On June 28, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for ORIC-533 to proceed into a first-in-human clinical trial. ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens (Press release, ORIC Pharmaceuticals, JUN 28, 2021, View Source [SID1234584394]).

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The FDA clearance of our IND application for ORIC-533 is a significant milestone for ORIC as we move into the clinic with a second novel, internally discovered oncology drug candidate," said Jacob Chacko, M.D., president and chief executive officer. "In preclinical studies, ORIC-533 has demonstrated higher potency within a high AMP environment compared to all CD73 and adenosine receptor inhibitors against which it was compared. Furthermore, in addition to the potential best-in-class properties of ORIC-533, we are excited about its differentiated clinical development plan that will explore its single agent activity in contrast to the combination studies that dominate the CD73 field today."

Based on a preclinical collaboration with an academic key opinion leader that generated compelling single agent activity in patient derived model systems in an undisclosed tumor type, the company plans to pursue a single agent clinical development plan in this indication. ORIC plans to initiate the Phase 1 clinical trial with ORIC-533 in the second half of 2021 to evaluate safety, PK and preliminary efficacy in cancer patients.

This is the first of three planned IND/CTA filings for 2021, with the IND filing for ORIC-944 and CTA filing for ORIC-114 expected in the second half of the year.

About ORIC-533

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens. ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, other small molecule CD73 inhibitors and inhibitors of adenosine receptors. Preclinical data suggest ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment. In preclinical studies, nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, reflective of AMP levels observed in tumors.

On June 28, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUN 28, 2021, View Source [SID1234584393]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from June 21, 2021, to June 25, 2021:

No. of shares

Average price (DKK)

Total value (DKK)

Accumulated through last announcement

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 292,606 shares as treasury shares, corresponding to 0.45% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On June 28, 2021 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported it has entered into a license agreement with the University of North Carolina Lineberger Comprehensive Cancer Center (UNC Lineberger) and Massachusetts General Hospital (Mass General) covering certain intellectual property and technology rights regarding the company’s CaspaCIDe (inducible caspase-9, or iC9) safety switch and related technologies, and the use of rimiducid (Press release, Bellicum Pharmaceuticals, JUN 28, 2021, View Source [SID1234584392]). CaspaCIDe may facilitate the use of cell therapies where cytokine release syndrome and neurotoxicities have been observed, in the pursuit of novel targets with on-target/off-tumor safety concerns, and in conjunction with next generation higher potency cell therapy constructs.

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This agreement with UNC Lineberger and Mass General covers four CAR-T programs incorporating Bellicum’s technology currently in development, two of which are owned by UNC Lineberger and two of which are co-owned by both institutions. Under this agreement, upon out-license of each program to an industry partner, Bellicum will receive an upfront payment and be entitled to a percentage of certain consideration paid to the institutions by the industry partner and a single digit percent royalty on the global sales of the product. Additional details of the financial arrangements are not disclosed.

"We are thrilled by the opportunity to expand the impact of our CaspaCIDe technology to benefit patients through this agreement with leading oncology research and treatment centers of excellence," said Rick Fair, President and CEO of Bellicum Pharmaceuticals. "We believe the agreement reflects the potential value of our switch technology, which may enhance the benefit/risk profile of cell therapies. We continue to incorporate the technology into our internal programs and intend to make it more broadly available via external collaborations."

"The unique inducible caspase-9 technology covered by this agreement has the potential to improve the safety profile of cellular immunotherapies, reduce the risk of serious adverse events, and improve patient outcomes," stated Gianpietro Dotti, M.D., Co-leader, Immunology Program, UNC Lineberger. "We are pleased to incorporate Bellicum’s CaspaCIDe into four of our promising cell therapy constructs."

About CaspaCIDe

CaspaCIDe (inducible caspase-9, or iC9) is Bellicum’s chemical induction of dimerization (CID) safety switch technology designated to eliminate cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. Infusion of rimiducid is designed to trigger activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. In clinical studies, use of CaspaCIDe has resulted in clinical improvement in most patients as early as 24 hours after rimiducid administration. Further, because CaspaCIDe is designed to be permanently incorporated into Bellicum’s cellular therapies, the safety switch has the potential to be available for use when needed long after the initial therapy is delivered.

On June 28, 2021 Sanofi’s ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate its growth trajectory, reported that it has signed an agreement with STADA for the divestiture of 16 Consumer Healthcare products commercialized in Europe (Press release, Sanofi, JUN 28, 2021, View Source [SID1234584391]). The transaction with STADA ensures that these products will continue to be available to consumers.

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"As discussed during our Capital Markets Day in February, simplifying the CHC product portfolio is an important part of our strategy to focus our resources and efforts where we can bring the most value, especially to consumers. We are pleased these products will continue to be available for consumers as we focus on becoming a fully integrated standalone business" said Julie Van Ongevalle, Executive Vice-President, Sanofi and Head of Sanofi Consumer Healthcare.

The agreement covers the registrations, trademarks, and related commercial rights of 16 products across Europe.

"This acquisition further strengthens STADA as a top-five player in Europe’s consumer healthcare market, supports our growth acceleration, and is another proof point of STADA as a go-to-partner," commented STADA’s CEO, Peter Goldschmidt.

Sanofi does not anticipate any impact of this divestiture to its European-based workforce.

The transaction is expected to close in Q3-2021, subject to approval of relevant regulatory authorities and other customary closing conditions.

On June 28, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that it has entered into an agreement to transfer the rights for the commercialization of Apealea (paclitaxel micellar) in the Nordics and Baltics to Inceptua Group (‘Inceptua’), effective immediately (Press release, Oasmia, JUN 28, 2021, View Source [SID1234584390]). Inceptua already has exclusive rights for the commercialization of Apealea in the rest of Europe, following an agreement signed with Oasmia’s global strategic partner for Apealea, Elevar Therapeutics, Inc. in 2020.

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Apealea is approved by the European regulatory authorities for use in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Under the terms, Inceptua now possesses the rights to commercialize Apealea throughout the whole of Europe. Oasmia will be eligible for double-digit royalties on sales.

François Martelet, M.D., CEO of Oasmia, commented: "This agreement allows Oasmia to continue streamlining operations as we focus on expanding our oncology development pipeline. Elevar has selected Inceptua as they are an ideal partner for Apealea in the Nordics and Baltics and in the best position to make a success of commercializing Apealea in Europe, with strong capabilities and suitable infrastructure."