On December 9, 2020 Biochain reported that There have been tremendous advances in cancer treatment since President Richard Nixon declared war on malignancies in 1971 (Press release, Biochain, DEC 9, 2020, View Source [SID1234572520]). Despite having treatments such as targeted radiation, estrogen blockers, and CAR-T cell immunotherapies, early detection of cancer remains one of the most important factors. For instance, the five-year relative survival rate for non-small cell lung cancer is 61% when cancer has not yet spread outside the lung. The survival rate drops to 35% once the cancer invades nearby structures, and to 6% once it metastasizes to other organ systems.

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However, early detection of cancer has proven easier said than done, and not without risks. When screening for cancer certain number of patients experience anxiety and undergo unnecessary invasive procedures based on false positives. While some cancers make for relatively easy screening such as cervical cancer via the Pap test, many cancers are inaccessible, and tissue biopsy too invasive for population-level screenings.

The oncologist’s objective is to come up with a less invasive way of screening the healthy population for specific and accurate indications of early-stage cancer. This motivated scientists to develop "liquid biopsy," where doctors hope to detect tumor-specific protein biomarkers or cancer-associated genetic mutations in circulating free DNA (cfDNA) blood samples.

In an article published in the journal Science, Johns Hopkins researchers Bert Vogelstein and Nickolas Papadopoulos and their colleagues appear to have done exactly that.

A leap in early cancer detection

A breakthrough was achieved using a liquid biopsy test called "DETECT-A" ̶̶ Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing ̶ which involved more than 9,911 women who had no history of cancer. The study used a multi-cancer blood test, to identify 26 undiagnosed cancers in 10 different organ systems: appendix, breast, colorectal, kidney, lung, lymphomas, ovary, thyroid, uterine and unknown primary site. The tumors were then localized using techniques such as PET-CT, a combination that was 99.6% specific.

Importantly, 17 of the cancers detected by the blood test were diagnosed at an early stage. Twelve of the 26 patients were in remission and eight were still in treatment or had stable disease nine months post-diagnosis.

This was a landmark result for the liquid biopsy field and the industry took note. A more advanced version of the multi-cancer blood test known as CancerSEEK had been licensed by Johns Hopkins to Thrive Earlier Detection Corp for development. On Oct. 27, Exact Sciences announced it would acquire Thrive for $2.15 billion.

Foundational technology

Although much of the liquid biopsy breakthrough has come from next-generation sequencing (NGS) and machine learning, the fundamentals of the field are still focused on an accurate and successful sampling process. If there is no adequate sample in the first place, no algorithm can support it. The DETECT-A study made use of the cfPure extraction kit from BioChain, a magnetic bead-based technology that demonstrated high yields in extracting cfDNA from blood plasma. "In order to get that cfDNA, you need to have the right tools," says BioChain’s Production and R&D Manager Dr. Franklin Chin, "and we have them. Our extraction kit is the first step in any research that involves cfDNA biomarker discovery"

The cfPure kits are available from BioChain in three different sizes for the extraction of a maximum of 250 ml of cfDNA from human plasma samples. The kit has two different versions: the original cfPure kit which maximizes yield, and the "V2," which minimizes carryover of genomic DNA into the final elution.

Dr. Bert Vogelstein and his colleagues used the original version of cfPure kits, and the fact that such pioneering researchers used BioChain’s technology in a groundbreaking study to process tens of thousands of samples is a source of pride for BioChain. "Dr. Vogelstein is one of the pioneers of liquid biopsy research," Chin says, "that he is using our kit is pretty big for us."

Detection of early-stage cancer using the DETECT-A test is just the first of many breakthroughs BioChain hopes their technology will enable. Beyond early diagnosis, for instance, there are efforts at precision tumor treatment and companion diagnostics, according to Chin. Many cancers are drug-resistant, and that resistance is based on their mutational profile. Pairing the cfPure kit with NGS using specific biomarker panels can help identify the mutational landscape for a patient, indicating the therapies best suited to treating their specific cancer.

Chin also hopes to see BioChain’s technology used in the creation of biomarker panels to help identify mutations with a strong correlation to oncogenesis. "You need to have a solid foundation," he says. "You need to collect as many samples as possible, analyze them, and come up with a panel of biomarkers." That will expand the reach and accuracy of liquid biopsy, and, ultimately, the success of cancer treatments. That’s something Chin and BioChain are excited to be a part of.

A menu of research solutions

Whatever your research needs, BioChain offers a cfPure cell-free DNA extraction kit providing market-leading yields for the best possible input for NGS or other processing.

BioChain also offers blood plasma and tissue samples for researchers who need inputs to develop and test their technologies and offers the cfPure cell-free DNA extraction process as a service for those who cannot perform the extractions themselves.

On December 9, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Breast Cancer Research reported an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors (Press release, Oncolytics Biotech, DEC 9, 2020, View Source [SID1234572519]).

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In the AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, early-stage breast cancer patients are treated with pelareorep, with or without atezolizumab (Tecentriq), plus an appropriate therapy for each patient’s breast cancer subtype, followed by surgery. The SABCS poster includes 17 out of the 20 HR+/HER2- breast cancer patients comprising the study’s first two cohorts, the targeted patient population for our intended phase 3 study. Treatment with pelareorep increased the CelTIL score in tumor biopsies, which has been associated with improved clinical outcomes. In addition, pelareorep treatment dramatically upregulated PD-L1 expression in the tumor microenvironment (TME). These findings highlight the potential of pelareorep to act synergistically with checkpoint inhibitors and also provides a basis for the near doubling of overall survival observed in a prior phase 2 trial when pelareorep was added to chemotherapy in HR+/HER2- breast cancer patients (link to PR, link to poster).

"AWARE-1 data demonstrate pelareorep’s consistent remodeling of the tumor immune environment," said Dr. Aleix Prat, M.D., Ph.D., Translational Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "Pelareorep seems to train the immune system to target cancer cells while simultaneously promoting tumor inflammation and priming a response to immune checkpoint blockade. This demonstrates pelareorep’s potential to overcome the immunosuppressive nature of the tumor microenvironment which could limit checkpoint inhibitor efficacy."

Key data and conclusions from the SABCS poster include:

72% of evaluated patients (n=18) saw an increase in CelTIL, the study’s primary endpoint that is associated with favorable clinical outcomes.
The maximum percentage increase in CelTIL (~300%) was achieved in a cohort 2 patient receiving pelareorep in combination with checkpoint blockade therapy.
On average, there was a 105-fold increase in TME PD-L1 expression (n=13) from baseline (pre-pelareorep administration) to surgery (21-days post-administration).
Tumor microenvironment PD-L1 expression increased in all evaluated patients (n=13).
Preliminary imaging mass cytometry analysis showed pelareorep treatment promoted broad anti-tumor changes in the TME, including enhanced CD8+ T cell activation and the recruitment of memory T cells.
Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "In the AWARE-1 study, pelareorep delivered consistent increases in tumor PD-L1 expression and recruitment of anti-cancer immune cells into tumors, as well as increases in CelTIL score for over 70% of the patients. This is highly encouraging given the association between CelTIL and clinical outcomes, and we hope to observe the same success from our phase 2 BRACELET-1 trial, which is exclusively enrolling HR+/HER2- breast cancer patients."

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, added, "Immune deserts or immunosuppressive tumor microenvironments limit tumor PD-L1 expression levels and thereby limit regulatory approval and commercial success of checkpoint inhibitors in certain breast and other malignancies. AWARE-1 data show that pelareorep can alter the tumor microenvironment and induce robust PD-L1 expression, highlighting the potential of pelareorep to boost the efficacy of checkpoint inhibitors and increase the proportion of patients eligible for these therapies. We expect this synergistic potential to enable the continued execution of our strategy to develop pelareorep-based therapies in collaboration with industry leaders."

The electronic poster, titled "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)" is available in the SABCS virtual poster hall and on the Posters & Publications page of Oncolytics’ website (LINK).

Ongoing ‘trial-in-progress’ posters giving an overview of Oncolytics’ IRENE and BRACELET-1 study designs were also presented at SABCS and are available at the same locations.

About AWARE-1

AWARE-1 is an open-label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep, with or without atezolizumab, and the standard of care therapy according to breast cancer subtype. Patients are biopsied as part of their initial breast cancer evaluation, then again on day three following initial treatment, and a final tissue sample after three weeks, on the day of their mastectomy. Data generated from this study are intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to View Source

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On December 9, 2020 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the pricing of an underwritten public offering of 25,652,174 shares of its common stock at a public offering price of $5.75 per share for total gross proceeds of approximately $147.5 million (the "Offering") (Press release, Curis, DEC 9, 2020, View Source [SID1234572518]). Curis has granted the underwriters a 30-day option to purchase up to an additional 3,847,826 shares of common stock on the same terms and conditions. The Offering is expected to close on or about December 11, 2020, subject to customary closing conditions.

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Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC are acting as joint book-runners for the Offering. H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. are acting as co-lead managers for the Offering.

Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.

The securities in the Offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018 and an additional registration statement on Form S-3 (File No. 333-224627) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these 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 December 9, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that data from the front-line triple negative breast cancer (TNBC) cohort from the ongoing MARIO-3 clinical trial was presented during the 2020 San Antonio Breast Cancer Symposium (SABCS) (Press release, Infinity Pharmaceuticals, DEC 9, 2020, View Source [SID1234572517]). MARIO-3 is the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination in the front-line setting with atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) in patients with unresectable locally advanced or metastatic TNBC.

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"These promising initial data suggest that the addition of eganelisib to atezolizumab and nab-paclitaxel has the potential to provide improved patient outcomes in front-line triple negative breast cancer," said Erika Hamilton, M.D., Program Director, Breast Cancer and Gynecologic Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, and MARIO-3 Lead Study Investigator. "The tumor reduction seen, irrespective of PD-L1 status, combined with eganelisib’s safety and tolerability profile, which demonstrated no new or additive safety signals, suggest that eganelisib has potential as a new treatment option for advanced TNBC patients."

Brian Schwartz, M.D., consulting Chief Physician of Infinity Pharmaceuticals, said, "We are particularly excited to report that the addition of eganelisib to treatment with atezolizumab and nab-paclitaxel has led to very encouraging overall response rates of 100% in PD-L1 positive patients and 50% in PD-L1 negative patients. This is important because, while the accelerated approval of combination therapy of atezolizumab and nab-paclitaxel as a front-line treatment for PD-L1 positive patients is an important step in addressing the severe unmet need in TNBC, this type of breast cancer remains an aggressive and difficult-to-treat disease, and more treatment options are needed particularly in PD-L1 negative setting. We also continue to be pleased by the safety and tolerability profile of the 30mg dose of eganelisib in multiple combinations including in MARIO-3. These data suggest that this novel triplet regimen may be broadly beneficial across patient populations in TNBC, including PD-L1 negative patients with limited treatment options and poor outcomes. In addition, the translational data from the study are highly consistent with prior results from MARIO-1, which together are supportive of the unique immune modulating activity of eganelisib across multiple indications. These strong, early data leave us increasingly confident in the potential of eganelisib in TNBC, and we look forward to continued progress and execution in the ongoing MARIO-3 study."

Key presentation highlights:

Poster presentation titled, "MARIO-3 phase II study initial data evaluating a novel triplet combination of eganelisib (IPI-549), atezolizumab (atezo), and nab-paclitaxel (nab-pac) as first-line (1L) therapy for locally advanced or metastatic triple-negative breast cancer (TNBC)" presented by Erika Hamilton, M.D.

100% of evaluable patients (n=13) demonstrated tumor reduction
69.2% (9/13) overall response rate (ORR) with best responses of complete response (CR) or partial response (PR)
100% (5/5) ORR (CR + PR) with 1 CR and 4 PRs observed in PD-L1 positive patients
50% (4/8) ORR (CR + PR) with 4 PRs observed in PD-L1 negative patients
Translational data are supportive of eganelisib’s immune modulation mechanism with treatment associated with decreased M2 macrophages and myeloid derived suppressor cells (MDSCs) and increased T cell reinvigoration as measured in peripheral blood.
The novel triple combination treatment with eganelisib, atezolizumab (atezo) and nab-paclitaxel (nab-pac) demonstrated safety in line with expectations of the component drugs with no additive or new safety signals. The most common ≥ Grade 3 treatment-emergent adverse events were decreased neutrophil count (21.4 percent), diarrhea (14.3 percent), and rash (14.3 percent). Only one patient (7.1 percent) experienced ≥ Grade 3 ALT/AST increase, and this patient had a Grade 3 elevation.
Enrollment is ongoing. As of the November 6th cut-off for the SABCS presentation 20 of 60 patients enrolled, and the 7 most recently enrolled patients remained on treatment but had not yet had their first assessment. Infinity expects to complete enrollment in MARIO-3 in mid-2021.

Earlier this year the U.S. Food and Drug Administration (FDA) granted Fast Track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting. Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions while fulfilling an unmet medical need, enabling drugs to reach patients more rapidly. A drug or treatment regimen that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA on matters pertaining to the drug’s clinical development plan as well as eligibility for accelerated approval and priority review.

Eganelisib SABCS 2020 Poster Links:

Infinity MARIO-3 SABCS 2020 Poster: MARIO-3 phase II study initial data evaluating a novel triplet combination of eganelisib (IPI-549), atezolizumab (atezo), and nab-paclitaxel (nab-pac) as first-line (1L) therapy for locally advanced or metastatic triple-negative breast cancer (TNBC)

Arcus ARC-2 SABCS 2020 Poster: ARC-2: Efficacy and Safety of Etrumadenant (AB928) + Pegylated Liposomal Doxorubicin (PLD) ± Eganelisib (IPI-549) in Participants with Metastatic Ovarian and Triple Negative Breast Cancer

Conference Call Information

A live webcast of the conference call with synchronized slides can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 2088322. An archived version of the webcast will be available on Infinity’s website for 30 days.

On December 9, 2020 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines which act in the small intestine with systemic effects, reported that it is prioritizing EDP1908 as its lead clinical candidate in oncology given its superior preclinical activity over EDP1503 (Press release, Evelo Biosciences, DEC 9, 2020, View Source [SID1234572516]). The Company will halt patient recruitment in the Phase 1/2 clinical trial of EDP1503 and will wind down the study. The Company also announced that additional interim clinical data from its Phase 1/2 open-label study evaluating EDP1503 in combination with pembrolizumab in patients with triple-negative breast cancer (TNBC) were presented today in a poster session at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting. The presentation showed that as of a cutoff date of October 30, 2020, EDP1503 was well-tolerated, with an overall response rate (ORR) of 17 percent and a disease control rate (DCR) of 25% in the 12 patients who received the higher dose of EDP1503. These results suggest that the small intestinal axis, SINTAX, has the potential to be targeted with oral, gut-restricted medicines.

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"The EDP1908 preclinical data presented last month at the Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) meeting showed that orally administered bacterial extracellular vesicles (EV) showed encouraging preclinical activity without systemic distribution. Based on the strength of the preclinical results from EDP1908 compared to those we observed during our early development of EDP1503, combined with the EDP1503 clinical results, we have decided to focus on advancing EDP1908 as our lead oncology product candidate," said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. "EVs may offer oncology patients better outcomes and serve as the foundation of a new class of potentially safe, effective, and affordable immuno-oncology medicines. We are now scaling up manufacturing in order to advance EDP1908 into the clinic in the first half of 2022."

Reminder of Data Presented at SITC (Free SITC Whitepaper) Annual Meeting
In the preclinical study presented at SITC (Free SITC Whitepaper), tumor-bearing mice were treated with ascending doses of either oral EDP1908 or the parental microbial strain of EDP1908, or with anti-PD-1. Treatment with EDP1908 resulted in superior tumor growth control versus either the parent microbial strain or anti-PD-1 therapy, with an observed dose-dependent reduction in tumor growth. The effects were at least comparable to those reported in the literature for intra-tumorally administered immune stimulators.

Treatment with EDP1908 significantly reduced tumor growth in syngeneic mice compared to vehicle, and activated IFNγ-positive cytolytic and helper lymphocytes, dendritic cells, and interferon gamma-induced protein 10 (IP-10) in the tumor microenvironment. Fluorescent biodistribution analysis showed that EDP1908 was not detected outside the gastrointestinal tract. These data suggest that EDP1908 activated innate immunity locally on host immune cells in the gut and triggered distal immune responses within the tumor microenvironment, with no apparent adverse safety or tolerability issues.

Additional Interim Data Presented at SABCS from the Phase 1/2 Clinical Trial of EDP1503 in Combination with Pembrolizumab
As of the data cutoff date of October 30, 2020, 15 patients had been treated across two EDP1503 doses, including three patients treated with low dose EDP1503 (two capsules twice daily (BID)) and 12 patients treated with high dose EDP1503 (four capsules BID). 27 percent of patients had received prior anti-PD-(L)1 therapy.

Interim Safety Results
As of the cutoff date, the combination of EDP1503 and pembrolizumab was generally well-tolerated with the majority of treatment-related adverse events (AEs) reported by investigators being Grade 1 or 2. Across all grades, treatment-related AEs reported by investigators most commonly included abdominal distension (20%), decreased appetite (20%), diarrhea (13%), flatulence (13%), nausea (13%), pruritis (13%) and rash maculo-papular (13%). Investigators reported a single treatment-related Grade 3 AE in one patient (diarrhea). No treatment-related Grade 4 or 5 AEs or serious AEs were reported, and one patient discontinued EDP1503 due to a treatment-related AE.

Interim Efficacy Results
Fifteen patients were evaluable for response assessment as of the cutoff date, as measured using the Response Evaluation Criteria in Solid Tumors (RECIST). Among all 15 patients treated, the ORR was 13 percent, and the DCR was 20 percent. In patients receiving high dose EDP1503 therapy (n=12), the ORR was 17 percent and the DCR was 25 percent, with partial responses observed in two patients and stable disease observed in one patient. One patient who had relapsed on prior therapy with an anti-PD-L1 inhibitor combination had a partial response to the EDP1503 and pembrolizumab combination treatment. The patient was on treatment for 10.5 months and had no measurable disease visible on their latest PET scan as of the data cutoff date.

About Extracellular Vesicles
Some bacteria produce EVs that share molecular content with the parent bacterium, in particles that are roughly one-one thousandth the volume and are not capable of self-replicating. EVs enable bacterial communication and survival during stress, host-immune modulation, material exchange and cell-cell interactions. EV’s significantly smaller size compared to microbes may enable improved distribution and target engagement.