On April 3, 2023 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported interim data demonstrating the potential of CPI-818, the Company’s ITK inhibitor, for the treatment of T cell lymphoma (TCL) at the 10TH Whistler Global Summit on Hematologic Malignancies, which took place March 29 to April 2, 2023 in Whistler British Columbia, Canada (Press release, Corvus Pharmaceuticals, APR 3, 2023, View Source [SID1234629741]). The CPI-818 data was presented by John Reneau, MD, PhD, from The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator for the Phase 1/1b clinical trial of CPI-818 for TCL.

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"T cell lymphoma is a challenging disease to treat and there is significant need for new approaches given the limited efficacy of current therapeutic options," said Dr. Reneau. "CPI-818 has a novel mechanism of action that includes the stimulation of normal T cells to infiltrate and destroy tumors. Our recent work indicates that the peripheral blood absolute lymphocyte count is a biomarker that may predict patients most likely to benefit from CPI-818. This positions our trial to build on the results CPI-818 has already demonstrated – monotherapy activity in advanced, relapsed patients, with potential for higher response rates driven by this new biomarker."

CPI-818 Phase 1/1b T Cell Lymphoma Data
CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL. As of February 23, 2023, 20 patients were enrolled in the 200 mg cohort (optimal dose), including 13 evaluable for tumor response. There have been 1 complete response (CR) of 24 months duration, 1 equivocal CR awaiting confirmatory PET scan of 13+ months duration (a previous partial response (PR)), 1 nodal CR of 21 months duration and 1 PR of 7 months duration. Ten patients continue on therapy, including seven who have not yet been evaluated for tumor response.

Corvus has identified minimum absolute lymphocyte count (ALC) above 900 per cubic milliliter of blood as a biomarker associated with response to CPI-818. Interim data from the 200 mg cohort in the Phase 1/1b clinical trial indicate that this minimum ALC level is required for tumor response and disease control. As of February 23, 2023, four of eight patients with ALC above 900 had objective responses (those four patients are described above), all eight had disease control (stable disease, PR, CR) and the median progression free survival (PFS) was 28.1 months. No objective responses were seen in five patients (0 of 5) with ALC below 900 and the PFS was 2.1 months.

New interim data, as of February 23, 2023, presented by Dr. Reneau evaluated the effect of ALC on PFS of patients based on their last prior chemotherapy treatment before receiving CPI-818. There was no significant difference in the PFS achieved in patients with ALC less than 900 per cubic milliliter (PFS = 3.2 months) compared to patients with ALC greater than or equal to 900 per cubic milliliter (PFS = 3.4 months), which suggests the ALC biomarker is not predictive for standard therapies. This result is consistent with CPI-818’s proposed mechanism of action, which involves the enhancement of normal lymphocyte function, and indicates that the improved results seen with CPI-818 in patients with ALC above 900 is not due to more favorable patient characteristics.

The swimmer and waterfall tumor plots for these patients, along with the data summarizing the ALC biomarker data, are included in Dr. Reneau’s presentation slides, which are available on the Publications and Presentations page of the Corvus website.

"The data from our Phase 1/1b trial of CPI-818 for T cell lymphoma continues to be strong, with durable and deep tumor responses observed to date," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are encouraged that enrollment has accelerated and that we have implemented a biomarker that we believe will enable us to enroll patients most likely to benefit from CPI-818, which is of particular importance as we plan for a registration Phase 3 randomized clinical trial. I want to thank Dr. Reneau and all our investigators for their participation in the trial and for the work they do in support of patients.

On April 3, 2023 Corcept Therapeutics Incorporated (Nasdaq: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported the preliminary results of its previously announced tender offer to purchase up to 7,500,000 shares of its common stock, par value $0.001 per share, at a price not greater than $22.00 nor less than $19.25 per share, in cash, less any applicable withholding taxes and without interest (the "Tender Offer"), which expired one minute after 11:59 p.m., New York City time, on March 31, 2023 (Press release, Corcept Therapeutics, APR 3, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-preliminary-results-tender-offer [SID1234629740]).

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Based on the preliminary count by Continental Stock Transfer & Trust Company, the depositary for the Tender Offer (the "Depositary"), 6,630,151 shares of Corcept’s common stock were validly tendered and not properly withdrawn at or below a purchase price of $22.00 per share, including 2,040,587 shares tendered by notice of guaranteed delivery. In accordance with the terms and conditions of the Tender Offer, based on these preliminary results, Corcept expects to purchase 6,630,151 shares of common stock at a purchase price of $22.00 per share, for an aggregate cost of $145,863,322, excluding fees, any excise taxes and expenses relating to the Tender Offer. The number of shares that Corcept expects to purchase in the Tender Offer represents approximately 6 percent of the total number of shares of common stock outstanding as of March 30, 2023. Corcept expects to have 101,435,180 shares of common stock outstanding immediately following payment for the shares of common stock purchased in the Tender Offer.

The number of shares of common stock expected to be purchased by Corcept and the aggregate purchase price are preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the Depositary and is based on the assumption that all shares of common stock tendered through notice of guaranteed delivery will be delivered within the two trading-day settlement period. The actual number of shares of common stock to be purchased by Corcept and the actual purchase price information will be announced following the completion by the Depositary of the confirmation process. Payment for the shares of common stock accepted for purchase under the Tender Offer will occur promptly thereafter.

The sole dealer manager for the Tender Offer is Piper Sandler & Co. D.F. King & Co., Inc. is serving as the information agent for the Tender Offer and Continental Stock Transfer & Trust Company is serving as the depositary. For all questions relating to the Tender Offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 821-8781, or call the dealer manager, Piper Sandler & Co. at (312) 267-5100.

On April 3, 2023 Chimeric Therapeutics Ltd (ASX:CHM)’s reported that CHM 1101 glioblastoma abstract has been selected for presentation at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from 2-6 June 2023 in Chicago, Illinois (Press release, Chimeric Therapeutics, APR 3, 2023, View Source [SID1234629739]).

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The abstract titled ‘Phase 1b multicenter study to evaluate CHM 1101 in patients with recurrent or progressive glioblastoma’ was selected for presentation from more than 6,500 abstracts submitted.

Chimeric noted that it is pleased that ASCO (Free ASCO Whitepaper) has selected the abstract for presentation as it highlights the clinical trial design and objectives of the company’s new multi-site Phase 1B clinical trial with CHM 1101 in patients with recurrent or progressive glioblastoma (GBM).

Details of the abstract presentation are as follows:

Section: Central Nervous System Tumors

Abstract #: 418236

Title: Phase 1b multicenter study to evaluate CHM 1101 in patients with recurrent or progressive glioblastoma

Session Date and Time: 3 June 2023, 1:15 PM-4:15 PM

Phase 1 clinical trial
Last month, Chimeric welcomed the initiation of the fourth dose cohort of City of Hope’s phase 1 clinical trial evaluating the safety and tolerability of Chimeric’s CHM 1101 cell therapy.

The first patient in the fourth dose cohort in the phase 1 clinical trial in recurrent/progressive glioblastoma has received dosing at City of Hope Cancer Center in the US.

This cohort will see patients treated at a total dose of 440 X 106 CHM 1101 (CLTX CAR T cells) through dual routes of intratumoral and intraventricular administration.

Progression to this level follows the successful completion of the third dose cohort without any dose-limiting toxicities in January 2023.

On April 3, 2023 Boston Scientific Corporation (NYSE: BSX) will webcast its conference call discussing financial results and business highlights for the first quarter ended March 31, 2023 on Wednesday, April 26, 2023 at 8:00 a.m. EDT. The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer (Press release, Boston Scientific, APR 3, 2023, View Source [SID1234629738]). The company will issue a news release announcing financial results for the first quarter on April 26 prior to the conference call.

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A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.

On April 3, 2023 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), a clinical-stage biotech company focusing on the discovery and development of next generation antibody-drug conjugate ("ADC") therapeutics to treat patients with cancer and autoimmune diseases, reported that the companies have entered into exclusive license and collaboration agreements for two ADC assets to develop, manufacture and commercialize the two assets globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region (Press release, BioNTech, APR 3, 2023, View Source [SID1234629737]). With this collaboration, ADCs will become an additional drug class in BioNTech’s oncology portfolio with the aim to further support BioNTech’s mission of developing highly efficacious therapies for cancer patients at every stage of disease.

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ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents.

As part of the collaboration, BioNTech will gain access to DualityBio’s lead candidate, DB-1303, which is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2 (HER2), a target that is overexpressed in a variety of cancers, which contributes to the aggressive growth and spread of cancer cells. Antibody therapy targeting HER2 has been shown to be an effective treatment strategy for HER2-expressing cancers. The DB-1303 program received the Fast Track designation from the U.S. Food and Drug Administration ("FDA") and is currently in a Phase 2 clinical trial (NCT05150691) for HER2-expressing advanced solid tumors.

BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311.

"Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as a broadly applicable precision medicine drug class that might be an alternative to standard chemotherapy," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "The addition of these two ADCs to our portfolio strengthens our pipeline of immunotherapies and expands our capabilities with the aim to provide therapeutic benefits for patients with a range of solid tumors, along the entire patient journey."

"We are delighted to partner with BioNTech, a leading company which brings transformational medicine to patients through innovation," said John Zhu, Ph.D., Founder and CEO of DualityBio. "This is a recognition of not only DualityBio’s next-generation ADC platform, but also its internal discovery and development capabilities. With this strategic partnership, we are committed to working together to advance the development of innovative therapies for the benefit of patients worldwide."

Under the terms of the agreements, DualityBio will receive upfront payments for both asset licenses totaling $170 million, and additional development, regulatory and commercial milestone payments for both assets, potentially totaling over $1.5 billion. DualityBio will be eligible to receive single-digit to double-digit tiered royalties on net sales for both ADC assets. BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region), while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. As part of the agreement for DB-1311, DualityBio has the right to exercise a co-development cost and profit/loss sharing option for DB-1311 for the U.S. market, as well as a co-promotion option for the U.S. market.

About DB-1303
DB-1303, a third generation HER2 ADC molecule built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform, exhibited potent antitumor activity in both HER2 positive and HER2 low tumor models with a favorable safety profile and a potentially expanded therapeutic window. Both preclinical data and preliminary clinical data from DB-1303 suggest the potential of DB-1303 to address unmet medical needs in various HER2 expressing cancers.

About DB-1311
DB-1311 is an ADC comprised of a humanized antibody and DualityBio’s proprietary DITAC linker-payload. It has exhibited potent antitumor activity in a range of tumor models representing multiple cancer types and has been well tolerated in preclinical studies, with a good pharmacokinetics profile. The wide therapeutic window demonstrated by preclinical antitumor activity and its safety profile support the potential of DB-1311 to address unmet medical needs across a broad range of cancers.