On June 27, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the completion of an in-depth operational review designed to extend the Company’s cash runway and deliver on its commitment to develop next-generation ADCs to bring more good days to patients and generate increased value for shareholders (Press release, ImmunoGen, JUN 27, 2019, View Source [SID1234537299]). Based on the outcomes of this review, the Company will prioritize continued development of mirvetuximab and a select portfolio of three earlier-stage product candidates targeting solid tumors and hematological malignancies. The Company will end the current quarter with approximately $240 million on its balance sheet and expects this cash, together with expense reductions resulting from the operational changes announced today and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.

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The operational review commenced following the announcement that FORWARD I, ImmunoGen’s Phase 3 clinical trial evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, did not meet the primary endpoint. Data from FORWARD I did, however, demonstrate a consistent efficacy signal across a range of parameters in the pre-specified subset of patients with high FRα expression. Following consultation with the U.S. Food and Drug Administration (FDA), the Company will pursue a new Phase 3 study in this patient population.

In light of these developments and with the goal of extending the Company’s existing cash runway, ImmunoGen has established three strategic priorities for the business: execute a registration study for mirvetuximab in platinum-resistant ovarian cancer; advance a select portfolio of earlier-stage product candidates; and further strengthen its balance sheet through partnering. Consistent with these priorities, ImmunoGen will focus on the following core activities:

Initiate the registration study for mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year;

Complete enrollment and continue follow up in the ongoing FORWARD II mirvetuximab combination cohorts;

Continue IMGN632 development in patients with relapsed acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), and other CD123-positive hematologic malignancies in collaboration with Jazz Pharmaceuticals;

Advance two additional assets that demonstrate ImmunoGen’s continued innovation in ADCs: IMGC936, which is in co-development with MacroGenics with an IND expected by the end of 2019; and the Company’s next generation anti-FRα ADC, which is expected to enter development in mid-2020; and

Monetize its remaining portfolio and platform technologies through out-licensing transactions or asset sales.

Correspondingly, the Company will reduce ongoing expenses through the following portfolio prioritization and restructuring initiatives:

Discontinue the development of IMGN779 in adults with relapsed/refractory CD33-positive AML;

Suspend all other research activities;

Reduce its workforce by approximately 220 employees, with a majority of these employees separating from the business by mid-July 2019; and

Seek to sub-lease excess office and lab space.

Following a transition period, the savings generated by the restructuring are expected to reduce ImmunoGen’s quarterly expenses by more than 50%. As a result of the workforce reduction, the Company expects to record a one-time charge totaling approximately $16.4 million related to termination benefits and other related expenses. This charge is expected to be recorded in the quarter ending June 30, 2019, and the related cash payments will be substantially paid out by June 30, 2020. In addition, an anticipated charge of $3.7 million is expected to be incurred for retention benefits in the same time period. Updated 2019 financial guidance will be provided when ImmunoGen announces it second quarter operating results on August 2, 2019.

"I thank the employees separating from the business for their significant contributions to ImmunoGen and to the advancement of the ADC field," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Reorganizing the business is critical to the Company’s future, enabling us to extend our cash position and continue the development of mirvetuximab and our portfolio of promising ADCs in earlier stages of development. We look forward to continued progress with the business, including the start of the registration study for mirvetuximab by year-end and additional monotherapy and combination data at ESMO (Free ESMO Whitepaper) in September, identifying a recommended Phase 2 dose and initiating combination studies with IMGN632 in the second half of the year, and filing an IND for IMGC936 by the end of 2019."

"This was an extremely difficult decision for the Board, as we believe deeply in the therapeutic promise of ADCs, the Company’s science, and its people," said Steve McCluski, ImmunoGen’s Chairman of the Board. "These are, however, the right steps to take to bring mirvetuximab to patients and offer the best opportunity to capture long-term value for our shareholders, whom we thank for their support."

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8 a.m. ET to discuss these results. To access the live call by phone, dial 1-786-789-4797; the conference ID is 6921368. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through July 9, 2019.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

ABOUT FORWARD I

FORWARD I is a Phase 3 trial in which 366 patients were randomized 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients were diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FRα and were treated with up to three prior regimens. The primary endpoint of this study was progression free survival (PFS), which was assessed in the entire study population and in the subset of patients with high FRα expression. ImmunoGen estimates that 12,000-14,000 patients per year in the U.S. meet these criteria, with a comparable number in the major markets in Europe.

ImmunoGen partnered with the GOG Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which was conducted in North America and Europe.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant or platinum-agnostic ovarian

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cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

On June 27, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported it has terminated the rights offering of its securities previously announced on April 18, 2019 (Press release, DelMar Pharmaceuticals, JUN 27, 2019, View Source [SID1234537298]). The termination results from an assessment by the Company’s management that current market conditions are not conducive for an offering on terms that would be in the best interests of the Company’s shareholders. The Company intends to withdraw its registration statement on Form S-1 and post-effective amendment thereto related to the rights offering previously filed with the US Securities and Exchange Commission.

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On June 27, 2019 ArQule, Inc. (Nasdaq: ARQL) reported the closing of its previously announced underwritten public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,387,500 shares at the public offering price of $9.75 per share (Press release, ArQule, JUN 27, 2019, View Source [SID1234537297]). The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by ArQule to 10,637,500 shares and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and estimated expenses of the offering payable by ArQule, to approximately $103.7 million.

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The Company intends to use the net proceeds of the offering to fund its clinical programs and for general corporate purposes.

SVB Leerink and RBC Capital Markets acted as joint bookrunning managers for the offering. Oppenheimer & Co. Inc. and Needham & Company acted as co-lead managers, and Roth Capital Partners, B. Riley FBR and JonesTrading Institutional Services LLC acted as co-managers for the offering.

The securities described above were offered by ArQule pursuant to an effective shelf registration statement on Form S-3 (File. No. 333-232306), including a base prospectus, that was filed by ArQule with the Securities and Exchange Commission ("SEC") and automatically became effective on June 24, 2019. A final prospectus supplement and accompanying prospectus relating to the offering filed with the SEC is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, by telephone at (877) 822-4089.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On June 27, 2019 AstraZeneca reported positive overall survival (OS) results from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung cancer (SCLC), a disease with significant unmet need and limited treatment options for patients (Press release, AstraZeneca, JUN 27, 2019, View Source [SID1234537295]).

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A planned interim analysis conducted by an Independent Data Monitoring Committee concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS in patients treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy options vs. chemotherapy alone. The safety and tolerability for this Imfinzi combination was consistent with the known safety profiles of these medicines.

AstraZeneca will submit these results for presentation at a forthcoming medical meeting.

José Baselga, Executive Vice President, Oncology R&D said: "The Phase III CASPIAN results offer new hope for patients who are facing the devastating diagnosis of small cell lung cancer, and for whom new medicines are urgently needed. This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options."

CASPIAN is a randomised, open-label, multi-centre, global, Phase III trial of Imfinzi plus platinum-based chemotherapy options or the combination of Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone as a 1st-line treatment for patients with extensive-stage SCLC. The trial will continue to the final analysis of OS for the combination of dual immune checkpoint blockade with chemotherapy. This combination includes tremelimumab, an anti-CTLA4 antibody and potential new medicine, with Imfinzi, an anti-PDL1 antibody, and chemotherapy.

Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.

Imfinzi is approved for unresectable, Stage III non-small cell lung cancer in more than 45 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial.

About CASPIAN

The CASPIAN trial is a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of patients with extensive-stage SCLC. The trial compared Imfinzi in combination with etoposide and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone. In the experimental arms, patients were treated with up to four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and prophylactic cranial irradiation.

The trial is being conducted in more than 200 centres across 22 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint is OS.

About small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.2 About two-thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.3 SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.4 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.3

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Australia, Israel, India, United Arab Emirates, Qatar, Macau and Hong Kong.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumours.

About tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers.

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 EGFR-mutated 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 (osimertinib) and ongoing Phase III trials FLAURA, ADAURA and LAURA as well as the Phase II exploratory combination trials SAVANNAH and ORCHARD.5-7

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer. Imfinzi (durvalumab), an anti-PDL1 antibody, is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in combination with tremelimumab and/or chemotherapy (AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III trials).

About AstraZeneca’s approach to Immuno-Oncology (IO)

IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. Our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumours.

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, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our 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 June 27, 2019 LSK BioPharma (LSKB) reported that it has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for rivoceranib (apatinib) which enrolled 460 advanced or metastatic gastric cancer patients (Press release, LSK BioPharma, JUN 27, 2019, View Source [SID1234537293]). While the rivoceranib arm did achieve better median overall survival (OS) compared with placebo, and a result comparable to other approved drugs in gastric cancer, the result was not statistically significant. Overall survival was the primary endpoint in the ANGEL study. Rivoceranib demonstrated a highly significant improvement in median progression-free survival (PFS), which was a secondary endpoint. Rivoceranib was also generally well tolerated and safety results were consistent with prior studies. LSKB will conduct analyses as additional data become available such as overall response rate (ORR) and time-to-progression, follow surviving patients, and keep an open dialogue with regulatory agencies to determine the appropriate path to approval for rivoceranib in this gastric cancer monotherapy indication. The Company plans to continue ongoing clinical development programs in other indications including, earlier lines of therapy for gastric cancer with combination therapy, colorectal cancer, and hepatocellular carcinoma.

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About Rivoceranib (Apatinib)

Rivoceranib, also known as apatinib or Aitan (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis.

LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib (apatinib) is currently listed in 260 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.