December 6, 2021 MaaT Pharma S.A. ("MaaT Pharma" or the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome[1]-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported the partial exercise of the Over-Allotment Option in the context of the Company’s initial public offering on the regulated market of Euronext Paris (code ISIN : FR0012634822- ticker: MAAT) (Press release, MaaT Pharma, DEC 6, 2021, View Source [SID1234596486]).

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On December 3, 2021, Joint Global Coordinator and Joint Bookrunner, Portzamparc BNP Paribas, acting as stabilization agent, partially exercised the Over-Allotment Option resulting in the issuance of 314,055 additional new shares (out of a maximum of 349,999 shares) for a total amount of c. €4.2m, at the offering price of €13.50 per share.

As a result, the total number of MaaT Pharma shares offered in the context of the Company’s IPO amounts to 2,647,388 shares, thus increasing the size of the offering to c. €35.7m after the settlement-delivery of the additional new shares scheduled on December 7, 2021.

Following the settlement-delivery of the additional new shares, MaaT Pharma’s share capital will consist of 9,828,835 shares.

In addition, in accordance with the provisions of the Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and with Article 6 of the EU Delegated Regulation 2016/1052 of March 8, 2016, regarding conditions applicable to share buy-back programmes and stabilisation measures, Portzamparc BNP Paribas, acting as stabilization agent, declares having carried out the following stabilization operations on the Company’s shares:

The stabilization period began on November 8, 2021 and ended on December 3, 2021. The final stabilization operation was carried out on December 3, 2021. The stabilization transactions were carried out under the following conditions:

Trade date Intermediary Buy/Sell Daily total of shares Weighted average price (in EUR) Lowest / Highest price (in EUR) Aggregate amount (in EUR) Market
08/11/2021 Portzamparc Buy 6 453 13.5 13.5 87 115.50 Euronext Paris
09/11/2021 Portzamparc Buy 250 13.5 13.5 3 375.00 Euronext Paris
10/11/2021 Portzamparc Buy 820 13.5 13.5 11 070.00 Euronext Paris
11/11/2021 Portzamparc Buy 1 111 13.5 13.5 14 998.50 Euronext Paris
12/11/2021 Portzamparc Buy 2 520 13.5 13.5 34 020.00 Euronext Paris
15/11/2021 Portzamparc Buy 5 050 13.3812 13.3 / 13.5 67 575.06 Euronext Paris
16/11/2021 Portzamparc Buy 904 13.3272 13.2 / 13.5 12 047.79 Euronext Paris
17/11/2021 Portzamparc Buy 1 550 13.0388 12.6 / 13.5 20 210.14 Euronext Paris
18/11/2021 Portzamparc Buy 2 722 13.1242 12.7 /13.5 35 724.07 Euronext Paris
19/11/2021 Portzamparc Buy 295 13.4486 13.4 / 13.5 3 967.34 Euronext Paris
22/11/2021 Portzamparc Buy 0 – Euronext Paris
23/11/2021 Portzamparc Buy 208 13.3885 13.35 / 13.45 2 784.81 Euronext Paris
24/11/2021 Portzamparc Buy 90 13.3222 13.1 / 13.4 1 199.00 Euronext Paris
25/11/2021 Portzamparc Buy 340 13.2824 13.1 / 13.3 4 516.02 Euronext Paris
26/11/2021 Portzamparc Buy 582 12.9768 12.85 / 13.2 7 552.50 Euronext Paris
29/11/2021 Portzamparc Buy 725 12.413 12.3 / 12.8 8 999.43 Euronext Paris
30/11/2021 Portzamparc Buy 2381 11.9515 11.3 / 12.8 28 456.52 Euronext Paris
01/12/2021 Portzamparc Buy 513 12.9397 12.85 / 12.95 6 638.07 Euronext Paris
02/12/2021 Portzamparc Buy 200 12.77 12.6 / 13 2 554.00 Euronext Paris
03/12/2021 Portzamparc Buy 9230 13.2248 12.8 / 13.5 122 064.90 Euronext Paris

Share Ownership

Following the IPO and the partial exercise of the Over-Allotment Option, the share ownership and voting rights is as follows (to the Company’s best knowledge) :

After the exercise of the Over-Allotment Option
Shareholders Total number of shares % of share capital and voting rights
Hervé Affagard 133 848 1.36%
Total legal representatives 133 848 1.36%
Fonds Seventure 2 345 236 23.86%
Crédit Mutuel Innovation SAS 1 412 364 14.37%
Biocodex SAS 977 905 9.95%
Symbiosis LLC 2 027 702 20.63%
FPCI Fonds PSIM 1 177 439 11.98%
Other investors 368 883 3.75%
Total historical shareholders 8 309 529 84.54%
Employees and consultants 248 838 2.53%
Treasury shares 0 0.00%
Floating 1 136 620 11.56%
TOTAL 9 828 835 100.00%

Availability of the Prospectus

The Registration Document of the Company approved by the AMF on October 1, 2021, under the number I.21-057, the supplement of the Registration Document approved by the AMF on October 14, 2021, under the number I.21-061, the Security Notes and the summary of the Prospectus are available free of charge and on simple request from MaaT Pharma and on the following websites: amf-france.org and investir.maatpharma.com. The approval of the Prospectus should not be considered as an endorsement on the securities offered or admitted to trading on the regulated market of Euronext Paris.

[1] The microbiome (also called intestinal flora) refers to all the microorganisms (bacteria, archaea, yeasts, viruses, etc.) naturally present in the intestine. It plays a major role in the education and modulation of the immune system and in the metabolism.

On December 6, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported positive interim data from its ongoing Phase 1/2 GoCAR-T clinical trials, including a confirmed partial response (PR) in the first cohort of mCRPC patients treated in the clinical trial for BPX-601 (Press release, Bellicum Pharmaceuticals, DEC 6, 2021, View Source [SID1234596502]). Bellicum has also entered into an agreement for a $35 million private placement of equity securities with two biotechnology specialist investment funds. Proceeds from the financing will be used to support ongoing clinical development of BPX-601 and BPX-603.

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"We are highly encouraged by the observation of anti-tumor activity of BPX-601 in the first mCRPC cohort, particularly in this heavily pre-treated patient population with limited therapeutic options," said Rick Fair, President and Chief Executive Officer of Bellicum. "The additional capital we raised through this private placement will support our ongoing clinical development of BPX-601 and BPX-603 to further pursue this early efficacy signal."

Clinical Trial Updates

BPX-601 GoCAR-T in Metastatic Castration-Resistant Prostate Cancer
Cell dose escalation and optimization of the lymphodepletion regimen was completed in the Phase 1/2 clinical trial of BPX-601 in metastatic pancreatic cancer patients. Earlier this year, enrollment was initiated in previously-treated mCRPC patients at the previously-cleared dose level.

In the first three-patient cohort of mCRPC treated at 5×106 cells/kg BPX-601 followed by single-dose rimiducid:

No dose-limiting toxicities were observed. Adverse events were comparable to those previously seen with BPX-601 and rimiducid in metastatic pancreatic cancer and typical of other cell therapy regimens.
A confirmed partial response was observed in one patient by RECIST v1.1 criteria on CT scan, accompanied by substantial reduction in PSA in response to treatment with BPX-601 and rimiducid.
Enrollment is ongoing in the second dose cohort in mCRPC of 5×106 cells/kg followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022.

BPX-603 Dual-Switch GoCAR-T in HER2+ Solid Tumors
Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is Bellicum’s first dual-switch GoCAR-T product candidate incorporating Bellicum’s iMC activation and CaspaCIDe safety switch technologies, which in tandem may serve to enhance cell proliferation, persistence, and anti-tumor effect while also enabling effective management of adverse events.

In the first patients treated in this trial at dose level 1 of 0.1×106 cells/kg BPX-603 alone or followed by weekly rimiducid:

No dose-limiting toxicities were observed.
Serious adverse events reported were pleural effusion and pneumonia. Neither was determined to be related to study drug.
Other Grade 3+ treatment-emergent adverse events reported were neutropenia, leukopenia, and anemia.
No CRS or ICANS events were reported.
Limited cell engraftment and expansion were observed.
Enrollment is ongoing at dose level 2 of 1×106 cells/kg alone or followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022.

Stated Charity Scripture, PharmD, Chief Development Officer of Bellicum, "The early clinical activity we have observed with BPX-601 in mCRPC and the manageable safety profiles observed across both studies are highly encouraging. Given the very low starting cell dose in the BPX-603 trial, the lack of clinical efficacy at dose level 1 was in line with our expectations. I am thrilled to be re-joining Bellicum in a full-time capacity at such an exciting time in our programs’ development. We look forward to continued dose escalation to more fully evaluate the safety and potential efficacy of these product candidates."

Private Placement Completed

Bellicum will issue, in the private placement, pre-funded warrants to purchase up to 20,559,210 shares of common stock and accompanying warrants to purchase up to 2,055,920 shares of common stock. Each pre-funded warrant to purchase common stock is being sold together with one warrant to purchase one-tenth of one share of common stock at a combined unit price of $1.7024. The common stock warrants will be immediately exercisable at an exercise price of $1.69 per share of common stock and will expire seven years from the date of issuance. Each pre-funded warrant will have an exercise price of $0.0001 per share and will be exercisable immediately.

The aggregate offering size, before deducting placement agent commissions and other offering expenses, is expected to be approximately $35.0 million, excluding any proceeds that may be received upon exercise of the common warrants. Bellicum anticipates using the net proceeds from the offering, together with its existing capital resources, to fund ongoing and planned BPX-601 and BPX-603 clinical trials, and for general corporate purposes, including research and development and to fund working capital.

In conjunction with the equity financing announced today, the holders of the option to purchase securities associated with Bellicum’s August 2019 Private Placement have waived their rights, in full, to exercise their right to purchase Series 2 preferred stock and associated warrants, and Series 3 preferred stock and associated warrants, respectively.

Mr. Fair added, "We are pleased to have the support provided in the financing announced today. The waiver of the rights to exercise the Series 2 and Series 3 options is also a positive step in the simplification of our capital structure."

The private placement is expected to close on December 7, 2021. A Current Report on Form 8-K containing more detailed information regarding the financing will be filed with the Securities and Exchange Commission.

MTS Securities, LLC, an affiliate of MTS Health Partners, L.P., is acting as exclusive placement agent in the financing.

The Securities issued or to be issued to the purchasers in the Offering announced today, subject to the closing, were, or will be issued, as applicable, pursuant to an exemption from registration under the Securities Act of 1933 (the "Securities Act"). The securities have not been and will not be registered under the Securities Act or any state or other jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdiction’s securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Securities or any other securities, nor shall there be any offer, solicitation or sale of the Securities or any other securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.

On December 6, 2021 bioAffinity Vice President of Research David Elzi, Ph.D., reported that it will discuss how bioAffinity successfully uses RNA interference to knock down expression of two genes that results in killing cancer cells with little or no effect on normal cells at Cell Bio, a joint meeting of the American Society for Cell Biology (ASCB) and European Molecular Biology Organization (EMBO), held virtually Dec. 6-11, 2021 (Press release, BioAffinity Technologies, DEC 6, 2021, View Source [SID1234596519]).

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"bioAffinity’s research expands the use of RNAs in the fight against cancer."

Dr. Elzi will present a poster titled "Silencing of two LDL-family receptors, CD320 and LRP2, results in cancer cell toxicity, while normal cells seem unaffected" and will be available for questions from meeting participants on Monday, Dec. 6, at 4 p.m. CST. A video presentation by Dr. Elzi will be available for viewing throughout the conference.

"bioAffinity’s discovery of a fundamental vulnerability of cancer opens the way to new therapies that kill cancer without harm to normal tissue," Dr. Elzi said. "In particular, bioAffinity’s research shows how the Company has designed and used siRNAs to kill multiple cancers at the cellular level, including prostate, lung, breast, brain and skin cancers, without harm to normal cells."

"Recent scientific discoveries related to RNAs and their application in medicine have been astonishing, leading to life-saving therapies including the use of mRNA vaccines to eradicate the SARS-Cov-2 virus causing the COVID-19 pandemic," said bioAffinity President and CEO Maria Zannes. "bioAffinity’s research expands the use of RNAs in the fight against cancer."

Cell Bio, the joint meeting of ASCB and EMBO, showcases the diverse global community engaged in cell biology by focusing on scientific discovery, research, education, professional development, and diversity and inclusion.

On December 6, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported dosing of the first patient in a new Phase 2 study evaluating oral selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a monotherapy versus physician’s choice in patients with myelofibrosis (MF) previously treated with a JAK 1/2 inhibitor (XPORT-MF-035; NCT04562870) (Press release, Karyopharm, DEC 6, 2021, View Source [SID1234596468]).

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This randomized, multi-center, open-label Phase 2 study is designed to evaluate the safety and efficacy of selinexor monotherapy and is expected to enroll up to 112 patients, who will be randomized 1:1 to receive either low dose, once-weekly oral selinexor or physician’s standard treatment choice (per clinical practice). The primary endpoint of the study is the percentage of patients with spleen volume reduction (SVR) of ≥35% from baseline as assessed by an Independent Review Committee. The first patient has been dosed at the Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola, Italy, by the Lead Principal Investigator, Dr. Alessandro Lucchesi, Sr. Consultant and Research Hematologist under the guide of Professor Giovanni Martinelli, the Chief Scientific Director.

Initiation of this Phase 2 study follows encouraging preliminary data from the Phase 2 ESSENTIAL trial, which will be highlighted in an oral presentation given by Srinivas Tantravahi, MBBS, MRCP, University of Utah Hospital, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Annual and Exposition on Saturday, December 11, 2021 at 1:00 p.m. ET. In the investigator-sponsored ESSENTIAL study (NCT03627403), which is evaluating selinexor in patients with MF previously treated with a JAK inhibitor, preliminary data showed that 33% of patients that received at least 24 weeks of selinexor treatment achieved ≥35% SVR. The responses were durable, and the first patient remained on study for more than two years. Patients had a median duration of 22 months of prior JAK inhibitor therapy with 11 out of 12 patients having disease refractory to ruxolitinib.

"As part of our strategic imperatives and pipeline priorities, we remain focused on diseases with the highest unmet needs and greatest potential to make an impact in patient outcomes," said Sharon Shacham, PhD, MBA, Co-Founder and Chief Scientific Officer of Karyopharm. "Myelofibrosis is a serious and life–threatening blood cancer defined by stem cell–derived clonal myeloproliferation, bone marrow fibrosis, anemia, enlarged spleen, low blood counts and short survival. With JAK inhibitors being the only class of drugs approved for this disease, there remains limited therapeutic options for patients who either progress following treatment with a JAK inhibitor or are intolerant. We believe selinexor has the potential to hold an important place in the myelofibrosis treatment paradigm and with dosing of the first patient underway, we plan to provide updates as the study progresses."

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B–cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony–stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.

On December 6, 2021 ITI reported that it will be attending SITC (Free SITC Whitepaper) 2022 in Boston, MA (Press release, Immunomic Therapeutics, DEC 6, 2021, View Source [SID1234596487])

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The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting & Pre-Conference Programs brings together stakeholders across the cancer immunotherapy field to advance the science, discover breakthroughs and educate the world on cancer immunotherapy.

As the largest conference solely focused on cancer immunotherapy, the Annual Meeting & Pre-Conference Programs provides international leaders from academia, regulatory and government agencies, as well as industry representatives with a multidisciplinary educational and interactive environment focused on improving outcomes for all cancer patients.