On May 16, 2022 Scandion Oncology (Scandion) reported that will publish its Q1 2022 interim report on Thursday, May 19, 2022 before 09:00 CET (Press release, Scandion Oncology, MAY 16, 2022, View Source;2022,c3567316 [SID1234614574]).

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Scandion Oncology’s Executive Management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

The information was provided by the contact person above for publication on May 16, 2022, at 08.30 CET.

On May 16, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the first patient has been dosed in its Phase 1/2 clinical trial of CFT8634, an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors (Press release, C4 Therapeutics, MAY 16, 2022, View Source [SID1234614645]).

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"The initiation of our first clinical trial of CFT8634 is a significant milestone for C4 Therapeutics as we apply our TORPEDO platform to an oncology target currently considered ‘undruggable’ and work to provide a new treatment option for patients living with synovial sarcoma and SMARCB1-null tumors," said Adam Crystal, M.D., Ph.D., chief medical officer of C4 Therapeutics. "Based on our pre-clinical research showing that the BRD9 degrader CFT8634 is potent, selective and efficacious in models of synovial sarcoma and malignant rhabdoid tumors, we believe CFT8634 may offer an effective targeted treatment for patients who currently have limited therapeutic options."

The Phase 1/2 trial will primarily investigate safety, tolerability and anti-tumor activity with secondary and exploratory objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT8634. The Phase 1 portion of the study will evaluate CFT8634 as an oral, single agent therapy for patients with synovial sarcoma and SMARCB1-null tumors to identify a recommended Phase 2 dose. Following identification of recommended dosage, the Phase 2 portion of the trial is expected to expand to the following investigational arms: one in synovial sarcoma, and one in SMARCB1-null tumors. Across the Phase 1/2 trial, C4T plans to enroll approximately 90 patients.

CFT8634 is C4T’s second oncology program to enter clinical studies from its internally developed research pipeline. CFT8634 is C4T’s first BiDAC degrader candidate to be evaluated in the clinic.

To learn more about the CFT8634 clinical trial, visit clinicaltrials.gov (identifier: NCT 05355753).

About CFT8634
CFT8634 is a BiDAC degrader targeting BRD9 for the treatment of cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1-null cancers. BRD9 has been considered an "undruggable" target due to the inability of bromodomain inhibitors to effectively treat these cancers. Unlike BRD9 inhibition, BRD9 degradation has been shown to be efficacious in pre-clinical models of synovial sarcoma. By leveraging C4T’s TORPEDO platform, C4T developed CFT8634, an orally bioavailable, selective degrader of BRD9. In March 2022, C4T announced

the U.S. Food and Drug Administration had granted orphan drug designation (ODD) to CFT8634.

About Synovial Sarcoma and SMARCB1-null Tumors
Synovial sarcoma is a rare and aggressive subtype of soft tissue sarcoma. It accounts for approximately 10 percent of all sarcoma diagnoses. An estimated 900 people are diagnosed with synovial sarcoma in the U.S. each year. Approximately one-third of patients are diagnosed under the age of 30.

SMARCB1-null tumors include malignant rhabdoid tumor, poorly differentiated chordoma, epithelioid sarcoma and other rare cancers; some subtypes are most commonly diagnosed in children and young adults.

Both synovial sarcoma and SMARCB1-null tumors are believed to be dependent on BRD9 and, as a result, CFT8634 may be an effective treatment.

On May 16, 2022 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 a clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada) (Press release, Athenex, MAY 16, 2022, View Source [SID1234614661]). The agreement applies to the expansion phase of the Phase 1 clinical trial evaluating Athenex’s oral paclitaxel in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for certain NSCLC patients.

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The agreement will support the expansion phase of the trial to further investigate the preliminary encouraging results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain NSCLC patients. The two companies will form a Joint Development Committee to review the clinical trial results.

"We are keen to collaborate with Merck to further investigate the therapeutic potential of Oraxol plus KEYTRUDA in patients with NSCLC patients who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy," said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. "If the preliminary efficacy and safety data can be confirmed, it may lead to a new paradigm in the treatment of certain NSCLC patients."

KX-ORAX-011 is an ongoing Phase 1 trial evaluating Oraxol in combination with pembrolizumab in patients with advanced solid tumors. Following completion of the dose escalation phase, the expansion phase is currently evaluating the combination therapy in patients with NSCLC who progressed on previous anti-PD1/ anti-PD-L1 therapy or in combination with chemotherapy. The NSCLC expansion cohort is actively recruiting and aims to enroll approximately 50 patients.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar ("oral paclitaxel") is in the earlier stages of development for solid malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and low absorption of encequidar enables the oral administration of IV chemotherapies.

On May 16, 2022 Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company developing innovative cancer therapies and powerful diagnostics based on its proprietary pre|CISION and Affimer platforms, reported that AffyXell, its joint venture with South Korean drug maker Daewoong Pharmaceutical, has expanded its strategic partnership with GenScript ProBio, a leading biopharmaceutical manufacturer (Press release, AffyXell Therapeutics, MAY 16, 2022, View Source [SID1234614677]).

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AffyXell is a joint venture established in January 2020 by Daewoong Pharmaceutical and Avacta, developing the next generation of cell and gene therapies based on mesenchymal stem cells which incorporate Affimer immunotherapies. This new class of stem cell therapy is designed to produce Affimer proteins, in situ in the body, that reduce inflammatory or autoimmune responses to the stem cell therapy to potentially enhance their therapeutic effects.

GenScript ProBio, part of Genscript Biotech Corporation (HKG: 1548), is a leading global contract development and manufacturing organisation providing a best-in-class, one-stop platform for research and development of biological drugs, DNA plasmids and lentiviruses, and for clinical production of cell and gene therapy products.

AffyXell and GenScript ProBio are extending their strategic manufacturing partnership, which they entered into in December 2021, that covers AffyXell’s first drug development programme to include additional future programmes. The partnership covers process development and production of viral vectors required for the production of AffyXell’s future cell therapy products. In addition, as part of this strategic alliance, GenScript has now committed to take an equity position in AffyXell at a future funding round, and the two companies will collaborate in the area of business development, including potential out licensing.

Dr Alastair Smith, Chief Executive Officer of Avacta, commented: "This is an important strategic partnership for AffyXell with a world leading contract development and manufacturing partner. The fact that GenScript ProBio are prepared to take a strategic equity stake in AffyXell is a very strong validation of the potential for AffyXell’s next generation cell and gene therapies, and the future valuation of the business."

"We are delighted with the excellent progress being made by AffyXell with the Affimer immunomodulators provided by Avacta under our joint venture agreement."

Jongsang Ryu, Chief Executive Officer of AffyXell, commented: "We were able to attract strategic investment from the CDMO partner as the excellence and potential of our next-generation cell therapy platform have been recognized."

"This agreement will be an opportunity to accelerate the development of therapies targeting intractable diseases, providing meaningful options for the suffering patients."

Dr Brian Min, Chief Executive Officer of GenScript ProBio commented: "We are pleased to partner with AffyXell and are honored to support this next-generation cell therapy project with GenScript ProBio’s stable and high-yield viral vector platform. We expect many patients to benefit from this innovative genetically modified mesenchymal stem cells therapy soon."

On May 16, 2022 Exicure, Inc. (NASDAQ: XCUR), an early-stage biotechnology company focused on the development of next generation nucleic acid therapies targeting RNA to address both genetic and non-genetic neurological disorders and hair loss disorders, reported financial results for the quarter ended March 31, 2022 and provided an update on its business strategy and corporate progress (Press release, Exicure, MAY 16, 2022, View Source [SID1234614704]).

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"Exicure is off to a promising start in 2022 as we have made progress with our preclinical SCN9A program for the treatment of pain with several potential therapeutic candidates identified and we are conducting initial in vivo animal studies to support candidate selection in 2023," commented Matthias Schroff, Ph.D., Chief Executive Officer of Exicure. "We continue to advance our partnered programs with Ipsen and AbbVie, and the recently announced private placement investment led by CBI USA, Inc. ("CBI USA") is expected to provide us with additional resources as we continue our mission to pursue treatments for patients with unmet medical needs," concluded Dr. Schroff.

Corporate Progress

Recent highlights include:

On May 10, 2022, Exicure announced a $5.0 million raise in a private placement transaction priced at market premium
Agreed to sell an aggregate of 26,021,011 shares of the Company’s common stock to certain accredited investors in a private placement in public equity ("PIPE") financing at a purchase price of $0.1937 per share, representing an approximately 45% premium to the 10-day volume weighted-average share price from May 9, 2022.
New investor CBI USA led the transaction; existing investor, Abingworth LLP, also participated.
Transaction is expected to close on or about May 19, 2022, subject to the satisfaction of customary closing conditions.
In connection with the PIPE, CBI USA received the right to nominate a member to the Company’s board of directors (the "Board"), effective as of the closing date. CBI USA will also have the right to designate one individual to attend all meetings of the Board in a nonvoting observer capacity.
Net proceeds from the transaction expected to support the Company’s advancement of its preclinical program, including the development of its SCN9A product candidate, as well as other working capital and general corporate purposes.
Corporate highlights for the first quarter of 2022 include:

Repaid in full all outstanding indebtedness and other obligations under the Company’s credit facility with MidCap, effective March 15, 2022.
Continued to advance the Company’s SCN9A preclinical discovery program. Exicure anticipates results from initial in vivo animal studies by year-end 2022, with the goal of therapeutic candidate selection in the second half of 2023.
Progressed work with partnered programs towards potential pre-clinical milestones in 2023.
Actively pursuing out-license opportunities for the Company’s clinical asset, cavrotolimod.
Continuing to pursue near-term partnering opportunities for pain and other neuroscience programs.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and short-term investments were $27.6 million as of March 31, 2022, as compared to $48.3 million as of December 31, 2021. The Company expects that its cash and cash equivalents, together with the expected $5.0 million gross proceeds from the PIPE transaction in May 2022, will enable it to fund its current operations into the first quarter of 2023.

Revenue: Revenue was $2.6 million for the quarter ended March 31, 2022, reflecting an increase of $1.6 million from revenue of $1.0 million for the quarter ended March 31, 2021. The increase in revenue of $1.6 million is mostly due to the recognition of non-cash revenue of $2.1 million associated with the Company’s collaboration with Ipsen Biopharm Limited, partially offset by a decrease in revenue of $0.5 million associated with the Company’s collaboration with AbbVie Inc.

Research and Development (R&D) Expense: Research and development expenses were $7.1 million for the quarter ended March 31, 2022, as compared to $10.3 million for the quarter ended March 31, 2021. The decrease in R&D expense for the three months ended March 31, 2022 of $3.1 million reflects a reduction in employee headcount and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021.

General and Administrative (G&A) Expense: General and administrative expenses were $3.2 million for the quarter ended March 31, 2022, as compared to $2.9 million for the quarter ended March 31, 2021. The increase in G&A expense of $0.3 million for the three months ended March 31, 2022 was mostly due to higher legal costs and retention award expense for current employees, partially offset by a decrease in recruiting costs, investor relations costs, and stock-based compensation.

Net Loss: The Company had a net loss of $8.3 million for the quarter ended March 31, 2022, as compared to a net loss of $12.5 million for the quarter ended March 31, 2021. The decrease in net loss was primarily driven by lower R&D expense and higher non-cash revenue during the period.

Going Concern: Given the Company’s current cash position, operating plans and forecasted negative cash flows from operating activities over the next twelve months, management believes there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that its unaudited condensed consolidated financial statements for the quarter ended March 31, 2022 are issued. The Company will require substantial additional financing to address the Company’s working capital and other financing needs to pursue its business strategy.