On April 16, 2019 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported the following statement regarding recent market activity (Press release, IMV, APR 16, 2019, View Source [SID1234535155]).

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In recent weeks, shares of IMV Inc. have come under unwarranted market pressure and the management team believes it is prudent to provide a mid-quarter update on the health of the business and the Company’s upcoming Q2 clinical milestones.

"From a financial and clinical results standpoint, IMV has recently achieved noteworthy milestones and, based on clinical results observed thus far, our long term outlook remains unchanged and very promising," said Frederic Ors, Chief Executive Officer. "We have strengthened our balance sheet and expanded our shareholder base through a recent equity offering completed with Wells Fargo as lead underwriter. In addition, IMV has also reported promising clinical results from the phase 2 cohort of the DECIDE clinical study, which we believe confirm the potential activity of DPX-Survivac as monotherapy."

Phase 2 Cohort of the DECIDE Clinical Study in Ovarian Cancer

As reported earlier this year, IMV’s latest clinical results update indicated that six patients receiving DPX-Survivac monotherapy with intermittent low-dose cyclophosphamide (mCPA) reached the first CT scan assessment and key related findings were as follows:

83% of the subjects (5 of 6) showed stable disease (SD), including two tumor regressions;
80% (4 of 5) of those with stable disease were in subjects with a lower baseline tumor burden (BTB) of less than 5 centimeters, which also included the two tumor regressions.
In earlier stages of this trial, durable clinical responses occurred after 140 days. As of March 25, 2019, these responses had endured for 20 months or more. Additional data at the 140-day mark of this cohort will be available by the end of the first half of 2019. The amended phase 2 cohort of the DECIDE trial focuses on patients with low tumor burden (less than 5 centimeters targeting the enrollment of at least 16 additional patients at numerous sites in the U.S. and Canada.

Phase 2 Study in Combination with KEYTRUDA in Relapsed/Refractory DLBCL (SPIREL)

As of April 5, 2019, ten patients have been enrolled and treated across four different clinical sites in Canada. Additional patients are being screened and IMV expects to report updated clinical data at about the same time than the bi-annual International Conference on Malignant Lymphoma, which will be held in Lugano Switzerland starting June 18, 2019.

Phase 2 Basket Trial in Combination with KEYTRUDA in Multiple Solid Tumors

Screening and enrollment of patients is ongoing at multiple clinical sites across the U.S. and Canada for five cohorts of patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung (NSCLC) cancers as well as tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

The first patients have been dosed in the ovarian and lung cancer cohorts and IMV expects to report preliminary clinical results on several of the solid tumor indications before the end of 2019.

The following table indicates IMV expected milestones between now and the first half of 2020 as at the date of this release.

Milestones

Key dates
Initiation of Basket trial in 5 solid tumor indications
September 2018 x

First preliminary Phase 2 clinical results with Merck Keytruda in DLBCL
September 2018 x

Phase 1b/2 clinical results in Ovarian with Incyte
December 2018 x

Meeting with FDA on Ovarian cancer program
December 2018 x

Dosing of first patient in Basket trial
March 2019 x

Phase 2 monotherapy results in Ovarian – ASCO (Free ASCO Whitepaper) June 2019
Phase 1/1b monotherapy long term follow-up – ASCO (Free ASCO Whitepaper) June 2019
Phase 2 clinical results with Merck Keytruda in DLBCL – ICML June 2019
Preliminary clinical results Basket trial in 5 indications H2 2019
Potential registration trial in Ovarian and/or DLBCL for FDA
accelerated/breakthrough designation

H2 2019
Top line clinical results for Basket trial H1 2020
Meeting with FDA on potential accelerated registration trial from Basket trial H1 2020

On April 16, 2019 Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to APR-246 for the treatment of patients with MDS having a TP53 mutation (Press release, Aprea, APR 16, 2019, View Source [SID1234535157]). In addition, FDA has also granted Orphan Drug Designation to APR-246 for treatment of MDS.

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"The granting of Fast Track designation and Orphan Drug Designation by FDA for APR-246 in TP53 mutated MDS underscores the significant unmet medical need in this disease," said Christian S. Schade, President and Chief Executive Officer of Aprea. "With our Phase 3 clinical study in MDS underway, we look forward to continuing our productive dialogue with FDA and bringing APR-246 to patients as soon as possible."

The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, tax credits related to clinical trial expenses, and an exemption from FDA user fees.

About p53 and APR-246

The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

APR-246 has been shown to reactivate mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce programmed cell death in human cancer cells. APR-246 has demonstrated pre-clinical anti-tumor activity in a wide variety of solid and hematological (blood) tumors, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase I/II clinical program with APR-246 has been completed, demonstrating a favorable safety profile, biological activity and clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in approximately 20% of MDS and AML patients and are associated with poor overall prognosis.

On April 16, 2019 BioAtla , LLC, a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics for the oncology market, reported that Himalaya Therapeutics SEZC, a Cayman Island corporation and majority owned subsidiary of BioAtla, has the exclusive license from BioAtla to develop and commercialize several specific, differentiated product candidates for the Greater China market of the PRC, Hong Kong, Macau and Taiwan (Press release, BioAtla, APR 16, 2019, View Source [SID1234621324]). The Himalaya Therapeutics portfolio includes two CAB candidates, CAB-AXL-ADC and CAB-ROR2-ADC, each currently in Phase 1/2 clinical trials conducted by BioAtla at sites in the United States. In addition, Himalaya Therapeutics will participate in BioAtla’s potential Greater China derived returns from the recently announced BioAtla and BeiGene, Ltd. global co-development and collaboration agreement for the development, manufacture and commercialization of CAB-CTLA-4 (BA3071). Himalaya will also support BioAtla’s global clinical trials effort in Greater China.

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"We believe that Himalaya’s product development and business related activities directly addressing Greater China will maximize the strategic opportunities for both BioAtla and Himalaya in the world’s second largest pharmaceutical market," stated Carolyn Short, General Manager of Himalaya Therapeutics. "The access to clinical development capabilities in China can accelerate the global development and potential commercialization of the BioAtla product portfolio and effectively address markets with strong growth potential and high unmet medical need," added Scott Smith, President of BioAtla.

Recent sweeping changes to the China regulatory processes for the development of pharmaceutical products now closely align them with those in the United States and broadens the use of clinical data for regulatory purposes between the two nations. Consequently, close coordination of clinical development in the U.S. and China of a pharmaceutical candidate is highly desireable and more efficient. Furthermore, the access to capital markets for early-stage biotechnology companies in China has recently been greatly enhanced especially with the revision to the stock listing requirements on the Hong Kong Stock Exchange. Himalaya Therapeutics is expected to fund its operations independent from BioAtla. These were primary motivating factors for Beijing Sinobioway Group Company and its related investor groups to contribute all of their rights to certain and any future CAB candidates that were part of their 2015 collaboration agreement with BioAtla in exchange for a minority equity position in Himalaya Therapeutics.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

On April 16, 2019 Agilent Technologies Inc. (NYSE: A) reported that it will release second-quarter fiscal 2019 financial results after the stock market closes on May 14 (Press release, Agilent, APR 16, 2019, https://www.agilent.com/about/newsroom/presrel/2019/16apr-gp19010.html [SID1234535158]). The company will host a live webcast of its investor conference call in listen-only mode.

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Date: Wednesday, May 14, 2019
Time: 1:30 PM (Pacific Time)
Web access: https://www.investor.agilent.com/

Listeners may log on and select "Q2 2019 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain on the company site for 90 days.

In addition, a telephone replay of the conference call will be available at approximately May 14, 2019 at 4:30PM (Pacific Time) after the call and through May 21 by dialing +1 855 859-2056 (or +1 404 537 3406 from outside the United States) and entering pass code 3086626

On April 16, 2019 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage, biopharmaceutical company focused on oncology, and BioSense Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical company, reported a collaboration and license agreement to advance the development and commercialization of RX-3117 for pancreatic cancer and other cancers in Greater China (Press release, Rexahn, APR 16, 2019, View Source [SID1234535162]).

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Under the agreement, Rexahn will grant BioSense an exclusive license to develop and commercialize RX-3117 in Greater China. Rexahn will receive an upfront payment and will be eligible to receive additional development, regulatory and commercial milestones up to a total of $226 million contingent on achieving regulatory and commercial goals related to pancreatic cancer and additional indications. Rexahn will also be eligible to receive tiered royalties in the low double digits to mid teens on annual net sales in the territory. The companies will collaborate to develop RX-3117 for pancreatic cancer and other indications. BioSense will fund all activities related to the development and commercialization of RX-3117 in Greater China and will initiate a Phase 2 study to evaluate the drug candidate in up to three additional indications not previously studied by Rexahn.

"Rexahn is focused on developing novel therapies for people with difficult-to-treat cancers. This partnership will enable us to extend the development of RX-3117 to patients in Greater China and also to evaluate RX-3117 in additional indications in collaboration with BioSense," said Douglas Swirsky, President and CEO of Rexahn. "We are excited to work with the experienced regulatory and development team at BioSense to advance the development of RX-3117 towards regulatory approval in Greater China."

Andy Li, PhD, President and CEO of BioSense Global, added, "We are delighted to partner with Rexahn to develop RX-3117 for the Greater China markets. Cancer is the leading cause of death in China with over four million new diagnoses and almost three million deaths per year. Prognosis is poor for certain cancers and treatment options are limited. Despite the significant success of immunotherapy, chemotherapy will remain a critical component of treatment regimens for many cancers. With its unique tumor-targeting mechanism, we believe RX-3117 could become a safer, more efficacious yet affordable treatment option to patients and doctors. We are excited to advance the development of RX-3117 for cancers that are especially prevalent among Chinese patients."

Additional information on the collaboration and license agreement can be found in the Current Report on Form 8-K being filed by Rexahn today with the Securities and Exchange Commission.

About RX-3117

RX-3117 is a novel, investigational, oral, small molecule nucleoside compound. Once intracellularly activated (phosphorylated) by UCK2, it is incorporated into the DNA or RNA of cells and inhibits both DNA and RNA synthesis, which induces apoptotic death of tumor cells. Due to the high level of over expression of UCK2 in cancer cells, RX-3117 offers the potential for a targeted anti-cancer therapy with an improved efficacy and safety profile. RX-3117 is currently being studied in a Phase 2a clinical trial in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) in first line metastatic pancreatic cancer patients and a Phase 2a clinical trial in patients with advanced or metastatic bladder cancer. It has received Orphan Drug designation for the treatment of pancreatic cancer. Additional information on RX-3117 can be found at: View Source

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.