On June 3, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, is reported an analyst and investor event today featuring distinguished oncologists Professor Johann de Bono and Dr. Rebecca Kristeleit, to discuss clinical findings and possible next steps for its oral, highly selective Chk1 inhibitor, SRA737 (Press release, Sierra Oncology, JUN 3, 2019, View Source [SID1234536813]).

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On Saturday, June 1st, Sierra reported positive preliminary clinical data from its two first-in-human Phase 1/2 studies of SRA737, as monotherapy and as SRA737+LDG (low dose gemcitabine), at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago. Detailed results were issued by press release on June 1st and are available on Sierra’s website at www.sierraoncology.com. Anti-cancer activity was demonstrated across multiple indications and genetic contexts, with SRA737+LDG specifically achieving a notable 30% response rate in anogenital cancer patients, an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, subjects whose tumors harbored FA/BRCA gene network mutations displayed favorable outcomes, including an Overall Response Rate = 25% and Disease Control Rate = 81%.

"These positive data indicate that SRA737 is a demonstrably active anti-cancer drug that we believe warrants further development. The initial efficacy and favorable tolerability profile described at ASCO (Free ASCO Whitepaper) also enables several potentially promising opportunities for its development in combination with other therapeutics, in particular with PARP inhibitors and immunotherapy agents where we have previously reported robust preclinical efficacy data," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We also look forward to announcing regulatory clarity for our lead asset momelotinib in the near-term. We have been holding productive discussions with regulators and continue to prepare for a Phase 3 clinical trial intended to potentially support its registration. Given momelotinib is our lead drug candidate and highest priority, we will be exploring options to enable the continued advancement of SRA737 in the context of our emerging pipeline."

SRA737 Analyst & Investor Event
The company is hosting an Analyst and Investor Event on Monday, June 3, 2019, to discuss these clinical findings and potential next steps in the development strategy for SRA737+LDG.

Date and Time: June 3, 2019, 6:00 – 7:00 am CT

Location: History event room, Marriot Marquis Hotel, 2121 S Prairie Ave, Chicago, Illinois.

The event will feature presentations by two distinguished oncologists:

Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, will discuss the critical role of Chk1 in tumor cell survival during replication stress, as well as describe potential opportunities to combine SRA737 with other therapeutic modalities including PARP inhibitors and immunotherapy agents.
Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Honorary Consultant Medical Oncologist at University College London (UCL) Cancer Institute & UCLH Dept. of Oncology, a leading expert in gynecological malignancies, will discuss her clinical experience with SRA737+LDG, and potential development opportunities for this novel combination in the treatment of anogenital cancers.
Event registration and webcast information are available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.

About SRA737 and SRA737+LDG
SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). Tumors with high levels of replication stress become reliant on Chk1 to mitigate the potentially catastrophic consequences of excess genomic instability.

Intrinsic sources of replication stress can include genetic alterations in tumor suppressors, oncogenes or DNA Damage Repair genes. Tumors harboring defects in these gene classes are hypothesized to have higher levels of intrinsic replication stress due to dysregulated cell cycle control, increased proliferation demands and increased genomic instability. SRA737+LDG is a novel drug combination, where non-cytotoxic low dose gemcitabine (LDG) acts as a potent extrinsic inducer of replication stress.

Sierra Oncology retains the global commercialization rights to SRA737.

On June 3, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported results from a preplanned analysis of immunologic responses in the cohort of patients with triple negative breast cancer (TNBC) from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of nelipepimut-S (NPS) +/- trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patients (Press release, Sellas Life Sciences, JUN 3, 2019, View Source [SID1234536812]). This analysis was presented on June 2, 2019 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL.

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"Effective adjuvant/maintenance therapy strategies are urgently needed to prevent recurrence or to prolong remission in patients with TNBC after successful frontline standard therapy for early-stage disease. In this setting, immune-directed therapy with NPS, a peptide vaccine targeting HER2, a protein expressed at low levels in TNBC, along with trastuzumab, led to high rates of antigen-specific immunization by both ex vivo and in vivo validated measures, corroborating the immunobiological synergy between these two agents," said Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2b study.

"These ex vivo and in vivo results in TNBC patients, particularly the newly discovered correlation between mounting an immune response and remaining clinically relapse-free over time, provide a solid mechanistic rationale for the previously observed clinically meaningful and statistically significant prolongation in disease-free survival (DFS), and the significant decrease in the frequency of relapses identified by standard clinical follow-up, in favor of NPS plus trastuzumab," said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"As we continue discussions with potential partners and the U.S. Food and Drug Administration (FDA) on this promising program, we remain excited with these data demonstrated in the TNBC population," added Dr. Stergiou.

The Phase 2b study enrolled patients with HER2-low expressing breast cancer who remained clinically disease-free after completion of frontline standard of care therapy. Patients were selected to harbor node-positive disease and/or TNBC, as well as expressing human leukocyte antigen (HLA) types indicated for NPS administration (A2, A3, A24/26; pertinent to approx. 85% of the global population). Patients were randomized to placebo with granulocyte-macrophage colony-stimulating factor (GM-CSF) (n=139) or NPS with GM-CSF (n=136), while they all received trastuzumab every 3 weeks for one year. The Company previously reported results of the final analysis of efficacy and safety outcomes in the cohort of patients whose tumors did not express hormone receptors, TNBC (n=97). DFS of patients treated with NPS plus trastuzumab (n=53) was 92.6% compared to 70.2% for those treated with trastuzumab alone (n=44) and represented a clinically meaningful and a statistically significant improvement with the combination therapy, p=0.01. This was associated with a statistically significant reduction by 71.9% (p=0.01) in the frequency of clinically detected recurrences in favor of the combination in the TNBC cohort.

Ninety-one of the 97 TNBC patients in this clinical study were analyzed for immune responses (IR) at five timepoints, 51 of whom received the combination therapy. IR were evaluated ex vivo by clonal expansion of antigen NPS-specific cytotoxic T-lymphocytes (CTL) by dextramer-staining/flow cytometry at predefined time points over three years. In vivo IR were assessed by cutaneous delayed type hypersensitivity (DTH) reactions periodically, by measuring the diameter of skin induration (in mm) post intradermal NPS treatment.

NPS plus trastuzumab-treated TNBC patients exhibited increases in CTL frequencies compared with baseline by 1.1-, 1.73-, and 2.86-fold at 18, 24 and 30 months, respectively. The mean CTL frequencies in these patients increased from 29±0.1 per 10-4 at baseline to 112±2.6% at 30 months, a 2.86-fold difference that was highly clinically indicative (p = 0.058), as compared with patients receiving trastuzumab only, whereby CTL frequencies were 20±0.1 per 10-4 at baseline compared with 52±1.6 per 10-4 at 30 months, a 1.6-fold non-significant difference (p=0.70). Three patients in the combination arm recurred (5.9%) as compared with 12 (30%) in the trastuzumab-alone arm. TNBC patients treated with NPS plus trastuzumab whose disease recurred did not mount an IR by ex vivo assessment (absolute CTL frequency change) or by in vivo DTH (no change in skin induration), while non-recurrent patients mounted both vigorous NPS-specific clonal CTL expansion and enhanced in vivo DTH.

On June 3, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Chief Executive Officer, Kenneth L. Waggoner, and PharmaCyte’s consultant cellular biologist, David Judd, will be on site at Austrianova’s GMP manufacturing facility in Bangkok, Thailand, as the production of its clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is underway (Press release, PharmaCyte Biotech, JUN 3, 2019, View Source [SID1234536811]).

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Mr. Waggoner and Mr. Judd will observe the culturing of the genetically altered HEK-293 cells both before and after they are encapsulated. Mr. Judd has a broad array of experience in development of cell culture media for many primary cells and cell lines and is particularly knowledgeable in the growth of HEK-293 cells. He has developed manufacturing processes, cell assays, biochemical analysis, cell culture processes and downstream recovery strategies. Although Mr. Judd has already offered advice to both PharmaCyte and Austrianova via telephonic communications, his actual on-site presence should prove to be invaluable. Mr. Judd will lend assistance in helping correct any unforeseen problems in the production process as the latest two staggered manufacturing "runs" are carried out and completed.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "After the changes to the manufacturing process allowed us to get back on track and proceed with GMP production of the "CypCaps," our clinical trial product for the company’s planned clinical trial in LAPC, I felt it was necessary to be on-site with David, our consulting expert in the culture of HEK-293 cells, to oversee the process and ensure we are staying on the path and clinical trial development timeline that we’ve developed to submit our Investigational New Drug application (IND). His presence will be particularly important since this time two manufacturing runs will be performed in a staggered fashion rather than consecutively as has been done in the past."

While in Thailand, Mr. Waggoner, Mr. Judd, Prof. Dr. Walter H. Günzburg and Dr. Brian Salmons of Austrianova and possibly others will be interviewed on the progress of the production, the testing of the clinical trial product, factors involved in the manufacturing process that will be included in the submission of the IND and various other topics related to the company’s planned clinical trial in LAPC.

While on-site at the GMP facility in Thailand, the company expects to post pictures, videos and interviews on its social media platforms. Shareholders and others who are interested in PharmaCyte’s content, should follow the company’s social media platforms:

Follow PharmaCyte on Facebook at: View Source
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On June 3, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers, reported new data presented at the the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from its Phase 1/2 O-12-M1 clinical study of lead candidate melflufen (Press release, Oncopeptides, JUN 3, 2019, View Source [SID1234536810]). The data demonstrate that melflufen may offer positive disease stabilization and favorable time to next treatment (TTNT) outcomes in heavily-pretreated patients with relapsed/refractory multiple myeloma (RRMM).

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Overall conclusions from the data presented include:

Melflufen plus dexamethasone treatment results in disease stabilization in 76% of RRMM patients, which translates to a median TTNT of 7.9 months (10.6 months when censoring at time of death), which compares favorably with other relevant trials.
A median OS of 20.7 months in an advanced RRMM population, suggesting that melflufen therapy is associated with a long?term benefit and allows patients to receive further treatment to control disease.
Results support those of previous data showing the promising efficacy profile of melflufen for the treatment of RRMM.
The data is presented by Professor Paul G. Richardson, MD, RJ Corman Professor of Medicine at Harvard Medical School and Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, USA.

Oncopeptides recently announced that, following discussions with the U.S. Food & Drug Administration (FDA), the company has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma. The company targets to submit the application in the first quarter of 2020 based on the positive data from the ongoing Phase 2 HORIZON clinical trial.

"We are committed in helping patients with myeloma get access to melflufen given the safety and efficacy profile that is emerging from our clinical trials," said Jakob Lindberg, CEO of Oncopeptides. "In addition to the data presented at ASCO (Free ASCO Whitepaper), data from the melflufen clinical programs have also been selected for four presentations at the 2019 EHA (Free EHA Whitepaper) Annual Congress, including updated data from the HORIZON Phase 2 pivotal clinical trial that will serve as the foundation for our NDA submission."

The full poster presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting can be found on the company webpage under:

www.oncopeptides.com / Investors & Media / Presentations / 2019 ASCO (Free ASCO Whitepaper) Annual Meeting – poster

About the O-12-M1 Clinical Trial
O?12?M1 is a Phase 1/2 study with melflufen plus dexamethasone in 62 patients with RRMM who had ≥2 prior lines of therapy, prior exposure to at least an IMiD and a proteasome inhibitor, and disease progression on last line of therapy. Final study results were presented at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

Summary of O-12-M1 Data
At the time of data cutoff on November 9, 2017, 45 patients had been treated with 40 mg melflufen and dexamethosone. Median age was 66 years (47-78). 60% of patients were ISS stage II/III and 44% were high-risk cytogenetics. Patients had four median prior lines of therapy, with 91% of patients being single refractory, 67% of patients double refractory and 7% triple refractory. Further, 53% of patients were alkylator refractory. At data cutoff, 44 pts (98%) discontinued melflufen + dexamethasone, mainly due to adverse events (40%) and PD (31%). 27 patients received subsequent therapy. Median time from start of melflufen and dexamethasone to first subsequent therapy or death (TTNT), whichever occurred first, was 7.9 months (95% CI: 5.68-11.01). The majority of patients’ (52%) next therapy was single-agent with or without steroid therapy, and approximately half of patients receiving subsequent therapy (44%) received at least two subsequent lines of therapy.

Table: TTNT with Melflufen in O-12-M1 and Other Agents in RRMM

TTNT with Melflufen in O-12-M1

For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 (0)8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 (0)70 853 72 92

This information was submitted for publication at 15.00 CET, June 3, 2019

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On June 3, 2019 Novartis reported new data and clinical trial updates in NSCLC at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. This includes primary efficacy results from the GEOMETRY mono-1 Phase II clinical trial demonstrating that investigational MET inhibitor capmatinib (INC280) shows promise as a potential treatment option for patients with locally advanced or metastatic NSCLC that harbor MET exon-14 skipping mutation (Press release, Novartis, JUN 3, 2019, View Source [SID1234536809]). There are currently no approved targeted therapies to treat this particularly aggressive form of NSCLC. Results of the Phase II study will be presented at an oral session today at ASCO (Free ASCO Whitepaper), June 3, 2019, at 8:00 a.m. CDT (Abstract #9004)[1].

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GEOMETRY mono-1 is an international, prospective, multi-cohort, non-randomized, open-label study evaluating 97 adult patients with locally advanced or metastatic NSCLC harboring MET exon-14 skipping mutation who received capmatinib tablets 400 mg orally twice daily. Primary efficacy results among treatment-naive patients (Cohort 5b: 28 patients) were a 68% overall response rate (ORR) based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1 (95% CI: (47.6 – 84.1)). Forty-one percent of previously treated NSCLC patients (Cohort 4: 69 patients) also responded (95% CI: (28.9 – 53.1)). Data on median duration of response (DOR), a key secondary endpoint, was 11.14 months (95% CI: (5.55 – NE)) and 9.72 months (95% CI: (5.55 – 12.98)), respectively. Intracranial activity in 54% (n=7/13) of patients, including some cases of complete resolution of brain lesions, was also observed by ad hoc neuro-radiologist review in patients with brain lesions. All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response.

The most common treatment related adverse events (AE) (>=10% all grades) across all cohorts (n=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%); the majority of the AEs were grades 1/2.

"New lung cancer treatment options are critical, as this deadly disease affects more than 2 million new patients around the world each year," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. "The GEOMETRY mono-1 results are encouraging, and we look forward to discussing these results with health authorities with the hope of bringing this targeted treatment option to people with this aggressive type of lung cancer."

Capmatinib Granted Orphan Drug and Breakthrough Therapy Designation Status
The U.S. Food and Drug Administration recently granted capmatinib Breakthrough Therapy Designation for patients with metastatic NSCLC harboring MET exon-14 skipping mutation with disease progression on or after platinum-based chemotherapy. Previously, both the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency recognized capmatinib with Orphan Drug status. It is estimated that 3% to 4% of all patients with NSCLC have an identified MET mutation[3].

"The efficacy observed with capmatinib in the GEOMETRY mono-1 trial is promising," said Juergen Wolf, MD, University Hospital, Cologne. "In addition to positive overall response rate among first-line patients with the MET mutation, the duration for the responses, including the activity in the brain, and capmatinib’s safety profile are important milestones for this patient population. As a group, patients with MET mutated NSCLC often require special clinical considerations, as they are generally older and with poor prognosis further limiting their treatment options."

About GEOMETRY mono-1
GEOMETRY mono-1 is an international, prospective, multi-cohort, non-randomized, open-label Phase II study to evaluate the efficacy and safety of single-agent capmatinib (INC280) in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring MET amplification and/or mutations. Patients with locally advanced or metastatic NSCLC harboring MET exon-14 skipping mutation (centrally confirmed) were assigned to Cohorts 4 (previously treated patients) or 5B (treatment-naive), regardless of MET amplification/gene copy number, and received 400 mg capmatinib tablets orally twice daily. The primary endpoint was ORR based on the BIRC assessment per RECIST v1.1. The key secondary endpoint was duration of response (DOR) by the BIRC. The GEOMETRY mono-1 study found an ORR in the treatment-naive patients (n=28) of 67.9% (95% CI: 47.6 – 84.1) and an ORR of 40.6% (95% CI: 28.9 – 53.1) in the previously treated patients (n=69). Median DOR was 11.14 months (95% CI: 5.55-NE) in treatment-naive patients and 9.72 months (95% CI: 5.55-12.98) in previously treated patients[1].

The most common treatment-related AEs included peripheral edema, nausea, creatinine increase and vomiting. Of patients treated with capmatinib, 84% experienced an AE, with 36% having grade 3/4 AEs (only 4.5% were Grade 4)[1].

Capmatinib (INC280) is an investigational, oral and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

Studying Tumor-Promoting Inflammation in Lung Cancer – Ongoing CANOPY Trials
Trials in Progress (TiP) updates on the CANOPY clinical program were also included in the ASCO (Free ASCO Whitepaper) updates. CANOPY is made up of three randomized, double-blind and placebo-controlled Phase III trials evaluating canakinumab (ACZ885), a selective IL-1ß inhibitor (Abstract #TPS9124) [4],[5].

CANOPY-A is a Phase III multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of canakinumab as adjuvant therapy in adult subjects with stages II-IIIA and NSCLC following complete surgical resection. The primary endpoint is disease-free survival (Abstract #7013).
CANOPY-1 is a randomized, double-blind, placebo-controlled, Phase III study investigating canakinumab versus placebo in combination with platinum-based chemotherapy (CTx) and pembrolizumab in previously untreated patients with stage IIIB/IIC-IV squamous and non-squamous NSCLC. The study will evaluate the incidence of dose-limiting toxicity (DLT) in the first 42 days of treatment, as well as PFS and overall survival (OS).
CANOPY-2 is a randomized, double-blind, placebo-controlled, Phase III study investigating canakinumab or placebo plus docetaxel in stage IIIB-IV NSCLC patients previously treated with PD-1 or PD-L1 inhibitors, as well as CTx. The primary endpoints are incidence of DLT in the first 42 days of treatment and OS.
Novartis Commitment to Lung Cancer
Worldwide, lung cancer causes more deaths than colon, breast and prostate cancer combined, and more than 2 million new cases of lung cancer are diagnosed each year[2]. Despite treatment advances, patients with NSCLC still have a poor prognosis and limited treatment options. This includes the nearly 70% of NSCLC patients who have a genomic mutation that may be targeted with available therapies[6]. To determine the most appropriate treatment, medical organizations recommend genomic testing for patients with lung cancer[7].

Novartis Oncology’s research has helped transform treatment approaches for patients living with NSCLC. Novartis continues its commitment to the global lung cancer community through ongoing studies, as well as the exploration of investigational compounds in NSCLC, including those that target genetic biomarkers and tumor promoting inflammation.