On December 15, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead program, investigating ST101 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy (Press release, Sapience Therapeutics, DEC 15, 2021, View Source [SID1234597227]). This is the second FTD designation received for the ST101 program, following FTD for recurrent glioblastoma (GBM), announced in early December 2021. ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes expansion cohorts in patients with cutaneous melanoma and refractory GBM.

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Dr. Barry Kappel, Sapience’s CEO and President, commented, "Melanoma is the fifth most diagnosed cancer in the U.S., with more than 100,000 new cases per year, and no well-established standard of care treatment regimen. We believe we have a significant opportunity to deliver a novel therapeutic option with ST101, which has a durable clinical efficacy and an excellent safety profile, for melanoma patients whose disease has progressed following treatment with anti-PD-1 therapy."

Dr. Gina Capiaux, PhD, Sapience’s Head of Regulatory Affairs added, "This is the second Fast Track designation received for ST101, underscoring the advancement of our ST101 program and its potential therapeutic benefit for both melanoma and GBM patients. We are grateful for the opportunity to quickly advance the development of ST101 for patients in need."

Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Sapience also previously received Orphan Drug Designation from the U.S. FDA and European Commission for ST101 for the treatment of glioma.

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted Fast Track Designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation by the European Commission for the treatment of glioma.

On December 15, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept"), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported an update to its offer to purchase up to 10,000,000 shares of its common stock at a price not greater than $23.75 nor less than $20.75 per share closing at one minute after 11:59 P.M., New York City time, on December 15, 2021 (the "Tender Offer") (Press release, Corcept Therapeutics, DEC 15, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-waiver-condition-its-tender-offer [SID1234597226]).

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Corcept’s Board of Directors has determined that it is advisable to proceed with the Tender Offer despite the recent fluctuations in the price of Corcept’s stock and has therefore declined to exercise Corcept’s option, as set forth in the offer to purchase, to terminate the Tender Offer due to changes in the company’s stock price.
The Tender Offer is subject to other terms and conditions, which are described in detail in the offer to purchase. Except for the waiver of the share price condition set forth above, the terms and conditions of the Tender Offer remain the same.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the Tender Offer makes any recommendation as to whether or not any stockholder should participate in the Tender Offer or as to the purchase price or purchase prices at which stockholders may choose to tender their shares.

The sole dealer manager for the Tender Offer is Truist Securities, Inc. D.F. King is serving as the information agent for the Tender Offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. 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) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

On December 15, 2021 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has exercised its first license option for an Invir.IO oncolytic virus (OV) developed from their on-going OV collaboration (Press release, Transgene, DEC 15, 2021, View Source [SID1234597225]). The exercise of this option for an OV, integrating an undisclosed transgene, will result in Transgene receiving an $8 million payment from AstraZeneca. Transgene is also eligible to receive development, regulatory and sales-based milestones payments as well as a royalty based on future commercial sales.

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Hedi Ben Brahim, Chairman and CEO of Transgene, commenting on today’s news said, "We are delighted that AstraZeneca has decided to exercise its first license option for an oncolytic virus generated from our on-going Invir.IO collaboration. We have developed a very productive working relationship with the AstraZeneca team and based on long standing expertise developing Vaccinia based viruses capable of carrying payloads that enhance the OV’s antitumoral properties. We are looking forward to seeing this exciting OV candidate progress into clinical development."

Transgene’s Invir.IO collaboration agreement with AstraZeneca started in 2019. Under the terms of the agreement Transgene is contributing its OV expertise, including viral design, and engineering, to the collaboration. It is also providing access to its novel and improved Vaccinia Virus double-deleted (TK- RR-) backbone, which forms the basis for its Invir.IO platform, and is responsible for in vitro preclinical development of the OV candidates generated from the collaboration. AstraZeneca has selected several transgenes to be integrated within candidates generated with the Invir.IO viral backbone and is responsible for further in vivo preclinical development. Under the terms of the agreement, up to five novel oncolytic immunotherapies can be co-developed.

Transgene has an in-house pilot manufacturing capability that allows it to produce GMP batches of Invir.IO drug candidates for clinical development.

Recent clinical data, presented by Transgene in September 2021 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) virtual meeting confirmed that OVs based on Transgene’s proprietary double deleted VVcopTK-RR- virus backbone can be administered intravenously (see press release here). Transgene believes that Invir.IO OVs delivered via the intravenous route could greatly expand the number of solid tumors that could be treated with this therapy, significantly increasing the commercial potential of Transgene’s OV candidates.

On December 15, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that clinical experience for naxitamab and data from the Company’s SADA technology programs will be presented at the Company’s R&D event, which will take place virtually today at 12 p.m. Eastern Time (Press release, Y-mAbs Therapeutics, DEC 15, 2021, View Source [SID1234597223]).

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Investors, analysts, members of the media and public may access the event via a live webcast.

The Y-mAbs research and development day will feature presentations from oncology key opinion leaders ("KOLs") Javier E. Oesterheld, M.D. (Atrium Health) and Jaume Mora, M.D., Ph.D. (SJD Barcelona Children’s Hospital). An update on Y-mAbs’ broad and advanced product pipeline, including the Company’s SADA Technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).

SADA Technology

Dr. Lisby will present new details on the proposed mechanism of action for the SADA Technology. The Company plans to file an Investigational New Drug Application ("IND") with the US Food & Drug Administration ("FDA") for GD2-SADA by the end of this year.

Naxitamab

Dr. Mora, who has experience treating neuroblastoma patients with both naxitamab and a competing anti-GD2 antibody, will present compassionate use data regarding an investigational infusion protocol for naxitamab, systematically increasing the infusion rate during the treatment. Using the revised infusion rate, for which a provisional patent application has been filed by Y-mAbs and the co-inventors Jaume Mora from SJD Barcelona Children’s Hospital and Dr. Nai-Kong Cheung, MD, PhD, and Shakeel Modak, MD, both from Memorial Sloan Kettering Cancer Center ("MSK") in New York, it was observed that the protocol may help with managing Grade 3 and Grade 4 adverse events.

DANYELZA (naxitamab-gqgk)

Dr. Oesterheld will present his personal experience from Levine Children’s Hospital after several patient treatment experiences with DANYELZA (naxitamab-gqgk).

"I am delighted to see that the efforts led by Dr. Mora and supported by Y-mAbs as well as Dr. Cheung and Dr. Modak from MSK has led to what we believe may be a significant discovery. After years of experience in the clinic, we believe that Dr. Mora’s method of managing the infusion rate of naxitamab now potentially may open up the use of naxitamab for a wide range of GD2 positive indications, such as breast cancer, melanoma, sarcomas, small-cell lung cancer and other cancers, for which we can now consider planning Phase 2 studies," said Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer further notes, "We are excited to share these new updates on both our naxitamab program and the SADA Technology. We believe that the prospects for the SADA Technology which combines antibodies and radioactive payloads are highly encouraging and could potentially revolutionize many cancer treatments known today."

Researchers at MSK developed naxitamab and the SADA Technology, which are exclusively licensed by MSK to Y-mAbs. As a result of these licensing arrangements, MSK has institutional financial interest related to the compound and technology and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest, anaphylaxis, hypotension, bronchospasm and stridor and neurotoxicity, such as severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 15, 2021 Targovax ASA’s (the "Company") stock exchange reported that published on 14 December 2021 regarding the preliminary results in the rights issue of 101,744,186 new shares in the Company (the "Offer Shares") at a subscription price of NOK 1.72 per share (the "Rights Issue") (Press release, Targovax, DEC 15, 2021, View Source [SID1234597218]). The subscription period for the Rights Issue in the Company expired at 16:30 hours (CET) on 14 December 2021.

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At the expiry of the subscription period in the Rights Issue, the Company had received subscriptions for a total of 109,748,125 Offer Shares.

The final allocation of the Offer Shares in the Rights Issue has now been completed based on the allocation criteria set out in the Company’s prospectus dated 29 November 2021, comprising a registration document and a securities note (jointly, the "Prospectus").

The board of directors of the Company has allocated a total of 101,744,186 Offer Shares in the Rights Issue, of which 69,352,805 Offer Shares were allocated based on validly exercised subscription rights and the remaining Offer Shares were allocated to the subscribers who had exercised their subscription rights and over-subscribed Offer Shares on a pro rata basis based on the number of subscription rights exercised by each such subscriber, which includes the two underwriters who subscribed for Offer Shares in the subscription period.

Notifications of allocated Offer Shares and the corresponding subscription amount to be paid by each subscriber are expected to be distributed later today, on 15 December 2020. Payment for the allocated Offer Shares falls due on 17 December 2021 in accordance with the payment procedures described in the Prospectus.

The Offer Shares may not be transferred or traded before they have been fully paid and the share capital increase pertaining to the Rights Issue has been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). It is expected that the share capital increase will be registered in the Norwegian Register of Business Enterprises on or about 21 December 2021 and that the Offer Shares will be delivered to the VPS accounts of the subscribers to whom they are allocated on or about the next day. The Offer Shares are expected to be tradable on the Oslo Stock Exchange from and including 22 December 2021.