On March 25, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune diseases, reported data from its Phase IIb AIPAC clinical trial in HER2-negative / Hormone Receptor positive (HR+) metastatic breast cancer (MBC) (Press release, Immutep, MAR 25, 2020, View Source [SID1234555945]).

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AIPAC is a multicentre, placebo-controlled, double-blind, randomised study evaluating the Company’s lead product candidate, eftilagimod alpha (efti, LAG-3Ig or IMP321) in combination with paclitaxel, a taxane standard of care chemotherapy, in 227 MBC patients to boost the T-cell immune responses against tumours.

63% of patients who received paclitaxel plus efti were progression-free at the 6-month landmark (at the end of the chemo-immunotherapy combination phase) and according to RECIST 1.1 based on blinded independent central readers (BICR). This compares favourably to 54% of patients who received paclitaxel plus placebo. The PFS data yielded an unadjusted hazard ratio (HR) of 0.93. The secondary endpoint of Overall Response Rate (ORR) increased to 48.3% in the efti group, from 38.4% in the placebo group.

Favourable results were reported in multiple predefined patient subgroups, e.g.:

patients with low monocytes count at baseline had a positive HR of 0.61 (median PFS of 5.45 vs. 7.29 months) favouring efti

patients with a more aggressive, more immunogenic luminal B type had a positive HR of 0.65 (median PFS of 5.45 vs. 7.29 months) favouring efti

patients with lower general performance status at baseline had a positive HR of 0.76 (median PFS of 6.67 vs. 7.13 months) favouring efti

The combination of efti and paclitaxel chemotherapy was overall safe and well tolerated, further building upon efti’s strong safety profile to date.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

These results, together with consideration of the Overall Survival (OS) and the immuno-monitoring data expected to be reported later this year, could allow the Company to build a platform to commence planning for a phase III clinical trial of efti in metastatic breast carcinoma. This will include the hypotheses for the primary and secondary endpoints and the appropriate stratification for different patient subgroups. Immutep will advance its discussions with the regulatory authorities accordingly.

Immutep CSO and CMO, Dr Frederic Triebel said: "The PFS results reported from the AIPAC study in a randomised clinical setting indicate an overall trend for clinical efficacy in HR-positive metastatic breast carcinoma, which is not a particularly immunogenic tumor and very interesting results in some meaningful subgroups. We would like to thank the patients and their families, along with the investigators for participating in this important study."

Immutep CEO, Marc Voigt stated: "We are pleased to see a clinical benefit for patients receiving efti in HR-positive metastatic breast carcinoma in multiple patient subgroups. This is just one of the four advanced solid tumor indications targeted in our efti clinical development program. We are pleased to see an efficacy trend and will carefully assess the data for further development of efti given our positive data in patient subgroups. More AIPAC results should become available in the coming months, including immuno-monitoring data and Overall Survival data."

"Another piece of evidence for efti efficacy in cancer patients comes from the interim results we are seeing from our ongoing phase II TACTI-002 trial of efti. In TACTI-002, 47% of first line non-small cell lung cancer patients responding to the combination treatment of efti with pembrolizumab, an anti-PD-1 therapy. These results are remarkable given that usually only 20% of patients respond to pembrolizumab monotherapy in this PDL-1 all comer trial indication."

AIPAC Principal Investigator, Hans Wildiers of University Hospitals Leuven, Leuven, Belgium, said: "I am pleased to see this innovative chemo-immunotherapy approach in AIPAC is well tolerated by patients, while showing a numerically (non-significant) higher progression free survival rate compared to chemotherapy alone. Hormone receptor positive breast tumours represent the majority of metastatic breast cancer patients and any active well tolerated adjunct to the weekly paclitaxel standard of care regimen, is desirable. This combination warrants further investigation in larger and more biomarker selected populations."

Further Reporting from AIPAC

The Company expects to present these clinical results in more detail at an upcoming conference. Patients are continuing in the follow up phase of the study enabling OS data to be collected. Immutep expects to report OS data in late-2020.

Webcast Details

Immutep will present this AIPAC data in a global webcast, details are as follows:

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

Date & Time: Thursday, March 26th, 8am Australian Eastern Daylight Time / Wednesday, March 25th, 5pm US Eastern Daylight Time
Register: Interested parties can register via a link to the webcast on the Company’s website or via the following link: View Source
Questions: Investors are invited to submit questions in advance via [email protected].
A replay of the webcast will also be available at www.immutep.com from the day after the event.

About the AIPAC trial

Active Immunotherapy PAClitaxel (AIPAC) is a Phase IIb clinical trial in HER2-negative/ HR positive metastatic breast cancer. Based on Immutep’s LAG-3 technology, the study evaluates the combination of the Company’s lead product candidate, eftilagimod alpha (efti, LAG-3Ig or IMP321), and a taxane chemotherapy, called paclitaxel, as an immunotherapy. This combination is aimed at boosting the immune response against tumour cells compared to chemotherapy alone. In AIPAC, 227 hormone receptor positive metastatic breast cancer patients are randomised 1:1 to treatment A (paclitaxel chemotherapy plus placebo) or treatment B (paclitaxel chemotherapy plus eftilagimod alpha) for six months.

Patients receive weekly paclitaxel at Days 1, 8 and 15 with either efti of placebo injected subcutaneously, on Days 2 and 16 of each 4-week cycle, repeated for 6 cycles. Thereafter, patients pass over to the maintenance phase with efti alone.

The primary end point is to determine progression-free survival (PFS) and key secondary objectives include overall survival, safety, quality of life and objective response rate.

For more information regarding the AIPAC trial, visit clinicaltrials.gov (identifier NCT02614833) and View Source).

On March 25 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported financial and operating results for the fourth quarter and year ended December 31, 2019, and provided a corporate update (Press release, Oncocyte, MAR 25, 2020, View Source [SID1234555826]).

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"We started 2020 in a strong position with significant accomplishments that support our strategy to provide actionable answers to physicians and their patients with the goal of improving outcomes and survival," said Ron Andrews, Chief Executive Officer of Oncocyte. "I am incredibly proud to have officially transitioned to a commercial stage company with the launch of DetermaRxTM, the first test for chemotherapy benefit prediction in patients with NSCLC. We have successfully onboarded all 7 of our early access partners and they have started sending patient samples to our lab and, notably, all physicians have re-ordered the test, a very important indicator of future utilization. To date, we have identified 7 "high-risk" patients and believe we are already saving lives by identifying high-risk patients whose treatment course will now include adjuvant chemotherapy instead of surgical resection alone. This is a remarkable advancement for early NSCLC patients, and we are honored to be able to provide clarity for these patients and their physicians when making critical decisions after surgery. We look forward to receiving our final coverage decision from CMS and our continued progress in widespread adoption of this important test."

Mr. Andrews continued, "While we are doing our part to minimize the COVID-19 situation in our local communities, we have been able to continue lab operations in compliance with applicable orders and mandates, and have made great strides in expanding our suite of important tests with the acquisition of Insight Genetics which includes DetermaIOTM, our immunotherapy response prediction test. With the recently announced CLIA validation of DetermaIOTM, and the subsequent commercial launch for research use in academic and biopharma settings, we are poised to provide a valuable and potentially transformative test that we believe, based on recently published clinical data, outperforms currently available PD-L1 and TMB immunotherapy response prediction tests. We also have continued our progress in advancing DetermaDxTM , and we were pleased to announce the completion of CLIA validation in early January, consistent with our previous guidance, and believe we are now are on track with clinical validation and preparations for commercial availability. Taken together, it is clear that Oncocyte is transforming into a leader for early lung content. While cancer surgeries are being impacted by the current COVID-19 situation, our discussions with surgeons indicate that these patients will still be getting treated and surgeries will restart soon, so our focus is on being ready when that moment happens. We look forward to continued execution across our commercialization and development efforts for a milestone rich 2020."

Recent Corporate Highlights

●Successfully completed acquisition of Insight Genetics

oAcquisition broadens Oncocyte’s portfolio of molecular diagnostic tests with addition of DetermaIOTM, a potentially transformative immunotherapy response prediction test demonstrated to outperform PD-L1 and TMB tests

oCompleted CLIA validation of DetermaIOTM, enabling research use launch of the test as a reliable and robust option for academic research and biopharma companies

oUnlocks significant pharma services opportunity including immunotherapy trials and development of companion diagnostics in lung cancer and other solid tumors

oAcquisition significantly expands Oncocyte’s suite of proprietary tests to manage key decision points potentially across multiple stages and types of cancer, as immunotherapies are currently approved for thirteen solid tumor types

●Transformed into a commercial stage company with launch of DetermaRxTM

oAnnounced commercial availability of DetermaRxTM in early January, transforming Oncocyte to a commercial stage company. With multiple sites already onboarded and testing beginning, the commercial team is focused on driving rapid adoption across specialty physicians

oDetermaRxTM, a CLIA-validated lung cancer treatment stratification test, broadens Oncocyte’s capabilities with an extensively validated and published molecular test that enables the identification of early-stage lung cancer patients at high risk for recurrence that are likely to benefit from chemotherapy. OncoCyte acquired the rights to commercialize this test from Razor Genomics in September 2019

oReceived regulatory approval to begin distribution of DetermaRxTM in Canada

oProvided an educational grant in support of an accredited Continuing Medical Education (CME) Activity: Advances in Diagnostic Testing: Assessing Your Patient’s Risk of Recurrence to Inform Treatment Decisions in Early-Stage NSCLC

●Successful Completion of CLIA Validation Study of DetermaDxTM

oDemonstrates the successful transfer of the research assay to the rigorous environment of Oncocyte’s commercial CLIA laboratory

oOncocyte has commenced Clinical Validation, which is expected to be completed in Q2 2020. Upon successful completion of Clinical Validation and establishment of performance parameters, Oncocyte will begin preparations for commercial availability

●Presented data at the CHEST Annual Meeting 2019 on the Immune Response for Nodule Evaluation (IRENE) clinical cohort used for the development and validation of DetermaDxTM. IRENE is one of the largest reported clinical study cohorts in lung nodule management with 62 sites in the U.S. and over 3,000 enrolled patients. IRENE is uniquely representative across clinical settings with a focus on community practices, where most lung cancer patients are diagnosed and treated

●Successfully completed a $7.6 million registered offering of common shares, priced at the market, directly with fundamentally driven, healthcare focused institutional investors. The proceeds strengthened Oncocyte’s balance sheet, which will support the strategic commercial launch of the DetermaRxTM lung cancer stratification test and the continued development of DetermaDxTM

●Moved Oncocyte’s administrative and executive headquarters to Orange County, California, in January 2020. Plans to construct a clinical diagnostic laboratory and a research laboratory at the new location are being implemented. The move best suited Oncocyte’s need to find talented individuals to join its growing team and provides opportunities to engage with oncology patients in the community setting, as well as potentially reduce overall operating costs associated with our CLIA Lab Service

Fourth Quarter and Annual 2019 Financial Highlights

At December 31, 2019, Oncocyte had cash, cash equivalents, and marketable securities of $22.5 million as compared to $8.5 million at December 31, 2018. On March 20, 2020 Oncocyte put in place an at-the-market (ATM) offering for access to additional working capital.

For the fourth quarter ended December 31, 2019, Oncocyte reported a net loss of $8.0 million, or $(0.15) per share, as compared to $4.5 million, or $(0.11) per share, for the fourth quarter ended December 31, 2018.

For 2019, Oncocyte reported a net loss of $22.4 million, or $(0.44) per share, compared to $15.8 million, or $(0.42) per share for 2018.

Operating expenses, as reported, for the three months ended December 31, 201,9 were $7.5 million, an increase of $3.5 million as compared to the same period in 2018. Operating expenses, as adjusted, for the three months ended December 31, 2019, were $6.7 million, an increase of $3.1 million as compared to the same period in 2018.

Operating expenses, as reported, for the year ended December 31, 2019, were $22.2 million, an increase of $7.0 million as compared to the same period 2018. Operating expenses, as adjusted, for the year ended December 31, 2019, were $18.6 million, an increase of $6.1 million as compared in 2018.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for fourth quarter of 2019 were $2.3 million as compared to $1.2 million for the same period in 2018, an increase of $1.1 million. The increase was primarily attributable to personnel and laboratory related expenses for the completion of CLIA validation of DetermaDxTM. Research and development expenses for 2019 were $6.8 million as compared to $6.5 million for 2018, remained relatively unchanged.

General and administrative expenses for the fourth quarter of 2019 were $4.2 million, as compared to $2.6 million for the same period in 2018, an increase of $1.6 million. General and administrative expenses for the year ended December 31, 2019, were $13.3 million, as compared to $7.0 million for 2018, an increase of $6.3 million. The increases were primarily attributable to personnel and related expenses, including management transition costs; investment banking expenses; legal, business development, investor relations, recruiting, audit and accounting related expenses; and noncash stock-based compensation expense due to additional equity grants. As Oncocyte transitioned from Lineage Cell Therapeutics ("Lineage" formerly BioTime, Inc.) Shared Services by the second half of 2019, Oncocyte hired its own administrative, human resources, legal, finance and accounting functions and teams. This transition also included the termination of the Shared Facilities agreement with Lineage as of December 31, 2019, in which Oncocyte leased its own facilities and laboratories and moved into its Irvine, California, headquarters in January 2020.

Sales and marketing expenses for the three months ended December 31, 2019, were $1.0 million, as compared to $0.3 million for the same period in 2018, an increase of $0.7 million. Sales and marketing expenses for 2019 were $2.2 million, as compared to $1.7 million for 2018, an increase of $0.5 million. The increases were primarily due to sales and marketing efforts, including key hires and ramp-up in activities for commercialization of DetermaRxTM.

Conference Call

The Company will host a conference call today, March 25, 2020, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13700598. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: View Source

On March 24, 2020 ProMIS Neurosciences, Inc. ("ProMIS" or the "Company") (TSX: PMN) (OTCQB: ARFXF) announces that the Company has received approval from the Toronto Stock Exchange to amend the exercise price of an aggregate of 44,182,530 outstanding common share purchase warrants (the "Warrants") that were previously issued on August 9, 2017, August 28, 2017, October 30, 2017, April 30, 2018, January 22, 2019, June 26, 2019, November 15, 2019, and December 30, 2019 (the "Warrant Repricing") (Press release, ProMIS Neurosciences, MAR 24, 2020, View Source [SID1234555788]). The Warrants will expire on the date that is five years from the original date of issuance. Outstanding Warrants currently held by Insiders of the Company will be excluded from the Warrant Repricing.

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The exercise price of the Warrants is being repriced to CDN $0.13 (USA $0.09) per share, effective April 8, 2020 until May 22, 2020 (the "Warrant Repricing Period"). At the end of the Warrant Repricing Period, the Warrants will revert to the original exercise price. All other terms of the Warrants shall remain the same.

The Company will deliver a new exercise notice (the "New Exercise Notice") to the Warrantholders for exercise during the Warrant Repricing Period. All Warrantholders who wish to exercise their Warrants during the Warrant Repricing Period will be required to surrender their respective Warrant Certificates representing their Warrants, along with a properly completed New Exercise Notice to the Company, in accordance with the instructions provided in the New Exercise Notice.

Table: List of warrant series subject to repricing:

Date of Issuance Number of Warrants Outstanding (not held by Insiders) Original Exercise Price Expiry Date
August 9, 2017 4,808,101 $ 0.30 August 9, 2022
August 28, 2017 2,232,200 $ 0.30 August 28, 2022
October 30, 2017 77,000 $ 0.285 August 28, 2022
April 30, 2018 9,975,228 $ 0.48 April 30, 2023
January 22, 2019 13,279,269 $ 0.48 January 22, 2024
June 26, 2019 280,000 $ 0.48 June 26, 2024
November 15, 2019 9,939,066 $ 0.35 November 15, 2024
December 30, 2019 3,591,666 $ 0.35 December 30, 2024
Total: 44,182,530
The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This news release does not constitute an offer for sale of securities for sale, nor a solicitation for offers to buy any securities.

On March 24, 2020 OncoQuest Inc. ("OncoQuest" or the "Company"), a privately held, cancer immunotherapy company reported the publication of two reports relating to the recently completed Phase 2 trial conducted in the US and Italy utilizing oregovomab, the Company’s lead investigational drug in frontline ovarian cancer (Press release, OncoQuest, MAR 24, 2020, View Source [SID1234555804]).

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The first report which appears in the journal Gynecologic Oncology is titled Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, reported the clinical results in the completed 97-patient randomized controlled multi-site study in which 47 patients were randomized to receive chemoimmunotherapy with standard carboplatin and paclitaxel chemotherapy combined with oregovomab or standard chemotherapy (standard carboplatin and paclitaxel).

The study was conducted with a median of 42 months follow up and shows highly statistically significant outcomes for both progression-free and overall survival favoring the chemoimmunotherapy arm. The risk of progression and of death was reduced by more than 50% in the chemoimmunotherapy arm. Safety data shows that the addition of orgeovomab did not add incremental toxicity to chemotherapy.

The second report published in Cancer Immunology, Immunotherapy is titled Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer. The report examined translational laboratory outcomes from a subset of the Italian cohort of patients in the above described study from the laboratory of Professor Scambia at Catholic University Hospital in Rome. The report confirms that chemoimmunotherapy increased the presence of CA125-specific CD8+T lymphocytes measured in the peripheral blood compared to chemotherapy, which correlated with favorable clinical outcomes. Myeloid derived immune suppression was measured by MDSC4 (flow cytometry) and NMLR (neutrophil-monocyte to lymphocyte ratio) and it was found that lower levels of these parameters at baseline predicted more favorable outcomes in the patients receiving chemoimmunotherapy compared to chemotherapy. These findings offer promise of development of a readily accessible prognostic indicator for guiding the therapeutic strategy for newly diagnosed patients who would be candidates for chemoimmunotherapy with orgeovomab.

"The publication of our Phase II clinical results in peer reviewed journals validates the quality of the clinical data generated from our clinical study", said Dr. Madiyalakan, CEO of OncoQuest "We have discussed our Phase 2 results in an End of Phase 2 meeting with the FDA and based on those discussions are proceeding with our planned Phase 3 registration trial."

The Company is currently planning to launch a Phase 3 trial in Q2 2020. The planned Phase 3 study is expected to enroll over 600 patients with newly diagnosed, advanced ovarian cancer globally. The double-blind, placebo-controlled trial design is expected to incorporate analyses of the effect of the addition of oregovomab in both the adjuvant and neo-adjuvant settings. In both the adjuvant and neo-adjuvant arms, the primary endpoint will be to evaluate progression-free survival of patients treated with oregovomab plus a standard-of-care chemotherapy combination, carboplatin and paclitaxel, compared to the chemotherapy alone.

On April 17, 2020 Rafael Pharmaceuticals, Inc. (‘Rafael’ or the ‘Company’), a leader in the growing field of cancer metabolism-based therapeutics, reported that it has enrolled more than 75% of the 500 patients needed for its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500), which is evaluating the efficacy and safety of Rafael’s lead compound CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy (Press release, Rafael Pharmaceuticals, MAR 24, 2020, View Source [SID1234556415]).

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‘We are continuing to enroll patients ahead of schedule, as the patients in our trials suffer from life-threatening diseases and are in dire need of treatment; patient safety is our top priority,’ said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. ‘In order to support our clinical trial sites and enrolled patients during this unsettling and unprecedented time, we have established a COVID-19 task force to closely monitor our clinical trials and make changes as needed. We want to express our deepest gratitude to all of the principal investigators, nurses, hospital staff, patients and their families for their continued support and cooperation.’

‘To Save a Life is to Save a Universe’ – Rafael’s motto – represents its dedication to patients who suffer from rare cancers globally, as well as to its employees and the communities it serves. As such, the company has implemented measures to help ensure the continuity of its clinical trials and programs, while maintaining the safety of patients, clinicians and employees. The COVID-19 task force will closely monitor all clinical trials and collect data relevant to the patients’ study treatments and schedules.

Rafael is working closely with the clinical trial sites to preempt and promptly address any potential challenges and ensure that clinical supplies are available in sufficient quantities in order to support the continuity of care of all enrolled patients. Each clinical trial site has implemented their own safety measures based on guidelines from local authorities. If patients have questions about their clinical trial, they should reach out to the clinical trial coordinator at their medical center.

About CPI-613 (devimistat)
CPI-613 (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represent a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.