On November 12, 2021 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, reported that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D. will present at the Jefferies Virtual London Healthcare Conference (Press release, Keros Therapeutics, NOV 12, 2021, View Source [SID1234595398]).

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The presentation will be available on Thursday, November 18 starting at 3:00 a.m. ET at View Source and archived in the Investors section of the Keros website at View Source A replay will be available for 90 days following the conclusion of the event.

On November 12, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that pre-clinical data from its proprietary, multi-specific NK cell engager platform, ANKETTM, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in collaboration with partner, Sanofi (poster #852) (Press release, Innate Pharma, NOV 12, 2021, View Source [SID1234595397]).

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Specifically, the companies will share new data on IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using Innate’s proprietary multi-specific antibody format1 that targets CD123 on acute myeloid leukemia (AML) cells and now co-engages NKp46 and CD16a on NK cells.

CD123 is an attractive target as it is expressed at high levels in the majority of AML patients2. However, overcoming resistance to antibody-dependent cellular cytotoxicity (ADCC) has been a challenge.

In pre-clinical studies, IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells.

In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.

"There is a strong need to develop effective therapies to treat acute myeloid leukemia, the most common acute leukemia in adults," said Pr. Eric Vivier, Ph.D., DVM, Chief Scientific Officer at Innate Pharma. "We’re pleased to present pre-clinical data on IPH6101/SAR443579 that shows antitumor activity against AML, and more specifically, the potential of engaging NK cells through NKp46 and CD16 via our ANKETTM technology. We look forward to seeing Sanofi dose the first patient in the clinic with this molecule soon."

Innate will also present a second ANKETTM poster (poster #851) at SITC (Free SITC Whitepaper) entitled, "Harnessing Innate Immunity in Cancer Therapies: the Example of Natural Killer Cell Engagers." The data will highlight the induction of a unique NK cell activation pathway by its tetra-specific ANKETTM molecule. The abstract can be accessed here.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKETTM molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and an interleukin-2 receptor (via an IL-2 variant, IL-2v) via a single molecule. This leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In pre-clinical studies, Innate’s tri-1 and tetra-specific ANKETTM technologies promote potent NK cell activation, cytotoxicity and efficient control of tumor growth in pre-clinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6101/SAR443579:

In the first research program of the Sanofi collaboration, IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using Innate’s proprietary multi-specific antibody format1, has shown antitumor activity in pre-clinical models, including supportive pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies leading to its selection as a drug candidate for development.

About the Innate-Sanofi agreement:

The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the license agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

On November 12, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in the Stifel 2021 Virtual Healthcare Conference that will be held November 15th – 17, 2021 (Press release, Hookipa Biotech, NOV 12, 2021, View Source [SID1234595395]).

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Corporate Presentation: Monday, November 15, 2021 at 10:40 AM EST
Webcast Link: View Source

The webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On November 12, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, will present a company overview at the Stifel 2021 Virtual Healthcare Conference on Tuesday, November 16, 2021 at 2:40 p.m. ET (Press release, Geron, NOV 12, 2021, View Source [SID1234595393]).

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A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

On November 12, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the third quarter ended Sept. 30, 2021 (Press release, Forma Therapeutics, NOV 12, 2021, View Source [SID1234595392]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"During the third quarter, we made significant progress pursuing our commitment not only to serving the needs of people living with sickle cell disease with our lead program, etavopivat, but also targeting prostate cancer with initial FT-7051 results, in addition to new olutasidenib clinical data accepted for presentation at ASH (Free ASH Whitepaper) next month," said Frank Lee, president and chief executive officer of Forma.

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

Enrollment in etavopivat open label extension completed. Full enrollment of 15 patients in the open label extension (OLE) was completed during the quarter. Patients in the OLE are being administered etavopivat 400 mg once daily for up to 12 weeks and assessed for hematologic and hemolytic response, and improvement in markers of red blood cell (RBC) health, including oxygenation and deformability, as well as systemic biomarkers of SCD.
CPB/p300 Program in Prostate Cancer:

Initial FT-7051 Phase 1 clinical trial results presented at NCI/AACR/EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Preliminary results included data as of Sept. 1, 2021, from eight men enrolled in the trial. FT-7051 was administered in 28-day cycles, with 21 days of dosing followed by seven days of no dosing. The initial pharmacokinetic (PK) analysis of FT-7051 documented rapid absorption, with drug concentrations that approached the predicted efficacious dose based on estimates from preclinical animal models. Skin biopsies of the men participating in the study demonstrated a reduction in H3K27AC, a marker of activity in the CBP/p300 pathway. The majority of the treatment-emergent adverse events (TEAEs) were mild or moderate, at Grade 2 or lower, with no events leading to treatment discontinuation. The first evaluable patient completing more than 90 days of treatment demonstrated an ongoing response of >80% decline in prostate-specific antigen (PSA80) from baseline with stable disease.
Corporate

Upcoming investor conference participation. Forma will participate in the Jefferies London Healthcare Conference taking place Nov. 16-19. The pre-recorded presentation will be available Nov. 18 at 8:00am Greenwich Mean Time (GMT) in the "News & Investors" section of Forma’s website at www.FormaTherapeutics.com.
Investor briefing to discuss results presented at ASH (Free ASH Whitepaper). Forma will hold an investor briefing Dec. 13 at 8:00 am Eastern Time (ET). The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.
Upcoming Milestones

Updated Phase 1 OLE trial results for etavopivat in SCD to be presented at ASH (Free ASH Whitepaper) Dec. 11-14. Results to be presented will include 15 patients being administered etavopivat 400mg once daily for up to 12 weeks and assessed for hematologic and hemolytic response, and improvements in markers of RBC health including oxygenation and deformability, and systemic markers of SCD.
Patient enrollment continues in Phase 2/3 registrational trial, the Hibiscus Study. The Hibiscus study includes two co-primary end points (hemoglobin and vaso-occlusive crises) that support the traditional approval pathway. Based on ongoing feedback from the FDA, although accelerated approval is still an available regulatory pathway, Forma will need to provide additional information to support hemoglobin response as a surrogate endpoint eligible for accelerated approval for etavopivat. The company plans to continue to seek accelerated approval for etavopivat utilizing hemoglobin response rates as a surrogate endpoint by providing additional data to support that hemoglobin response rates predict for a clinical benefit.
Additional etavopivat trials to begin late 2021/1H:22. Forma plans to initiate a Phase 2 trial in transfusion dependent SCD and both transfusion dependent and independent thalassemia prior to the end of the year, and a pediatric SCD trial beginning in the first half of 2022.
Olutasidenib results in R/R AML to be presented at ASH (Free ASH Whitepaper) Dec. 11-14. Results from the Phase 2 trial will show the impact of the combination of olutasidenib and azacitidine on rates of remission and transfusion independence in patients with mutant isocitrate dehydrogenase 1 (mIDH1) AML. Analyses of safety and efficacy will be presented at the ASH (Free ASH Whitepaper) annual meeting.
Additional FT-7051 clinical results in mCRPC to be presented in 2022. Men with mCRPC continue to be enrolled in the dose escalation portion of the Phase 1 trial. Forma plans to present updated results from the trial at a scientific conference in mid-2022.
Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials or and the ability to access sites participating in clinical trials.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $531.8 million as of Sept. 30, 2021, as compared to $645.6 million as of Dec. 31, 2020. Current cash runway is projected through the third quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses were $30.7 million for the quarter ended Sept. 30, 2021, compared to $24.8 million for the quarter ended Sept. 30, 2020. The increase was primarily attributable to an increase in research and development staff to support advancement of etavopivat and other programs, an increase in equity-based compensation, and increases in external predevelopment and preclinical programs, conduct of the Phase II/III etavopivat trial in SCD patients and study start-up costs related to a trial in thalassemia/transfusion dependence.
General and Administrative (G&A) Expenses: G&A expenses were $12.7 million for the quarter ended Sept. 30, 2021, compared to $7.5 million for the quarter ended Sept. 30, 2020. The increase was primarily attributable to equity-based compensation, costs due to executive and staff hiring, legal, consulting, and other professional fee expenses, and other related general and administrative costs.
Net Loss: Net loss was $43.3 million for the quarter ended Sept. 30, 2021, compared to net loss of $27.6 million for the quarter ended Sept. 30, 2020.
Forma will conduct a conference call and webcast Nov. 12 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss third quarter 2021 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 6662686.

The live webcast will be available in the "News & Investors" section of Forma’s website www.formatherapeutics.com.