On November 5, 2019 PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical-stage biotechnology company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported the presentation of new preclinical data from its wholly-owned immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, Md (Press release, PureTech Health, NOV 5, 2019, View Source [SID1234550362]).

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The two scientific posters detail the Company’s continued progress in advancing two fully human monoclonal antibodies (mAbs) developed to inhibit two foundational immunosuppressive orchestrators, galectin-9 (LYT-200) and pathogenic gamma delta-1 (γδ1) T cells (LYT-210).

"These data further show the unique position and importance of galectin-9 and γδ1 as immunosuppressors in cancer biology. Both have been observed to have powerful properties to disable immune-mediated cancer attack, which may explain some of the fundamental efficacy limitations of other immuno-oncology therapies," said Joseph Bolen, PhD, chief scientific officer at PureTech. "Our novel antibodies targeting galectin-9 and γδ1 have produced compelling single-agent preclinical data against a number of difficult-to-treat cancers in models where approved immunotherapies haven’t worked. We are excited to share our continued progress with the scientific community at premier conferences such as SITC (Free SITC Whitepaper)."

The new data presented at SITC (Free SITC Whitepaper) indicate that galectin-9 is not only a potent therapeutic target, but also a potentially relevant biomarker. Across multiple cohorts, galectin-9 was significantly increased in blood samples of individuals with primary and metastatic pancreatic cancer, lung tumors, and colorectal carcinoma, compared to healthy individuals.

"These findings validate the importance of galectin-9 in cancer biology and its potency as a target," said George Miller, MD, Director of S. Arthur Localio Laboratories and Director of the Cancer Immunology Program at NYU School of Medicine and a PureTech collaborator. "Our research indicates that galectin-9 is a master immunosuppressor; it induces a highly favorable microenvironment for tumor growth. LYT-200 has potential both as a single agent and in combination with checkpoint inhibitors to have therapeutic potential by reversing the immunosuppression which can be present in the tumor microenvironment."

PureTech expects to file an Investigational New Drug application (IND) for LYT-200 in the first half of 2020 and to initiate a Phase 1a/1b clinical trial in solid tumors in 2020. The mAb has been tested as a single agent as well as in combination with anti-PD1 checkpoint inhibitors in preclinical murine and human-derived ex vivo models, showing robust and reproducible activity, immune activation potential as well as excellent drug properties.

PureTech also presented data on its monoclonal antibody LYT-210 that targets γδ1 T cells whose immunosuppressive features leads to a tumor permissive microenvironment. The research presented at SITC (Free SITC Whitepaper) showed that γδ1 T cells were the most abundant T cell within the studied tumors, which included pancreatic, colorectal, cholangiocarcinoma, and liver cancer, and represented up to 50% of all infiltrating T cells. PureTech also presented data showing that LYT-210 depletes immunosuppressive γδ1 T cells through cytotoxicity and phagocytosis. Together, these findings further support the ability of LYT-210 to potentially restore the immune system’s ability to fight difficult-to-treat cancers. PureTech expects to file an IND for LYT-210 in 2021 for solid tumors.

"These data show that γδ1 cells play a key role in suppressing the immune system’s ability to attack tumors. LYT-210 is designed to remove and destroy pathogenic γδ1 T cells enabling immune mediated cancer attack. We therefore believe LYT-210 holds significant promise as a potential immunotherapy," said Dr. Miller.

On November 5, 2019 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a leading U.S.-based multi-platform clinical-stage gene therapy company, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket is scheduled to present on Wednesday, November 13, 2019, at 2:15 p.m. Eastern Time at the Barclays Gene Editing & Gene Therapy Summit, New York, N.Y (Press release, Rocket Pharmaceuticals, NOV 5, 2019, View Source [SID1234550361]).

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On November 5, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported financial results for the three months ended September 30, 2019 and provided a business update (Press release, Seres Therapeutics, NOV 5, 2019, View Source [SID1234550360]).

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"Seres continues to advance our microbiome programs, and the Company is well resourced to reach important corporate milestones in 2020, including two late-stage clinical readouts: SER-287 Phase 2b study in mild-to-moderate ulcerative colitis and SER-109 Phase 3 study in recurrent C. difficile infection," said Eric D. Shaff, President and Chief Executive Officer at Seres. "We are very pleased that our SER-109 ECOSPOR III study is now approaching target enrollment. SER-109 could provide patients with a meaningful new treatment option and also provide definitive clinical validation for our microbiome therapeutic approach. We are eagerly looking forward to top-line results from both of these important programs."

Program Updates and Corporate Highlights

SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an orally-administered, biologically-derived, live microbiome therapeutic candidate designed to modulate the gastrointestinal microbiome of individuals with ulcerative colitis. Seres continues to enroll the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis. The SER-287 Phase 2b ECO-RESET study is expected to enroll approximately 201 patients. Based on U.S. Food and Drug Administration feedback, Seres expects that with positive Phase 2b study results, the study could serve as one of two pivotal trials to enable a SER-287 Biologics License Application submission. Seres expects Phase 2b ECO-RESET study top-line results in the second half of 2020.
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an orally-administered, biologically-derived, live microbiome therapeutic candidate designed to restore the depleted, or dysbiotic, gastrointestinal microbiome of patients with recurrent C. difficile infection. The Company continues to enroll the ECOSPOR III trial, which is evaluating efficacy and safety in 188 patients with recurrent C. difficile infection. All patients enrolled in ECOSPOR III are required to test positive for C. difficile cytotoxin to ensure enrollment of only patients with an active C. difficile infection. As of October 31, ECOSPOR III was more than 85% enrolled, and top-line study results are expected in mid-2020.
SER-301 preclinical candidate for ulcerative colitis: The Company has nominated the lead candidate for SER-301, a rationally-designed, live microbiome therapeutic for ulcerative colitis. Next-generation, rationally-designed microbiome therapeutics may provide important benefits that include the optimization of pharmacological properties for target diseases and streamlined manufacturing. The consortia of bacteria in SER-301 are designed to modify the microbiome and microbe-associated metabolites in the gastrointestinal tract to modulate ulcerative colitis-relevant anti-inflammatory and immune pathways and to improve epithelial barrier integrity. SER-301 incorporates species associated with clinical efficacy in prior Seres human studies. Further, bacterial species selected for inclusion in SER-301 have been confirmed to engraft across human subjects. The consortia has demonstrated the capacity to modulate disease-relevant cellular mechanisms in human cell-based screening assays and in vivo models. Seres is entitled to a $10 million milestone payment associated with the SER-301 Phase 1 clinical study from its ongoing collaboration with Nestlé Health Science. Seres expects to initiate clinical development in early 2020.
SER-401 Phase 1b in metastatic melanoma: SER-401 is an orally-administered, biologically-derived, live microbiome therapeutic candidate comprising bacteria that reflect the bacterial signature in the gastrointestinal microbiome associated with response to checkpoint inhibitor immunotherapy. The ongoing Phase 1b study, supported by the Parker Institute for Cancer Immunotherapy and The University of Texas MD Anderson Cancer Center, will evaluate the potential for SER-401 to improve clinical response to nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy, and will evaluate tumor biopsies and various biomarkers. Seres expects to obtain SER-401 Phase 1b preliminary study results in the second half of 2020.
New debt financing: Seres entered into a debt financing agreement with Hercules Capital in October 2019 that provides the Company with up to $50 million in additional capital. The Company received a first tranche of approximately $25 million following the agreement closing. Two subsequent tranches of $12.5 million each would become available to the Company upon the achievement of certain milestones.
Financial Results
Seres reported a net loss of $16.4 million for the third quarter of 2019, as compared to a net loss of $21.9 million for the same period in 2018. The third quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company’s microbiome therapeutics platform. The third quarter net loss figure was inclusive of $7.0 million in recognized revenue associated primarily with the Company’s collaborations with Nestlé Health Science and AstraZeneca.

Research and development expenses for the third quarter of 2019 were $18.3 million, as compared to $23.7 million for the same period in 2018. The research and development expense was primarily related to Seres’ late stage SER-109 and SER-287 clinical development programs.

General and administrative expenses for the third quarter of 2019 were $5.9 million, as compared to $7.6 million for the same period in 2018. General and administrative expenses were primarily due to headcount, professional fees and facility costs.

Seres ended the third quarter with approximately $83.8 million in cash, cash equivalents and investments. This amount does not include the $25 million in debt capital obtained in October 2019.

Cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential incoming milestone payments, into the second quarter of 2021.

Conference Call Information
Seres’ management will host a conference call today, Nov. 5, 2019 at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 3577505. To join the live webcast, please visit the "Investors and Media" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On November 5, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its third quarter 2019 financial results on Tuesday, November 12, 2019 (Press release, Gossamer Bio, NOV 5, 2019, View Source [SID1234550359]).

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In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 4:30 p.m. ET on Tuesday, November 12, 2019 to discuss the Company’s financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source Alternatively, the conference call may be accessed through the following:

Conference ID: 1981058
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

On November 5, 2019 BioLineRx Ltd. (NASDAQ: BLRX) and (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported results of a Phase 2b trial assessing the efficacy of BL-8040 in combination with KEYTRUDA (pembrolizumab) for the treatment of metastatic pancreatic cancer (Press release, BioLineRx, NOV 5, 2019, View Source [SID1234550358]). The data demonstrated that the dual combination shows clinical activity in heavily pretreated patients. The results of this investigator-sponsored study will be presented by MD Anderson Cancer Center in a poster titled, "A phase IIB study of Pembrolizumab plus BL-8040 in metastatic pancreatic cancer: Clinical outcomes and biological correlates," at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting, which is being held November 6-10, 2019 in National Harbor, Maryland.

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"These promising data demonstrate that the dual combination of BL-8040 and KEYTRUDA shows encouraging clinical activity even in an extremely challenging patient population of heavily pretreated pancreatic cancer patients. The results confirm similar findings, as measured by disease control and extended overall survival, from the dual combination arm of the Phase 2a COMBAT/KEYNOTE-202 study previously announced, thus reaffirming the strong rationale for continued development," said Philip Serlin, Chief Executive Officer of BioLineRx. "We are now eagerly looking forward to announcing results from the ongoing triple combination arm of the COMBAT/KEYNOTE-202 study, investigating the effect of BL-8040, KEYTRUDA and chemotherapy on metastatic pancreatic cancer patients, by the end of the year. We are rapidly approaching this important data milestone, and believe that BL-8040 as part of a combination regimen could represent a significant advancement in the treatment of pancreatic cancer."

This open-label Phase 2b study, under a clinical collaboration between BioLineRx and MD Anderson Cancer Center, enrolled 20 metastatic pancreatic cancer patients who progressed after at least one prior line of chemotherapy. Patients were treated for two weeks with BL-8040 as a single agent (1.25 mg/kg) followed by 3-week cycles of BL-8040 (days 1, 4, 8 and 11) in combination with pembrolizumab (day 1). Biopsies for tumor biology were performed before treatment, after BL-8040 monotherapy (optional), and after the drug combination. Top of Form

Of the 20 patients enrolled, 15 were evaluable for the primary endpoint of radiologic response. Of these 15 evaluable patients, one patient showed a partial response, two patients had stable disease and 12 patients experienced disease progression, resulting in a disease control rate of 20%. The overall median time to progression was two months, while the median time to progression for patients showing disease control was seven months. Median overall survival was seven months, while median survival for the patients showing disease control was 12 months. The combination was generally well tolerated with injection site discomfort being the most commonly reported adverse event. Four patients experienced grade 3 toxicities and one patient had a grade 4 dyspnea.

In addition to the improved survival, tumor biopsies showed greater infiltration of T cells, especially cytotoxic CD8+ T cells, into the tumor niche in patients who demonstrated clinical benefit, compared with patients that experienced disease progression.

About BL-8040

BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers. CXCR4 has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and preclinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.