On April 3, 2018 Cancer Therapeutics CRC (CTX) is reported that appointment of Brett Carter as Chief Executive Officer (Press release, Cancer Therapeutics CRC, APR 3, 2018, View Source [SID1234525374]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Brett will succeed Dr Warwick Tong who has led CTX for the past 6 years and who will continue to provide services to the organisation in an advisory capacity. These changes reflect a transition plan agreed between Dr Tong and the CTX Board to evolve the organisation from a Federally supported Cooperative Research Centre (CRC) into an independent and self-sustainable organisation.

Commenting on the appointment, Dr Tony Evans Chair of CTX, said
:
"We are delighted to appoint Brett as Chief Executive Officer. Brett has excellent management skills, extensive industry experience and a track record of executing pharmaceutical deals, making him the ideal candidate to lead CTX moving forward. I would like to thank Warwick for his dedicated leadership of the organisation over the past 6 years. Warwick has made many contributions to CTX however I would like to specifically highlight his involvement in the PRMT5 licensing deal to Merck, which was one of Australia’s largest ever pre-clinical asset licensing deals."

Commenting on the appointment, Mr Carter, said:
"Cancer is Australia’s leading cause of pre-mature death and CTX’s unique and highly successful business model has resulted in the development of drug products that have the potential to provide cures for cancer patients. I am very excited to be taking over the leadership of an organisation with such a strong culture of innovation and delivery.
To move from a medical research hub to a global biotechnology leader, Australia needs organisations like CTX, that build the drug discovery and development capability necessary to translate the country’s world class medical research into clinical and commercial outcomes.

I want to thank Warwick for his mentorship over the past year and I look forward to working with the CTX team and stakeholders as we embark on the next stage of the organisation’s evolution."

On April 3, 2019 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- and nine-month periods ended January 31, 2018 (Press release, Cotinga, APR 3, 2018, View Source [SID1234533156]). Recent highlights include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Advanced the clinical development of COTI-2:

In November 2017, Cotinga announced pharmacokinetic (PK) data from its ongoing Phase 1 trial of COTI-2, which showed that COTI-2 exhibited rapid absorption, long half-life and lack of long-term drug accumulation, which support the potential for daily oral dosing and the continued development of COTI-2 as a potential treatment for patients;
In December 2017, Cotinga announced pharmacodynamic (PD) data and positive signals of efficacy from its ongoing Phase 1 trial of COTI-2, which suggest COTI-2 may be a potentially efficacious treatment for patients;
In January 2018, Cotinga announced publication of positive data from a preclinical study demonstrating that combining COTI-2 with commonly used chemotherapeutic agents improves efficacy and exhibits favorable drug resistance and toxicity profile in human cancer cell lines, which suggest COTI-2 may be potentially efficacious as a combination therapy;
Subsequent to the reporting quarter, in March 2018, Cotinga announced that the Company submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2. The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of solid tumor cancers.
Solidified identity as a clinical-stage pharmaceutical company:

In January 2018, the Company changed its name to Cotinga Pharmaceuticals Inc. The new brand signified the Company’s evolution from a technology-driven company to a clinical-stage pharmaceutical company. The name is derived from the Cotingas, one of the world’s largest and most diverse bird species, and symbolizes the Company’s focus on developing innovative therapies to treat a wide spectrum of cancers.
"We were excited to announce multiple meaningful clinical and corporate developments in the third fiscal quarter," said Alison Silva, President & Chief Executive Officer. "The encouraging interim clinical data we announced over the past several months, along with the positive preclinical data we published earlier this year, facilitated a thorough assessment of our clinical development strategy for COTI-2. Based on the findings of that assessment, we submitted a regulatory package to the FDA to expand our ongoing Phase 1 trial to evaluate COTI-2 as a combination therapy in a broad patient population. We are eager to explore the potential of combination therapy with COTI-2 in the clinic, and look forward to implementing this new trial design in the months ahead. Working towards securing sufficient funds to support this clinical development strategy was a top priority during the fiscal quarter and remains so in the fourth quarter. We will report on our progress as those financing efforts advance."

Financing
In December 2017, Cotinga announced it had entered into an agreement with a U.S. investment bank to act as exclusive placement agents on a best-efforts basis for a cross-border private placement equity financing. The objectives of the financing include broadening the investor base to include institutional and other sophisticated investors in the life sciences sector. The Company’s ability to advance its programs is highly dependent upon the outcome of its financing efforts, which are targeted to close in April 2018. The proceeds from the equity financing are intended to primarily support the continued clinical development of COTI-2. The results of the equity financing may require the Company to reprioritize or alter its strategies in respect of its programs.

Upcoming Milestones
COTI-2:

Implementation of protocol amendment to expand ongoing Phase 1 trial of COTI-2 to evaluate COTI-2 as a combination therapy in an expanded patient population expected to commence mid-calendar year 2018.
Readout of additional exploratory endpoint data from the dose escalation portion of the Phase 1 trial in gynecological malignancies expected mid-calendar year 2018;
Initiation of additional combination studies with standard of care chemo- and radiotherapeutics in multiple oncology indications expected in calendar year 2018.
COTI-219:

Continuation of GMP manufacturing work and further mechanism of action preclinical studies to enable an IND filing.
Financial Results
The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1 clinical trial of COTI-2 in gynecological malignancies and HNSCC.

For the three-months ended January 31, 2018, the Company incurred a net loss of $1.279 million, or $0.08 per share, compared to a net loss of $1.238 million, or $0.08 per share, for the three-months ended January 31, 2017. The comparable net loss during the three-month period is primarily due to a decrease in Research and Development ("R&D") expense and General and Administration ("G&A") expense, offset by a lower favorable swing in the valuation of the warrant liability.

For the nine-months ended January 31, 2018, the Company incurred a net loss of $3.301 million, or $0.21 per share, compared to a net loss of $4.302 million, or $0.29 per share, for the nine-months ended January 31, 2017. The decrease in net loss during the nine-month period is primarily due to a decrease in G&A expense and a favorable swing in the valuation of the warrant liability, partially offset by an increase in R&D expense.

There was no revenue for the three- and nine-month periods ended January 31, 2018 or in the comparative periods in the year prior.

Operating expenses in the three- and nine-month periods ended January 31, 2018 decreased by $0.632 million and $0.408 million respectively over the same periods in the year prior, primarily due to a decrease in G&A expense and Sales and Marketing ("S&M") expense, partially offset by an increase in R&D expense and lower investment tax credits.

R&D expense in the three- and nine-month periods ended January 31, 2018 decreased by $0.123 million and increased by $0.182 million respectively over the same periods in the year prior. The decrease in R&D expense in the three-month period is primarily due to a decrease in clinical trial expenses, synthesis and miscellaneous R&D expenses and share-based compensation, partially offset by an increase in in vivo/in vitro testing and salaries and benefits. The increase in R&D expense in the nine-month period is primarily due to an increase in synthesis and miscellaneous R&D expenses, in vivo/in vitro testing, and salaries and benefits, partially offset by a decrease in clinical trial expenses and share-based compensation.

G&A expense in the three- and nine-month periods ended January 31, 2018 decreased $0.519 million and $0.572 million respectively over the same period in the year prior due to a reduction in salaries and benefits, share-based compensation expense, and marketing and travel. These decreases were partially offset by an increase in professional fees, corporate governance, rent and insurance.

S&M expense in the three- and nine-month periods ended January 31, 2018 decreased by $0.026 million and $0.116 million respectively compared to the same periods in the year prior due to a decrease in professional fees and marketing and travel. These decreases were partially offset by an increase in other S&M expenses.

ITC income for the three- and nine-month periods ended January 31, 2018 decreased by $0.037 million and $0.098 million respectively compared to the same periods in the year prior due to a decrease in eligible R&D expenditures.

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- and nine-month periods ended January 31, 2018, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

On April 3, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the full year ended December 31, 2017 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, APR 3, 2018, View Source [SID1234525156]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During 2017 we made meaningful progress advancing both our clinical and corporate objectives, which has positioned us for continued growth throughout 2018 and beyond," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path. "As we move into 2018, we expect to implement the protocol amendments to our Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia, to prepare for a Phase 1 clinical trial of BP1002 in lymphoma, to begin enrollment of a Phase 1 clinical trial of prexigebersen in solid tumors potentially by year-end, and to start a series of IND-enabling studies for BP1003 in pancreatic cancer. We continue to have confidence in the performance and potential of our DNAbilize platform technology to produce exciting drug candidates to help patients with high unmet medical need."

Recent Corporate Highlights

·Reported Pre-Specified Interim Results from Phase 2 Study of Prexigebersen in Combination with LDAC to Treat AML. Of the 17 evaluable patients, four patients achieved complete responses, one patient achieved a leukemia free, one patient had significantly reduced bone marrow blasts and three patients achieved stable disease. In total, 47% of the evaluable patients showed some form of response to the combination treatment, including four patients with complete remission (23%) and four patients with stable disease.

·Published Data in The Lancet Haematology. In March 2018, the Company announced that data from its Phase 1/1b study of prexigebersen (BP1001) as a treatment for hematological malignancies was published in The Lancet Haematology in an article titled, "Liposomal Grb2 antisense oligodeoxynucleotide (BP1001) in patients with refractory or relapsed haematological malignancies: a single-centre, open-label, dose-escalation, phase 1/1b trial."

·Announced Third Drug Candidate, BP1003, for Treatment of Pancreatic Cancer. In November 2017, Bio-Path announced its third drug candidate, BP1003, entered into preclinical development for the treatment of pancreatic cancer. BP1003 targets the Stat3 protein and is currently being studied in patient-derived tumor models. Previous ex vivo tumor studies have shown BP1003 to successfully penetrate pancreatic tumors and enhance the efficacy of standard frontline treatments. Bio-Path expects to initiate IND-enabling studies for BP1003 in 2018.

Upcoming Events

·Presentation at the 2018 AACR (Free AACR Whitepaper) Annual Meeting. Bio-Path will present preclinical animal model data at the upcoming AACR (Free AACR Whitepaper) Annual Meeting on Wednesday, April 18, 2018, at the Experimental and Molecular Therapeutics Session, Section 36, from 8:00 a.m. – 12:00 p.m. ET in Chicago. The abstract (#5786) is titled: "Grabbing GRB2: The use of liposome-incorporated Grb2 antisense oligonucleotides as a novel therapy in gynecologic malignancies."

Financial Results for the Full Year Ended December 31, 2017

The Company reported a net loss attributable to common stockholders of $8.1 million, or $0.80 per share, for the year ended December 31, 2017, compared to a net loss attributable to common stockholders of $6.8 million, or $0.73 per share, for the year ended December 31, 2016. The increase was primarily due to the deemed dividend related to the warrant conversion in 2017. The per share amounts above have been adjusted to give effect to the 1-for-10 reverse stock split that occurred on February 8, 2018.

Research and development expenses were $5.5 million for both the years ended December 31, 2017 and December 31, 2016.

General and administrative expenses for the year ended December 31, 2017 increased to $3.5 million, compared to $3.0 million for the year ended December 31, 2016. The increase was primarily due to increased legal and audit fees.

As of December 31, 2017, the Company had cash of $6.0 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the year ended December 31, 2017 was $8.0 million compared to $8.1 million for the comparable period in 2016. Net cash used in investing activities for the year ended December 31, 2017 was $0.5 million. Net cash provided by financing activities for the year ended December 31, 2017 was $5.1 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full year 2017 financial results and to provide a general update on the Company. To access the conference call please dial 844-815-4963 (domestic) or 210-229-8838 (international) and refer to the conference ID number 5195559. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On April 3, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next-generation cancer medicines using its data science and precision chemistry product engine, reported the publication of a comprehensive genomic landscape analysis illuminating the breadth, frequency and potential disease-driving significance of somatic mutations in RNA splicing factor genes in human cancers (Press release, H3 Biomedicine, APR 3, 2018, View Source [SID1234525375]). The findings demonstrate that splicing factor mutations, which lead to RNA splicing dysregulation, are highly prevalent in many hematologic and solid tumor cancers, suggestive of their role as a hallmark of tumor formation and growth and, thus, opportunities for therapeutic intervention. RNA splicing is the biological process by which pre-cursor messenger RNA (pre-mRNA) is edited into a mature messenger RNA (mRNA). Splicing factors carry out the editing process which is catalyzed by the core spliceosome complex. H3 Biomedicine scientists’ research and findings were published in the most recent online version of Cell Reports. (Seiler M. et al, "Somatic mutational landscape of splicing factor genes and their functional consequences across 33 cancer types"). This manuscript is part of The Cancer Genome Atlas (TCGA) Program, a joint effort of the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In recent years, somatic mutations in core splicing factors have been described in certain hematologic malignancies but the breadth of splicing factor mutations has been largely underappreciated. The findings published today give us for the first time a comprehensive understanding of just how common splicing factor mutations are across many types of cancer and of the role they may play in promoting tumor formation and progression," said Markus Warmuth, M.D., President and Chief Executive Officer of H3 Biomedicine Inc. "This knowledge further validates the therapeutic approach of modulating spliceosome dysregulation to control tumor formation and growth, one of our core focus areas at H3 Biomedicine as evidenced by H3B-8800, our small molecule modulator of the SF3b complex, which is currently being evaluated in a Phase 1 clinical trial for patients with hematologic cancers and splicing factor mutations. In addition, the research findings open up an expansive, actionable trove of spliceosome targets that could be explored with novel therapeutic strategies."

Using whole exome and RNA sequencing data in TCGA, H3 data scientists analyzed over 10,000 patient samples across 33 tumor types to identify somatic mutations in RNA splicing factors. The analysis of over 400 splicing factor genes identified 119 genes as having putative driver mutations, including over-representation, recurrent loss-of-function or recurrent hotspot (oncogene-like) mutations.

Mutations in splicing factor genes were found in all 33 tumor
types with the frequency of mutations in multiple splicing factor genes as high as 60% in patient samples of the same tumor types, representing a much larger occurrence than previously reported. In addition, H3 scientists, as exemplified in case studies of five genes, showed that mutations in splicing factor genes led to dysregulated or altered splicing in mutated cells.
"This research and analysis exemplifies our differentiated drug discovery approach. We have the computational power and know-how to mine vast amounts of genomic data and reveal critical insights that we in turn utilize to develop and investigate highly targeted, precision approaches to cancer," said Lihua Yu, Ph.D., Chief Data Science Officer of H3 Biomedicine Inc. "We’re particularly proud of this work because, beyond informing our own drug discovery efforts, it will help advance the entire field’s understanding of the role dysregulated RNA splicing plays in cancer."
H3 Biomedicine is advancing novel cancer therapies that target core splicing factor mutations. A Phase 1 trial is underway in patients with hematologic malignancies for the company’s first spliceosome pathway-targeting cancer therapeutic, H3B-8800, a potent, selective and orally bioavailable small molecule modulator of wild-type and mutant SF3b complex, a splicing factor gene. The study is evaluating the safety and preliminary efficacy of H3B-8800 in patients with myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia who carry mutations in splicing factor genes. Preclinical data demonstrate that H3B-8800 modulates RNA splicing and shows preferential antitumor activity in a range of spliceosome-mutant cancer models.

Splicing modulation is one of several research focus areas of H3 Biomedicine. H3 Biomedicine has two additional investigational therapies in Phase 1 clinical trials, including:

H3B-6545, an oral, first-in-class ESR1 covalent antagonist targeting wild-type and mutant estrogen receptor α in endocrine-therapy resistant metastatic breast cancer patients; and

H3B-6527, an oral, potent and highly selective small molecule covalent inhibitor of FGFR4 for treatment of hepatocellular carcinoma (HCC) patients with overexpression of FGF19.

On April 3, 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 that the Company and its collaborators from MD Anderson Cancer Center and Northwestern Medicine will present data on COTI-2, Cotinga’s lead compound currently in a Phase 1 trial, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 taking place April 14-18, 2018 in Chicago, Illinois (Press release, Cotinga, APR 3, 2018, View Source [SID1234533157]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Title: Safety and early efficacy signals for COTI-2, an orally available small molecule targeting p53, in a phase I trial of recurrent gynecologic cancer
Presentation Date and Time: Sunday April 15th, 2018 1:00 PM – 5:00 PM Central Time
Presentation Location: McCormick Place South, Hall A, Poster Section 42

Phase 1 Trial of COTI-2
The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and HNSCC. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy. In March 2018, the Company submitted a protocol amendment to expand the trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval and subject to sufficient financing, the Company expects to implement the protocol amendment mid-calendar year 2018.