On September 10, 2024 Xencor, Inc. ("Xencor") (Nasdaq: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, reported that it has commenced an underwritten public offering of shares of its common stock, or, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of common stock (Press release, Xencor, SEP 10, 2024, View Source [SID1234646476]). Xencor also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate number of shares of its common stock (including shares of common stock underlying pre-funded warrants) offered in the public offering at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants, if any, to be sold in the proposed offering are to be sold by Xencor. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Leerink Partners, Raymond James and RBC Capital Markets are acting as joint book-running managers for the proposed offering. Wedbush PacGrow is acting as a co-manager for the offering.

Xencor currently intends to use the net proceeds from the proposed offering for general corporate purposes, which may include research and development, capital expenditures, working capital and general and administrative expenses.

The proposed offering is being made pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-270030), previously filed with the Securities and Exchange Commission (the "SEC") on February 27, 2023 and which automatically became effective upon filing. The securities may be offered only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by email at [email protected]; or from RBC Capital Markets, LLC, Attention: Equity Capital Markets, Brookfield Place, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On September 10, 2024 Delta-fly pharma reported that a phase I/II clinical trial of DFP-10917 in combination with venetoclax (VEN) in patients with acute myeloid leukemia (AML) who have received prior VEN-containing therapy was approved by the U.S. Food and Drug Administration (FDA) on April 8, 2024 ( Delta-Fly Pharma Inc: Notice of Authorization to Conduct Phase I/II Study of DFP-10917 in Combination with Venetoclax | Business Wire ) (Press release, Delta-Fly Pharma, SEP 10, 2024, View Source [SID1234646492]). Today, we are pleased to announce that the first patient has been enrolled at the University of Virginia Hospital based on Investigational Review Board (IRB) approval. The University of Virginia Hospital is the clinical site that has enrolled the most patients in the Phase III study of DFP-10917 as a single agent in patients with relapsed/refractory AML.

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Pharmaceutical companies have already expressed interest in the Phase III study of DFP-10917 as a monotherapy. In addition, many companies, including pharmaceutical giants, have expressed interest in the Phase I/II combination study of DFP-10917 with VEN, due to the large potential market size for the treatment of AML.

VEN alone is not effective against AML, but it becomes effective in combination with azacitidine (DNA methylation inhibitor), which is currently recognized as a standard treatment for AML despite safety concerns. We will therefore provide significantly more combination therapy of VEN and DFP-10917 (G2/M arrest) compared to the current standard treatment for AML. Up to 39 patients will be enrolled in this study. The endpoints are complete remission rate and progression-free survival. After the completion of the Phase I/II study, Delta-Fly Pharma, Inc. will cooperate with a pharmaceutical giant to file a New Drug Application (NDA).

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On September 10, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) and Genesis Therapeutics, Inc. reported that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets (Press release, Gilead Sciences, SEP 10, 2024, View Source [SID1234646477]).

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Genesis is pioneering generative and predictive artificial intelligence (AI) technologies to help create therapeutics for challenging targets. This collaboration will deploy Genesis’ field-leading AI platform, GEMS (Genesis Exploration of Molecular Space), to assist in generating and optimizing molecules for targets selected by Gilead. The companies will collaborate closely on preclinical research activities and Gilead will have exclusive rights for potential clinical development and commercialization of collaboration compounds.

"The use of generative AI in drug development, enabled by people, science and other new technology, has shown potential to accelerate the discovery of molecules for challenging targets," said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. "We look forward to working with Genesis to apply their AI platform to discover and advance novel therapies that may address significant unmet patient needs ."

"Many promising protein targets have a paucity of relevant training data, which makes it difficult to apply off-the-shelf machine learning methods," said Evan Feinberg, Ph.D., founder and CEO of Genesis. "We have designed our physical AI platform to address this issue and enable drug discovery campaigns for difficult targets. Genesis is thrilled to combine our expertise in generative AI and drug discovery with Gilead’s deeply experienced research and development teams, with the shared goal of creating breakthrough therapies for patients."

Terms of the Agreement

Under the terms of the agreement, Genesis will receive an upfront cash payment of $35 million across three targets and Gilead will have an option to nominate additional targets for a predetermined per-target fee. Across programs, Genesis is eligible to receive additional preclinical, development, regulatory, and commercial milestone payments. Genesis is also eligible to receive tiered royalties on net sales should Gilead successfully commercialize products from the collaboration.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Genesis is expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $0.02.

On September 10, 2024 enGene Holdings Inc. (Nasdaq: ENGN, or "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and previously EG-70), is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), reported its financial results for the third quarter ended July 31, 2024 and provided a business update (Press release, enGene, SEP 10, 2024, View Source [SID1234646493]).

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"Detalimogene was designed to be the most practical therapy for patients living with NMIBC and the urologists caring for them," said Ron Cooper, Chief Executive Officer of enGene. "We believe the unmet need for bladder cancer patients is significant and that detalimogene has the potential to offer a highly differentiated profile with a unique combination of clinical activity, tolerability, and ease of use. We look forward to sharing preliminary results from our pivotal LEGEND study later this month."

Anticipated Milestones and Strategic Corporate Updates

Release of preliminary data from LEGEND Cohort 1: The Company expects to release preliminary data from the LEGEND study’s pivotal BCG-unresponsive cohort by the end of September.

Key leadership hires and board additions: In July 2024, enGene announced that Ron Cooper joined the Company as Chief Executive Officer and member of the Board of Directors. The Company also announced the promotion of Dr. Raj Pruthi to Chief Medical Officer.

Third Quarter 2024 Financial Results

Cash and cash equivalents, as of July 31, 2024, were $257.7 million. The Company expects that its existing cash and cash equivalents will fund operating expenses, debt obligations and capital expenditures into 2027.

Three Months ended July 31, 2024

Total operating expenses were $16.8 million for the three months ended July 31, 2024, compared to $6.2 million for the three months ended July 31, 2023. Research and development expenses increased by $7.6 million, mainly due to increasing manufacturing and clinical costs related to our pivotal LEGEND study and headcount costs. General and administrative expenses increased by $2.9 million, primarily driven by headcount costs and other expenses driven by director and officer insurance expense as the Company scales its general and administrative function to support the operation of a public company.

For the three months ended July 31, 2024, net loss attributable to common shareholders was approximately $14.1 million, or $0.32 per share, compared to approximately $6.0 million, or $8.55 per share, for the same period for the three months ended July 31, 2023. The increase in net loss is mainly attributed to the increase in operating expenses partially offset by net interest income earned during the period.

On September 10, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the acceptance of a late-breaking abstract of the mature data from the ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052) clinical trial to be presented as an oral presentation at a plenary session at the International Gynecologic Cancer Society (IGCS) Annual Meeting taking place October 16-18, 2024 in Dublin, Ireland (Press release, Verastem, SEP 10, 2024, View Source [SID1234646478]). The presentation will include updated safety and efficacy data from the RAMP 201 trial evaluating the combination of avutometinib, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, in patients with low-grade serous ovarian cancer (LGSOC), including overall response rate, progression free survival, and duration of response.

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"The robust interim data from the ongoing RAMP 201 clinical trial in LGSOC, announced earlier this year, enabled us to initiate the rolling NDA submission to the FDA," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We look forward to the oral presentation at IGCS of the mature RAMP 201 data and engaging with experts in ovarian cancer as part of the international gynecologic community. We also remain on track to finalize our clinical module and complete our NDA submission in the fourth quarter of this year."

About the Avutometinib and Defactinib Combination

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other MEK-only inhibitors.

Verastem Oncology is currently conducting clinical trials with avutometinib in RAS/MAPK driven tumors as part of its Raf And Mek Program or RAMP. RAMP 301 (NCT06072781) is an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib, a selective FAK inhibitor, versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC). RAMP 201 (NCT04625270) is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and enrollment has been completed for the entire RAMP 201 trial, including regimen selection and expansion of the go forward regimen.

Verastem has initiated a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the investigational combination of avutometinib and defactinib in adults with recurrent LGSOC and expects to complete its NDA submission in the second half of 2024 with a potential FDA decision in the first half of 2025. The FDA granted Breakthrough Therapy Designation of the investigational combination of avutometinib and defactinib for the treatment of all patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC.

Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) in combination with avutometinib and defactinib and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively. The RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to avutometinib and defactinib combination for the treatment of pancreatic cancer.