On October 19, 2023 Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that BT8009, the company’s lead investigational therapy in development to treat metastatic bladder (urothelial) cancer, has been selected to participate in the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program recently launched by the U.S. Food and Drug Administration (FDA) (Press release, Bicycle Therapeutics, OCT 19, 2023, View Source [SID1234636136]). BT8009 is one of up to nine products selected for the first year of the CDRP Program, which the FDA created to facilitate CMC development for therapies with expedited clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. Through the CDRP Program, Bicycle Therapeutics plans to work closely with the FDA to facilitate CMC development and expedite commercial manufacturing readiness of BT8009.

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"We are honored to participate in the inaugural cohort of the FDA’s CDRP Program," said Mike Hannay, D.Sc., FRPharmS, senior vice president and head of CMC at Bicycle Therapeutics. "We look forward to working closely with the FDA to ensure the commercial manufacturing readiness for BT8009 keeps pace with its expedited clinical development. We welcome the guidance we will receive through more frequent and dedicated CMC discussions with the FDA, and in turn we hope the agency will become more familiar with our novel Bicycle technology and its sophisticated manufacturing process."

"At Bicycle Therapeutics, we are pioneering an entirely new class of drugs with the goal of treating cancer and many other diseases. We believe BT8009 has the potential to be a transformative therapy for patients with metastatic bladder cancer, which is underscored by its selection for the FDA’s CDRP Program in addition to its Fast Track designation and recently announced expedited development plan and registrational pathway," said CEO Kevin Lee, Ph.D. "On behalf of our entire team, I would like to thank the FDA for their continued collaboration as we work with urgency to develop and deliver this promising therapy to patients."

In September, Bicycle Therapeutics announced its plan to expedite development of BT8009 in metastatic bladder cancer following alignment with the FDA on the therapy’s Phase 2/3 registrational trial, called Duravelo-2. The innovative trial design allows for the potential accelerated approval of BT8009 in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. The company plans to initiate the Duravelo-2 trial in the first quarter of 2024.

About BT8009
BT8009 is an investigational Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen with elevated levels of expression in multiple tumor types, including bladder (urothelial) cancer. It is currently being evaluated in a Phase 1/2 clinical trial enrolling patients with Nectin-4 expressing advanced solid tumors. BT8009 will be evaluated in the Phase 2/3 Duravelo-2 trial, a global, multi-center, adaptive study designed to assess the safety and efficacy of the therapy for metastatic bladder cancer.

On October 19, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported the closing of its merger with Biosight, Ltd. ("Biosight"), pursuant to which Ayala acquired Biosight (Press release, Ayala Pharmaceuticals, OCT 19, 2023, View Source [SID1234636135]). The combined company will operate under the name Ayala Pharmaceuticals, Inc., and its shares will continue to trade on the OTCQX under Ayala’s current ticker symbol ("ADXS").

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"We are pleased to close the merger with Biosight which expands our product pipeline," said Ken Berlin, President & CEO. "We have added aspacytarabine (BST-236), a novel antimetabolite, which is in clinical development for AML and could potentially serve as a superior backbone therapy for unfit AML as part of combination treatment regimens. Our primary focus continues to be completing the ongoing Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors and we look forward to continuing our mission of bringing innovative therapies to people with rare tumors and aggressive cancers."

Management and Organization

As previously announced, the combined company will be led by Ayala’s existing senior management team, with Ken Berlin serving as President and CEO; Andres Gutierrez, MD, PhD, Executive VP and Chief Medical Officer; and Dana Gelbaum, MSc, MBA, General Manager and Chief Business Officer. Roy Golan, CPA, LLM, previously Executive VP & CFO of Biosight, has been appointed Chief Financial Officer of the combined company. The board of directors of the combined company is comprised of David Sidransky, MD (Chairman); Robert Spiegel, MD, FACP; Murray Goldberg; Vered Bisker-Leib, PhD, MBA; Roni Appel, MBA; Pini Orbach, PhD; Yuval Cabilly, PhD; and Ken Berlin, with an additional board member expected to be added at a later date.

On October 19, 2023 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported that it will release financial and operational results for the third quarter of 2023, on Thursday, November 2, 2023, before markets open (Press release, Aurinia Pharmaceuticals, OCT 19, 2023, View Source [SID1234636134]). Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update. Interested participants can dial 877-407-9170 / +1 201-493-6756 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

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On October 19, 2023 Amgen (NASDAQ:AMGN) reported that it will host a webcasted call for the investment community at 8:00 a.m. ET on Tuesday, Oct. 24, 2023 following the presentation of new data from Amgen’s innovative oncology portfolio including AMG 193 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2023 and data from tarlatamab, xaluritamig, and LUMAKRAS (sotorasib) that will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 (Press release, Amgen, OCT 19, 2023, View Source [SID1234636133]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, members of Amgen’s development team as well as clinical investigators will participate. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 19, 2023 4SC AG (4SC or "the Company") (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported a business update for the three months ended 30 September 2023, as well as its current outlook (Press release, 4SC, OCT 19, 2023, View Source [SID1234636118]). The full report is available for download on 4SC’s website.

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4SC is focused primarily on the development of resminostat (Kinselby), and, in particular, preparation of the marketing authorisation for the commercialization of resminostat (Kinselby), a unique maintenance treatment for CTCL.

Key highlights of Q3 2023
Data from the Company’s RESMAIN study was published in September 2023 at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting. In this study, resminostat (Kinselby) showed*:
A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
A clinically meaningful improvement in median "total" PFS of 24.3 months, compared to 14.9 months for those in the placebo group
Side effects of resminostat were mainly mild to moderate, manageable and reversible
In Q3, 4SC has been actively progressing the preparation of its Marketing Authorization Application in the European Union, Switzerland and the United Kingdom
In addition, a significant effort has been made in preparing for discussions with the United States (US) Food and Drug Administration regarding requirements for marketing resminostat (Kinselby) for CTCL in the US
On 27 September 2023, the Company announced that the US FDA had granted resminostat (Kinselby) orphan drug designation, which gives a number of benefits, most importantly seven years’ market exclusivity in the US
4SC’s partner for Japan, Yakult Honsha Co. Ltd (Yakult Honsha) is continuing with its preparation and filing of a marketing application for resminostat (Kinselby) in Japan.
Cash balance development in Q3 2023 and financial forecast
As at 30 September 2023, 4SC held cash balance/funds of €10.44 million compared to €12.16 million as of 30 June 2023. The decrease of cash funds in the first nine months of 2023 is mainly a result of the expenditure on the ongoing RESMAIN clinical study.

The monthly use of cash from operations amounted to €487 thousand in Q3 2023. The average monthly use of cash for 2023 is now expected to be between €500 – €700 thousand, a significant reduction from the previous forecast of between €800 thousand – €1.1 million.

Based on current financial and operating activities, the Manage­ment Board estimates that current funds should now be sufficient to finance 4SC into the third quarter of 2024, longer than previously expected.

Post Period Event
In October 2023, the European Commission adopted the European Medicines Agency’s decision to grant orphan drug designation to resminostat (Kinselby) in cutaneous T-cell lymphoma (CTCL). Orphan drug designation (ODD) provides privileged status to drugs that show promise for the treatment of rare diseases in the European Union. ODD qualifies 4SC for benefits including protocol assistance, market exclusivity and fee reductions.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "The last quarter has been a very busy and productive period for 4SC. Not only has the RESMAIN study demonstrated the significant benefit of resminostat (Kinselby) as a maintenance treatment for patients suffering from CTCL, a debilitating and incurable condition, but we have also secured orphan drug designation in both the US and, post period, in Europe. This designation comes with meaningful benefits, including market exclusivity for seven and ten years respectively. We remain focused on securing marketing authorization for resminostat (Kinselby) and are actively engaged in finding the right partner to take Kinselby forward to patients."