On November 18, 2020 Obsidian Therapeutics, Inc. and The University of Texas MD Anderson Cancer Center reported a multi-year strategic collaboration designed to expedite the research and development of novel engineered tumor infiltrating lymphocytes (TILs) for the treatment of solid tumors (Press release, Obsidian Therapeutics, NOV 18, 2020, View Source [SID1234571319]). The agreement pairs Obsidian and its novel cytoDRiVE technology platform with MD Anderson’s extensive experience and state-of-the-art capabilities in TIL cell therapy, led by the Biologics Development platform, within the Therapeutics Discovery division.

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The collaboration is focused on developing TIL armored with regulated membrane-bound IL15 (referred to as cytoTIL) with the potential to enhance anti-tumor efficacy and reduce tumor burden in patients suffering from different types of solid tumors. The teams will collaborate to accelerate the development of cytoTIL, including process and analytical development and clinical readiness activities.

"TIL therapy has emerged as a promising option for treating patients with solid tumors, though its widespread use today is limited by safety and efficacy challenges," said Rodabe Amaria, M.D., associate professor of Melanoma Medical Oncology at MD Anderson. "We are pleased to work with Obsidian to advance their novel cytoTIL program, which has the potential to drive more durable treatment responses and expand TIL therapy to a broader group of our patients."

The cytoTIL therapy is engineered using Obsidian’s cytoDRiVE platform technology, which precisely and reversibly controls protein expression and activity using FDA-approved orally bioavailable drugs. By leveraging regulated membrane-bound IL15 to drive antigen-independent expansion of T cells and transactivation of NK cells, cytoTIL therapy is anticipated to improve patient response to TIL treatment and expand patient eligibility to those who currently cannot benefit from this transformative therapy.

"We are delighted to work with MD Anderson’s Biologics Development team to build upon the success of first generation TIL therapies and bring the first controllable TIL therapy to patients as rapidly as possible," said Paul Wotton, Ph.D., CEO of Obsidian Therapeutics. "Through its cell therapy research platforms, deep clinical development experience, and industrial manufacturing capabilities, MD Anderson is a best-in-class collaborator to advance and accelerate cutting-edge cell therapies."

MD Anderson’s Biologics Development platform is built around an experienced team focused on pioneering impactful biologic therapeutics, including antibodies and cell therapies. With a state-of-the-art 60,000 sq. foot GMP cell-therapy manufacturing facility, the platform joins MD Anderson expertise with the rigor of industrial development. Biologics Development offers a strong starting point for early-stage companies to access the breadth of MD Anderson capabilities in cell therapy development.

MD Anderson is implementing an Institutional Conflict of Interest Management and Monitoring Plan for any research related to this relationship.

On November 18, 2020 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third quarter 2020 financial results (Press release, Kronos Bio, NOV 18, 2020, View Source [SID1234571318]).

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"Kronos Bio experienced transformational growth in 2020. With the acquisition of the portfolio of SYK inhibitors from Gilead Sciences, we are positioned to initiate late-stage clinical testing next year of our lead investigational therapy entospletinib in patients with newly diagnosed NPM1-mutated acute myeloid leukemia. Furthermore, in the first half of 2021, we plan to begin clinical testing of KB-0742, our CDK9 inhibitor, in patients with advanced solid tumors," said Norbert Bischofberger, Ph.D., president and CEO. "We have expanded our leadership team and filled key roles across the organization. Additionally, with the completion of two financing rounds, including our upsized IPO, we are well-capitalized to execute on our mission to develop and deliver therapies that have the potential to change patients’ lives."

Recent Highlights

In July 2020, acquired Gilead Sciences’ portfolio of spleen tyrosine kinase (SYK) inhibitors, including entospletinib, which Kronos Bio is developing as a frontline treatment for patients with NPM1-mutated acute myeloid leukemia (AML).

Expanded the company’s leadership team with the hiring of Barbara Kosacz, chief operating officer and general counsel, and Dr. Yasir Al-Wakeel, chief financial officer and head of corporate development, and appointed Elena Ridloff to the company’s Board of Directors as chair of the audit committee.

In September 2020, closed a private financing round of approximately $155.2 million of convertible notes.

In October 2020, completed an upsized initial public offering (IPO) of 15,131,579 of common stock, including full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of $287.5 million, before deducting underwriting discounts and commissions and offering expenses.

In October 2020, published in Cell Chemical Biology the results of a preclinical study of KB-0742, the company’s potent oral, highly selective cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors. These results were previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June 2020.
Third Quarter Financial Highlights

Cash, Cash Equivalents and Short-Term Investments: As of September 30, 2020, cash, cash equivalents and short-term investments totaled $211.3 million, which excludes approximately $263.9 million in net proceeds from the company’s October 2020 upsized IPO.

R&D Expenses: Research and development expenses were $16.8 million for the third quarter of 2020, which includes $0.2 million in stock-based compensation expense.

G&A Expenses: General and administrative expenses were $4.1 million for the third quarter of 2020, which includes $1.0 million in stock-based compensation expense.

Net Loss: Net loss was $39.7 million, or $6.48 per basic and diluted share, for the quarter ended September 30, 2020. This includes a non-recurring $15.2 million non-cash change in fair value of convertible notes.

On November 18, 2020 EORTC reported that Results of the 15-year update of the EORTC 22922/10925 phase III trial on internal mammary and medial supraclavicular (IM-MS) lymph node irradiation in stage I–III breast cancer were published in The Lancet Oncology journal this month1 (Press release, EORTC, NOV 18, 2020, https://www.eortc.org/blog/2020/11/18/15-year-follow-up-of-eortc-22922-10925-phase-iii-trial-shows-reduction-in-breast-cancer-mortality-and-recurrence-but-does-not-confirm-improved-overall-survival/ [SID1234571309]).

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This trial assessed the impact on overall survival of elective IM-MS irradiation. Breast cancer can spread to the regional lymph nodes, through the axillary and internal mammary nodes to the medial supraclavicular nodes. Traditionally, non-metastasised breast cancer is treated by surgical resection of the primary tumour with surgical axillary staging and, in case of involved axillary lymph nodes, elective nodal irradiation of the non-dissected axillary, the internal mammary and medial supraclavicular lymph nodes. While studies have shown a favourable effect of locoregional postoperative irradiation, an increased risk of non-breast cancer-related mortality was also seen, which is assumed to be due to radiation on the heart, resulting in some centres continuing to use locoregional nodal treatment while others restricting their treatments.

This trial was conducted across 46 radiation oncology departments from 13 countries. A total of 4004 patients, up to the age of 75, with unilateral stage I–III adenocarcinoma of the breast, with axillary nodal involvement and/or a primary tumour located centrally or in the medial quadrants of the breast, were randomised to IM-MS irradiation or no IM-MS irradiation. Surgery consisted of mastectomy or breast-conserving surgery and axillary lymph node dissection or sentinel lymph node biopsy.

Results showed that 27·7% patients in the IM-MS irradiation group and 28·4% patients in the control group had died. Overall survival rate at 15 years was 73·1% in the IM-MS irradiation group and 70·9% in the control group. Breast cancer recurrence and breast cancer mortality rates at 15 years were lower in the IM-MS irradiation group (24.5% and 16·0% respectively) than in the control group (27.1% and 19·8%, respectively). No significant differences were seen in the IM-MS irradiation group versus the control group for disease-free survival, or distant metastasis-free survival. Causes of death between groups were similar.

After a follow-up of 10.9 years, the study showed that regional nodal irradiation improved overall disease-free survival, distant disease-free survival, and breast cancer mortality. At 15·7 years of follow-up, the trial confirmed a significant reduction of breast cancer-related mortality and any recurrence after medial supraclavicular and internal mammary lymph node irradiation in stage I–III breast cancer. However, this is not translated into improved overall survival. Remarkably, toxicity after IM-MS irradiation was very limited, without an increased non-breast cancer related mortality.

Philip PoortmansProfessor Philip Poortmans, Principal Investigator of the study, from Iridium Kankernetwerk and Faculty of Medicine and Health Sciences, University of Antwerp, Belgium commented: "The 15-year results of the EORTC trial hoped to shed light in the uncertainties surrounding selecting the right breast cancer patients for more extensive regional lymph node treatment. Unfortunately, it is not clear yet. For the time being, supported by the low level of side effects, we advise elective nodal irradiation for patients at high risk for recurrence, especially in case of a long-life expectancy and providing that modern volume-based treatment techniques are used. We continue follow-up up to 20 years and contribute to the ongoing EBCTCG meta-analysis, both helping to sort out the remaining questions."

On November 18, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "ImmunoPrecise") (TSXV: IPA) (OTCQB: IPATF) (FSE: TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that, further to a news release issued on November 4, 2020, subject to the approval of the TSX Venture Exchange, the consolidation of the Company’s issued and outstanding common shares (the "Common Shares") on the basis of five (5) pre-consolidation Common Shares for one (1) post-consolidation Common Share (the "Consolidation") will be effective as of market open on November 23, 2020 (Press release, ImmunoPrecise Antibodies, NOV 18, 2020, View Source [SID1234571265]). The Company’s stock symbol will remain unchanged. The ISIN and CUSIP numbers for the Common Shares will be CA45257F2008 and 45257F200, respectively.

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The Consolidation will result in the number of issued and outstanding Common Shares being reduced from 83,809,015 to 16,761,803, and each shareholder will hold the same percentage of Common Shares outstanding immediately after the Consolidation as such shareholder held immediately prior to the Consolidation.

Registered shareholders that hold physical share certificates will receive a letter of transmittal from Computershare Trust Company of Canada, the transfer agent for the Common Shares, describing the process by which such shareholders may obtain new share certificates representing their post-Consolidation Common Shares.

On November 17, 2020 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported a business update for the third quarter of 2020 (Press release, Cue Biopharma, NOV 17, 2020, View Source [SID1234608289]).

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"We are very pleased with the progress we continue to make advancing CUE-101 through the ongoing Phase 1 monotherapy dose escalation trial," said Daniel Passeri, chief executive officer of Cue Biopharma. "We are encouraged by the datasets to date from this ongoing study, have completed dosing cohort 6, at 4mg/kg and were recently cleared by the Safety Review Committee to begin dosing cohort 7, at 8mg/kg."

Anish Suri, chief scientific officer and president of Cue Biopharma, added, "We believe that we remain well-positioned for continued execution of our development plans for our lead asset CUE-101, which is representative of our IL-2 based CUE-100 series, and the continued build-out of our pipeline via our proprietary protein engineering approach, as also exemplified by recent scientific presentations at the SITC (Free SITC Whitepaper) meeting last week."

Third Quarter 2020 Financial Results

Collaboration revenue was $704,000 and $984,000 for the three months ended September 30, 2020 and 2019, respectively.

Research and development expenses were $7.5 million and $5.3 million for the three months ended September 30, 2020 and 2019, respectively. This increase of approximately $2.2 million was due primarily to an increase in clinical trial activity, drug manufacturing costs, and stock-based compensation expense, offset by a decrease in travel expenses during the third quarter of 2020 as the COVID-19 pandemic continued to hamper business travel throughout the quarter.

General and administrative expenses were $3.3 million and $2.8 million for the three months ended September 30, 2020 and 2019, respectively. This increase of approximately $0.5 million was due primarily to increases in stock-based compensation and legal fees offset by a decrease in travel expenses for the third quarter of 2020.

"As of September 30, 2020, we had approximately $91.8 million in cash, cash equivalents and marketable securities, which we believe will allow us to support the clinical development of our lead asset CUE-101 into the second quarter of 2022," said Kerri-Ann Millar, chief financial officer of Cue Biopharma.

Recent News & Business Updates

Presented three posters highlighting the company’s clinical and pipeline progress at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting (SITC 2020). The posters include a clinical update on CUE-101, the lead drug candidate from the IL-2 based CUE-100 series and data supporting the potential of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform to selectively engage and modulate targeted T cells within the body in a manner that could address a broad range of indications.

Entered into an amendment to the Global License and Collaboration agreement with LG Chem that extended the deadline for LG Chem to exercise its option for an additional Immuno-STAT program from November 6, 2020 to April 30, 2021.

Appointed Tamar Howson to the board of directors. Ms. Howson brings broad corporate and business development experience to the board, having held executive leadership positions in several global biopharmaceutical and pharmaceutical companies as well as her extensive board service.

Presented preclinical data focused on the in vivo detection of tumor antigen-specific T cells in a peer-reviewed paper published in Nature Methods titled, "In vivo detection of antigen-specific CD8 T cells by immuno-positron emission tomography." The study was co-authored by Steven C. Almo, Ph.D., co-founder of Cue Biopharma, professor and chair of biochemistry, professor of physiology & biophysics and the Wollowick Family Foundation chair in multiple sclerosis and immunology at Albert Einstein College of Medicine and Hidde Ploegh, Ph.D., a renowned expert in molecular immunology and a member of the program in cellular and molecular medicine at Boston Children’s Hospital.

Extended cash runway during the third quarter of 2020 through sales of shares of common stock under an ATM equity offering sales agreement for aggregate proceeds of $14.3 million, net of commissions paid, with Stifel Nicolaus & Company, Inc., who acted as sales agent.
Members of the Cue Biopharma executive management team will provide an update on the ongoing Phase 1 clinical trial of CUE-101 for the treatment of HPV+ HNSCC, technology platforms and pipeline progress, as well as updates on its strategic objectives and anticipated milestones today, Tuesday, November 17 at 4:30 p.m. EST.