On November 22, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimed’s innate cell engager (ICE) AFM13 (Press release, Affimed, NOV 22, 2021, View Source [SID1234595909]).

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As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1×106, three patients with 1×107 and 12 patients with 1×108 AFM13-pre-complexed cbNK cells per kg body weight.

As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses (CR) and nine partial responses (PR). Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

"The patients enrolled in this study were all heavily pre-treated with a median of 6 lines of prior therapy and had progressive disease after their previous line of therapy," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "We are encouraged by the response rates that we continue to observe in these difficult to treat patients. The data are in line with data presented at AACR (Free AACR Whitepaper) earlier this year. We also continue to see a very good safety profile of the combination, which is important as many of these patients have been very heavily pretreated and cannot tolerate aggressive therapies. Combining our ICE molecules with NK cells is an integral part of our strategy to bring innovative therapies to patients in need. We believe these preliminary data provide further validation of this approach."

Conference Call/Webcast Information

Affimed will host a conference call and webcast on December 9th, 2021, at 8:30 a.m. EST to review the data. Affimed’s management will discuss the results to date, the current treatment landscape for CD30+ lymphomas, and next steps for the study. Dr. Yago L. Nieto, M.D., Ph.D, Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine from M.D Anderson Cancer Center will also be available during the call.

To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source or View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1×108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28.

MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.

Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at www.clinicaltrials.gov (NCT04101331).

On November 22, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Regeneron has extended the research term of its collaboration with the Company to discover and develop gene therapies for hearing loss (Press release, Decibel Therapeutics, NOV 22, 2021, View Source [SID1234595908]). The research term will be extended to November 15, 2023, and Regeneron will pay Decibel an extension fee of $10 million in Q4 of 2022.

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Under the collaboration launched in 2017, Decibel is developing three gene therapy programs targeting congenital, monogenic hearing loss with Regeneron. Decibel plans to initiate in 2022 a Phase 1/2 clinical trial of DB-OTO, the Company’s lead gene therapy product candidate, designed to provide hearing to individuals born with profound hearing loss due to mutation of the otoferlin gene. Decibel is also advancing AAV.103 and AAV.104, gene therapy programs targeting other monogenic forms of hearing loss, with Regeneron. AAV.103 aims to restore hearing in individuals with mutations in the GJB2 gene, and AAV.104 aims to restore hearing in individuals with mutations in the STRC gene.

"Decibel and Regeneron scientists have worked closely to advance our gene therapy pipeline for the treatment of congenital, monogenic hearing loss, bringing our lead program, DB-OTO, within sight of the clinic. We are pleased that Regeneron has elected to extend the research term, which extends our access to Regeneron’s world-leading genomic and genetic technologies, and therapeutic discovery and development expertise," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "This collaboration, which plays to each party’s strengths, is an important part of our ability to accelerate the discovery and development of innovative genetic therapies for patients in need."

"The inner ear is a highly promising frontier for gene therapy, and we believe that the programs being developed in collaboration with Decibel could lead to novel medicines that help people with congenital, monogenic hearing loss," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer, Regeneron. "We’re pleased to extend this successful collaboration, which is an important component of Regeneron’s growing genetics medicine portfolio. Regeneron and Decibel will continue to work together to combine novel gene therapy technologies with deep biologic expertise, so as to bring life-changing medicines to those suffering with hearing loss."

Through the collaboration, Regeneron provides Decibel with broad access to its proprietary suite of technologies to support Decibel’s goal of discovering new medicines for congenital, monogenic hearing loss. Regeneron also directly participates in and provides financial support for Decibel’s research and development efforts under the collaboration through milestone payments and reimbursement intended to fund approximately half of the costs of the collaboration programs. Decibel retains worldwide development and commercialization rights to the product candidates being developed in the collaboration and will pay Regeneron tiered royalties based on net sales.

On November 22, 2021 BioCryst Pharmaceuticals, Inc. (the "Company") reported that entered into the following material definitive agreements: (i) a Purchase and Sale Agreement entered into with RPI 2019 Intermediate Finance Trust ("RPI") (the "2021 RPI Royalty Purchase Agreement"), pursuant to which the Company sold to RPI the right to receive certain royalty payments from the Company for a purchase price of $150 million in cash, and (ii) a Purchase and Sale Agreement entered into with OCM IP Healthcare Holdings Limited, an affiliate of OMERS Capital Markets ("OMERS") (the "OMERS Royalty Purchase Agreement", together with the 2021 RPI Royalty Purchase Agreement, the "Royalty Purchase Agreements"), pursuant to which the Company sold to OMERS the right to receive certain royalty payments from the Company for a purchase price of an additional $150 million in cash (Filing, 8-K, BioCryst Pharmaceuticals, NOV 22, 2021, View Source [SID1234595907]).

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Under the 2021 RPI Royalty Purchase Agreement, RPI is entitled to receive tiered, sales-based royalties on net product sales of ORLADEYO in the United States and certain key European markets (collectively, the "Key Territories"), and other markets where the Company sells ORLADEYO directly or through distributors (collectively, the "Direct Sales") in an amount equal to: (i) 0.75% of aggregate annual net sales of ORLADEYO for annual net sales up to $350 million and (ii) 1.75% of annual net sales of ORLADEYO for annual net sales between $350 million and $550 million (with no royalty payments payable on annual net sales over $550 million). RPI is also entitled to receive a tiered revenue share on amounts generally received by the Company on account of ORLADEYO sublicense revenue or net sales by licensees outside of the Key Territories (the "Other Markets") in an amount equal to: (i) 3.0% of the proceeds received by the Company for upfront license fees and development milestones for ORLADEYO in the Other Markets, (ii) 3.0% of proceeds received by the Company on annual net sales of up to $150 million in the Other Markets, and (iii) 2.0% of proceeds received by the Company on annual net sales between $150 million and $230 million in the Other Markets (with no royalty payments payable on annual net sales above $230 million in the Other Markets).

Under the 2021 RPI Royalty Purchase Agreement, RPI is also entitled to receive tiered, sales-based royalties on net product sales of BCX9930 and another earlier stage Factor D inhibitor in an amount equal to: (i) 3.0% of worldwide aggregate annual net sales up to $1.5 billion and (ii) 2.0% of worldwide aggregate annual net sales between $1.5 billion and $3 billion (with no royalty payments payable on annual net sales above $3 billion). RPI is also entitled to receive tiered profit share amounts of up to 3.0% from certain other permitted sales in certain other markets.

The royalties payable under the 2021 RPI Royalty Purchase Agreement are in addition to the royalties payable to RPI under that certain Purchase and Sale Agreement by and between the Company and RPI dated as of December 7, 2020.

Under the OMERS Royalty Purchase Agreement, commencing with the calendar quarter beginning October 1, 2023, OMERS will be entitled to receive tiered, sales-based royalties on Direct Sales in an amount equal to: (i) 7.5% of aggregate annual net sales of ORLADEYO for annual net sales up to $350 million and (ii) 6.0% of annual net sales of ORLADEYO for annual net sales between $350 million and $550 million (with no royalty payments payable on annual net sales over $550 million) (the "Regime A Royalty Rate"). If annual Direct Sales for calendar year 2023 reach a specified amount set forth in the OMERS Royalty Purchase Agreement, then for each calendar quarter beginning on or after January 1, 2024, OMERS will be entitled to receive the Regime A Royalty Rate. If annual Direct Sales for calendar year 2023 are less than the specified amount, OMERS will be entitled to receive tiered, sales-based royalties on Direct Sales in an amount equal to: (i) 10.0% of aggregate annual net sales of ORLADEYO for annual net sales up to $350 million and (ii) 3.0% of annual net sales of ORLADEYO for annual net sales between $350 million and $550 million (with no royalty payments payable on annual net sales over $550 million) (the "Regime B Royalty Rate").

In addition, OMERS is also entitled to receive a tiered revenue share on amounts generally received by the Company on account of ORLADEYO sublicense revenue or net sales by licensees in the Other Markets in an amount equal to: (i) 20.0% of the proceeds received by the Company for upfront license fees and development milestones for ORLADEYO in the Other Markets, (ii) 20.0% of proceeds received by the Company on annual net sales of up to $150 million in the Other Markets, and (iii) 10.0% of proceeds received by the Company on annual net sales between $150 million and $230 million in the Other Markets (with no royalty payments payable on annual net sales above $230 million in the Other Markets). OMERS is also entitled to receive profit share amounts of up to 10% from certain other permitted sales in certain other markets.

The Company will be required to make payments (i) to RPI in respect of net sales or sublicense revenue in each calendar quarter from and after October 1, 2021, and (ii) to OMERS in respect of net sales or sublicense revenue in each calendar quarter from and after October 1, 2023. OMERS will no longer be entitled to receive any payments on the date in which aggregate payments actually received by OMERS equals either 142.5% or 155.0% of the $150 million purchase amount, depending on sales levels in calendar year 2023.

The transactions contemplated by each of the Royalty Purchase Agreements are referred to herein as the "Royalty Sales."

Under the Royalty Purchase Agreements, the Company has agreed to specified affirmative and negative covenants, including without limitation covenants regarding periodic reporting of information by the Company to RPI and OMERS, as applicable, third-party audits of royalties paid under the Royalty Purchase Agreements, and restrictions on the ability of the Company or any of its subsidiaries to incur indebtedness (which restrictions are eliminated after the achievement of certain milestones specified in the Royalty Purchase Agreements) other than certain royalty sales and as is permitted to be incurred under the terms of the Company’s Credit Agreement with Athyrium (each defined below), as amended. The Royalty Purchase Agreements also contain representations and warranties, other covenants, indemnification obligations, and other provisions customary for transactions of this nature.

The foregoing description of the Royalty Purchase Agreements does not purport to be complete and is qualified in its entirety by reference to the complete text of each of the Royalty Purchase Agreements, which will be filed as exhibits to the Company’s Annual Report on Form 10-K for the year ending December 31, 2021.

Common Stock Purchase Agreement

On November 19, 2021, concurrent with entering into the Royalty Purchase Agreements, the Company and RPI entered into a Common Stock Purchase Agreement (the "Stock Purchase Agreement"), pursuant to which the Company agreed to issue 3,846,154 shares of the Company’s common stock (the "Shares") for an aggregate purchase price of approximately $50 million, at a price of $13.00 per share, calculated based on the 20-day volume weighted average price. The Stock Purchase Agreement also contains representations and warranties, other covenants, indemnification obligations, and other provisions customary for transactions of this nature.

The foregoing description of the Stock Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Stock Purchase Agreement, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2021.

Amendment Number One to Credit Agreement

On November 19, 2021, the Company entered into an amendment to its Credit Agreement, dated as of December 7, 2020, by and among the Company, as borrower; BioCryst Ireland Limited, a wholly-owned subsidiary of the Company, as guarantor; the other guarantors from time to time party thereto (all such guarantors, together with the borrower, the "Loan Parties"); the lenders from time to time party thereto; and Athyrium Opportunities III Co-Invest 1 LP ("Athyrium"), as lender and as administrative agent for the lenders (the "Existing Credit Agreement"). The Existing Credit Agreement provided for (i) an initial term loan in the principal amount of $125 million (the "Term A Loan") funded on December 7, 2020 and (ii) two additional term loans in the respective principal amounts of $25 million (the "Term B Loan") and $50 million (the "Term C Loan" and, collectively with the Term A Loan and the Term B Loan, the "Term Loans" and each, a "Term Loan").

The Amendment Number One to Credit Agreement, by and among the Loan Parties, the lenders party thereto, and Athyrium, amends the Existing Credit Agreement (the Existing Credit Agreement as so amended, the "Credit Agreement") (i) to permit the Company to enter into the 2021 RPI Royalty Purchase Agreement, the OMERS Royalty Purchase Agreement and the other definitive documentation related thereto and to perform its obligations thereunder; (ii) to require the Company to pay to Athyrium, for the account of the lenders, a make-whole premium plus certain fees set forth in the Credit Agreement in the event that the Company does not draw the Term B Loan or the Term C Loan, as applicable, by the end of the applicable period available to draw the Term B Loan or the Term C Loan, subject to certain exceptions set forth in the Credit Agreement; and (iii) to require the Company to pay to Athyrium, for the account of the lenders, a make-whole premium plus certain fees set forth in the Credit Agreement in the event that the Company either (x) terminates the commitments in respect of the Term B Loan or the Term C Loan, as applicable, on or prior to the end of the applicable period available to draw the Term B Loan or the Term C Loan, or (y) prepays or repays, or is required to prepay or repay, voluntarily or pursuant to a mandatory prepayment obligation under the Credit Agreement (e.g., with the proceeds of certain asset sales, certain ORLADEYO out-licensing or royalty monetization transactions (excluding the Royalty Sales), extraordinary receipts, debt issuances, or upon a change of control of the Company and specified other events, subject to certain exceptions), all of the then-outstanding Term Loans, in each case, subject to certain exceptions set forth in the Credit Agreement.

The foregoing description of the material terms of the Credit Agreement does not purport to be complete and is subject to, and is qualified in its entirety by reference to, the full text of the Credit Agreement, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2021.

The information set forth in Item 1.01 of this Current Report on Form 8-K under the caption "Common Stock Purchase Agreement" is incorporated by reference into this Item 3.02. The Shares were offered and sold without registration under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 506 promulgated under the Securities Act as sales to an accredited investor.

On November 22, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported Andrew Robbins, Chief Executive Officer and President will participate in a fireside chat and one-on-one investor meetings during the Piper Sandler 33rd Annual Healthcare Conference, taking place virtually November 29 – December 2, 2021 (Press release, Cogent Biosciences, NOV 22, 2021, View Source [SID1234595905]).

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The pre-recorded fireside chat will be available to conference attendees starting at 10:00 a.m. ET today and will remain available through the end of the conference on Thursday, December 2. Access to the recording will be available under the "Events" tab on the investor relations section of the Cogent Biosciences website at: View Source

On November 22, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will present virtually at the Piper Sandler 33rd Annual Healthcare Conference 2021 as follows (Press release, Eagle Pharmaceuticals, NOV 22, 2021, View Source [SID1234595904]):

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View Source

The webcast of the previously recorded presentation will be accessible on demand and archived for 90 days thereafter, via the Company’s website at www.eagleus.com, under the Investors section.

Eagle will be participating in 1×1 meetings on December 1. Meetings can be requested exclusively via Piper Sandler.