On November 29, 2022 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported that it has exercised its first of five exclusive, target-specific options with LegoChem Biosciences for antibody-drug conjugate (ADC) SOT106, which is currently being evaluated in preclinical studies across a multitude of solid tumor indications (Press release, SOTIO, NOV 29, 2022, View Source [SID1234626212]).

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In November of 2021, SOTIO and LCB entered into a multi-target exclusive collaboration and license agreement under which SOTIO obtained the rights to deploy LCB’s ADC technology for up to five ADC programs. SOTIO is responsible for the research, development, manufacturing and worldwide commercialization of the ADC products.

"We are pleased with the progress we have made this year on our innovative antibody-drug conjugate pipeline. We advanced our lead program targeting CLDN18.2, SOT102 into the Phase 1 dose escalation portion of the CLAUDIO-01 trial and have now exercised this option for SOT106. ADCs remain one of the most actively pursued drug classes in oncology and we are encouraged that SOT106, an ADC with the potential to treat some of the most challenging solid tumor indications, continues to show promise in preclinical studies," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "The rapid and successful development of this collaboration with LegoChem Biosciences reiterates our commitment to providing patients with efficacious and safe cancer therapeutic options."

"We are very excited that a successful outcome has been achieved in such a short time since the partnership launched a year ago." said Dr. Yong-Zu Kim, the CEO & President of LCB. "This result has come from a combination of SOTIO’s deep antibody discovery expertise and LegoChem’s industry-leading and differentiated ADC platform technology. We look forward to further achieving progress in our efficient and close partnership as this effort continues into generating new drug candidates."

The exercise of the first option triggers an undisclosed milestone payment by SOTIO to LCB.

About SOT106
SOT106 is a novel ADC based on SOTIO Biotech’s proprietary antibodies and LCB’s industry-leading ConjuAllTM ADC platform technology with potential best-in class efficacy, safety and tolerability currently in preclinical development against multiple solid tumor indications.

On December 8, 2022 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for breast cancer, reported that it has entered into definitive agreements with certain institutional and accredited investors for the sale of senior secured convertible debentures and warrants to purchase shares of the Company’s common stock, resulting in total gross proceeds of approximately $3.1 million before deducting the placement agent’s fees and other offering expenses (Press release, Theralink Technologies, NOV 29, 2022, View Source [SID1234624962]).

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Under the terms of the securities purchase agreement, the Company has agreed to sell senior secured convertible debentures, with a principal amount of approximately $3.4 million (including OID of 10%), with a 12-month term. The debentures bear an interest rate of 10% per annum and, upon a qualified financing, will be converted into either (a) the securities sold by the Company in such qualified financing, at a price per share equal to the lesser of $0.003 per share or a 30% discount to the price of securities sold in such qualified financing, or (b) newly issued convertible preferred securities, at a price per share equal to the price described in the foregoing clause (a) or the 5-day VWAP on the 181st day following such exchange, subject to a partial redemption right at the time of the qualified offering. The warrants, calculated at 100% of the principal amount of the debentures, are exercisable upon the earlier of the maturity date of the debentures or a qualified financing at an exercise price equal to the price of the securities sold in such qualified financing or, if no qualified financing has occurred prior to the maturity date of the debentures, the lower of $0.003 per share or 70% of the 10-day VWAP prior to such maturity date.

Additionally, in connection with this offering, holders of certain existing convertible notes and convertible preferred shares of the Company agreed to convert their securities into an aggregate of approximately $13.4 million of the senior secured convertible debentures and warrants on the terms described in the foregoing paragraph.

Joseph Gunnar & Co., LLC is acting as the sole placement agent for the offering.

The convertible debentures and warrants (and shares of common stock underlying the convertible debentures and warrants) described above were offered in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the securities purchase agreement entered into with the investors, the Company has agreed to use its commercially reasonable efforts to file a registration statement with the SEC upon the closing of the qualified financing covering the resale of the shares of common stock underlying the convertible debentures and the shares issuable upon exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

ON November 29, 2022 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, reported the selection of CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, resulting from its research collaboration and licensing agreement with Integral Molecular (Press release, Integral Molecular, NOV 29, 2022, View Source [SID1234624604]).

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CLDN6 is differentially expressed on cancer cells with no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others. With the potential to reach a large patient population and selective expression on cancer cells, CLDN6 has emerged as an exciting drug target.

Context’s lead candidate, CTIM-76, is a CLDN6 x CD3 bispecific antibody that incorporates a highly selective CLDN6 binding arm and a CD3 binding single-chain Fv domain in an IgG format with a silenced Fc that is designed to be functionally monovalent to avoid aberrant T-cell activation and to enhance the safety profile. Research has demonstrated that CTIM-76 is potent with specific lysis of CLDN6+ cancer cells over normal cells and can activate cytotoxic T cells without concomitant activation of free cytokines – critical determinants of immunotherapy safety and activity. Preclinical studies suggest the potential for convenient dosing with low immunogenicity risk and manufacturing can be scalable to address the significant number of patients who are potentially eligible for CTIM-76 therapy.

"This year has been marked by several exciting and significant milestones for Context, culminating in naming our lead CLDN6 clinical development candidate, CTIM-76, a bispecific antibody showing high selectivity for CLDN6," said Martin Lehr, CEO of Context Therapeutics. "We selected this bispecific based on the specificity which suggests its potential to address the need for potent therapeutic modalities for cancer without compromising patient safety. With the selection of CTIM-76 as our lead CLDN6 candidate, we are well-positioned to rapidly advance our clinical development plan in CLDN6-positive tumors including, but not limited to, ovarian cancer. We have initiated IND-enabling studies and expect to submit our Investigational New Drug Application (IND) for CTIM-76 to the U.S. Food and Drug Administration in Q1 2024."

"Despite being an attractive target, therapeutic monoclonal antibodies (MAbs) targeting CLDN6 are difficult to discover due to an abundance of closely related family members and an absolute need for high specificity. Context and Integral Molecular have been able to isolate and optimize rare antibodies against CLDN6 that do not cross-react with other CLDN family members," said Joseph Rucker, Ph.D., VP of R&D at Integral Molecular.

R&D Webinar
On Thursday, December 1, 2022, at 11 a.m. ET, members of the Context team, including management, and Integral Molecular will host a webinar to discuss the selection process and nomination of CTIM-76. There will be a question-and-answer period following the formal presentation. To register for the webinar, please visit View Source

On November 29, 2022, bluebird bio, Inc. (the "Company") reported that it has entered into an asset purchase agreement (the "PRV Transfer Agreement") with argenx BV ("Buyer"), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher ("PRV") to Buyer (Press release, bluebird bio, NOV 30, 2022, View Source [SID1234624594]). The Company was awarded the voucher under a U.S. Food and Drug Administration ("FDA") program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV when SKYSONA (elivaldogene autotemcel) received accelerated approval by the FDA for the treatment of early, active cerebral adrenoleukodystrophy. Pursuant to the PRV Transfer Agreement, Buyer agreed to pay the Company $102 million, payable in cash, upon the closing of the sale.

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The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, a copy of which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.

On November 29, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") has designated 1261229 B.C. Ltd., the entity that directly or indirectly holds 88.7% of the issued and outstanding shares of Bausch + Lomb Corporation ("Bausch + Lomb"), as an unrestricted subsidiary of the Company in accordance with the terms of the Company’s debt documents (Press release, Bausch Health, NOV 29, 2022, View Source [SID1234624592]). In connection therewith, all of the subsidiaries of 1261229 B.C. Ltd., including Bausch + Lomb and its subsidiaries, are also now unrestricted subsidiaries of the Company and, as a result, are no longer subject to the covenants under the Bausch Health debt documents.

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The Company continues to evaluate potential options to maximize stakeholder value, which include its ongoing focus on its balance sheet and liquidity.