On June 15, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that new interim data from the Phase 1b dose escalation study evaluating AFM13, its lead NK cell engager candidate, at the European Hematology Association (EHA) (Free EHA Whitepaper) 23rd Congress in Stockholm (Press release, Affimed, JUN 15, 2018, View Source [SID1234527342]). Dr. Eva Domingo of the Instituto Catalán de Oncología L’Hospitalet, Barcelona, Spain, presented the poster, titled A Phase 1 Study Investigating the Combination of AFM13 and the Monoclonal Anti-PD-1 Antibody Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data. The poster is available on the Affimed website at: View Source

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Assessment of 18 patients treated at the highest AFM13 dose showed best overall response rate (ORR) of 89% (16/18 patients) and complete metabolic response rate (CmR) of 28% (5/18 patients). The ORR and CmR for these 18 patients compare favorably to those of anti-PD-1 monotherapy in similar patient populations.

Responders included three patients who were either primary refractory to or had relapsed during front-line therapy and were refractory to all subsequent lines of therapy. The combination of AFM13 and pembrolizumab was well tolerated, with most adverse events mild to moderate in nature and manageable with standard of care measures.

"The high response rates in this study, in terms of both partial and complete responses, continue to compare favorably to the historical data of anti-PD-1 monotherapy, and would be expected to translate into meaningful progression free and overall survival over time," said Dr. Stephen Ansell, Principal Investigator of the study. "Importantly, these data have shown that AFM13 can be safely administered in combination with Keytruda and has the potential to improve patient outcomes."

A total of 30 patients were recruited into the Phase 1b study with enrollment completed in February 2018. The interim analysis included 24 of the 30 patients (6 from cohorts 1 and 2, and 18 from cohort 3 and the extension cohort) who had undergone at least one post-baseline disease assessment as of the data cut-off date.

"We are very excited about the potential opportunities for AFM13 to benefit patients with CD30-positive malignancies," said Dr. Leila Alland, Affimed’s Chief Medical Officer. "We are planning additional studies of AFM13 in patients with CD30-positive malignancies and are actively seeking guidance from experts on our development plans including potential accelerated approval paths."

Conference Call and Webcast Information

Affimed’s management will host a conference call today, June 15, 2018, at 8:30 a.m. ET. For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing +1 929-477-0448 (international numbers are available on Affimed’s homepage) five minutes prior to the start of the call and providing the Conference ID 6246081. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

About AFM13

AFM13 is a first-in-class tetravalent, bispecific NK cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in Hodgkin lymphoma (HL) and

in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy in a monotherapy setting in studies in Hodgkin Lymphoma and CD30+ lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD1 antibody Keytruda (pembrolizumab) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition. AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration.

About Affimed’s Phase 1b study of AFM13 in combination with Keytruda (pembrolizumab) (NCT02665650)

Ongoing Phase 1b study to evaluate the safety and tolerability of the combination of the Affimed’s lead product candidate AFM13 with pembrolizumab (Keytruda) as salvage therapy after failure of standard therapies including brentuximab vedotin (BV) in relapsed or refractory (R/R) Hodgkin lymphoma (HL). Patients received escalating doses of AFM13 in combination with pembrolizumab at a flat dose of 200 mg administered every 3 weeks following the classical 3+3 design. Response assessment is performed every 12 weeks by PET/CT according to the Lugano Classification Revised Staging System for malignant lymphoma.

On June 15, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported the presentation of preclinical data demonstrating that CG-806, a highly potent pan-FLT3/pan-BTK inhibitor, exhibits a distinct mechanism of action and greater potency on patient-derived hematologic cancer cells than ibrutinib, a BTK inhibitor approved for the treatment of certain hematologic malignancies (Press release, Aptose Biosciences, JUN 15, 2018, View Source;p=RssLanding&cat=news&id=2354764 [SID1234527344]). The data were presented in a poster on Friday, June 15, at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 14-17, 2018 in Stockholm, Sweden.

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CG-806 is an oral small molecule pan-FLT3/pan-BTK inhibitor being developed by Aptose for acute myeloid leukemia (AML) and B-cell malignancies. It is a highly potent, reversible (non-covalent) inhibitor of the wild type and mutant forms of the Bruton’s tyrosine kinase (BTK) enzymes. Ibrutinib, a covalent BTK inhibitor approved for chronic lymphocytic leukemia (CLL) and certain B-cell malignancies, is limited by acquired resistance, as well as refractory disease and tolerance challenges.

The poster, entitled CG’806, A NON-COVALENT PAN-FLT3/PAN-BTK INHIBITOR, EXHIBITS UNIQUE BINDING TO WILD TYPE AND C481S MUTANT BTK AND GREATER POTENCY THAN IBRUTINIB AGAINST MALIGNANT B CELLS, compared CG-806 and ibrutinib with respect to BTK binding mode, kinase inhibition profiles and cytotoxic activity against patient-derived and cultured malignant B-cells. Kinase profiling revealed that CG-806 most potently inhibits kinases from the BTK, FLT3, TRK, and AURK clusters and had similar potency against BTK-WT (IC50 = 8.4 nM) and C481S mutant (IC50 = 2.5 nM), as opposed to ibrutinib that was >60-fold less potent against the C481S mutant. CG-806 did not inhibit TEC, EGFR or ERBB2/4, which are related to ibrutinib’s side effects; CG-806 also demonstrated a favorable safety profile. CG-806 inhibited cell proliferation 2-6,000 times more potently than ibrutinib in 14 tested malignant B-cell lines; it also had greater activity on primary CLL samples than ibrutinib.

"A safe and potent agent that inhibits all forms of BTK and other key rescue pathways (including AKT/PI3K, ERK and NFƙB) is needed for patients intolerant, refractory and resistant to ibrutinib," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "These data strongly support the clinical development of CG-806 to address the limitations and challenges of ibrutinib. CG-806 is being readied for the clinic and we look forward to reporting on its development."

The EHA (Free EHA Whitepaper) poster can be accessed here or at the Publications & Presentations section of the Aptose website, www.aptose.com.

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

On June 15, 2018 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company developing novel epigenetic therapies, announced positive interim data from an ongoing Phase 2 study of its lead candidate tazemetostat, a potent, selective, orally available EZH2 inhibitor, as a monotherapy for patients with relapsed or refractory follicular lymphoma (FL) (Press release, Epizyme, JUN 15, 2018, View Source [SID1234527346]). The data, presented today at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, show that tazemetostat demonstrated meaningful clinical activity and was generally well tolerated in these heavily pre-treated patients.

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Interim data as of May 1, 2018 included 82 evaluable patients across two cohorts, prospectively assigned by EZH2 status. In the EZH2 activating mutation cohort (n=28), an objective response rate (ORR) of 71 percent was observed; 11 percent of patients achieved a complete response (CR), and 61 percent achieved a partial response (PR). Twenty-nine percent achieved stable disease (SD) as best response; of those, 21 percent are still on study with the potential to respond. All patients in this cohort experienced reduction in tumor burden, and no patients experienced progressive disease (PD) as best response. At the time of this analysis, the median progression-free survival (PFS) was 49 weeks and the median duration of response (DOR) was 32 weeks, and both endpoints continue to mature.

In the fully-enrolled cohort of FL patients with wild-type (WT) EZH2 (n=54), the ORR was 33 percent; six percent achieved a CR, and 28 percent achieved a PR. An additional 31 percent of patients achieved SD as best response, including one patient who is still receiving treatment. At the time of this analysis, the median PFS was 30 weeks and median DOR was 76 weeks. The median DOR figure continues to mature, with more than half of the responders still on therapy.

"I am impressed by the sustained clinical activity and the good tolerability of tazemetostat in this heavily pre-treated patient population. This is important for patients with relapsed or refractory follicular lymphoma, as both the response rates and durations of response usually tend to decrease with each successive line of treatment," said Gilles Salles, M.D., Ph.D., at the University Hospital of Lyon France, and president of the Lymphoma Study Association (LYSA) cooperative group. "I believe tazemetostat has the potential to fill a significant unmet need for these patients and continued investigation of tazemetostat as single agent or in combination with other agents is warranted."

*median not yet reached; data continue to mature
†includes discontinued patients with response ongoing at time of discontinuation
This ongoing global, multi-center Phase 2 study is assessing the safety and efficacy of 800 mg of tazemetostat, administered orally twice daily, in adult patients who had received at least two prior therapies. The two cohorts represented in the interim assessment included patients with an EZH2 activating mutation or those with WT EZH2. The primary endpoint is ORR, defined as CR and PR. Secondary endpoints include PFS, DOR and safety/tolerability.

Tazemetostat was generally well tolerated in this study. Interim safety results at the time of this analysis show only six percent of FL patients discontinued treatment due to treatment-related adverse events (AEs). AEs of Grade 3 or higher were reported across 17 percent of patients, the most frequent of which included thrombocytopenia, anemia, asthenia and fatigue.

"Today’s interim update underscores our belief that tazemetostat may be an important therapeutic candidate in relapsed or refractory follicular lymphoma and may play a key role in the treatment landscape, regardless of mutational status," said Robert Bazemore, president and chief executive officer of Epizyme. "The patients who are participating in this study deserve our gratitude. At Epizyme, we are dedicated to continuing our work with the global investigator community to resolve the partial clinical hold and complete enrollment in this study, in an effort to bring tazemetostat to people living with follicular lymphoma."

Investor Conference Call Reminder
Epizyme will host an investor conference call and webcast today at 8:30 a.m. EDT to discuss interim clinical activity and tolerability data from adult patients with relapsed or refractory FL who are receiving tazemetostat in the company’s ongoing Phase 2 study. To participate in the call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 4869637. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast will be archived on the website for 60 days.

About Follicular Lymphoma (FL)
An estimated 40,000 people in the U.S. and EU5 are treated for FL each year. FL is an incurable and deadly form of cancer that is most frequently treated with multiple lines of systemic chemotherapy. As a result, there remains a significant need for an effective, convenient and tolerable medicine that patients can take for long durations.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 1 and 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma (ES) and other INI1-negative tumors; both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL); mesothelioma and combination studies in DLBCL

Dr Reddy’s has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Dr Reddy’s, 2018, JUN 15, 2018, View Source [SID1234527343]).

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On June 14, 2018 AIVITA Biomedical reported the randomization of its first patient in the Company’s Phase II clinical trial for newly diagnosed advanced ovarian cancer (Press release, AIVITA Biomedical, JUN 14, 2018, View Source [SID1234527445]). The double-blind study will enroll approximately 99 patients who will receive AIVITA’s patient-specific ovarian cancer vaccine, or a control agent. This milestone achievement is the first application of AIVITA’s new ROOT OF CANCER technology, a revolutionary immunotherapy that targets cancer-initiating cells.

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AIVITA has received seven patient tumor specimens from a single clinical site, and has successfully generated a treatment for each patient, yielding a 100% manufacturing success rate. Given the success of patient recruitment and manufacturing, AIVITA will now expand the clinical study to multiple centers.

"I’m very proud that our AIVITA team has so clearly demonstrated feasibility and reproducibility in manufacturing these patient-specific treatments," said Dr. Robert Dillman, AIVITA’s Chief Medical Officer. "Quick, reliable and cost-effective production is critical for the viability of both patient and company."

AIVITA’s ROOT OF CANCER technology may soon be applied to both melanoma and glioblastoma multiforme patients. The Company is seeking approval to commercialize the treatment of melanoma patients in Japan and was recently approved to conduct a Phase 2 clinical study in glioblastoma multiforme by the US FDA.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of female cancer deaths, with an estimated 22,240 new diagnoses in 2018 and 14,070 deaths. The median age at diagnosis is 63, with a 5-year survival rate of less than 50% for all, and about 35% for the two thirds who have advanced disease (stage III or IV) at the time of initial diagnosis. Current standard of care includes surgical debulking and several courses of chemotherapy.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

The ovarian Phase II double-blind study will enroll approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).

For additional information about AIVITA’s AVOVA-1 trial patients can visit www.clinicaltrials.gov/ct2/show/NCT02033616