On November 10, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported its financial results for the quarter ended September 30, 2021, its recent business highlights, and a preview of anticipated select milestones in the remainder of 2021 (Press release, Sutro Biopharma, NOV 10, 2021, View Source [SID1234595130]).

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"We are pleased to announce that enrollment has been completed for the STRO–002 Phase 1 dose-expansion cohort for patients with advanced ovarian cancer. Additionally, we are prioritizing the STRO-002 franchise through additional studies, given the potential for this to be an important treatment option for patients with FolRα-expressing tumors," said Bill Newell, Sutro’s Chief Executive Officer. "For our STRO-001 program, we continue with dose escalation to achieve a recommended Phase 2 dose and support the work of our partner, BioNova, in Greater China, to explore the therapeutic potential in less heavily pretreated patients with multiple myeloma, non-Hodgkin’s lymphoma, and acute myeloid leukemia."

Recent Business Highlights and Anticipated 2021 Select Milestones

STRO-002, FolRα-Targeting Antibody-Drug Conjugate (ADC): STRO-002 is being studied in patients with ovarian cancer and endometrial cancer.

The patient enrollment of 40 patients has been completed for the Phase 1 dose-expansion cohort for advanced ovarian cancer, with participation from clinical sites across the U.S. and in Spain.
Sutro is expected to report initial data for the dose-expansion cohort in the second half of 2021; the data are expected to inform regulatory discussions and registration strategy, including the planned identification of patient populations that may benefit optimally from treatment with STRO–002.
Sutro has opened a new cohort of the Phase 1 dose-expansion study of STRO-002 for endometrial cancer and is currently enrolling patients. A STRO-002 study in combination with bevacizumab has cleared protocol and the first patient is expected later this year.
Nonclinical data on STRO-002 as a potential therapeutic targeting a rare pediatric acute myeloid leukemia (AML) subtype expressing FolRα will be presented by investigators at the Fred Hutchinson Cancer Research Center (Fred Hutch) as an oral presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021). Details are as follows:
Publication Number:

209

Presentation Title:

Targeting FOLR1 in High-Risk CBF2AT3-GLIS2 AML with STRO-002 FOLR1-Directed Antibody-Drug Conjugate

Presentation Time:

Saturday, December 11, 2021, at 3:00 PM ET

Session Name:

604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel Molecular Therapies in AML

STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B–cell malignancies, including patients with non-Hodgkin’s lymphoma and multiple myeloma, continues with dose escalation.

Dose escalation is ongoing to achieve a recommended phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the multiple myeloma (MM) cohort and 4.2 mg/kg in the non-Hodgkin’s lymphoma (NHL) cohort.
Nonclinical data on STRO-001 as a potential therapeutic targeting AML and acute lymphoblastic leukemia (ALL) will be presented by investigators at the Fred Hutch as an oral presentation at ASH (Free ASH Whitepaper) 2021. Details are as follows:
Publication Number:

509

Presentation Title:

Therapeutic Targeting of CD74 with STRO-001 Antibody-Drug Conjugate in AML and ALL

Presentation Time:

Sunday, December 12, 2021, at 5:30 PM ET

Session Name:

604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel Strategies to Overcome Resistance to BCL-2 Inhibition

Additional Pipeline: Research and preclinical development are underway for several internal candidates.

Sutro announced multiple discovery and preclinical candidates, including ADCs targeting ROR1 and Tissue Factor, a 5T4-CD3 bispecific T-Cell Engager (TCE), and cytokine derivatives, including IFNα and IL-12.
Discovery and preclinical work on these programs are underway to determine Sutro’s next program to advance to the clinic.
Collaboration Updates: Sutro continues to seek to maximize the value of its cell-free platform by working with partners on programs in multiple disease spaces and geographies.

In October of this year, Sutro entered into a collaboration with BioNova Pharmaceuticals Limited (BioNova) to assess the therapeutic potential for STRO-001 in potentially less heavily pretreated patient populations with MM, NHL, and AML within Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Merck extended the first cytokine derivative research program by up to two years to continue the work on an additional candidate. Sutro received an initial payment of $2.5 million and is eligible to receive up to a total of $10 million in connection with the research program extension.
Sutro continues to manufacture clinical trial material for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA–targeting ADC, for treatment of patients with multiple myeloma.
Third Quarter 2021 Financial Highlights
Cash, Cash Equivalents and Marketable Securities
As of September 30, 2021, Sutro had cash, cash equivalents and marketable securities of $254.2 million, as compared to $326.5 million as of December 31, 2020, with projected runway into the second half of 2023, based on current business plans and assumptions. The above balance does not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock
As of September 30, 2021, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $39.8 million. The non-operating, unrealized gain of $4.5 million for the three months ended September 30, 2021 was due to the increase since June 30, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue
Revenue was $8.5 million for the three months ended September 30, 2021, as compared to $17.8 million for the same period in 2020, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, EMD Serono, BioNova, and from any additional collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses
Total operating expenses for the three months ended September 30, 2021 were $43.2 million, as compared to $28.4 million for the same period in 2020. The 2021 period includes non-cash expenses for stock-based compensation of $6.5 million and depreciation and amortization of $1.1 million, as compared to $3.1 million and $1.0 million, respectively, in the comparable 2020 period. Total operating expenses for the three months ended September 30, 2021 were comprised of research and development expenses of $26.6 million and general and administrative expenses of $16.6 million, which are expected to increase in 2021 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On November 10, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended September 30, 2021, and provided an update on clinical and corporate progress (Press release, Affimed, NOV 10, 2021, View Source [SID1234595129]).

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"In the past months, we have significantly expanded our efforts to ensure the development of our leading candidates, AFM13 and AFM24, which we believe will result in multiple catalysts over the next several quarters," said Adi Hoess, CEO of Affimed. "We are excited about AFM28, a ROCK platform-based ICE, which we believe will be a novel and promising approach for difficult-to-treat AML patients. We know NK cells have shown some activity in AML and, coupled with what we are seeing in the AFM13 study in combination with NK cells we are hopeful that this highly differentiated product candidate will offer a new treatment option to those patients currently left behind," he concluded.

Clinical Stage Program Updates
AFM13 (CD30/CD16A)

Affimed is continuing to recruit patients in the REDIRECT study (AFM13-202) after reporting positive results from the preplanned interim futility analysis in March 2021; based on this successful interim analysis, the high- and low-CD30 expressing cohorts of this trial have been combined into one. Affimed expects to complete enrollment in the study in the first half of 2022.
REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).

Affimed reported that there were no dose-limiting toxicities observed in the dose escalation part of the investigator sponsored study (IST) at The University of Texas MD Anderson Cancer Center. The study, which is investigating the treatment of CD30-positive lymphoma patients with AFM13 precomplexed cord blood-derived natural killer (NK) cells (AFM13-104), continues to enroll patients at the highest dose level. As of October 31, 2021, 18 patients had been treated in the study, including 12 patients at the highest NK cell dose. An amendment to the protocol for the study has been submitted to allow for the enrollment of up to 40 patients at the highest dose level to generate additional data on safety and efficacy. The expansion would include patients with Hodgkin Lymphoma and non-Hodgkin Lymphoma. As presented at AACR (Free AACR Whitepaper) in April 2021, the first four patients showed a 100% objective response rate with two out of four patients (50%) achieving a complete response. Affimed expects to present additional data from the study at a company-sponsored event in December 2021.
AFM24 (EGFR/CD16A)

For AFM24, an EGFR/CD16A targeted innate cell engager (ICE) for patients with EGFR-expressing solid tumors, Affimed is executing a strategy intended to deliver the highest probability of success. As such, the objective is to treat patients with EGFR-expressing tumors with AFM24 as monotherapy (AFM24-101) in 3 indications, with AFM24 in combination with an anti-PD-L1 antibody (AFM24-102) in at least 3 indications and with AFM24 in combination with autologous NK cells in 3 indications (AFM24-103).
In AFM24-101, the monotherapy phase 1/2a clinical trial, a weekly dose of 480 mg has been identified as the recommended phase 2 dose based on a comprehensive review of safety, pharmacokinetic and pharmacodynamic data, including exposure and NK cell CD16A receptor occupancy. Of note, four out of six patients dosed in the 480 mg cohort remain on therapy based on investigator assessment of clinical benefit; two of these patients have demonstrated stable disease beyond three months and continue on treatment. Affimed expects to start the dose expansion phase of the trial at the recommended phase 2 dose in the fourth quarter of 2021. The trial will include the following indications:
Renal cell carcinoma (clear cell), failing standard of care (SoC) including TKIs and PD1 targeted therapy
Non-small cell lung cancer (EGFR-mutant), failing SoC TKIs and PD1 naïve; and,
Colorectal cancer, failing chemotherapy plus EGFR-targeted antibodies In parallel, Affimed will continue to evaluate higher doses of AFM24 to generate additional safety data, and enrollment has begun in a cohort to evaluate a weekly dose of 720 mg.
AFM24-102, the phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in EGFR-expressing solid tumors, is on track to start in the fourth quarter of 2021. The combination trial will include the following indications:
Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy
Gastric/gastroesophageal junction (GEJ) cancer failing chemotherapy and/or PD1 targeted therapy; and,
A basket of EGFR-expressing tumors comprising pancreatic, hepatocellular and biliary tract cancer failing standard of care therapy for the respective disease
AFM24-103, the phase 1/2a combination study of AFM24 with NKGen Biotech’s autologous NK cell therapy, SNK01, a first-in-human proof of concept trial in EGFR-expressing solid tumors, is now open to recruit patients. As previously announced, the combination trial will include the following indications:
Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy
Squamous cell carcinoma of the head and neck, failing chemotherapy and PD1 targeted therapy; and,
Colorectal cancer including those with mutations, failing standard of care therapy
Preclinical Program
AFM28 (CD123/CD16A)

Preclinical candidate AFM28, developed on the company’s proprietary ROCK platform, is a bispecific, tetravalent ICE that targets CD16A on NK cells and macrophages, as well as CD123 on leukemic cells and leukemic stem cells that are prevalent in AML. The high affinity to CD16 and CD123 initiates antibody-dependent cell-mediated cytotoxicity (ADCC) against CD123+ tumor cells.
Preclinical data demonstrates that AFM28 induces tumor cell lysis more potently than conventional anti-CD123 antibodies, even at low CD123 expression. Further, AFM28 shows a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. In a preclinical toxicology study in cynomolgus monkey, AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity suggesting a good safety profile and the potential to eliminate CD123+ cells in vivo. Clinical investigation of AFM28 is planned to start in second half of 2022.
Third Quarter 2021 Financial Highlights
(Figures for the quarters ended September 30, 2021, and 2020 are unaudited.)

As of September 30, 2021, cash and cash equivalents totaled €198.7 million compared to €146.9 million on December 31, 2020. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.

Net cash used in operating activities for the quarter ended September 30, 2021 was €25.6 million compared to €3.6 million for the quarter ended September 30, 2020.

Total revenue for the quarter ended September 30, 2021, was €8.7 million compared with €10.5 million for the quarter ended September 30, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.

Research and development expenses for the quarter ended September 30, 2021 amounted to €20.6 million compared to €10.1 million for the quarter ended September 30, 2020. The increase is largely due to increased costs for AFM24, including costs associated with the ongoing phase 1/2a clinical trial and manufacturing costs for clinical trial material required for the ongoing study and planned future studies, as well as an increase in costs associated with early-stage development/discovery activities. In addition, there was an increase associated with research and development that is non-project specific, including share-based payment expense, intellectual property-related expenses and facility costs.

General and administrative expenses were €6.8 million in the quarter ended September 30, 2021, compared to €3.5 million in the quarter ended September 30, 2020. The increase relates largely to higher personnel expenses due to an increase in headcount, higher premiums for our Directors and Officers liability insurance, increase in share-based payment expense and higher legal and consulting expenses.

Net finance income for the quarter ended September 30, 2021 was €1.5 million compared to net finance loss of €3.1 million in the quarter ended September 30, 2020. Net finance income/loss is largely due to foreign exchange gains/losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the quarter.

Net loss for the quarter ended September 30, 2021 was €17.1 million, or loss of €0.14 per common share, compared with a net loss of €6.0 million, or €0.07 loss per common share, for the quarter ended September 30, 2020.

The weighted number of common shares outstanding for the quarter ended September 30, 2021 was 119.8 million. Additional information regarding these results will be included in the notes to the consolidated financial statements as of September 30, 2021, of Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro. Conference Call and Webcast Information Affimed will host a conference call and webcast today, November 10, 2021, at 8:30 a.m. EST to discuss third quarter 2021 financial results and recent corporate developments. The conference call will be available via phone and webcast. 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 6166004 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 A replay of the webcast will be accessible at the same link for 30 days following the call.

On November 10, 2021 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that members of management will participate in several upcoming conferences (Press release, argenx, NOV 10, 2021, View Source [SID1234595128]):

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Guggenheim Healthcare Talks | Idea Forum | 3rd Annual Neuro/Immunology Day. Fireside chat on Monday, November 15, 2021 at 9:40 a.m. ET.
Evercore ISI 4th Annual HealthCONx Conference. Fireside chat on Tuesday, November 30, 2021 at 12:35 p.m. ET.
Piper Sandler 33rd Annual Healthcare Conference. Pre-recorded fireside chat will be made available on November 22, 2021 at 10:00 a.m. ET.

Additional information regarding these events will be available on the Investors section of the argenx website at argenx.com/investors.

On November 10, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that management will participate in two upcoming virtual investor conferences (Press release, Harpoon Therapeutics, NOV 10, 2021, View Source [SID1234595123]):

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A fireside chat at Stifel’s 2021 Virtual Healthcare Conference on Monday, November 15, 2021 at 4 p.m. ET / 1 p.m. PT; and

A pre-recorded fireside chat at Piper Sandler’s 33rd Annual Healthcare Conference will be available on the conference website beginning at 10 a.m. ET / 7 a.m. PT on November 22, 2021. A link to the fireside chat will also become available at the same time on the Harpoon website on the Events page. Harpoon will be participating in 1×1 meetings with investors on Tuesday, November 30, and meetings can be requested exclusively via Piper Sandler.
The webcasts will be available from the Events and Presentations section of the company’s website at View Source and will be archived there shortly after the events.

On November 10, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, reported the appointment of Alison Long, M.B.B.Ch., Ph.D., to its leadership team as Chief Medical Officer, effective December 15, 2021 (Press release, Kaleido Biosciences, NOV 10, 2021, View Source [SID1234595120]). In her new role, Dr. Long will be responsible for leading the development of Kaleido’s ongoing and future clinical programs, including the development of KB295 and KB109 in ulcerative colitis and chronic obstructive pulmonary disease, respectively.

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"Alison is an exciting addition to our team who will play a critical role as we continue preparations to advance our two lead programs into Phase 2 clinical trials under IND and CTA next year," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Her extensive experience in drug development, which includes leading five clinical programs to regulatory approvals, will be invaluable as Kaleido moves towards advancing our Microbiome Metabolic Therapies into multiple indications. Additionally, she will lead our medical affairs team as well as support translational microbiome research and the development of further new drug development candidates."

"I am honored to be joining this talented team at Kaleido during a pivotal stage of growth for the Company," said Dr. Long. "There are significant opportunities to leverage the immunomodulatory potential of the human microbiome to treat disease. The data thus far has demonstrated Kaleido’s differentiated Microbiome Metabolic Therapy approach is the key to unlocking that potential. I look forward to working with the Kaleido team and applying important learnings from recent clinical readouts to continue this forward momentum and advancement of our clinical development activities."

Dr. Long has almost two decades of experience working in the pharmaceutical and biotechnology industry, and a proven track record developing therapies, which include five successful regulatory approvals over her career. She most recently served as interim Chief Medical Officer and Senior Vice President, Head of Clinical Development at Freeline Therapeutics, and was responsible for the clinical development, clinical operations, medical affairs, and regulatory functions of Freeline’s development programs. Prior to her role at Freeline, she served as Head of Clinical Research and Development at Spark Therapeutics, where she oversaw the scientific and clinical development of all programs, including gene therapy in Huntington’s and Pompe diseases, as well as Inherited Retinal Disorders. Dr. Long has also previously served as Vice President, Clinical Development, Hemophilia at uniQure, Vice President, Head of Clinical at Aegerion Pharmaceuticals, and Medical Director with Biogen, where she focused on the development and subsequent EU approval of Elocta. Prior to her executive positions, Dr. Long was a physician scientist at AFG Biosolutions and The Institute for Ethnomedicine, after spending 12 years as a practicing physician. She received her medical degree from the University of Witwatersrand, and Ph.D. in biodefense from George Mason University.