On December 13, 2019 Susan G. Komen, the world’s leading breast cancer organization, reported the results of a clinical trial, led by Komen Scholar Dr. Bryan Schneider, that moves us closer to predicting recurrence and informing the treatment of triple negative breast cancer (TNBC) (Press release, Susan G Komen, DEC 13, 2019, View Source [SID1234552371]). The results were presented at the 2019 San Antonio Breast Cancer Symposium.

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Schneider and his colleagues conducted a clinical trial at over 25 sites that looked at circulating tumor cells (CTCs) and circulating DNA (ctDNA) from the blood to determine their effectiveness at predicting recurrence, and the prognosis for patients with TNBC. TNBC has limited treatment options and a poor prognosis for patients.

"The results showed that breast cancer recurrence could be predicted for these patients and physicians may be able to use this information in the future to identify patients who are at high risk for recurrence," Schneider said. "Through this approach, researchers can also identify patients who have an incredibly good prognosis leading to the potential for future studies focused on novel de-escalation approaches for some TNBC patients."

A key aspect of this study is that over 25% of the patients enrolled were African-American women – a population that is more likely to be diagnosed with the difficult to treat TNBC. Additionally, more than 25% of the patients enrolled were under the age of 35, which is another population disproportionally impacted by TNBC.

The results of the trial have led to a second clinical trial to refine how liquid biopsy can inform treatment for TNBC patients. "The potential promise of knowing more about your risk and options from a simple blood test is phenomenal," says Schneider.

Victoria Wolodzko, senior vice president of Mission at Susan G. Komen, added, "We have been talking about the potential of liquid biopsy for a long time and we are excited to see this technology working for breast cancer patients. We look forward to the results of the follow-up trial that will lead to better treatment strategies for TNBC patients and give physicians and patients better tools to guide precision medicine."

On December 13, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP"), a an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported its financial results for the first quarter of fiscal 2020 ending October 31, 2019 (Press release, Helix BioPharma, DEC 13, 2019, View Source [SID1234552356]).

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OVERVIEW

The Company recorded a net loss and total comprehensive loss, including non-controlling interest of $2,211,000 ($0.02 loss per common share) and $1,379,000 ($0.01 loss per common share) for the three-month periods ended October 31, 2019 and 2018, respectively. Fluctuations in net loss and total comprehensive loss is mainly the result of cash reserves available to be deployed on ongoing research and development activities and operating, general and administration expenses.

The Company experienced a working capital deficiency for several quarters until recently when on August 21, 2019 the Company closed a private placement financing for gross proceeds of $7,000,005 which included the disposition of a 25% stake in the Company’s Polish subsidiary, Helix Immuno-Oncology S.A. As previously disclosed, the Company intends to fully divest its remaining interest in its Polish subsidiary to raise additional capital to fund the Company’s clinical development programs while retaining licensing agreements for future royalties and milestones payments.

In addition, the Company has been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising sufficient capital to qualify the Company for a listing on a U.S. stock exchange such as NASDAQ in order to further advance the Company’s clinical development programs.

On December 11, 2019 the Company announced that patient enrollment and screening had commenced on its Phase Ib/II clinical study in the U.S. The study is entitled "A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 plus Doxorubicin for the Treatment of Patients with Previously Treated Advanced Pancreatic Cancer". The Phase Ib portion of the study involves three dose escalating cohorts enrolling a total of nine (9) patients. The Phase II portion of the study will enroll an additional eleven (11) patients depending on meeting safety and efficacy criteria.

Research and development Research and development costs for the three-month periods ended October 31, 2019 and 2018 totalled $1,511,000 and $1,014,000, respectively. The following table outlines research and development costs expensed for the Company’s significant research and development projects for the three-month periods ending October 31: 2019 2018

L-DOS47 research and development expenses for the three-month periods ended October 31, 2019 and 2018 totalled $1,211,000 and $861,000, respectively.

L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., the LDOS002 European Phase I/II clinical study in Poland, the LDOS003 Phase II clinical study in Poland and the Ukraine and the Company’s newly approved Phase Ib/II clinical study in the U.S. (LDOS006).

As a result of closing a private placement for gross proceeds of $7,000,005 on August 21, 2019, the Company committed to various expenditures related to its L-DOS47 clinical development program, specifically as it relates to the Company’s’ recently approved IND clinical study for previously treated advanced pancreatic cancer (LDOS006). The Company expects to enrol the first patient by the end of the calendar year 2019. In the meantime, the Company’s other NSCLC studies (LDOS001 and LDOS002) are both in late stages of development within their respective clinical phases and the Company is working on finalizing the data for reporting.

V-DOS47 research and development expenses for the three-month periods ended October 31, 2019 and 2018 totalled $111,000 and $130,000, respectively. The Company’s wholly owned subsidiary in Poland has a grant funding agreement with the Polish National Centre for Research and Development ("PNCRD") for research and development expenditures associated with V-DOS47. The Company’s subsidiary received $27,000 and $135,000 in the three-month periods ended October 31, 2019 and 2018, respectively, from the PNCRD.

Trademark and patent related expenses for the three-month periods ended October 31, 2018 and 2017 totalled $153,000 and $25,000, respectively. The Company continues to ensure it adequately protects its intellectual property.

Operating, general and administration Operating, general and administration expenses for the three-month periods ended October 31, 2019 and 2018 totalled $709,000 and $373,000, respectively. The increase in operating, general and administration expenses mainly reflects higher third-party advisor expenditures such as legal & accounting, investor & media relations, investment banking services and stock-based compensation from options granted over their vesting period. In addition, the much lower operating expenditures for the three-month period ending October 31, 2018 was also the result of cost cutting initiatives.

LIQUIDITY AND CAPITAL RESOURCES
The Company reported a consolidated net loss and total comprehensive loss including non-controlling interest of $2,211,000 for the three-month period ended October 31, 2019 (October 31, 2018-$1,379,000). As at October 31, 2019 the Company has working capital of $430,000, shareholders’ equity of $666,000 and a deficit of $173,707,000. As at July 31, 2019 the Company had a working capital deficiency of $3,534,000, shareholders’ deficiency of $3,281,000 and a deficit of $171,531,000.

The Company experienced a working capital deficiency for several fiscal quarters, until recently when on August 21, 2019 the Company closed a private placement financing for gross proceeds of $7,000,005 which included a disposition of a 25% stake in the Company’s Polish subsidiary, Helix Immuno-Immunology S.A. As previously disclosed, the Company intends to fully divest its remaining interest in its Polish subsidiary to raise additional capital to fund the Company’s clinical development programs for future royalties and milestone payments.

In addition, the Company has been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising sufficient capital to qualify the Company for a listing on a U.S. stock exchange such as NASDAQ in order to further advance the Company’s clinical development programs.

The Company’s cash reserves of $1,650,000 as at October 31, 2019 in addition to the subsequent private placement the Company closed on August 21, 2019 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, and nor are they sufficient to see planned research and development initiatives through to completion. Though the funds raised have assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with working capital requirements To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs. 3

The Company’s Consolidated Statement of Net Loss and Comprehensive Loss and Consolidated Statement of Cash Flow for the three-month periods ended October 31, 2019 and 2018 are summarized below: The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.

On December 13, 2019 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported the closing of its previously announced underwritten public offering of 3,820,000 shares of its common stock at a public offering price of $22.25 per share (Press release, Rocket Pharmaceuticals, DEC 13, 2019, View Source [SID1234552372]). The gross proceeds to Rocket from the offering are expected to be approximately $84,995,000 million, before deducting the underwriting discounts and commissions and other offering expenses.

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Rocket intends to use the net proceeds from this offering to further fund the development of our pipeline of gene therapies for rare diseases, to support the buildout of in-house manufacturing capabilities, and for general corporate purposes.

J.P. Morgan, Cowen and Evercore ISI acted as joint-bookrunning managers for the offering. LifeSci Capital LLC acted as co-manager.

The public offering was made by Rocket pursuant to an effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A final prospectus supplement relating to and describing the terms of this offering was filed with the SEC on December 11, 2019. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926, or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at 1-888-474-0200 or by e-mail at [email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

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

On December 13, 2019 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported an update regarding its TELLOMAK Phase II trial evaluating the efficacy and safety of lacutamab (IPH4102, a potentially first-in-class anti-KIR3DL2 antibody) (Press release, Innate Pharma, DEC 13, 2019, View Source [SID1234552357]). The Company will take the following actions based on ongoing discussions with regulatory authorities regarding a quality issue related to the chemistry, manufacturing and controls (CMC) process:

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Lacutamab will not be administered to new patients in the TELLOMAK trial until additional feedback is received from the respective regulatory agencies overseeing our clinical trial.
Until further notice, the Company will continue to treat patients who are currently enrolled in the multi-center trial, except in Italy where the clinical trial has been suspended due to the feedback from Italian regulatory authorities.
This decision is related to issues with the Company’s manufacturing subcontractor, Rentschler Fill Solutions GmbH or "RFS" (now known as Impletio Wirkstoffabfüllung GmbH). RFS has recently withdrawn the Certificate of Conformity of batches they have produced, including the lacutamab batch currently used in the TELLOMAK trial. RFS was granted a Good Manufacturing Practice (GMP) certificate by the Austrian regulatory agency in August 2018 and further confirmed in October 2019. In parallel, RFS filed for bankruptcy.

The Company’s utmost priority is to ensure patient safety, and no new safety issues have been reported to date in the TELLOMAK trial. An extensive internal and third-party analysis concluded that there was no element that would affect the CMC quality of the product.

Innate will provide an update once it has received additional feedback from the relevant regulatory agencies. In parallel, the Company is working on resolution of the quality issues related to the CMC matter.

About Lacutamab:

Lacutamab (formerly IPH4102) is a potentially first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of CTCL, an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 85% of them with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It has a restricted expression on normal tissues.

Lacutamab was granted orphan drug status in the European Union and in the United States for the treatment of CTCL. In January 2019, the US Food and Drug Administration (FDA) granted Innate Pharma Fast Track designation for lacutamab for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.

About TELLOMAK Trial:

TELLOMAK is a global, open-label, multi-cohort Phase II clinical trial conducted in the United States and Europe. In this clinical trial, lacutamab is being evaluated alone and in combination with chemotherapy in patients with advanced TCL. TELLOMAK is expected to recruit up to 250 patients, with lacutamab evaluated:

As a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior treatments, including mogamulizumab,
As a single agent in approximately 90 patients with MF who have received at least two prior treatments, and
In combination with standard chemotherapy (gemcitabine and oxaliplatin) in approximately 100 patients with PTCL who have received at least one prior treatment.
In patients with MF and PTCL, the study is designed to evaluate the benefit of lacutamab according to KIR3DL2 expression. The study comprises two cohorts for each of the two indications, testing lacutamab in KIR3DL2 expressing and non-expressing patients. These cohorts follow a Simon 2-stage design that will terminate if treatment is considered futile. The Sézary syndrome arm of the study could enable the registration of lacutamab in this indication.

The primary endpoint of the trial is objective response rate. Key secondary measures include incidence of treatment emergent adverse events, quality of life, overall response rate, progression-free survival and overall survival.

On December 13, 2019 Isofol Medical AB (publ), (Nasdaq First North Premier: ISOFOL), reported the approval from the United States Patent and Trademark Office (USPTO) for a patent covering the clinical use of a biomarker analysis to detect cancer patients ability to respond to folate-based therapy cancer treatments (Press release, Isofol Medical, DEC 13, 2019, View Source [SID1234552374]).

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The patent is valid until 2035 and extends Isofol’s patent portfolio for its lead asset arfolitixorin, the company’s drug candidate entity with the potential to increase the effectiveness of folate-based chemotherapy regimens. Arfolitixorin is currently being studied in the ongoing global Phase 3 study AGENT, in patients with metastatic colorectal cancer.

Ulf Jungnelius, M.D., Chief Executive Officer of Isofol, comments: "We consider the patent to be of great strategic importance for Isofol. It can increase the benefit of folate-based cancer treatment by detecting patients’ ability to respond to the treatment. The patent can be applied to all types of cancer undergoing folate-based cancer treatment. It is our belief that the method can be extended to further cancer indications in the long term. Currently, we are focusing on validating arfolitixorin in our global Phase III study AGENT, in patients with metastatic colorectal cancer."

The granted patent, U.S. Patent No. 10,487,364, is directed to a method of treating cancer using a combination of an anti-cancer agent and a folate substance, such as arfolitixorin or leucovorin (LV). The patent pertains to detection of the levels of a number of biomarkers involved in folate transport and metabolism, which can predict an individual patient’s responsiveness to a conventional folate substance such as leucovorin. Following biomarker analysis, patients unresponsive to current prodrugs (LV) could be selected for treatment with arfolitixorin on the basis of the biomarker level to potentially helping increase the effectiveness of the treatment regimen used. Unlike leucovorin, which must be metabolised into MTHF in the body in order to be effective in the treatment of cancer, arfolitixorin is the active substance MTHF, which means that no metabolic activation is required and arfolitixorin consequently has the potential to achieve a more powerful antitumoural effect for all patients in combination with 5-FU treatment.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15:45 CET on December 13, 2019.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase 3 trial, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.