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Propanc Biopharma’s Intellectual Property Portfolio Undergoes Rapid Growth

On June 27, 2019 Propanc Biopharma, Inc. (OTC: PPCBD) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that Propanc’s intellectual property ("IP") portfolio has undergone rapid growth recently, with sixty-five patents currently either in force or pending in most major countries and regions around the world (Press release, Propanc, JUN 27, 2019, View Source [SID1234537304]). The IP covers Propanc’s underlying anti-cancer technology in development. In the past year, three additional patent families entered national phase, where a patent application is filed in individual countries and regions, in order to achieve grant status.

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"Our IP portfolio is a world leader in the field of administration of proenzymes for the treatment and prevention of metastatic cancer. IP is the cornerstone of any biotech company, and places us in a strong position to unlock significant value, as we plan to progress into a First-In-Human study and then hopefully towards proof of concept in a specific cancer indication, where we will then look at possible licensing opportunities," said Dr. Julian Kenyon, Propanc’s Chief Scientific Officer. "We are firmly of the opinion that our current market value does not truly reflect the advancement of our lead product, PRP, or its true potential as a breakthrough, long term treatment for aggressive and fast spreading cancers from solid tumors by targeting and eradicating cancer stem cells."

Propanc has a total of four patent families covering the use of proenzymes for treating cancer via a combination of trypsinogen and/or chymotrypsinogen pancreatic proenzymes, which includes Propanc’s lead product candidate, PRP. The IP portfolio includes composition of matter claims and a method of treatment to eradicate cancer stem cells. Further applications are also expected relating to the formulation and methods of use, as well as research programs with its joint research partners designed to further optimize the quality, safety and performance of PRP.

Advaxis Announces Increasing Focus On Neoantigen-Directed Immunotherapies And Closing Of Its Phase 3 AIM2CERV Study

On June 27, 2019 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that it is increasing its focus on neoantigen-directed immunotherapies and closing the AIM2CERV Phase 3 clinical trial with axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer (Press release, Advaxis, JUN 27, 2019, View Source [SID1234537303]). Advaxis intends to continue to support the clinical development of AXAL, its single-antigen construct, in other HPV-related cancers while redirecting resources towards advancing its neoantigen-directed programs. Specifically, the company plans to continue developing ADXS-NEO, currently in a Phase 1 clinical trial, in patients with several types of advanced or metastatic solid tumors including melanoma, lung, colorectal, head and neck and bladder cancers, and ADXS-HOT, currently in a Phase 1/2 clinical trial, for non-small cell lung cancer. The company anticipates advancing additional drug constructs from its ADXS-HOT program into the clinic over the next 18 months.

"We remain firmly committed to our Lm Technology platform, including our personalized and off-the-shelf approaches for neoantigen-directed therapies, and the development of AXAL against HPV-related cancers," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "While closing the AIM2CERV trial was a difficult decision due to the efforts of many individuals including the investigators and patients, the delays we incurred as a result of the recent FDA partial clinical hold and the estimated cost and time to completion for AIM2CERV led us to believe the best path forward for the company is to focus on our neoantigen programs. We believe this increased focus will enable a quicker and more cost-effective approach to demonstrate the strength and versatility of our Lm platform, thereby enhancing shareholder value."

The estimated remaining cost to complete the AIM2CERV trial ranges from $80 million to $90 million, and initial efficacy data is not anticipated for at least three years. Therefore, results from the clinical trial were not the basis for the decision to close the study, nor was safety as the trial recently underwent its third Independent Data Monitoring Committee (IDMC) review with no safety issues noted. The company plans to unblind the AIM2CERV clinical data generated to date and anticipates submitting these data for publication. In addition, Advaxis will continue to pursue monetization opportunities for AXAL.

"The emerging data from our neoantigen programs look very promising, and therefore these programs merit an increased focus of the company’s resources," stated Mr. Berlin. "With this redirection of resources to our neoantigen programs, we anticipate our cash usage for the next 12 months will be in the range of $33 million to $37 million, which includes $8 million to $9 million in non-recurring costs associated with prior AXAL studies including AIM2CERV. This reduction in our cash burn is a significant improvement over the past several years and also betters the goal we set of $45 million at the beginning of our fiscal year 2019." He concluded, "We believe these changes will enable us to pursue a leadership position in the neoantigen field by building upon the early and exciting data from our ADXS-NEO and ADXS-HOT programs."

ImmunoGen Announces Completion of Operational Review

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.

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.

Delmar Pharmaceuticals Announces Termination Of Rights Offering

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.

ArQule Announces Closing of Public Offering and Full Exercise of Option to Purchase Additional Shares

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.

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.