On October 2, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported that the U.S. Congress urges the Centers of Medicare & Medicaid Services (CMS) to consider coverage of colorectal cancer screening blood tests as part of the approved 2019 Health and Human Services (HHS) Appropriations Bill (Press release, Epigenomics, OCT 2, 2018, View Source [SID1234530237]).

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According to the Appropriations report issued in concert with the Appropriations Bill signed into law on September 28, 2018 the U.S. Congress stated its intent by urging CMS to provide "…coverage of blood tests…(which) could serve to deter or immediately recommend the need for colonoscopy so as to increase the number of patients that go in for testing and decrease the amount of late-stage colon cancer diagnoses."

"We are very pleased that the U.S. Congress has urged CMS to cover FDA approved blood tests for colorectal cancer screening. We believe this is a positive step towards legislative approval," said Greg Hamilton, Chief Executive Officer of Epigenomics AG. "Colorectal cancer remains the second-leading cause of cancer death in the United States as still 1 in 3 or approximately 30 million Americans are not screened. CMS coverage of blood tests could help to increase screening participation rates and ultimately save lives."

In March 2018, Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM) introduced the "Colorectal Cancer Detection Act of 2018" to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) "Donald Payne Sr. Colorectal Cancer Detection Act" introduced by Congressman Donald M. Payne, Jr. (D – NJ) in 2017. These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood tests.

About colorectal cancer (CRC)

The American Cancer Society projects there will be over 140,000 new diagnosed cases of colorectal cancer, and over 50,000 deaths, from colorectal cancer in 2018 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened. While the 5-year survival rate for early colorectal cancer (stage I) is 90%, only four- out-of-ten cases are diagnosed at this early stage. According to the American Cancer Society, this is in part due to the underuse of screening.

About Epi proColon

Epi proColon is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

On October 2, 2018, Immunomedics, Inc. (the "Company") entered into privately negotiated exchange agreements (the "Exchange Agreements") with a limited number of holders ("Noteholders") of its outstanding 4.75% Convertible Senior Notes due 2020 (the "Convertible Notes"), pursuant to which the Company agreed to exchange, in a private placement in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended (the "Exchanges"), approximately $12.9 million in aggregate principal amount of the Convertible Notes held by the Noteholders for approximately 2.57 million newly issued shares of the Company’s common stock, par value $0.01 per share (Filing, 8-K, Immunomedics, OCT 2, 2018, View Source [SID1234530614]).

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The Company anticipates that the Exchanges will be completed on or about October 5, 2018. Upon completion of the Exchanges, the aggregate principal amount of the Convertible Notes is expected to be reduced to approximately $7.1 million.

The Company expects to file the form of Exchange Agreement as an exhibit to its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2018. The foregoing description is qualified in its entirety by reference to the complete text of the form of Exchange Agreement when filed.

This Current Report does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

On October 2, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three-month period ended July 31, 2018 (Press release, Cotinga, OCT 2, 2018, View Source [SID1234533150]):

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. Recent highlights include: Advanced the clinical development of COTI-2:

In May 2018, Cotinga announced FDA clearance of a protocol amendment for its ongoing Phase 1b/2a trial of COTI-2. The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.
Presented novel scientific findings from its COTI-2 clinical program:

In June 2018, Cotinga and its collaborators from MD Anderson Cancer Center presented data on COTI-2 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois;
Subsequent to the reporting quarter, in September 2018, Cotinga presented data on COTI-2 at the 11th International Symposium on Translational Research in Oncology in Dublin, Ireland.
Secured financing and appointed management and board members to support corporate strategy:

In May 2018, Cotinga closed a brokered private placement and a non-brokered private placement for total proceeds of approximately CAD $2,010,000;
In July 2018, Cotinga announced the appointment of Victor Hugo as Chief Financial and the appointment of J. Matthew Bond as a member of the Board of Directors and Chairman of the Audit Committee.
"We began the fiscal year with renewed progress across the entire business, including implementation of an expanded protocol for our ongoing Phase 1b/2a clinical trial of COTI-2," said Alison Silva, President & Chief Executive Officer. "We were also pleased to reduce our operating expenses during the quarter, while simultaneously securing the capital and personnel necessary to support our corporate strategy. We look forward to continuing to provide updates at critical milestones as we efficiently advance COTI-2 through clinical development."

Upcoming Milestones

COTI-2:

Dose first patient with combination therapy in Phase 1b/2a clinical trial in solid tumor;
Complete additional exploratory endpoint data analysis for dose escalation portion of Phase 1 trial in gynecological malignancies;
Complete Phase 1 dose escalation trial in HNSCC;
Initiate p53 basket trial with COTI-2;
Initiate breast cancer trial with COTI-2.
COTI-219:

Complete IND-enabling studies;
Finalize GMP manufacturing;
File an IND.
Corporate:

Strengthen the balance sheet;
Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.
Financial Results

The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.

For the three-months ended July 31, 2018, the Company incurred a net loss of $0.982 million, or $0.04 per share, compared to a net loss of $0.242 million, or $0.02 per share, for the three-months ended July 31, 2017. The increase in net loss during the three-month period is primarily due to changes in fair value warrant liability, partially offset by decreases in Research and Development (R&D) expense, Sales and Marketing (S&M) expense and General and Administrative (G&A) expense.

There was no revenue for the three-month period ended July 31, 2018 or in the comparative period in the year prior.

R&D expense in the three-month period ended July 31, 2018 decreased by $0.283 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries and benefits due to lower headcount and preclinical testing.

S&M expense in the three-month period ended July 31, 2018 decreased by $0.048 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to cost reduction implemented last financial year.

G&A expense in the three-month period ended July 31, 2018 decreased by $0.287 million over the same period in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in salaries due to lower head count and lower share-based compensation.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three-month period ended July 31, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

On October 2, 2018 GO Therapeutics, Inc. (GO), a company applying new advances in glycoproteomics to develop antibody-based cancer therapeutics, reported that it has entered into a license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche) (Press release, GO Therapeutics, OCT 2, 2018, View Source [SID1234529713]). Under the terms of the agreement, GO will grant Roche a worldwide, exclusive license for antibodies generated to address a novel cancer-specific target to develop and commercialize a new glycotargeting bispecific antibody.

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"We are excited about this collaboration to develop an innovative immune-redirected therapy to potentially improve the lives of patients suffering from cancer in the future"

Under the terms of the agreement, Roche will pay GO upfront and near-term milestones of $9 million. GO will also be eligible to receive up to $186 million in potential milestone payments as well as mid-single-digit to low double-digit royalties on any future product sales. Further details about the transaction were not disclosed.

"We are excited about this collaboration to develop an innovative immune-redirected therapy to potentially improve the lives of patients suffering from cancer in the future," said Constantine Theodoropulos, chief executive officer of GO Therapeutics.

"GO’s glycoprotein targeting platform opens an exciting class of tumor-specific antigens that can help widen the therapeutic window for cancer therapies such as T-cell bispecific antibodies, CAR-T and ADCs (Antibody Drug Conjugates). Preclinical data show GO’s approach can provide superior specificity in targeting solid tumors over normal tissue, and demonstrate clean in-vivo toxicity profiles in the context of potent immunotherapies."

On October 2, 2018 Jnana Therapeutics reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Jnana Therapeutics, OCT 2, 2018, View Source [SID1234529773]).

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Jnana Therapeutics was launched in 2017 to build the first drug discovery platform targeting the solute carrier (SLC) family of metabolite transporters, which are the gates used by the cell to control metabolite movement. The company is taking a comprehensive approach to understanding SLCs and their underlying biology in order to unlock a new wave of druggable targets. From there, they are discovering and developing medicines to modulate critical disease pathways to improve outcomes for patients with severe diseases.

"We are pleased to be recognized as a Fierce 15 company, an award which reflects the innovative nature of our drug discovery platform and its potential to unlock SLC transporters as a novel therapeutic target class," said Joanne Kotz, Ph.D., Cofounder and President at Jnana. "Our purpose at Jnana is to push the frontiers of scientific knowledge by pioneering the comprehensive understanding and targeting of the SLC transporter family, which has never been systematically addressed in drug development, and create a new class of medicines that make a positive impact on patients and their families."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 16th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.