency remeasurement losses of CHF 1.2 million and CHF 4.2 million for the years ended December 31, 2018 and 2017, respectively, predominantly related to the cash balance of the Company as a result of fluctuations of the US Dollar against the Swiss Franc. The Company also recorded CHF 2.5 million and CHF 1.6 million for the years ended December 31, 2018 and 2017, respectively, for share-based compensation expenses.

On March 21, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK) reported further positive data from the DREAMM-1 study of patients with relapsed/refractory multiple myeloma who received GSK2857916, an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (Press release, GlaxoSmithKline, MAR 21, 2019, View Source [SID1234534544]). These results, published in Blood Cancer Journal (link) build upon results from the pre-specified interim analysis, which were first presented at the American Society of Haematology Congress in 2017.

These new data confirm that 60% of patients receiving GSK2857916 achieved an overall response rate (ORR). This ORR was identical to the rate previously reported in the interim analysis, after more than a year of follow-up, and demonstrates not only the potential efficacy of the medicine but the durability and depth of response. The number of patients achieving a complete response increased to 15% over this additional one year follow-up period. The median progression-free survival (PFS) was 12 months (95% CI [3.1-Not Estimable/NE]), an increase from the previously reported 7.9 months PFS. The median duration of response in the final analysis was 14.3 months (95% CI [10.6-NE]). All patients whose data were reported in the interim analysis were included in this analysis.

Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, commented, "These data are very encouraging and I am excited by what they could mean for people living with multiple myeloma. We are aggressively advancing this potential new medicine and plan to have pivotal data to support its filing by the end of this year."

A total of 35 patients were enrolled in Part 2 of the DREAMM-1 study independent of their BCMA expression levels. Amongst those heavily pre-treated patients not previously treated with the anti-CD38 monoclonal antibody, daratumumab, the ORR was 71% (95% CI [47.8%,88.7%]) with a mPFS of 15.7 months, (95% CI [2.3-NE]). In those patients who had previously been treated with daratumumab, the ORR was 38.5%; (95% CI [13.9-68.4]) with a mPFS of 7.9 months (95% CI [2.3-NE]).

No new safety signals were identified during this treatment period. The most commonly reported adverse events were thrombocytopenia (63%), blurred vision (51%), cough (40%), which were mostly mild or moderate (Grade 1 or 2). The most commonly reported Grade 3 or 4 adverse events were thrombocytopenia (35%) and anemia (17%) and were found to be manageable.

Paul Giusti, President and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF), said, "Significant advancements have been made in our knowledge, understanding and the treatment of multiple myeloma in the past decade, but there is so much more that we as a community need to do to accelerate better outcomes and quality of life for patients. Relapses are particularly challenging, so the need for treatment advances is a priority at the MMRF to ensure our patients can benefit from them in the future. We are encouraged by the results from this early study, and we look forward to seeing additional data later this year."

Multiple myeloma is the second most common blood cancer in the United States[i] and is generally considered treatable but not curable. Multiple myeloma commonly becomes refractory to available treatments, so research into new treatments is vital.

In 2017, GSK2857916 was awarded Breakthrough Therapy designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency; these designations are intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

About the DREAMM-1 study (NCT02064387)
DREAMM-1 is a first-in-human, open-label study of GSK2857916 to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of the antibody drug conjugate GSK2857916 in patients with relapsed/refractory multiple myeloma and other advanced haematologic malignancies expressing BCMA. The primary objective is safety; additional objectives include: response rate, pharmacokinetics and immunogenicity. The study consists of two parts: a dose escalation phase in which patients received GSK2857916 at escalating doses and a dose expansion phase in which all patients received GSK2857916 at the recommended phase 2 dose.

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 and APRIL. 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[iii].

About the DREAMM Clinical Trial Programme for GSK2857916 (GSK’916)
GSK2857916 is an antibody-drug 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.

GSK’916 is currently in clinical development in patients with relapsed/refractory multiple myeloma and other advanced haematologic malignancies expressing BCMA.

Trial Name
GSK ID/NCT ID
Status
Design
DREAMM-1
117159/ NCT02064387
Completed

DREAMM-2
205678/NCT03525678

Ongoing; recruitment complete
A Study to Investigate the Efficacy and Safety of Two Doses of GSK’916 in Subjects With Multiple Myeloma Who 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 GSK’916 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 GSK’916 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 GSK’916 with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma
DREAMM-6
207497/NCT03544281
Recruiting
Evaluate Safety, Tolerability, and Clinical Activity of GSK’916 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
Phase III study of GSK’916, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in participants with relapsed/refractory multiple myeloma
DREAMM-8
207499
Planned
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GSK’916 in Combination with Pomalidomide and Low-Dose Dexamethasone (GSK’916+Pd) 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 GSK916 + Standard of Care (SOC) vs. SOC in first line transplant ineligible multiple myeloma patients
DREAMM-10
207500
Planned
‘916+novel agent vs SOC

GSK2857916 is not currently approved for use anywhere in the world.

GSK in Oncology
GSK is focused on delivering transformational therapies for people living with cancer. GSK’s pipeline is focused on immuno-oncology, cell therapy and cancer epigenetics. 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.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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