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.

On November 17, 2020 BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, reported that it has closed a brokered private placement (the "Offering") of an unsecured convertible debenture unit of the Company (the "Unit") to a single subscriber, purchased at a price of $375,000, less an original discount of approximately 29.33%, for aggregate gross proceeds of $265,000 (Press release, BriaCell Therapeutics, NOV 17, 2020, View Source [SID1234574779]).

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The Unit is comprised of (A) $375,000 principal amount ("Principal Amount") of a 5.0% convertible unsecured debenture of the Company (the "Debenture"), due on the earlier of (i) 5 years from the issue date; (ii) the Company receiving $2,000,000 or more by way of private placement or public offering; or (iii) such earlier date as the principal amount hereof may become due, subject to extension upon mutual agreement of the Company and the holder of the Debenture; and (B) 69,188 common share purchase warrants of the Company ("Warrants").

The Debenture is convertible, at the option of the holder thereof, from the period beginning on May 16, 2021, until the repayment of the Debenture in full, into that number of common shares of the Company ("Common Shares") computed on the basis of the principal amount of the Debenture divided by the conversion price of $5.42 per Common Share (the "Conversion Price").

Each Warrant entitles the holder thereof to purchase one Common Share of the Company (each a "Warrant Share") for a period of five (5) years from the Closing Date at a price of $5.42 per Warrant Share, subject to adjustment as set forth in the Warrants. Each Warrant may also be exercised by presentation and surrender of the Warrant to the Company with a written notice of the Subscriber’s intention to effect a cashless exercise.

The Debenture will bear interest at a rate of 5.0% per annum and the Debenture may be prepaid in full or in part by the Company during the initial 120 day period after issuance of the Debenture without penalty. After 120 days, and only if the Company elects to prepay the Debenture prior to November 16, 2021, the Company will be required to pay a cash prepayment penalty equal to 35% of the Principal Amount of the Debenture (the "Prepayment Penalty"). In the event of default on the Debenture, the interest rate will increase to 12% per annum and a cash penalty payment equal to 40% of the Principal Amount of the Debenture will be added to the Principal Amount of the Debenture (the "Default Penalty"); and the Principal Amount, any accrued and unpaid interest and any other amount owing pursuant the Debenture, including any Prepayment Penalty and/or Default Penalty outstanding at that time shall be accelerated, and shall become immediately due and payable at the option of the holder.

In consideration for the services rendered by ThinkEquity, a division of Fordham Financial Management, Inc. (the "Broker"), the Broker received a cash commission of $26,500.00 from the Company in connection with the Offering. As additional consideration, the Company also issued to the Broker 4,890 non-transferable compensation warrants (the "Compensation Warrants"). Each Compensation Warrant is exercisable to acquire one Common Share at an exercise price of $5.42 at any time in whole or in part for a period of five (5) years from the Closing Date.

The completion of the Offering is subject to the final approval of the TSX Venture Exchange. All securities issued pursuant to the Offering will be subject to a hold period of four months and one day from the date of issuance, in accordance with applicable securities legislation.

The Company also wishes to announce that Richard Berman ("Mr. Berman") has tendered his resignation as a director of the Company with effect from October 26, 2020. The Board takes this opportunity to express its very sincere gratitude to Mr. Berman for his valuable contribution to the Board and the Company. There is no matter in relation to his resignation that needs to be brought to the attention of the shareholders of the Company.

On November 17, 2020 Hologic, Inc. (Nasdaq: HOLX) reported that its new Genius Digital Diagnostics System is now CE marked in Europe (Press release, Hologic, NOV 17, 2020, View Source [SID1234571171]). Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

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For more than 30 years, Hologic has developed and brought to market new advances in cervical cancer screening, including the first liquid-based cytology technology, the ThinPrep Pap Test, and the first FDA-approved mRNA-based HPV test, the Aptima HPV Assay. Hologic is redefining cervical cancer screening yet again by introducing Genius Digital Diagnostics for laboratories. The system can rapidly analyze all cells on a ThinPrep Pap test slide, narrowing tens of thousands of cells down to a gallery view of the most diagnostically relevant images. This will help provide healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients they serve.

"Application of AI requires digital images that are of exceptional quality," said Kevin Thornal, president, Diagnostic Solutions Division at Hologic. "Our teams developed a breakthrough imaging technology that converts physical glass cytology slides into digital images with superior clarity. From this digitalization, advanced image analysis and improved standardization are now achievable."

Genius Digital Diagnostics enables a more seamless and dynamic collaboration across laboratories within a network, connecting pathologists with remote review so each patient can benefit from the collective knowledge of geographically dispersed experts when needed. Digital case review promises to enhance the experience for lab partners by improving workflow and accelerating review time.

"As a part of our development process, we collaborated with cytotechnologists and pathologists to ensure we were developing a new system to meet their needs," said Michael Quick, vice president, R&D and Innovation at Hologic. "We’re always innovating so we can help our lab partners detect more diseases and save more lives every day."

Hologic now offers the first CE-marked comprehensive cervical cancer screening portfolio from sample collection to digital diagnosis. Genius Digital Diagnostics consists of a digital imager for image acquisition, an AI algorithm for analyzing images, an image management server for storing images, and a review station for case review. The complete system is scalable, designed to fit the present and future needs of laboratories.

On November 17, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that oral paclitaxel and encequidar ("oral paclitaxel") data will be presented in four separate poster presentations at the 2020 San Antonio Breast Cancer Symposium (SABCS) to be held virtually December 8-11 (Press release, Athenex, NOV 17, 2020, View Source [SID1234573869]). Presentations will include, from the pivotal Phase 3 clinical trial of oral paclitaxel in metastatic breast cancer (MBC), a spotlight poster on progression-free survival (PFS) and overall survival (OS), and posters on neuropathy (CIPN), and management of gastrointestinal (GI) side effects. An additional poster explores oral paclitaxel in the treatment of cutaneous angiosarcoma of the breast.

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The symposium will also feature an immersive Athenex Oncology virtual exhibit experience with distinct hubs for CIPN, Medical Affairs, and the Facing MBC Together program.

Details of the oral paclitaxel presentations are as follows:

Spotlight Poster Presentation

Abstract Title: Oral Paclitaxel and Encequidar (oPac+E) versus IV Paclitaxel (IVPac) in the treatment of metastatic breast cancer (mBC) patients (Study: KX-ORAX-001)

Session: Spotlight Poster Discussion 1

Program Number: PD1-08

Date and Time: Wednesday, December 9, 2020, at 4:00 PM to 5:15 PM Central Time (CT)

For more information, please visit: View Source

Abstracts selected for spotlight poster presentation will only have titles posted to the SABCS website until the embargo lifts on December 9, 2020, when the complete abstract will post online.

Additional Poster Presentations

Abstract Title: A phase 2 study of Oral Paclitaxel and Encequidar (oPac+E) in the treatment of cutaneous angiosarcoma: the breast angiosarcoma group

Program Number: PS13-05

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: View Source

Abstract Title: Lower rates of neuropathy with Oral Paclitaxel and Encequidar (oPac+E) compared to IV Paclitaxel (IVPac) in treatment of metastatic breast cancer (mBC): Study KX-ORAX-001

Program Number: PS13-06

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: View Source

Abstract Title: Oral Paclitaxel and Encequidar (oPac+E) in the treatment of metastatic breast cancer (mBC): Management of gastrointestinal adverse events (GI AE). Study KX-ORAX-001

Program Number: PS13-11

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: View Source

Athenex Exhibit Booth

Athenex Oncology will have an immersive virtual exhibit experience at SABCS. This unique booth will feature three separate hubs: 1) Chemotherapy-Induced Peripheral Neuropathy (CIPN) augmented reality simulation, designed to deepen a visitor’s understanding and virtually experience what it feels like to have CIPN; 2) Facing MBC Together, a public education and patient support program that addresses the issue of isolation for people living with metastatic breast cancer; and 3) Medical Affairs, where visitors can learn about how inhibition of P-gp facilitates absorption of orally administered chemotherapies. The booth will be accessible to meeting registrants throughout SABCS during exhibit hall hours, which are from 10am-7pm on Tuesday, December 8; 8am-7:45pm on Wednesday, December 9; and 10am-5pm on Thursday and Friday, December 10 and 11 (all Central Time).

On November 17, 2020 Bristol Myers Squibb reported cold water on Celgene shareholders who have been hoping to see a payout related to the merger of the two companies (Press release, BioSpace, NOV 17, 2020, View Source [SID1234571461]). This morning, the pharma giant signaled it will fail to meet a deadline related to $9 per share Contingent Value Rights (CVR) tickets, essentially killing that payment.

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When BMS and Celgene merged, CVR payouts hinged on the approval of three drugs. The first of the three CVR medicines, Celgene’s multiple sclerosis drug Zeposia (ozanimod), was approved in March. The other drugs related to the CVR are cancer treatments, ide-cel and liso-cel (lisocabtagene maraleucel). Under terms of the deal, ide-cel, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, must be approved by the U.S. Food and Drug Administration by March 31, 2021. The FDA accepted the Biologics License Application for ide-cel under priority review in September.

Liso-cel, though, is another matter. The deadline to meet the CVR milestone for this cancer drug is Dec. 31. BMS had a Prescription Drug User Fee Act (PDUFA) action date of Nov. 16, but COVID-19 threw a spanner into the works, pushing back the timeline for its review.

Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. BMS is seeking approval of the drug as a treatment for adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma. TRANSCEND NHL 001 is the largest study of CD19-directed CAR T cells to support a BLA to date.

In its announcement this morning, BMS said the delay is due to COVID-19-related travel restrictions at the FDA. The travel restrictions prevented the FDA from conducting an inspection of a third-party manufacturing facility in Texas before the PDUFA date. Because the regulatory agency could not ensure that the manufacturing facility meets its standards, it has deferred potential approval of liso-cel until the inspection can be completed. The FDA has not provided a new anticipated date for approval, BMS said.

Samit Hirawat, chief medical officer of Global Drug Development at BMS, said the company will continue to work with the FDA to support the ongoing review of the liso-cel BLA. Hirawat said the company is "committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need."

This isn’t the first delay for liso-cel that jeopardized potential approval. Earlier this year, the FDA delayed review of the BLA for liso-cel by three months, which gave it the Nov. 16 PDUFA date.