Affimed Announces Clinical Data Update on Lead Product Candidate AFM13 in CD30+ lymphoma at ICML 2019

On June 24, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported the presentation of data updates on two clinical studies at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (Press release, Affimed, JUN 24, 2019, View Source [SID1234537230]).

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The data from an oral and a poster presentation featured Affimed’s lead innate cell engager AFM13, a first-in-class tetravalent, bispecific antibody derived from the ROCK platform that is being developed to treat CD30-positive lymphomas. AFM13 specifically binds to CD30 on tumor cells and to CD16A on innate immune cells, such as NK cells and macrophages.

"The results of the completed Phase 1b study of AFM13 in combination with pembrolizumab in Hodgkin lymphoma and of Columbia University’s study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation substantiate the potential of AFM13 to make a difference in the lives of patients with limited to no treatment options," said Dr. Leila Alland, Affimed’s Chief Medical Officer. "We look forward to advancing our innate cell engagers in future clinical studies, including our registration-directed study of AFM13 in relapsed and refractory peripheral T cell lymphoma and transformed mycosis fungoides."

Final clinical results from a Phase 1b combination study of AFM13 and pembrolizumab in patients with relapsed or refractory Hodgkin lymphoma (Abstract #128, oral presentation)
Final results from a completed Phase 1b dose escalation study of AFM13 in combination with pembrolizumab (Keytruda) in patients with relapsed or refractory Hodgkin lymphoma (HL; NCT02665650) were presented during an oral session by Dr. Stephen M. Ansell, Professor of Medicine at Mayo Clinic Rochester, MN and Chair of Faculty Development and Recruitment, Division of Hematology, Department of Internal Medicine, and International Coordinating Principal Investigator of the study. Overall, the combination of AFM13 and pembrolizumab was well tolerated, with no new or worsening safety signals compared to known safety profiles of each agent alone. At the highest treated dose, the objective response rate (ORR) of 88% (by both independent and investigator assessments) and the complete response (CR) rates of 42% and 46% by investigator and independent assessments, respectively, compared favorably to the historical data of monotherapy pembrolizumab in a similar patient population, with the CR rates approximately double that of pembrolizumab. The estimated progression-free survival (PFS) was 78% and 45% at 6 and 12 months, respectively. Response rates were high amongst the subgroup of patients who were primary refractory to brentuximab vedotin (BV), with 11 of the 13 patients achieving an objective response (ORR 85%, 46% CR rate). A deepening of responses was reported over time in multiple patients, and patients previously transplant-ineligible transitioned to transplant after achieving an objective response with the combination of AFM13 and pembrolizumab.

"Despite advances in the treatment of patients with Hodgkin lymphoma, there remains a need for new treatment options for patients who have failed multiple lines of treatment," commented Dr. Ansell. "I am encouraged by the results achieved in this study, which showed that the combination of AFM13 and pembrolizumab is well-tolerated and achieved high and deep response rates even in patients who were refractory to brentuximab vedotin."

Updated clinical and immunological data from a Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation (Abstract #259, poster presentation)
New data from an AFM13 Phase 1b/2a study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation (NCT03192202) were presented by Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, and Principal Investigator of the study. In this study, AFM13 was well tolerated and resulted in a high ORR of 50% (1 CR and 4 PRs) including therapeutic activity post-BV failure. This included 2 of 5 responses in the subset of patients with transformed mycosis fungoides (T-MF), a particularly hard-to-treat disease.

Analysis of tumor biopsies showed increased numbers of NK cells both before and during treatment with AFM13 amongst the patients responding to therapy. This was also associated with markers of NK cell-mediated tumor cell killing. In the peripheral blood, NK cell activation markers were observed amongst the responders, and there were associated decreases in total numbers of circulating NK cells and regulatory T cells.

Overall, the data support the potential of AFM13 as a novel immuno-therapeutic to treat CD30-expressing lymphomas. A registration-directed Phase 2 international multicenter study of AFM13 in refractory peripheral T cell lymphoma (PTCL) and T-MF is planned.

Dr John Lambert appointed as new CEO

On June 24, 2019 Amplia Therapeutics (ASX: ATX) is reported the appointment of Dr John Lambert as Chief Executive Officer (Press release, Amplia Therapeutics, JUN 24, 2019, View Source;[email protected] [SID1234537229]). Long serving former CEO, Mr Simon Wilkinson, will remain on the Company’s Board as a non-executive director.

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Based in Melbourne, Dr Lambert has worked in drug discovery and development for over 20 years. His previous roles have included senior management positions at Biota Holdings Limited and Medicines Development for Global Health. His experience spans the full drug development lifecycle from early discovery, intellectual property protection, licensing, product development, and regulatory approval. John has been Amplia’s Operations Manager since August 2018 and has been directing all aspects of the Company’s clinical enabling work since that time.

"The appointment of Dr Lambert as Chief Executive is another important step in the transformation of Amplia" said Chairman Dr Warwick Tong. "John’s experience and enthusiasm make him the ideal candidate to deliver the near and medium term clinical development milestones we have set for the Company".

The Board of Amplia acknowledges the hard work and dedication of outgoing CEO Simon Wilkinson. "Mr Wilkinson has been a great champion for our Company for many years and we are especially pleased that he will be continuing as a director to ensure a smooth transition for Dr Lambert" said Dr Tong.

Dr Lambert commented "I am delighted to take up the Chief Executive role at Amplia Therapeutics. I’m particularly excited to be working alongside a Board with so much industry experience and I am looking forward to working with them to deliver on our objectives and drive value for our shareholders."

For Further Information
Dr Warwick Tong, Chairman
+61 450 296 930
www.ampliatx.com
Details of Dr Lambert’s remuneration as CEO follow.

Xenetic Biosciences, Inc. Announces Reverse Stock Split of Common Stock

On June 24, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), reported it will effect a one-for-twelve reverse stock split of its issued and outstanding common stock (Press release, Xenetic Biosciences, JUN 24, 2019, View Source [SID1234537228]). Pursuant to the Certificate of Change filed with the Secretary of State of the State of Nevada, the reverse stock split will be effective at 12:01 a.m., Eastern Time, on June 25, 2019. Xenetic expects that upon the opening of trading on June 25, 2019, its common stock will trade on the Nasdaq Capital Market on a split-adjusted basis under the current trading symbol "XBIO" and the new CUSIP number 984015 503.

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No fractional shares will be issued as a result of the reverse stock split. Any fractional shares that would result from the reverse stock split will be rounded up to the nearest whole share.

Stockholders of record are not required to send in their current stock certificates or evidence of book-entry or other electronic positions for exchange. Following the effectiveness of the reverse stock split, each stock certificate and book-entry or other electronic position representing issued and outstanding shares of Xenetic’s common stock will be automatically adjusted. Those stockholders holding common stock in "street name" will receive instructions from their brokers if they need to take any action in connection with the reverse stock split. Stockholders should direct any questions concerning the reverse stock split to their broker or Xenetic’s transfer agent and registrar, Empire Stock Transfer, Inc., at [email protected].

Thermo Fisher Scientific to Hold Earnings Conference Call on Wednesday, July 24, 2019

On June 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will release its financial results for the second quarter of 2019 before the market opens on Wednesday, July 24, 2019, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, JUN 24, 2019, View Source [SID1234537227]).

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During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, August 9, 2019.

Medtronic Announces Cash Tender Offers for up to $4.175 Billion of Outstanding Debt Securities Issued by Medtronic, Inc., Medtronic Global Holdings S.C.A. and Covidien International Finance S.A.

On June 24, 2019 Medtronic plc (the "Company") (NYSE:MDT) reported the commencement of two cash tender offers by its wholly-owned indirect subsidiaries, Medtronic, Inc. ("Medtronic, Inc."), Medtronic Global Holdings S.C.A. ("MGH") and Covidien International Finance S.A. ("CIFSA" and, together with Medtronic, Inc. and MGH, the "Offerors") (Press release, Medtronic, JUN 24, 2019, View Source;p=RssLanding&cat=news&id=2402104 [SID1234537226]). The first tender offer (the "Any and All Tender Offer") is for any and all of $1.175 billion total aggregate principal amount of the outstanding senior notes listed in Table 1 below (the "Any and All Notes"), which were issued by Medtronic, Inc. The second tender offer (the "Maximum Tender Offer" and, together with the Any and All Tender Offer, the "Tender Offers") is for up to $3.0 billion (the "Aggregate Maximum Purchase Price") combined aggregate purchase price (excluding accrued and unpaid interest to, but not including, the applicable settlement date and excluding fees and expenses related to the Tender Offers) of the outstanding senior notes listed in Table 2 below (the "Maximum Tender Offer Notes" and, collectively with the Any and All Notes, the "Notes").

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The tables below summarize certain information regarding the Notes and the Tender Offers, including the order of priority set forth in Table 2, subject to the Series Tender Caps, if applicable, and the Aggregate Maximum Purchase Price for the Maximum Tender Offer Notes. The Any and All Notes are not subject to a cap on the aggregate purchase price.

Table 1: Any and All Notes

Title of Security

CUSIP
Numbers

Issuer/Offeror

Principal Amount
Outstanding

U.S. Treasury
Reference
Security

Bloomberg
Reference Page

Fixed Spread(1)

Early Tender Payment
(2) (3)

4.125% Senior Notes due 2021 585055AV8 Medtronic, Inc. $500,000,000 2.375% U.S.T. due 3/15/2021 PX4 15 $30
3.125% Senior Notes due 2022 585055AX4 Medtronic, Inc. $675,000,000 2.375% U.S.T. due 3/15/2022 PX5 15 $30
Table 2: Maximum Tender Offer Notes

Title of Security

CUSIP
Numbers

Issuer/Offeror

Principal Amount
Outstanding

Acceptance
Priority
Level (4)

Series Tender Cap

U.S. Treasury
Reference
Security

Bloomberg
Reference Page

Fixed Spread

Early Tender Payment (2) (3)

6.500% Senior Notes due 2039 585055AQ9 Medtronic, Inc. $182,949,000 1 N/A 3.000% U.S.T. due 2/15/2049 PX1 85 $30
5.550% Senior Notes due 2040 585055AT3 Medtronic, Inc. $305,910,000 2 N/A 3.000% U.S.T. due 2/15/2049 PX1 75 $30
4.625% Senior Notes due 2045 585055BU9 Medtronic, Inc. $1,963,341,000 3 $100,000,000 3.000% U.S.T. due 2/15/2049 PX1 70 $30
4.625% Senior Notes due 2044 585055BD7 Medtronic, Inc. $176,594,000 4 N/A 3.000% U.S.T. due 2/15/2049 PX1 75 $30
4.500% Senior Notes due 2042 585055AW6 Medtronic, Inc. $128,650,000 5 N/A 3.000% U.S.T. due 2/15/2049 PX1 75 $30
4.375% Senior Notes due 2035 585055BT2 Medtronic, Inc. $2,381,619,000 6 $200,000,000 3.000% U.S.T. due 2/15/2049 PX1 50 $30
4.000% Senior Notes due 2043 585055AY2 Medtronic, Inc. $325,024,000 7 N/A 3.000% U.S.T. due 2/15/2049 PX1 75 $30
3.500% Senior Notes due 2025 585055BS4 Medtronic, Inc. $4,000,000,000 8 $1,300,000,000 2.000% U.S.T. due 5/31/2024 PX1 40 $30
3.625% Senior Notes due 2024 585055BC9 Medtronic, Inc. $850,000,000 9 N/A 2.000% U.S.T. due 5/31/2024 PX1 35 $30
6.550% Senior Notes due 2037 22303QAH3 Covidien International Finance S.A. $283,536,000 10 N/A 3.000% U.S.T. due 2/15/2049 PX1 75 $30
3.350% Senior Notes due 2027 58507LAC3 Medtronic Global Holdings S.C.A. $850,000,000 11 N/A 2.375% U.S.T. due 5/15/2029 PX1 30 $30
3.150% Senior Notes due 2022 585055BR6 Medtronic, Inc. $2,500,000,000 12 N/A 1.750% U.S.T. due 6/15/2022 PX1 25 $30
3.200% Senior Notes due 2022 22303QAN0 Covidien International Finance S.A. $650,000,000 13 N/A 1.750% U.S.T. due 6/15/2022 PX1 25 $30
2.950% Senior Notes due 2023 22303QAP5 Covidien International Finance S.A. $309,516,000 14 N/A 2.000% U.S.T. due 5/31/2024 PX1 25 $30
(1) If the Total Consideration (as defined below) based on the applicable Fixed Spread (as defined below) would have been below $1,000, then it will be equal to $1,000 per $1,000 principal amount.

(2) Per $1,000 principal amount.

(3) The Total Consideration for Notes validly tendered prior to or at the applicable Early Tender Date (as defined below) and accepted for purchase is calculated using the applicable Fixed Spread and is inclusive of the applicable Early Tender Payment (as defined below). The Total Consideration will be determined by taking into account the applicable par call date for each series of Notes, if any.

(4) The offers with respect to the Maximum Tender Offer Notes are subject to the Aggregate Maximum Purchase Price of $3.0 billion in aggregate purchase price and the Series Tender Caps. All references to the aggregate purchase price for the Maximum Tender Offer Notes include the applicable Total Consideration or Tender Offer Consideration (as defined below) and exclude applicable accrued interest and fees and expenses related to the Tender Offers. The Offerors will purchase an aggregate principal amount of Maximum Tender Offer Notes having an aggregate purchase price up to the Aggregate Maximum Purchase Price, subject to the Acceptance Priority Level and the Series Tender Caps as set forth in the table above. The Offerors reserve the right, but are under no obligation, to increase the Aggregate Maximum Purchase Price and/or any Series Tender Cap at any time, including on or after July 10, 2019, subject to applicable law, which could result in the Offerors purchasing an aggregate principal amount of Maximum Tender Offer Notes having a greater aggregate purchase price in the Maximum Tender Offers and/or purchasing an aggregate principal amount of such series of Capped Notes (as defined below) above the applicable sublimit set forth herein.

The Tender Offers are being made pursuant to an Offer to Purchase, dated June 24, 2019 (the "Offer to Purchase"), which sets forth the terms and conditions of the Tender Offers. The Tender Offers will expire at 12:00 midnight, New York City time, on July 24, 2019 (one minute after 11:59 p.m., New York City time, on July 24, 2019), or any other date and time to which such Tender Offer is extended (such date and time, as it may be extended with respect to a Tender Offer, the "Expiration Date"), unless earlier terminated. Holders of Notes must validly tender and not validly withdraw their Notes prior to 5:00 p.m., New York City time, on July 9, 2019, (such date and time, as it may be extended with respect to a Tender Offer, the "Early Tender Date"), to be eligible to receive the Total Consideration (as defined below), which is inclusive of the applicable cash amount set forth in the above tables under the heading "Early Tender Payment" (the "Early Tender Payment"). Holders of Notes who validly tender their Notes after the Early Tender Date but prior to the applicable Expiration Date will only be eligible to receive the applicable Tender Offer Consideration.

All holders of Notes accepted for purchase will also receive accrued and unpaid interest on Notes validly tendered and accepted for purchase from the applicable last interest payment date up to, but not including, the applicable settlement date.

The applicable consideration (the "Total Consideration") offered per $1,000 principal amount of Notes of each series validly tendered and accepted for purchase pursuant to the applicable Tender Offer will be determined in the manner described in the Offer to Purchase by reference to the applicable "Fixed Spread" for such Notes specified in the tables above plus the applicable yield to maturity based on the bid-side price of the applicable "U.S. Treasury Reference Security" specified in the tables above as quoted on the applicable page on the Bloomberg Bond Trader at 11:00 a.m., New York City time, on the first business day following the Early Tender Date which is expected to be July 10, 2019. The "Tender Offer Consideration" is equal to the Total Consideration minus the Early Tender Payment.

Maximum Tender Offer Notes tendered prior to or at the Early Tender Date and accepted for purchase will be accepted based on the acceptance priority levels noted on the front cover hereof, with 1 being the highest Acceptance Priority Level and 14 being the lowest Acceptance Priority Level (the "Acceptance Priority Levels") and will have priority over Maximum Tender Offer Notes tendered after the Early Tender Date, regardless of the Acceptance Priority Levels of the Maximum Tender Offer Notes tendered after the Early Tender Date. Maximum Tender Offer Notes of a series may be subject to proration if the aggregate principal amount of the Maximum Tender Offer Notes of such series validly tendered and not validly withdrawn would cause the Aggregate Maximum Purchase Price to be exceeded, or, in the case of each of the 4.625% Senior Notes due 2045, the 4.375% Senior Notes due 2035 and the 3.500% Senior Notes due 2025 (each a "Capped Note"), if the aggregate principal amount of the Capped Note validly tendered and not validly withdrawn is greater than applicable Series Tender Cap.

The Tender Offers will expire on the applicable Expiration Date. The settlement date for the Notes that are validly tendered on or prior to the Early Tender Date is expected to be July 12, 2019, the third business day following the Early Tender Date, assuming the conditions to the satisfaction of the applicable Tender Offer are satisfied. The settlement date for Notes that are validly tendered following the Early Tender Date but on or prior to the applicable Expiration Date is expected to be July 26, 2019, the second business day following the Expiration Date.

Notes that are validly tendered may be validly withdrawn at any time prior to 5:00 p.m., New York City time, on July 9, 2019 (unless extended, the "Withdrawal Deadline"). After such time Notes may not be withdrawn unless the applicable Offeror extends the Withdrawal Deadline.

In accordance with the indentures governing the Any and All Notes, and subject to available funding, Medtronic, Inc. may give notice of redemption for the redemption of any remaining 4.125% Senior Notes due 2021 or 3.125% Senior Notes due 2022 that are not validly tendered and accepted for purchase in the Any and All Tender Offers. Any such notice of redemption may be given as early as July 10, 2019. The Offerors, the Company or their affiliates may also from time to time, after completion of the applicable Tender Offer, purchase additional Notes in the open market, in privately negotiated transactions, through tender or exchange offers or otherwise, or the applicable Offeror may redeem Notes that are redeemable pursuant to their terms.

The Offerors’ obligation to accept for payment and to pay for the Notes validly tendered in the Tender Offers is not subject to any minimum tender condition but is subject to the satisfaction or waiver of the conditions described in the Offer to Purchase, including the financing condition that the Offerors shall have closed one or more debt financings resulting in net proceeds in an amount not less than the amount required, upon the terms and subject to the conditions of the applicable Tender Offer, to purchase all the Notes validly tendered and accepted for purchase in the Tender Offers and to pay accrued interest thereon and fees and expenses associated therewith. Following the Tender Offers, the Company does not intend to pursue any additional opportunistic refinancing in the Euro market for the next year. The Offerors reserve the right, subject to applicable law, to: (i) waive any and all conditions to the Tender Offers; (ii) extend or terminate the Tender Offers; (iii) increase or decrease the Aggregate Maximum Purchase Price and Series Tender Caps; or (iv) otherwise amend any of the Tender Offers in any respect.

Information Relating to the Tender Offers
Barclays Capital Inc., BofA Merrill Lynch and Goldman Sachs & Co. LLC are acting as the dealer managers (the "Dealer Managers") for the Tender Offers. The information agent and tender agent is Global Bondholder Services Corporation ("Global Bondholder"). Copies of the Offer to Purchase and related offering materials are available by contacting Global Bondholder at +1-866-470-4200 (U.S. toll-free) or +1-212-430-3774 (banks and brokers). Questions regarding the Tender Offer should be directed to Barclays Capital Inc., Liability Management Group at +1-212-528-7581 (collect) or +1-800-438-3242 (toll free), BofA Merrill Lynch, Liability Management Group, at +1-980-387-3907 (collect) or +1-888-292-0070 (toll-free) or Goldman Sachs & Co. LLC at +1-212-357-0215 (collect) or +1-800-828-3182 (toll-free).

None of the Offerors, the Company or their affiliates, their respective boards of directors or managing members, the Dealer Managers, Global Bondholder or the trustee with respect to any series of Notes is making any recommendation as to whether holders of Notes should tender any Notes in response to any of the Tender Offers, and neither the Offerors nor any such other person has authorized any person to make any such recommendation. Holders of Notes must make their own decision as to whether to tender any of their Notes, and, if so, the principal amount of Notes to tender.

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities. The Tender Offers are being made only pursuant to the Offer to Purchase and only in such jurisdictions as is permitted under applicable law.

The full details of the Tender Offers, including complete instruction on how to tender Notes, are included in the Offer to Purchase. The Offer to Purchase contains important information that should be read by holders of Notes before making a decision to tender any Notes. The Offer to Purchase may be downloaded from Global Bondholder’s website at View Source or obtained from Global Bondholder, free of charge, by calling toll-free at +1-866-470-4200 (bankers and brokers can call collect at +1-212-430-3774).