On September 4, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported the following two new additions to its senior leadership team (Press release, Synlogic, SEP 4, 2019, View Source [SID1234539307]):

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Richard Riese, M.D., Ph.D., has been appointed to the position of Chief Medical Officer, and will assume responsibilities from current president and CEO, Aoife Brennan, M.B., Ch.B.
Michael Slater, a former consultant to the Company, has been appointed to Head of Regulatory Affairs.
Separately, the company is announcing the departure of Todd Shegog, Chief Financial Officer, effective September 18, 2019.

"Richard and Michael bring expertise and many years of experience across all phases of clinical development in a broad range of rare and immunologically-based diseases, which will be key to Synlogic’s success as we advance and expand our Synthetic Biotic therapeutic platform," said Dr. Brennan. "We are excited to welcome them both to the team and look forward to their contributions."

"Synlogic is a leader in developing engineered bacteria as living medicines and has demonstrated its ability to advance these novel therapeutics into clinical trials," stated Dr. Riese. "I believe that its Synthetic Biotic platform has the potential to provide a novel therapeutic solution to address unmet medical need in a variety of conditions and I look forward to advancing this exciting new therapy to patients."

Dr. Riese is a physician scientist with over 15 years of experience in the pharmaceutical industry. He most recently served as Vice President, Clinical Development at Alnylam where he led clinical development projects in several areas across Alnylam’s rare disease portfolio. Previously, he served as head of Translational Clinical Sciences in the Research Unit at Alexion, where he was responsible for the clinical development strategy of all compounds from discovery to proof-of-concept. He earned a Ph.D. in biophysics and an M.D. from the Medical College of Wisconsin, and a B.S. in mathematics from the University of Wisconsin-Madison. Dr. Riese carried out postdoctoral research at the Medical College of Wisconsin and his residency training in internal medicine at Brigham and Women’s Hospital in Boston. Dr. Riese achieved certification by the American Boards of Pulmonary Medicine, Critical Care Medicine and Internal Medicine.

Mr. Slater is a senior level regulatory professional with more than 25 years of experience including hands-on preclinical and clinical regulatory strategy development from pre-investigational new drug (IND) application through drug approval. Mr. Slater was the Head of Regulatory Affairs and later, Development Operations at Merrimack Pharmaceuticals from 2010 to 2019. At Merrimack, Mr. Slater led the regulatory strategy resulting in the 2015 U.S. approval of Onivyde (irinotecan liposome injection), an orphan drug for the treatment of metastatic pancreatic cancer. In addition, he worked with Baxalta who acquired certain ex-US rights to Onyvide, to achieve approval in Europe and other countries. Prior to Merrimack, Mr. Slater held various regulatory roles in several biotech and pharmaceutical companies, including Millennium Pharmaceuticals, Acusphere, Inc., Anika Therapeutics, Inc., ImmuLogic Pharmaceuticals, Biogen and Hoechst Pharmaceuticals. With a background in applied biology, Mr. Slater also holds a B.Sc. in information science from Leeds Beckett University, UK. and is a Fellow of The Organization for Professionals in Regulatory Affairs.

In addition, the Company is announcing the departure of Todd Shegog, Chief Financial Officer, who is leaving the company to pursue another opportunity. The Company has commenced a search for a new CFO.

"I also want to take the opportunity to thank Todd for his contributions at Synlogic over the past three years, including leading us through the process of becoming a public company, and establishing a strong financial team and our internal controls and financial operations," said Dr. Brennan. "We have appreciated his leadership and wish him all the best in his future endeavors."

On September 4, 2019 AstraZeneca reported that it has received marketing authorisation from China’s National Medical Products Administration (NMPA) for Tagrisso (osimertinib) as a 1st-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions (Press release, AstraZeneca, SEP 4, 2019, View Source [SID1234539258]).

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The approval followed the Priority Review Pathway and is based on results from the Phase III FLAURA trial, which were published in The New England Journal of Medicine.

Dave Fredrickson, Executive Vice President, Oncology, said: "The FLAURA trial has demonstrated the potential of Tagrisso as a new standard of care and as an important new 1st-line treatment option for non-small cell lung cancer patients in China, where approximately 30-40% are diagnosed with an EGFR mutation – more than any other country in the world."

In the FLAURA trial, 1st-line use of Tagrisso provided a statistically-significant and clinically- meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death by a median of 18.9 months versus 10.2 months for those taking standard EGFR tyrosine kinase inhibitor (TKI) medicines (HR 0.46 [95% CI, 0.37-0.57], p<0.0001). This benefit was consistent across all patient subgroups including those with central nervous system (CNS) metastases.

Phase III FLAURA trial efficacy results according to investigator assessment

Tagrisso

(N=279)

EGFR TKI

(gefitinib or erlotinib)

(N=277)

Progression-free survival

Median PFS

(95% confidence interval [CI])

18.9 months

(15.2, 21.4)

10.2 months

(9.6, 11.1)

Hazard ratio (95% CI)

0.46 (0.37-0.57)

P-value

P<0.0001

Response rate*

Overall response rate*

(95% CI)

77%

(71, 82)

69%

(63, 74)

Complete response

2%

1%

Partial response

75%

68%

Duration of response (DoR)*

Median DoR

(95% CI)

17.6 months

(13.8, 22.0)

9.6 months

(8.3, 11.1)

*Confirmed responses.

AstraZeneca recently announced that Tagrisso additionally showed a statistically-significant and clinically-meaningful improvement in overall survival in this patient population.

Safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3 or higher adverse events (AEs) occurring in 34% of patients taking Tagrisso versus 45% in the comparator arm. The most common AEs in patients treated with Tagrisso were diarrhoea (58%), rash (58%), dry skin (36%), nail toxicity (35%), stomatitis (29%), fatigue (21%) and decreased appetite (20%).

Tagrisso was approved in China in March 2017 and added to the National Reimbursement Drug List (NRDL) effective from January 2019 for the 2nd-line treatment of adult patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed on or after EGFR-TKI therapy.

About lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.1 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC.2 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC.3-5 These patients are particularly sensitive to treatment with EGFR-TKIs which block the cell-signalling pathways that drive the growth of tumour cells. Approximately 25% of patients with EGFRm NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis.6 The presence of brain metastases often reduces median survival to less than eight months in patients not treated with Tagrisso.7

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.

Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in 75 countries, including the US, Japan, China and the EU, for 1st-line EGFRm advanced NSCLC, and in 84 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the adjuvant setting (ADAURA trial), in the locally-advanced unresectable setting (LAURA), in combination with chemotherapy in the advanced setting (FLAURA2), and with potential new medicines, including savolitinib in the Phase II trials SAVANNAH and ORCHARD.

About FLAURA

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. The trial was double-blinded and randomised, with 556 patients across 29 countries.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso, and ongoing Phase III trials ADAURA, LAURA, FLAURA and FLAURA2 as well as the Phase II combination trials SAVANNAH and ORCHARD.3-5

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents approximately three-quarters of all patients with lung cancer.8,9 Imfinzi (durvalumab), an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON, PEARL, and CASPIAN) and for patients in earlier stages of disease including potentially-curative settings (Phase III trials AEGEAN, PACIFIC-2, ADRIATIC, ADJUVANT BR.31, PACIFIC-4, and PACIFIC-5) and both as monotherapy and in combination with tremelimumab and/or chemotherapy.

About AstraZeneca in oncology

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

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

On September 4, 2019 Tiziana Life Sciences plc (NASDAQ: TLSA), a biotechnology company focusing on the discovery and development of innovative therapeutics for inflammation and oncology indications, reported additional positive Phase 2a clinical data exhibiting impressive clinical activity of Milciclib monotherapy in patients with advanced Sorafenib-resistant or -intolerant patients with unresectable or metastatic hepatocellular carcinoma (HCC) (Press release, Tiziana Life Sciences, SEP 4, 2019, View Source [SID1234539274]).

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This Phase 2a multi-center, single-arm, repeated-dose (100 mg once daily; 4 days on/3 days off for 4 weeks; defining each cycle) and 6-month duration study was conducted to evaluate the safety, tolerability and anti-tumor activity of Milciclib in Sorafenib-resistant patients with unresectable or metastatic advanced HCC. The trial enrolled 31 patients in Italy, Greece and Israel, of which 28 patients were evaluable. While the primary endpoint of this study was overall safety, secondary endpoints were also evaluated.

As previously announced on 22 July 2019, the clinical data from the Phase 2a trial indicated that Milciclib was well tolerated with manageable toxicities and no recorded drug related deaths, thereby meeting the trial’s primary endpoint. The Company now announces all the major highlights of the clinical data from the trial, which also indicate positive clinical activity relating to the secondary endpoints including progression-free survival ("PFS") and time to progression ("TTP").

MAJOR HIGHLIGHTS OF THE CLINICAL DATA

As per the study protocol, data collection was limited to 6-months. Thus, clinical data were not collected from patients under compassionate use treatment. The clinical activity assessment in evaluable patients was based on the investigators’ review using the modified Response Evaluation Criteria in Solid Tumors (mRECIST).

14 out of 28 (50%) evaluable patients completed 6-month duration of the trial.
9 out of 14 patients (64.2%) were approved by their respective ethical committees to continue the treatment.
5 of the 9 patients on compassionate use had received Milciclib for a total of 9, 9, 11, 13 and 16 months.
As of 1 September 2019, the remaining 4 patients continuing the treatment are in their 10th, 11th, 11th and 12th months.
Both median TTP and PFS were 5.9 months (95% Confidence Interval ("CI") 1.5-6.7 months) out of the 6-months duration of the trial.
17 of 28 (60.7%) evaluable patients showed ‘Stable Disease’ (SD; met at least once in an 8-week interval).
One patient (3.6%) showed ‘Partial Response’ (PR).
18 of 28 (64.3%) evaluable patients showed ‘Clinical Benefit Rate’ defined as CBR=CR+PR+SD (with CR representing Complete Remission).
Sorafenib (Bayer) was approved, based on the clinical data from the pivotal Phase 3 (SHARP) clinical trial1, as the first line therapy for naive HCC patients. The clinical data from that study showed median TTP of 5.5 months (95% CI 4.1-6.9 months), CBR of 43% and 71% SD by RECIST criteria1. Conversely, the clinical data from a phase 2 trial with Sorafenib in patients with advanced HCC, showed SD (33.6%), TTP of 4.2 months and median OS of 9.2 months2.

Regorafenib was approved, based on the clinical data from the pivotal Phase 3 (RESORCE) clinical trial3, as the second line therapy for sorafenib-resistant HCC patients. In this study, Regorafenib showed median PFS of 3.1 months (95% CI 2.8-4.2 months), median TTP of 3.2 months (95% CI 2.9-4.2 months) and disease control rate (DCR, similar to CBR) of 65% by mRECIST. On the other hand, the clinical data from a Phase 2 study in patients with intermediate and advanced HCC, Regorafenib showed median TTP of 4.3 months (95% CI 2.9-13.1 months), SD (69%) and PR was 3%4.

"The current therapies for HCC are often associated with severe toxicities, resulting in poor patient compliance. Hence, there is an immediate need for efficacious therapies that will not compromise patients’ quality of life. We believe that the overall safety profile of Milciclib is an important competitive advantage over existing therapies currently used for treating HCC" said Gabriele Cerrone, Chairman and founder of Tiziana Life Sciences.

"The positive clinical activity and tolerability data of Milciclib in Sorafenib-resistant and advanced HCC patients are very encouraging and provides affirmation for continued development of Milciclib, either as monotherapy or combination therapy" said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana. "We reported last year at AASLD that Milciclib produced pronounced synergistic anti-HCC activity in combination with any one of the FDA approved tyrosine kinase inhibitor (TKI) class of drugs, including Sorafenib (Nexavar), Regorafenib (Stivarga), and Lenvatinib (Lenvima)5. Thus, we believe that Milciclib in combination with any one of the TKI drugs has good potential to expand the Clinical Benefit Rate in HCC patients."

Cited References

1. Llovet, J., Ricci, S., Mazzaferro, V., Hilgard, P., Gane, E., Blanc, J-F., de Oliveira, A., Santoro, A., Raoul, J-L, Forner, A., Schwartz, M., Porta, C., Zeuzem, S., Bolondi, L., Greten, T., Galle, P., Seitz, J-F., Borbatch, I., Haussinger, D., Giannaris, T., Shan, M., Moscovici, M., Voliotiz, D., and J. Bruix. (2008) Sorafenib in Advance Hepatocellular Carcinoma. N Engl. J Med. 359:378.

2. Abou-Alfa, G., Schwartz, L., Ricci., S., Amadori, D., Santoro, A., Figer, A. De Greve, J., Douillard, J-Y., Lathia, C., Schwartz, B., Taylor, I., Moscovici, M. and L. Saltz. (2006). Phase II Study of Sorafenib in Patients with Advanced Hepatocellular Carcinoma. J. Clin. Oncol. 24:4293.

3. Bruix, J, Qin, S., Merle, P., Granito, A., Huang, Y-H, Bodoky, G., Pracht, M., Yokosuka, O., Rosmorduc, O., Breder, V., Gerolami, R., Masi, G., Ross, P., Song, T., Bronowicki, J-P., Ollivier-Hourmand, I., Kudo, M., Cheng, A-L., Llovet, J.M., Finn, R., LeBerre, M-A., Baumhauer, A., Meinhardt, G. and Han, G. (2017) Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet 389: 56.

4. Bruix, J., Tak, W-Y., Gasbarrini, A., Santoro, A., Colombo, M., Lim, H-Y., Mazzaferro, V., Wiest, R., Reig, M., Wagner, A., and Bolondi, L.(2013) Regorafenib as Second-Line Therapy for Intermediate or Advanced Hepatocellular Carcinoma: Multicentre, Open-Label Phase II Safety Study. Eur.J. Cancer 49:3412.

5. Jindal, A., Palejwala, V. and Shailubhai, K. (2018). Oral treatment with milciclib either alone or in combination with sorafenib inhibited tumor growth in an orthotopic model of hepatocellular carcinoma. Hepatology 68 Number 1 (Suppl): 879A (Abstract 1543)

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

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On September 4, 2019 Accuray Incorporated (NASDAQ: ARAY) reported that the Company will host an Investor Meeting during the American Society of Radiation Oncology (ASTRO) Annual Meeting, being held in Chicago, IL (Press release, Accuray, SEP 4, 2019, View Source [SID1234539291]). The presentations will commence at 3:00pm CT (4:00pm ET/1:00pm PT) and will conclude at 5:30pm CT (6:30pm ET/3:30pm PT).

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The program will include presentations by Accuray’s senior management team and clinical key opinion leaders about the Company’s solutions for addressing today’s cancer challenges and will also include question and answer sessions. The topics being discussed include: Solutions for Today’s Market, the Radixact System and the advanced Synchrony Motion Tracking and Correction Technology1, the CyberKnife System and CyberKnife VOLO Optimizer Technology, and U.S. Reimbursement Developments.

Due to the limited space, guests must register to attend Accuray’s ASTRO investor meeting. Please RSVP to Michael Polyviou at [email protected] by Monday, September 9, 2019.

For those not attending the ASTRO meeting, a webcast will be available on the Investor Relations page of the Company’s website at View Source A replay of the webcast will also be available on the Company’s website following the event.

On September 4, 2019 ImaginAb Inc., a clinical-stage immuno-oncology imaging company, reported that it is scheduled to attend and / or present at the following investor and scientific conferences in September and October 2019 (Press release, ImaginAb, SEP 4, 2019, View Source [SID1234539259]).

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World Molecular Imaging Congress 2019

September 4-7, 2019, Palais des congrès de Montréal, Montréal, Canada

Dr. Anna Wu, Ph.D., Founder and Chief Scientific Officer, will be attending and hosting meetings.

ESMO Congress 2019

September 27 – 1 October, 2019, Fira Gran Via, Barcelona, Spain

Dr. Anna Wu and Dr Toni Ribas, Ph.D., ImaginAb Science Advisory Board Member and President-Elect for The American Association for Cancer Research (AACR) (Free AACR Whitepaper), will be attending and hosting meetings. In addition, ImaginAb’s commercial team led by Ivan Plavec, Chief Business Officer (CBO), will be hosting meetings and available at the ImaginAb Booth #477.

Cavendish Global Conference: The 2019 Phoenix BioHealth Impact Forum

October 2-3, 2019, University Of Arizona – Phoenix Biomedical Campus, Phoenix, AZ, USA

Ian Wilson, CEO, will be attending and hosting meetings.

2nd Annual Advances in Immuno-Oncology USA Congress

October 8-9, 2019, DoubleTree by Hilton Hotel, San Diego, CA, USA

Ian Wilson, CEO, will be chairing a Panel Discussion on ‘Technological Challenges In Clinical Studies’ on October 9 at 13.30 PDT, Room 4.

Ian Wilson will also be presenting a session on ‘Insights on Reverse Translation for Patient Stratification in Clinical Studies’ on October 9 at 16.30 PDT, Room 4.

This follows CBO Ivan Plavec’s Pre-Congress Webinar on August 29, 2019, entitled ‘How CD8 Imaging Is Useful To Pharma Regarding Drug Research And Clinical Decision Making’ which is available to download here.

Optimum 11th Annual Healthcare Investor Conference

October 17, 2019, Bloomberg Headquarters, 3 Queen Victoria St, London, UK

Ian Wilson, CEO, will be attending and hosting meetings along with ImaginAb Board Director and Non-Executive Director at NICE, Tim Irish.

For further information please contact:

ImaginAb

Ian Wilson, Salli Walker
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications

Mary Clark, Supriya Mathur, Manel Mateus
Email: [email protected]
Phone: +44 20 3950 9144